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positivelyaware.com




                      September+OCTOBER 2012




                      CURE NEWS FROM
                      AIDS 2012
                      facing up
                      to lipoatrophy



                      POSITIVE
                      Women
                      Making decisions, creating
                      policy, and improving lives
ABOUT PREZISTA               ®



PREZISTA® (darunavir) is a prescription medicine. It is one treatment option         Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat
in the class of HIV (human immunodeficiency virus) medicines known as                 pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/
protease inhibitors.                                                                 ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™),
PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®),         or telaprevir (Incivek™)
in combination with other HIV medicines for the treatment of HIV infection        • Before taking PREZISTA, tell your healthcare professional if you are
                                                                                                              ®

in adults. PREZISTA® should also be taken with food.                                taking sildenafil (Viagra, Revatio®), vardenafil (Levitra,® Staxyn®),
                                                                                                              ®


   • The use of other medicines active against HIV in combination with              tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin
     PREZISTA®/ritonavir (Norvir ®) may increase your ability to fight HIV.          (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,®
     Your healthcare professional will work with you to find the right               Col-Probenecid®). Tell your healthcare professional if you are taking
     combination of HIV medicines                                                   estrogen-based contraceptives (birth control). PREZISTA® might reduce
                                                                                    the effectiveness of estrogen-based contraceptives. You must take
   • It is important that you remain under the care of your healthcare              additional precautions for birth control, such as condoms
     professional during treatment with PREZISTA®
                                                                               This is not a complete list of medicines. Be sure to tell your
PREZISTA® does not cure HIV infection or AIDS and you may                      healthcare professional about all the medicines you are taking or
continue to experience illnesses associated with HIV-1 infection,              plan to take, including prescription and nonprescription medicines,
including opportunistic infections. You should remain under the                vitamins, and herbal supplements.
care of a doctor when using PREZISTA.  ®
                                                                               What should I tell my doctor before I take PREZISTA®?
Please read Important Safety Information below, and talk to your
healthcare professional to learn if PREZISTA® is right for you.                   • Before taking PREZISTA, tell your healthcare professional if you have
                                                                                                             ®

                                                                                    any medical conditions, including liver problems (including hepatitis B
                                                                                    or C), allergy to sulfa medicines, diabetes, or hemophilia
IMPORTANT SAFETY INFORMATION
                                                                                  • Tell your healthcare professional if you are pregnant or planning
What is the most important information I should know
                                                                                    to become pregnant, or are breastfeeding
about PREZISTA®?
                                                                                     — The effects of PREZISTA® on pregnant women or their unborn
   • PREZISTA® can interact with other medicines and cause
                                                                                       babies are not known. You and your healthcare professional will
     serious side effects. See “Who should not take PREZISTA®?”
                                                                                       need to decide if taking PREZISTA® is right for you
   • PREZISTA® may cause liver problems. Some people taking
                                                                                     — Do not breastfeed. It is not known if PREZISTA® can be passed
     PREZISTA, together with Norvir ® (ritonavir), have developed liver
              ®
                                                                                       to your baby in your breast milk and whether it could harm your
     problems which may be life-threatening. Your healthcare professional
                                                                                       baby. Also, mothers with HIV should not breastfeed because HIV
     should do blood tests before and during your combination treatment
                                                                                       can be passed to your baby in the breast milk
     with PREZISTA. If you have chronic hepatitis B or C infection, your
                   ®

     healthcare professional should check your blood tests more often          What are the possible side effects of PREZISTA®?
     because you have an increased chance of developing liver problems            • High blood sugar, diabetes or worsening of diabetes, and increased
   • Tell your healthcare professional if you have any of these signs and           bleeding in people with hemophilia have been reported in patients
     symptoms of liver problems: dark (tea-colored) urine, yellowing                taking protease inhibitor medicines, including PREZISTA®
     of your skin or whites of your eyes, pale-colored stools (bowel              • Changes in body fat have been seen in some patients taking HIV
     movements), nausea, vomiting, pain or tenderness on your right                 medicines, including PREZISTA. The cause and long-term health
                                                                                                                    ®
     side below your ribs, or loss of appetite                                      effects of these conditions are not known at this time
   • PREZISTA® may cause a severe or life-threatening skin                        • Changes in your immune system can happen when you start taking
     reaction or rash. Sometimes these skin reactions and skin rashes               HIV medicines. Your immune system may get stronger and begin
     can become severe and require treatment in a hospital. You should              to fight infections that have been hidden
     call your healthcare professional immediately if you develop a rash.
     However, stop taking PREZISTA® and ritonavir combination treatment           • The most common side effects related to taking PREZISTA® include
     and call your healthcare professional immediately if you develop any           diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is
     skin changes with these symptoms: fever, tiredness, muscle or joint            not a complete list of all possible side effects. If you experience these
     pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed          or other side effects, talk to your healthcare professional. Do not stop
     eyes, like “pink eye.” Rash occurred more often in patients taking             taking PREZISTA® or any other medicines without first talking to your
     PREZISTA® and raltegravir together than with either drug separately,           healthcare professional
     but was generally mild                                                    You are encouraged to report negative side effects of
Who should not take PREZISTA®?                                                 prescription drugs to the FDA. Visit www.fda.gov/medwatch,
                                                                               or call 1-800-FDA-1088.
   • Do not take PREZISTA® if you are taking the following
                                                                                                                                                              28PRZDTC0288R8




     medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,    ®      Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI)
     Embolex, Migranal ), ergonovine, ergotamine (Cafergot, Ergomar ®),
             ®           ®                                     ®               for additional information on precautionary measures.
     methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral          Please read accompanying Patient Information for PREZISTA®
     midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort    and discuss any questions you have with your doctor.
     (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®),
     simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
IS THE PREZISTA
                                                                                       ®




 EXPERIENCE
   RIGHT FOR YOU?
  There is no other person in the world who is exactly like you. And
  no HIV treatments are exactly alike, either. That’s why you should
    ask your healthcare professional about PREZISTA® (darunavir).

    Once-Daily PREZISTA® taken with ritonavir and in combination
        with other HIV medications can help lower your viral load
             and keep your HIV under control over the long term.


      In a clinical study* of almost 4 years (192 weeks), 7 out of 10
                 adults who had never taken HIV medications before
               maintained undetectable† viral loads with PREZISTA®
                                         plus ritonavir and Truvada.®


      Find out if the PREZISTA® EXPERIENCE is right for you.
           Ask your healthcare professional and learn more
                                  at DiscoverPREZISTA.com


                     Please read the Important Safety Information and
                               Patient Information on adjacent pages.




                       Snap a quick pic of our logo to show your
                        doctor and get the conversation started.

          *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg
                         once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346).
                   †Undetectable was defined as a viral load of less than 50 copies per mL.

                         Registered trademarks are the property of their respective owners.


       Janssen Therapeutics,
       Division of Janssen Products, LP

      © Janssen Therapeutics, Division of Janssen Products, LP
                                  2012 06/12 28PRZ12036G
IMPORTANT PATIENT INFORMATION
                            PREZISTA (pre-ZIS-ta)                                 •	 	 o	 not	 have	 any	 kind	 of	 sex	 without	 protection.	 Always practice
                                                                                     D
                                  (darunavir)                                        safe sex by using a latex or polyurethane condom to lower the
                               Oral Suspension                                       chance of sexual contact with semen, vaginal secretions, or blood.
                            PREZISTA (pre-ZIS-ta)                                 Ask your healthcare provider if you have any questions on how to
                                  (darunavir)                                     prevent passing HIV to other people.
                                    Tablets                                       Who should not take PREZISTA?
Read this Patient Information before you start taking PREZISTA and                Do	not	take	PREZISTA	with any of the following medicines:
each time you get a refill. There may be new information. This                    •	 	 lfuzosin (Uroxatral®)
                                                                                     a
information does not take the place of talking to your healthcare                 •	 	 ihydroergotamine	(D.H.E.	45®, Embolex®, Migranal®), ergonovine,
                                                                                     d
provider about your medical condition or your treatment.                             ergotamine (Cafergot®, Ergomar®) methylergonovine
Also read the Patient Information leaflet for NORVIR® (ritonavir).                •	 	 isapride
                                                                                     c
What is the most important information I should                                   •	 	 imozide (Orap®)
                                                                                     p
know about PREZISTA?                                                              •	 	 ral midazolam, triazolam (Halcion®)
                                                                                     o
•	 	 REZISTA can interact with other medicines and cause serious
    P                                                                             •	 	 he herbal supplement St. John’s Wort (Hypericum perforatum)
                                                                                     t
    side effects. It is important to know the medicines that should not be        •	 	 he cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®,
                                                                                     t
    taken with PREZISTA. See the section “Who should not take                        Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®)
    PREZISTA?”                                                                    •	 	 ifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®)
                                                                                     r
•	 	 REZISTA may cause liver problems. Some people taking PREZISTA
    P                                                                             •	 	 ildenafil (Revatio®) only when used for the treatment of pulmonary
                                                                                     s
    in combination with NORVIR® (ritonavir) have developed liver                     arterial hypertension.
    problems which may be life-threatening. Your healthcare provider              Serious problems can happen if you take any of these medicines with
    should do blood tests before and during your combination treatment            PREZISTA.
    with PREZISTA. If you have chronic hepatitis B or C infection, your
    healthcare provider should check your blood tests more often                  What should I tell my doctor before I take PREZISTA?
    because you have an increased chance of developing liver problems.            PREZISTA may not be right for you. Before taking PREZISTA, tell your
•	 	 ell	your	healthcare	provider	if	you	have	any	of	the	below	signs	and	
    T                                                                             healthcare provider if you:
    symptoms of liver problems.                                                   •	 	 ave	liver	problems,	including	hepatitis	B	or	hepatitis	C
                                                                                     h
	 •	 	 ark	(tea	colored)	urine
       D                                                                          •	 	 re	allergic	to	sulfa	medicines
                                                                                     a
	 •	 	 ellowing	of	your	skin	or	whites	of	your	eyes
       y                                                                          •	 	 ave	high	blood	sugar	(diabetes)
                                                                                     h
	 •	 	 ale	colored	stools	(bowel	movements)
       p                                                                          •	 	 ave	hemophilia	
                                                                                     h
	 •	 	 ausea
       n                                                                          •	 	 re	 pregnant	 or	 planning	 to	 become	 pregnant.	 It	 is	 not	 known	 if	
                                                                                     a
	 •	 	 omiting
       v                                                                             PREZISTA will harm your unborn baby.
	 •	 	 ain	or	tenderness	on	your	right	side	below	your	ribs
       p                                                                             Pregnancy Registry: You and your healthcare provider will need to
	 •	 	oss	of	appetite
       l                                                                             decide if taking PREZISTA is right for you. If you take PREZISTA
                                                                                     while you are pregnant, talk to your healthcare provider about how
PREZISTA may cause severe or life-threatening skin reactions or rash.                you can be included in the Antiretroviral Pregnancy Registry. The
Sometimes these skin reactions and skin rashes can become severe                     purpose of the registry is follow the health of you and your baby.
and require treatment in a hospital. You should call your healthcare              •	 	 re	 breastfeeding	 or	 plan	 to	 breastfeed.	 Do	 not	 breastfeed. We do
                                                                                     a
provider immediately if you develop a rash. However, stop taking                     not know if PREZISTA can be passed to your baby in your breast
PREZISTA and ritonavir combination treatment and call your healthcare                milk and whether it could harm your baby. Also, mothers with HIV-1
provider immediately if you develop any skin changes with symptoms                   should not breastfeed because HIV-1 can be passed to the baby in
below:                                                                               the breast milk.
•	 fever
    	
                                                                                  Tell your healthcare provider about all the medicines you take including
•	 	 iredness
    t                                                                             prescription and nonprescription medicines, vitamins, and herbal
•	 	 uscle	or	joint	pain
    m                                                                             supplements. Using PREZISTA and certain other medicines may affect
•	 	 listers	or	skin	lesions
    b                                                                             each other causing serious side effects. PREZISTA may affect the way
•	 mouth	sores	or	ulcers
    	                                                                             other medicines work and other medicines may affect how PREZISTA
•	 	 ed	or	inflamed	eyes,	like	“pink	eye”	(conjunctivitis)
    r                                                                             works.
Rash occurred more often in patients taking PREZISTA and raltegravir              Especially tell your healthcare provider if you take:
together than with either drug separately, but was generally mild.                •	 	 edicine	to	treat	HIV
                                                                                     m
See “What are the possible side effects of PREZISTA?” for more                    •	 	 strogen-based	 contraceptives	 (birth	 control).	 PREZISTA	 might	
                                                                                     e
information about side effects.                                                      reduce the effectiveness of estrogen-based contraceptives. You
What is PREZISTA?                                                                    must take additional precautions for birth control such as a condom.
PREZISTA is a prescription anti-HIV medicine used with ritonavir and              •	 	 edicine	 for	 your	 heart	 such	 as	 bepridil,	 lidocaine	 (Xylocaine	
                                                                                     m
other anti-HIV medicines to treat adults with human immunodeficiency                 Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®,
virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a            Cardarone®), digoxin (Lanoxin ®), flecainide (Tambocor ®),
protease	inhibitor.	HIV	is	the	virus	that	causes	AIDS	(Acquired	Immune	              propafenone (Rythmol®)
Deficiency	Syndrome).                                                             •	 	 arfarin	(Coumadin®, Jantoven®)
                                                                                     w
                                                                                  •	 	 edicine	for	seizures	such	as	carbamazepine	(Carbatrol®, Equetro®,
                                                                                     m
When used with other HIV medicines, PREZISTA may help to reduce                      Tegretol®, Epitol®),	phenobarbital,	phenytoin	(Dilantin®, Phenytek®)
the	 amount	 of	 HIV	 in	 your	 blood	 (called	 “viral	 load”).	 PREZISTA	 may	
also	help	to	increase	the	number	of	white	blood	cells	called	CD4	(T)	cell	        •	 	 edicine	 for	 depression	 such	 as	 trazadone	 and	 desipramine	
                                                                                     m
which help fight off other infections. Reducing the amount of HIV and                (Norpramin®)
increasing	 the	 CD4	 (T)	 cell	 count	 may	 improve	 your	 immune	 system.	      •	 	 larithromycin	(Prevpac®, Biaxin®)
                                                                                     c
This may reduce your risk of death or infections that can happen when             •	 	 edicine	 for	 fungal	 infections	 such	 as	 ketoconazole	 (Nizoral®),
                                                                                     m
your immune system is weak (opportunistic infections).                               itraconazole (Sporanox®, Onmel®), voriconazole (VFend®)
PREZISTA	does	not	cure	HIV	infection	or	AIDS	and	you	may	continue	to	             •	 	 olchicine	(Colcrys®, Col-Probenecid®)
                                                                                     c
experience illnesses associated with HIV-1 infection, including                   •	 	 ifabutin	(Mycobutin®)
                                                                                     r
opportunistic infections. You should remain under the care of a doctor            •	 	 edicine	used	to	treat	blood	pressure,	a	heart	attack,	heart	failure,	
                                                                                     m
when using PREZISTA.                                                                 or to lower pressure in the eye such as metoprolol (Lopressor®,
                                                                                     Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®,
Avoid doing things that can spread HIV-1 infection.                                  Combigan®)
•	 Do	not	share	needles	or	other	injection	equipment.	                            •	 	 idazolam	administered	by	injection
                                                                                     m
•	 	 o	not	share	personal	items	that	can	have	blood	or	body	fluids	on	
    D                                                                             •	 	 edicine	 for	 heart	 disease	 such	 as	 felodipine	 (Plendil®), nifedipine
                                                                                     m
    them, like toothbrushes and razor blades.                                        (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
IMPORTANT PATIENT INFORMATION
•	 	 teroids	 such	 as	 dexamethasone,	 fluticasone	 (Advair	 Diskus®,
    s                                                                                •	 Changes in your immune system (Immune Reconstitution Syndrome)
    Veramyst®, Flovent®, Flonase®)                                                       can happen when you start taking HIV medicines. Your immune
•	 bosentan	(Tracleer®)
    	                                                                                    system may get stronger and begin to fight infections that have been
•	 medicine	 to	 treat	 chronic	 hepatitis	 C	 such	 as	 boceprevir	
    	                                                                                    hidden in your body for a long time. Call your healthcare provider
    (VictrelisTM), telaprevir (IncivekTM)                                                right away if you start having new symptoms after starting your HIV
•	 medicine	 for	 cholesterol	 such	 as	 pravastatin	 (Pravachol®),
    	                                                                                    medicine.
    atorvastatin (Lipitor®), rosuvastatin (Crestor®)                                 •	 	 ncreased bleeding for hemophiliacs. Some people with hemophilia
                                                                                         I
•	 	 edicine	 to	 prevent	 organ	 transplant	 failure	 such	 as	 cyclosporine	
    m                                                                                    have increased bleeding with protease inhibitors including
    (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus                   PREZISTA.
    (Rapamune®)                                                                      The most common side effects of PREZISTA include:
•	 	 almeterol	(Advair®, Serevent®)
    s                                                                                •	 diarrhea	                    •	 headache
•	 medicine	for	narcotic	withdrawal	such	as	methadone	(Methadose®,
    	                                                                                •	 nausea	                      •	 abdominal	pain
    Dolophine	 Hydrochloride),	 buprenorphine	 (Butrans®, Buprenex®,
    Subutex®), buprenorphine/naloxone (Suboxone®)                                    •	 rash		                       •	 vomiting
•	 	 edicine	 to	 treat	 schizophrenia	 such	 as	 risperidone	 (Risperdal®),
    m                                                                                Tell your healthcare provider if you have any side effect that bothers
    thioridazine                                                                     you or that does not go away.
•	 	 edicine	 to	 treat	 erectile	 dysfunction	 or	 pulmonary	 hypertension	
    m                                                                                These are not all of the possible side effects of PREZISTA. For more
    such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®),          information, ask your health care provider.
    tadalafil (Cialis®, Adcirca®)                                                    Call your doctor for medical advice about side effects. You may report
•	 	 edicine	 to	 treat	 anxiety,	 depression	 or	 panic	 disorder	 such	 as	
    m                                                                                side	effects	to	the	FDA	at	1-800-FDA-1088.
    sertraline (Zoloft®), paroxetine (Paxil®)
                                                                                     How should I store PREZISTA?
This is not a complete list of medicines that you should tell your                   •	 	 tore	 PREZISTA	 oral	 suspension	 and	 tablets	 at	 room	 temperature	
                                                                                         S
healthcare provider that you are taking. Ask your healthcare provider                    [77°F	(25°C)].
or pharmacist if you are not sure if your medicine is one that is listed
above. Know the medicines you take. Keep a list of them to show your                 •	 Do	not	refrigerate	or	freeze	PREZISTA	oral	suspension.
doctor	 or	 pharmacist	 when	 you	 get	 a	 new	 medicine.	 Do	 not	 start	 any	      •	 Keep	PREZISTA	away	from	high	heat.
new medicines while you are taking PREZISTA without first talking with               •	 	 REZISTA	oral	suspension	should	be	stored	in	the	original	container.
                                                                                         P
your healthcare provider.
                                                                                     Keep PREZISTA and all medicines out of the reach of children.
How should I take PREZISTA?
                                                                                     General information about PREZISTA
•	 	 ake	PREZISTA	every	day	exactly	as	prescribed	by	your	healthcare	
    T
    provider.                                                                        Medicines are sometimes prescribed for purposes other than those
                                                                                     listed	 in	 a	 Patient	 Information	 leaflet.	 Do	 not	 use	 PREZISTA	 for	 a	
•	 	 ou	must	take	ritonavir	(NORVIR®) at the same time as PREZISTA.
    Y                                                                                condition	 for	 which	 it	 was	 not	 prescribed.	 Do	 not	 give	 PREZISTA	 to	
•	 	 o	 not	 change	 your	 dose	 of	 PREZISTA	 or	 stop	 treatment	 without	
    D                                                                                other people even if they have the same condition you have. It may
    talking to your healthcare provider first.                                       harm them.
•	 Take	PREZISTA	and	ritonavir	(NORVIR®) with food.
                                                                                     This leaflet summarizes the most important information about
•	 	 wallow	PREZISTA	tablets	whole	with	a	drink.	If	you	have	difficulty	
    S                                                                                PREZISTA. If you would like more information, talk to your healthcare
    swallowing PREZISTA tablets, PREZISTA oral suspension is also                    provider. You can ask your healthcare provider or pharmacist for
    available. Your health care provider will help determine whether
    PREZISTA tablets or oral suspension is right for you.                            information about PREZISTA that is written for health professionals.
•	 	 REZISTA	 oral	 suspension	 should	 be	 given	 with	 the	 supplied	 oral	
    P                                                                                For	more	information,	call	1-800-526-7736.
    dosing syringe. Shake the suspension well before each usage.                     What are the ingredients in PREZISTA?
•	 	 f	you	take	too	much	PREZISTA,	call	your	healthcare	provider	or	go	
    I                                                                                Active ingredient: darunavir
    to the nearest hospital emergency room right away.                               Inactive ingredients:
What should I do if I miss a dose?                                                   PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline
People who take PREZISTA one time a day:                                             cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric
•	 	 f	 you	 miss	 a	 dose	 of	 PREZISTA	 by	 less	 than	 12	 hours,	 take	 your	
    I                                                                                acid monohydrate, sucralose, masking flavor, strawberry cream flavor,
    missed dose of PREZISTA right away. Then take your next dose of                  hydrochloric	acid	(for	pH	adjustment),	purified	water.
    PREZISTA at your regularly scheduled time.                                       PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide,
•	 	 f	you	miss	a	dose	of	PREZISTA	by	more	than	12	hours,	wait	and	then	
    I                                                                                crospovidone, magnesium stearate, microcrystalline cellulose. The film
    take the next dose of PREZISTA at your regularly scheduled time.                 coating	 contains:	 OPADRY®	 White	 (polyethylene	 glycol	 3350,	 polyvinyl	
People who take PREZISTA two times a day                                             alcohol-partially hydrolyzed, talc, titanium dioxide).
•	 	 f	 you	 miss	 a	 dose	 of	 PREZISTA	 by	 less	 than	 6	 hours,	 take	 your	
    I                                                                                PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide,
    missed dose of PREZISTA right away. Then take your next dose of                  crospovidone, magnesium stearate, microcrystalline cellulose. The film
    PREZISTA at your regularly scheduled time.                                       coating	 contains:	 OPADRY®	 Orange	 (FD&C	 Yellow	 No.  6,	 polyethylene	
•	 	 f	you	miss	a	dose	of	PREZISTA	by	more	than	6	hours,	wait	and	then	
    I                                                                                glycol	3350,	polyvinyl		 lcohol-partially	hydrolyzed,	talc,	titanium	dioxide).
                                                                                                             a
    take the next dose of PREZISTA at your regularly scheduled time.
                                                                                     This	Patient	Information	has	been	approved	by	the	U.S	Food	and	Drug	
If	a	dose	of	PREZISTA	is	skipped,	do	not	double	the	next	dose.	Do	not	               Administration.
take more or less than your prescribed dose of PREZISTA at any one
time.                                                                                Manufactured by:
What are the possible side effects of PREZISTA?                                      PREZISTA Oral Suspension
                                                                                     Janssen Pharmaceutica, N.V.
PREZISTA can cause side effects including:                                           Beerse, Belgium
•	 	 ee	 “What is the most important information I should know about
    S
    PREZISTA?”                                                                       PREZISTA Tablets
•	 	 iabetes	 and	 high	 blood	 sugar	 (hyperglycemia).	 Some people who
    D                                                                                Janssen	Ortho	LLC,	Gurabo,	PR	00778
    take protease inhibitors including PREZISTA can get high blood                   Manufactured for:
    sugar, develop diabetes, or your diabetes can get worse. Tell your               Janssen	Therapeutics,	Division	of	Janssen	Products,	LP,	Titusville	NJ	
    healthcare provider if you notice an increase in thirst or urinate               08560
    often while taking PREZISTA.                                                     NORVIR® is a registered trademark of its respective owner.
•	 	 hanges in body fat. These changes can happen in people who take
    C
    antiretroviral therapy. The changes may include an increased                     PREZISTA® is a registered trademark of Janssen Pharmaceuticals
    amount	 of	 fat	 in	 the	 upper	 back	 and	 neck	 (“buffalo	 hump”),	 breast,	   ©	Janssen	Pharmaceuticals,	Inc.	2006
    and around the back, chest, and stomach area. Loss of fat from the               Revised:	June	2012																			986588P
    legs, arms, and face may also happen. The exact cause and long-
    term health effects of these conditions are not known.
5537 N. Broadway St.
Chicago, IL 60640
phone: (773) 989–9400

fax: (773) 989–9494

email: inbox@tpan.com

www.positivelyaware.com



editor-in-Chief Jeff Berry
associate editor Enid Vázquez
copy Editors Sue Saltmarsh,
	Jason Lancaster
Web Master Joshua Thorne               EXCLUSIVELY ON

                                       www.positivelyaware.com
Creative director Rick Guasco


contributing writers
Keith R. Green, 	Liz Highleyman,
Sal Iacopelli, Laura Jones,
Jim Pickett, Matt Sharp                Surface vs. substance
                                       A website—and app—that encourages truth in Internet dating
photographers                          www.positivelyaware.com/2012/12_06/mister.shtml
Chris Knight, Joshua Thorne
                                       Additional conference coverage from AIDS 2012
                                       www.positivelyaware.com/2012/12_06/aids2012.shtml
Medical advisors
Daniel S. Berger, MD
Gary Bucher, MD
Michael Cristofano, PA
                                                         Follow us                                                     We read you
Joel Gallant, MD                                         on Facebook and on                                            comment on our articles
Swarup Mehta, PharmD                                     TwitteR (@posaware)                                           at POSITIVELYAWARE.COM



                                         © 2012. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network
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4   SEPTE MB E R +O C TO B ER 201 2	                                                                                             P os i t i v e lyAware .com
SEP+OCT 2012
                            VOLUME 24 NUMBER 6


                            D e pa r t m e n t s


                            6	 In Box

                            6	 Readers’ poll

                            7	   editor’s Note
                            	    What is a woman?

                            13	 Briefly
                            	    FDA approves Truvada for HIV prevention. Rapid
                                 home HIV test approved. Initial study results find
                                 dolutegravir/Epzicom is superior to Atripla.

                            34	 Conference Update
                            	    News from the XIX International AIDS Conference in
                                 Washington, D.C.

                            44	 ask the HIV specialist
                            	    Safe sex is for seniors, too.

                            45	 WHOLISTIC PICTURE
                            	    Battle of the sexes?

                            c o v e r F e at u r e s


                            22	 Securing care for HIV-positive women
                            	    Challenges and solutions for women living with HIV.

                            26	 Black women, society, and HIV
                            	   An expert talks about the context of infection.

                            28	 ‘Everyone needs a support system’
                            	   How one therapist helps HIV-positive women learn
                                 to take care of themselves.

                            30	 Nine months to birth day
                            	    HIV and pregnancy—keeping yourself and your
                                 baby healthy.

                            F e at u r e


                            41	 The mirror has two faces
                            	    A personal account of using facial filler for lipoatrophy.




                            On the cover and this page:
                            Tamara wilson, HIV-Positive since 1999,
                            photographed by chris Knight




P osi t i ve lyAware.com	                                        S E P T E MB E R+ OC TOB E R 2 01 2   5
In Box          join the conversation: inbox@tpan.com and @posaware                               Readers’ poll
                                                                                                  In the JULY+AUGUST issue, we asked


HIV testing in prison?                                                                            Before you tested HIV-positive,
                                                                                                  did you think you were at risk?

First let me say this is                                       I had no idea that anyone
strictly my opinion in                                          has the same problems as                         No.      I didn’t
answer to your reader’s                                         me. The issue touched me                         8%       think
poll question concern-                                          deeply.                                                   about it.
ing HIV testing in prison.                                           Simply knowing you’re                                16%
                                                                                                    Yes, but I
I believe it should be                                          there, that I can reach out         practiced
required upon entering                                          to someone for information          safer sex.
and leaving prison.                                             seems to make everything a          24%                     Yes, but I
    Prior to my incarcera-                                      little bit better. I’m not sure                             thought I was
                                                                                                                            at low risk.
tion, I worked at Prevention                                    how to receive future issues,
Point Philadelphia (a needle                                    but put me on your mailing
                                                                                                          Yes, but I        33%
                                                                                                        didn’t care.
exchange program), the Gay                                      list if at all possible!                         19%
& Lesbian AIDS Education                                                             —Dwayne E.
Initiative, and I spoke at various events                                             Florida
about HIV/AIDS in the prison system. I’ve
been positive for 18 years and for the last      Good wishes                                      Your comments:
11 years I’ve been trying to get as many         Comment on July+August Editor’s Note:            “I barebacked all the way after my first
people tested as possible.                       Thank you for the uplifting article, “Wish       encounter—I have no one to blame but
    At present, I have three and a half years    HIV Away.” Though easier said than done, I       myself and my lack of self-esteem.”
left on my sentence. During my incarcera-        know that I’ll be able to pick my head up in
tion, I have been a Peer Educator teaching       the morning and continue on with a posi-         “After I found out, I wanted to kill myself—
a class called Positive Voices behind the        tive outlook on the day. I’m not at the stage    my partner never told me he had HIV.”
Walls (a little plug never hurts!) and an        yet where people can know, only because
advocate for testing. I’m open about my          I’m just two months into this disease, but I     “Before I tested positive, I always
HIV status, so HIV can have a “face” that        know I will get there (fingers crossed).         practiced safe sex. But I also remember
defies the expectations of some of the                                                —Steven     feeling like no matter how much of a
men in here.                                                               via thebody.com        good boy I was, HIV was going to get me.”
    After taking my class for 16 weeks, I
have seen men’s attitudes change com-            Hidden no more                                   “I practiced safer sex until depression
pletely because they see me living healthy,      I have to let you guys know how much             and drugs got in my way.”
happy, with a loving family, and looking         I appreciated the article, “The Hidden
forward to a long life.                          People,” in your January+February 2012           “I never thought about it. I suspect I
    So, yes, testing should be mandatory,        issue. I would love to have the Muslim           was infected in 1986. At that time, there
along with education and good informa-           brothers come to Memphis to speak in the         wasn’t much information available
tion about prevention.                           very near future. My southern hat goes off       about infection and I had no idea what
                                      —Larry     to the writer Sue Saltmarsh for the article.     behavior was risky and what wasn’t.”
              White Deer, Pennsylvania           And love to Karim Rush, Shadeed Jenkins,
                                                 and Iman Boyd.                                   “I thought those who caught HIV led
You’re not the only one                              Great job, POSITIVELY AWARE! You             reckless lives, taking drugs and hav-
Finally, I’ve found relief! On May 21st, I       guys rock!                                       ing many anonymous partners and
read my first ever issue of Positively                                  —Anthony Hardaway         unprotected sex. I was naïve to believe
Aware—the March+April Drug Guide.                                          via the Internet       I would be OK if I limited myself to one
                                                                                                  casual partner every few months.”

Do the write thinG. Positively Aware treats all communications (letters, e-mail,
etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for      this issue’s poll question:
length, style, or clarity. Unless you tell us not to, we will use your name and city.             Who is more stigmatized
                                                                                                  because of HIV?
            Positively aware                                      We read you.
            5537 N. Broadway St.                                  SHare your comments
            Chicago, IL 60640                                     about our articles at           cast your vote at
            inbox@tpan.com                                        POSITIVELYAWARE.COM             positivelyaware.com

6   SEPTE M B E R +O C TO B ER 201 2	                                                                               P os i t i v e lyAware .com
Editor’s NOTE
                                          Jeff Berry
                                          @PAeditor




                      What is a woman?
                      I’ve had many teachers in life, including women                                    up of mostly women, HIV-positive           There are
                      who have taught me particularly important lessons about                            educator and activist Linda Scruggs        countless
                                                                                                         said it best by stating she wasn’t         examples in
                      courage, strength, resilience, caring, and compassion.                             going to ask for anything, because         our culture of
                                                                                                         women have been asking to be               strong, coura-
                          Cindy, the oldest of my three sisters, realized at an  counted in for the last two decades. “Today I stand here           geous women
                      early age that it was her job to help look after the other to give you some directions. We’ve decided to stop ask-            and their
                      four kids in the Berry clan. My sister Barb became a       ing, and maybe you just need the recipe.”                          many accom-
                      veterinarian, the first doctor in our family. The one who      Scruggs called for meaningful involvement of women             plishments
                      was closest to me in age, Wendy, became my best friend at every level, from the government to local communities               and contribu-
                      growing up. My mother Norma went back to work when         and organizations, and also made it clear that women are           tions to the
                      I started preschool in the early 1960’s, and continued     not just asking for male-run organizations that “tolerate” a       world. So why
                      working as a schoolteacher and elementary school prin-     women’s program. “We need the support and resources…               is it that so
                      cipal until she retired. And my grandmother, Ruby, lived   to give us the power to heal our sisters, to change our            many women
                      to be 101, and would often recount to us colorful stories  men. We are the mothers of the earth.”                             who are in
                      from her life, such as the one about traveling all day in      In her talk, Scruggs also shared part of what she says         positions
                      a covered wagon to see the Wright Brothers perform         got her to the stage that day. She learned she was HIV-            of power
                      breathtaking feats in their amazing flying machines.       positive while visiting a perinatal clinic and was 13-weeks        and leader-
                          All these women and others demonstrated to me          pregnant, and had to decide whether to terminate the               ship appear
                      wonderful qualities that I respected and admired, and      pregnancy and live five years, or have the baby and pos-           threatening
                      sought to emulate and incorporate into my own sense        sibly live three. She says she’s glad that day the doctor          to so many
                      of values and ideals. There are countless examples in      was wrong, and her son, Isaiah, was born free of HIV,              who live in
                      our culture of strong, courageous women and their          and he just recently turned 21.                                    our male-
                      many accomplishments and contributions to the world.           “I could’ve made the decision to have an abortion.             dominated
                      So why is it that so many women who are in positions       An abortion would not have been the first one I had had,           society?
                      of power and leadership appear threatening to so many      but I had an experience with God. I had an experience
                      who live in our male-dominated society?                    that…made me really look and reflect about women.
                          A recurring theme at this year’s International AIDS    After all, what is a woman who thinks she’s ugly? What
                      Conference was the role of women in ending the             is a woman who feels she has no self-value? What is a
                      epidemic. In her address at the conference opening         woman who allows not one, but two men to rape her in
                      plenary, Secretary of State Hillary Clinton talked about   silence? What is a woman who allows an uncle to molest
                      the essential role of communities, especially people liv-  her and others and still be silent?... What is a woman
                      ing with HIV, in turning the tide on the epidemic. “And it who feels that she’s been broken and voiceless? What is
                      will come as no surprise to you,” Clinton told the packed  a woman who’s afraid of understanding herself? What
                      audience, “that I would like to highlight the particular   is a woman who spent a lifetime trying to be someone
                      role that women play.”                                     other than herself?
                          Clinton pointed out that in Sub-Saharan Africa             “I’ll tell you, that cold November day, that woman
                      women account for 60% of people living with HIV.           was me, but it was through the support of this commu-
                      “Women want to protect themselves, and they want           nity that I was able to find a voice and a place, that
PHOTO: Chris Knight




                      adequate health care, and we need to answer their call,”   I could be just who I say I am. I am a woman.”
                      said Clinton. “Every woman should be able to decide
                      when and whether to have children. This is true if she is  Take care of yourself, and each other.
                      HIV-positive or not. Women need and deserve a voice in
                      the decisions that affect their lives.”
                          In a lively morning plenary session by a panel made

                      P osi t i ve lyAware.com	                                                                                  S E P T E MB E R+ OC TOB E R 2 01 2   7
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                  POSITIVELY AWARE
BRIEFLY
                                           Enid Vázquez




                       FDA approves Truvada for PrEP
                       The Food and Drug Administration (FDA)        reduction counseling, consistent and          participants who
                       in July approved Truvada as the first         correct condom use, regular HIV testing,      took Truvada in the
                       medication to help prevent HIV infec-         and screening for and treatment of other      prescribed once-
                       tion. As expected, the approval came          sexually-transmitted infections, stating      daily dose.
                       with restrictions.                            that “Truvada is not a substitute for safer       “The Partners
                           Truvada, a combination of tenofovir       sex practices.”                               PrEP trial was conducted
                       (Viread) and emtricitabine (Emtriva), is          Truvada now carries a Boxed Warning       in 4,758 heterosexual couples,
                       one of the most prescribed medications        on its drug label alerting health care        where one partner was HIV-infected and
                       for HIV in this country. For HIV preven-      professionals and uninfected individuals      the other was not (serodiscordant cou-
                       tion, the use of Truvada is called “PrEP,”    that Truvada for PrEP must only be used       ples),” the press release continued. “The
                       for “pre-exposure prophylaxis.”               by people confirmed to be HIV-negative        trial evaluated the efficacy and safety of
                           “[We] commend the FDA’s approval of       before being prescribed the drug and          [both] Truvada and [Viread] tenofovir
                       [Truvada] for the use of [PrEP] to prevent    tested at least every three months dur-       versus placebo in preventing HIV infection
                       HIV transmission. This approach can           ing use to reduce the risk of developing      in the uninfected male or female partner.
                       prevent many new infections and could         drug resistance. Both the antiviral and the   Results showed Truvada reduced the risk
                       dramatically impact HIV transmission          PrEP dose is one pill taken once daily.       of becoming infected by 75% compared
                       worldwide,” said Kenneth H. Mayer, MD,            Truvada maker Gilead Sciences worked      with placebo.
                       Medical Research Director and Co-chair        with the FDA to create a Risk Evaluation          “No new side effects were identified
                       of The Fenway Institute at Fenway Health.     and Mitigation Strategy (REMS) for            in the clinical trials evaluating Truvada
                       “My colleagues and I are delighted to have    Truvada PrEP. The REMS focuses on a pre-      for the PrEP indication. The most com-
                       helped to demonstrate the utility of this     scriber training and education program        mon side effects reported with Truvada
                       promising approach for HIV prevention.”       in counseling and managing individuals        include diarrhea, nausea, abdominal
                           David Ernesto Munar, President/CEO        who are taking or considering Truvada for     pain, headache, and weight loss. Serious
                       of the AIDS Foundation of Chicago, said,      PrEP. The REMS looks at the elements of       adverse events in general, as well as
                       “Our challenge now is to implement PrEP       a comprehensive HIV prevention strategy,      those specifically related to kidney or
                       as strategically as possible, and to ensure   the importance of adhering to the recom-      bone toxicity, were uncommon.”
                       the people who need it most, those who        mended daily dosing regimen, and the              As a condition of approval, Gilead
                       are most at risk for HIV, have access.”       serious risks of taking Truvada for PrEP if   Sciences is required to collect and
                           “This is an enormous turning point, a     already infected with HIV or of becoming      analyze samples from individuals who
                       real game changer, in the fight against       infected while taking it.                     become infected with HIV while taking
                       HIV,” said Jim Pickett, AFC’s Director            According to the press release,           Truvada to see if they’ve developed drug
                       of Prevention Advocacy and Gay Men’s          “Truvada’s safety and efficacy for PrEP       resistance. The company is also required
                       Health. “The toolbox we have now has          were demonstrated in two large, random-       to collect data on women who become
                       Truvada as PrEP. We can look forward to       ized, double-blind, placebo-controlled        pregnant while taking Truvada for PrEP
                       more sex acts being protected, especially     clinical trials. The iPrEx trial evaluated    and to conduct other research.
                       among individuals who have already            Truvada in 2,499 HIV-negative men                 “Today’s decision is the culmination
                       chosen, for whatever reason, to not use       or transgender women who have sex             of almost 20 years of research involving
                       condoms consistently.”                        with men and with evidence of high            investigators, academic and medical
                           According to a press release from the     risk behavior for HIV infection... Results    institutions, funding agencies, and nearly
Photo: Joshua Thorne




                       FDA, “Truvada is to be used for [PrEP] in     showed Truvada was effective in reduc-        20,000 trial participants around the
                       combination with safer sex practices to       ing the risk of HIV infection by 42% com-     world, and Gilead is proud to have been
                       prevent sexually-acquired HIV infection in    pared with placebo in this population.        a partner in this effort,” said Norbert
                       adults at high risk.”                         Efficacy was strongly correlated with         Bischofberger, PhD, Executive Vice
                           The FDA said Truvada for PrEP should      drug adherence in this trial.”                President, Research and Development
                       be used as part of a comprehensive                It was also shown in iPrEX that there     and Chief Scientific Officer, Gilead
                       HIV prevention plan that includes risk        was a 92% reduction of risk for HIV in        Sciences. >>

                       P osi t i ve lyAware.com	                                                                            S E P T E MB E R+ OC TOB E R 201 2   13
BRIEFLY
   Enid Vázquez




                                                 in the greatest expansion of HIV preven-        Rapid home
Moises Agosto
                                                 tion tools than at any other time in the
                                                 history of this epidemic. Coupled with the
                                                                                                 HIV test approved
                                                 reforms included in the Patient Protection
                                                 and Affordable Care Act, as well as the         In June, the Food and Drug
                                                 National HIV/AIDS Strategy, we are in a         Administration (FDA) approved the
                                                 position for the first time in over three       OraQuick In-Home HIV Test, an HIV
                                                 decades to finally end this epidem-             self-test kit that does not require sending
                                                 ic. Today’s decision is another important       a sample to a laboratory for analysis. The
                                                 step in realizing that goal.”                   kit, which tests a swab from your mouth,
                                                                                                 is approved for sale in stores and online

                                                 Dolutegravir/Epzicom                            to anyone age 17 and older. (Although
                                                                                                 HIV is not found in saliva, evidence of
                                                 superior to Atripla?                            exposure to the virus—called HIV anti-
                                                                                                 bodies—is found in the mouth and indi-
                                                 Shionogi-ViiV Healthcare LLC announced          cates infection.) A positive result at home
                                                 that initial results from its Phase 3 study     must then be followed up with a confir-
                                                 SINGLE (ING114467) show superiority of          matory blood test from a laboratory.
                                                 its investigational HIV medication dolute-          The FDA said the test can be falsely
   >> The following is from a statement          gravir plus Epzicom over Atripla, one of        negative for reasons that include the
   from Moises Agosto, Director of               the most widely prescribed antiviral med-       occurrence of HIV infection within three
   Treatment Education, Adherence, and           ications in the country. At 48 weeks, 88%       months before testing. People who
   Mobilization for the National Minority        of study participants on the dolutegravir       engage in behaviors that put them at
   AIDS Council (NMAC):                          regimen achieved undetectable viral             increased risk of getting HIV—including
                                                 load (less than 50 copies/mL) vs. 81% of        having unprotected sex with new part-
   “While PrEP shows substantial promise as      those on Atripla, a statistically significant   ners, or injecting illegal drugs—should be
   a supplement to current HIV prevention        difference. The company said the dif-           re-tested on a regular basis. They should
   efforts, it is by no means a panacea and      ference was primarily driven by a higher        not interpret a negative test to indicate
   is only effective when used in conjunction    rate of discontinuation due to adverse          that engaging in high risk behavior is
   with traditional prevention and risk reduc-   events in the Atripla arm. All individuals      safe.
   tion strategies, such as condom usage.        in the study were taking antiviral therapy
       “Anti-retroviral medications, like        for the first time, a group that does the
   Truvada, are extremely powerful drugs         best in HIV treatment. There were 414
   with the potential for serious side           individuals put on dolutegravir and 419
   effects. As such, PrEP should only be         put on Atripla. Overall, 2% of those on the
   used by individuals who are highly vul-       dolutegravir-based regimen discontinued
   nerable to HIV infection, including those     due to adverse events vs. 10% of those
   in sero-discordant couples, sex workers,      receiving the Atripla regimen. The most
   and gay men. Its efficacy is also directly    common adverse events while on Atripla
   related to an individual’s adherence to       were neurological (reported by 41% of
   a regimen, and should only be used by         Atripla recipients vs. 15% of participants
   those who can commit to taking it regu-       receiving the dolutegravir), while the
   larly. Finally, use of PrEP by individuals    most common drug-related adverse
   who may already be HIV-positive could         events with dolutegravir were in the gas-
   increase the risk of drug resistance.         trointestinal system (reported by 22% of
       “In recent years, there have been a       people on dolutegravir vs. 22% of those
   number of promising developments in           given Atripla).
   biomedical interventions—from treat-              Dolutegravir is an investigational
   ment as prevention and pre-exposure           integrase inhibitor (INSTI), the same class
   prophylaxis to microbicides and vaccine       as Isentress, the only INSTI currently on
   research. These advances have resulted        the market.

    14   SEP TE M B E R +O C TO BER 201 2	                                                                          P os i t i v e lyAware .com
E-NEWS |                Sign up for the weekly email newsletter of
                                                                                     positively aware. go to positivelyaware.com




From the Weekly E-News                        is an important step forward in our fight       Studies find
                                              against the disease.”
                                                                                              once-daily ‘Quad’
Website offers                                    ViiV Healthcare is the first pharma-
                                              ceutical company to support the program         is safe and effective
access to HIV meds                            with HIV/AIDS medications and funding.

for uninsured                                     The goal of HarborPath is to get all
                                              HIV/AIDS medications into the program
                                                                                              The findings of two large international
                                                                                              randomized studies published in The
HarborPath, a new non-profit organiza-        and serve uninsured individuals with:           Lancet medical journal indicate that the
tion, has been established to create a                                                        new once-daily pill combining three
program that offers a single place where      n	   An easy-to-use website with a single       antiretrovirals and a booster molecule is
uninsured HIV-positive people who                  portal to determine eligibility for the    a safe and effective alternative to two
otherwise qualify for manufacturer-                program and to fill prescriptions for      widely used drug regimens for newly
sponsored patient assistance programs              participating companies’ HIV/AIDS          diagnosed HIV-positive adults who have
(PAPs) can apply for and receive their             medications.                               had no previous treatment. The study
medications. The “one stop shop” portal       n	   Automatic notifications for both the       results also indicate that the new “Quad”
will provide a streamlined, online process         individual and the case manager of         pill is faster acting, doesn’t have the neu-
to qualify individuals and deliver the             qualification for the program.             ropsychiatric side effects associated with
donated medications through a mail-           n	   A pharmacy that ships a 3-month sup-       other combinations, and could improve
order pharmacy. HarborPath will pilot the          ply of all participating medications in    compliance with treatment.
program in states with high need, includ-          one package within two business days           “Patient adherence to medication is
ing Alabama, Texas, and Virginia.                  of final approval and confirms delivery    vital, especially for patients with HIV,
    To create the portal, HarborPath               of the medications.                        where missed doses can quickly lead to
worked closely with the National Alliance     n	   Renewal reminders to individuals and       the virus becoming resistant to medica-
of State and Territorial AIDS Directors            case managers to improve medication        tion. Older HIV treatment regimens
(NASTAD) and the Clinton Health Access             adherence.                                 involve taking several pills multiple times
Initiative (CHAI), which provided the seed    n	   A fully automated portal that case         a day,” explains Paul Sax from Brigham
funding for the organization. On World             managers can access at any time            and Women’s Hospital, Harvard Medical
AIDS Day 2011, President Bill Clinton noted        for up-to-the-minute status of an          School, lead author of the first study.
the need to fight HIV/AIDS in the U.S.             individual’s application or shipment. If   “Our results provide an additional highly
    “I am proud that my foundation is              needed, live support is also available     potent, well-tolerated treatment option,
partnering with NASTAD and other                   through a toll-free call center.           and highlight the simplicity of treatment
pharmaceutical manufacturers to make                                                          resulting from combining several anti-
sure Americans living with HIV have              Murray Penner, Deputy Executive              retrovirals in a single pill. Studies have
access to the life-saving medications         Director at NASTAD, said, “Under the cur-       shown that single pill treatments improve
they need,” said President Clinton. “This     rent PAP process, an individual or their        both adherence and patient satisfaction,
                                                           case manager has to apply          and help prevent prescription errors,
                                                           separately to each com-            thereby reducing the likelihood of treat-
                                                           pany’s program for these           ment failure and drug resistance.”
                                                           medications, which can be              The first study randomly assigned
                                                           complex and time-consum-           700 patients from centers across North
                                                           ing. Missing doses or failing      America to start treatment with two
                                                           to fill prescriptions because      different single tablet regimens—either
                                                           of complications sometimes         the Quad, combining the new integrase
                                                           associated with these pro-         inhibitor elvitegravir (EVG) boosted with
                                                           cesses may result in serious       cobicistat (a new pharmacoenhancer;
                                                           health consequences, or            COBI) plus emtricitabine/tenofovir
                                                           even death, in addition to         (Emtriva/Viread), or Atripla (efavirenz/
                                                           increased transmission of          emtricitabine/tenofovir), the current gold
                                                           the virus. HarborPath is           standard regimen approved by the FDA
                                                           designed to address this           in 2006.
                                                           urgent need in the U.S.”               After 48 weeks of treatment, 88% >>

P osi t i ve lyAware.com	                                                                               S E P T E MB E R+ OC TOB E R 201 2   15
BRIEFLY
Enid Vázquez




of patients given the Quad had sup-            was reached by 90% of people in the           first conference to be held in the U.S.
pressed viral loads (less than 50 copies/      Quad group compared with 87% in the           since President Obama lifted the travel
mL), compared with 84% in the Atripla          atazanavir/ritonavir/emtricitabine/teno-      ban on HIV-positive people, his anticipa-
group.                                         fovir group.                                  tion of such events as displays of the
    Adverse events that led to patients           The safety of the two regimens was         AIDS Memorial Quilt, a planned march
discontinuing treatment were infrequent        also similar.                                 and demonstration, the performance
and similar in both groups. Mild nausea                                                      of the Tony Award-winning play The
was more common with the Quad, but
patients were less likely to have dizziness,
                                               PA’s editor debuts                            Normal Heart, as well as the many global
                                                                                             leaders in AIDS policy, advocacy, and
abnormal dreams, insomnia, and rash            blog on HuffPo                                treatment advances that presented at the
compared with the Atripla regimen.                                                           conference.
    The second trial included 708              Positively Aware editor Jeff Berry has
treatment-naïve adults from 146 medical        joined other AIDS activists and journalists
centers across Australia, Europe, North
America, and Thailand. Patients were
                                               such as The Body’s Kellee Turrell, the AIDS
                                               Foundation of Chicago’s David Ernesto
                                                                                             Did he get infected?
randomly assigned to receive a once-daily      Munar, and others in becoming a blogger       In the July+August issue of Positively
Quad or a popular and recommended              published by The Huffington Post.             Aware, a young man in Chicago, Chris,
twice-daily combination of Norvir-                 In advance of the upcoming AIDS 2012      was anxiously awaiting the results of his
boosted Reyataz (atazanavir/ritonavir)         World AIDS Conference, Berry wrote            HIV tests following a potential exposure
plus Truvada (emtricitabine/tenofovir).        “Reflections from an Epidemic: Carrying       through sex (“PrEPing,” July+August).
    The primary endpoint, to achieve viral     the Torch to AIDS 2012.” In it, he talks      Two months later, he remains
levels below 50 copies/mL by week 48,          about the significance of this being the      HIV-negative.




                                  Simplify your life.



                   Turn your assorted prescription medicine bottles into single-dose packs.
               Easy to remember. Easy to take. Each pack contains all the pills of a single dose.
                             Free FedEx shipping anywhere in the continental U.S.

                                          J Discount Pharmacy
                                               Call to place your first order:

                                                 (773) 278-5337
16   SE P TE M B E R +O C TO BER 201 2	                                                                        P os i t i v e lyAware .com
TPAN, publisher of Positively Aware, is commemorating
                                       25 years of service to Chicago’s HIV community.
                          Join Jamar Rogers, of NBC’s “The Voice,” for a special performance.




                                             October 4, 2012
                                          5:30–8:30 PM | Chicago Cultural center

                                       Tickets available at     www.tpan.com
                                   Event sponsors                           ANNIVERSARY PARTNERS
                                                              $100,000 AND ABOVE        $50,000 AND ABOVE
                                                              Alphawood Foundation      Janssen Therapeutics
Photo: Matthew Garsteck




                                                              Bristol-Myers Squibb

                                                              $25,000 AND ABOVE         $10,000 AND ABOVE
                                                              Abbott Virology           AIDS Foundation of Chicago
                                                              EMD Serono                Blue Cross and Blue Shield
                                                              Lloyd A. Fry Foundation       of Illinois
                                                              ViiV Healthcare           Cheetah Gyms
                                                              Walgreens                 Gilead Sciences, Inc.
                                                                                        Macy’s
                                                                                        MillerCoors
                                                                                        Steamworks
COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil
                                                                                          fumarate) is a prescription medicine used as a complete
                                                                                          single-tablet regimen to treat HIV-1 in adults who have
                                                                                          never taken HIV medicines before. COMPLERA does not
                                                                                          cure HIV or AIDS or help prevent passing HIV to others.




                                                                                                                  one
                                                                                          The                                              for me




                                                                                           Patient model. Pill shown is not actual size.


INDICATION                                                                                 Do not take COMPLERA if you are taking the following medicines:
                                                                                           • other HIV medicines (COMPLERA provides a complete treatment for HIV infection.)
COMPLERA (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate
           ®
                                                                                           • the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®,
300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA®                   Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®),
(emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate)
                                                                                             phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat        • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®,
HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before.
                                                                                             Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®)
COMPLERA does not cure HIV and has not been shown to prevent passing HIV                   • a proton pump inhibitor medicine for certain stomach or intestinal problems,
to others. It is important to always practice safer sex, use latex or polyurethane           including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®),
condoms to lower the chance of sexual contact with any body fluids, and to never             omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
re-use or share needles. Do not stop taking COMPLERA unless directed by your               • more than 1 dose of the steroid medicine dexamethasone or dexamethasone
healthcare provider. See your healthcare provider regularly.                                 sodium phosphate
                                                                                           • St. John’s wort (Hypericum perforatum)
                                                                                           • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)
IMPORTANT SAFETY INFORMATION                                                               • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®,
Contact your healthcare provider right away if you get the following side effects            Epivir® or Epivir-HBV®, Epzicom®, Trizivir®)
or conditions while taking COMPLERA:                                                       • rilpivirine (Edurant™)
• Nausea, vomiting, unusual muscle pain, and/or weakness. These may be                     • adefovir (HEPSERA®)
  signs of a buildup of acid in the blood (lactic acidosis), which is a serious
                                                                                           In addition, also tell your healthcare provider if you take:
  medical condition                                                                        • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium
• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your
                                                                                             carbonate. Take antacids at least 2 hours before or at least 4 hours after you
  eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity),
                                                                                             take COMPLERA
  with liver enlargement (hepatomegaly), and fat in the liver (steatosis)
                                                                                           • a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine
• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly
                                                                                             (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these
  get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without
                                                                                             medicines at least 12 hours before or at least 4 hours after you take COMPLERA
  first talking to your healthcare provider. Your healthcare provider will monitor
                                                                                           • the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®,
  your condition
                                                                                             Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®)
COMPLERA may affect the way other medicines work, and other medicines may                  • an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazole
affect how COMPLERA works, and may cause serious side effects.                               (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®), voriconazole (Vfend®)
                                                                                           • methadone (Dolophine®)

                                                                                           This list of medicines is not complete. Discuss with your healthcare provider all
                                                                                           prescription and nonprescription medicines, vitamins, or herbal supplements you
                                                                                           are taking or plan to take.
Save up to                    You may be able to save on the co-pay for



                                                        200
                                                                                   your COMPLERA prescription with a Gilead

                                                     $                             HIV Co-pay Assistance Card.
                                                                                   Call 1-877-505-6986 for more information
                                                     per month                     or visit www.COMPLERA.com.*




      COMPLERA.                                      A complete HIV treatment in only 1 pill a day.
                                                     Ask your healthcare provider if it’s the one for you.




Before taking COMPLERA, tell your healthcare provider if you:                           Common side effects associated with COMPLERA:
• have liver problems, including hepatitis B or C virus infection                       • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea,
• have kidney problems                                                                    nausea, rash, tiredness, and depression
• have ever had a mental health problem
                                                                                        Other side effects associated with COMPLERA:
• have bone problems
                                                                                        • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles),
• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm
                                                                                          and pain
 your unborn child
• are breastfeeding; women with HIV should not breast-feed because they can pass        Tell your healthcare provider if you have any side effect that bothers you or that
 HIV through their milk to the baby                                                     does not go away. These are not all the possible side effects of COMPLERA. For more
                                                                                        information, ask your healthcare provider or pharmacist. Call your healthcare provider
Contact your healthcare provider right away if you experience any of the                for medical advice about side effects.
following serious or common side effects:
                                                                                        You are encouraged to report negative side effects of prescription drugs to the
Serious side effects associated with COMPLERA:
• New or worse kidney problems can happen in some people who take COMPLERA.
                                                                                        FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
  If you have had kidney problems in the past or take other medicines that can cause    Take COMPLERA exactly as your healthcare provider tells you to take it
  kidney problems, your healthcare provider may need to do blood tests to check your    • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to
  kidneys during your treatment with COMPLERA                                             help get the right amount of medicine in your body. A protein drink does not replace
• Depression or mood changes can happen in some people who take COMPLERA.                 a meal
  Tell your healthcare provider right away if you have any of the following symptoms:   • Stay under the care of your healthcare provider during treatment with

  feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of        COMPLERA and see your healthcare provider regularly
  hurting yourself (suicide) or have tried to hurt yourself
• Bone problems can happen in some people who take COMPLERA. Bone problems              Please see Patient Information for COMPLERA on the following pages.
  include bone pain, softening or thinning (which may lead to fractures). Your          *The co-pay program covers up to $200 per month for 1 year from card activation or until the
  healthcare provider may need to do additional tests to check your bones                card expires, up to $2400 in a calendar year. The program is subject to change or cancellation
• Changes in body fat can happen in people taking HIV medicine. These changes            at any time.
  may include increased amount of fat in the upper back and neck (“buffalo hump”),
  breast, and around the main part of your body (trunk). Loss of fat from the legs,
  arms and face may also happen. The cause and long-term health effect of these
  conditions are not known
• Changes in your immune system (Immune Reconstitution Syndrome) can happen
  when you start taking HIV medicines. Your immune system may get stronger and
  begin to fight infections that have been hidden in your body for a long time. Tell
  your healthcare provider if you start having new symptoms after starting your
  HIV medicine                                                                                              Learn more at www.COMPLERA.com
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Positively Aware

  • 1. positivelyaware.com September+OCTOBER 2012 CURE NEWS FROM AIDS 2012 facing up to lipoatrophy POSITIVE Women Making decisions, creating policy, and improving lives
  • 2. ABOUT PREZISTA ® PREZISTA® (darunavir) is a prescription medicine. It is one treatment option Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat in the class of HIV (human immunodeficiency virus) medicines known as pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ protease inhibitors. ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), or telaprevir (Incivek™) in combination with other HIV medicines for the treatment of HIV infection • Before taking PREZISTA, tell your healthcare professional if you are ® in adults. PREZISTA® should also be taken with food. taking sildenafil (Viagra, Revatio®), vardenafil (Levitra,® Staxyn®), ® • The use of other medicines active against HIV in combination with tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin PREZISTA®/ritonavir (Norvir ®) may increase your ability to fight HIV. (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,® Your healthcare professional will work with you to find the right Col-Probenecid®). Tell your healthcare professional if you are taking combination of HIV medicines estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take • It is important that you remain under the care of your healthcare additional precautions for birth control, such as condoms professional during treatment with PREZISTA® This is not a complete list of medicines. Be sure to tell your PREZISTA® does not cure HIV infection or AIDS and you may healthcare professional about all the medicines you are taking or continue to experience illnesses associated with HIV-1 infection, plan to take, including prescription and nonprescription medicines, including opportunistic infections. You should remain under the vitamins, and herbal supplements. care of a doctor when using PREZISTA. ® What should I tell my doctor before I take PREZISTA®? Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you. • Before taking PREZISTA, tell your healthcare professional if you have ® any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia IMPORTANT SAFETY INFORMATION • Tell your healthcare professional if you are pregnant or planning What is the most important information I should know to become pregnant, or are breastfeeding about PREZISTA®? — The effects of PREZISTA® on pregnant women or their unborn • PREZISTA® can interact with other medicines and cause babies are not known. You and your healthcare professional will serious side effects. See “Who should not take PREZISTA®?” need to decide if taking PREZISTA® is right for you • PREZISTA® may cause liver problems. Some people taking — Do not breastfeed. It is not known if PREZISTA® can be passed PREZISTA, together with Norvir ® (ritonavir), have developed liver ® to your baby in your breast milk and whether it could harm your problems which may be life-threatening. Your healthcare professional baby. Also, mothers with HIV should not breastfeed because HIV should do blood tests before and during your combination treatment can be passed to your baby in the breast milk with PREZISTA. If you have chronic hepatitis B or C infection, your ® healthcare professional should check your blood tests more often What are the possible side effects of PREZISTA®? because you have an increased chance of developing liver problems • High blood sugar, diabetes or worsening of diabetes, and increased • Tell your healthcare professional if you have any of these signs and bleeding in people with hemophilia have been reported in patients symptoms of liver problems: dark (tea-colored) urine, yellowing taking protease inhibitor medicines, including PREZISTA® of your skin or whites of your eyes, pale-colored stools (bowel • Changes in body fat have been seen in some patients taking HIV movements), nausea, vomiting, pain or tenderness on your right medicines, including PREZISTA. The cause and long-term health ® side below your ribs, or loss of appetite effects of these conditions are not known at this time • PREZISTA® may cause a severe or life-threatening skin • Changes in your immune system can happen when you start taking reaction or rash. Sometimes these skin reactions and skin rashes HIV medicines. Your immune system may get stronger and begin can become severe and require treatment in a hospital. You should to fight infections that have been hidden call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment • The most common side effects related to taking PREZISTA® include and call your healthcare professional immediately if you develop any diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is skin changes with these symptoms: fever, tiredness, muscle or joint not a complete list of all possible side effects. If you experience these pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed or other side effects, talk to your healthcare professional. Do not stop eyes, like “pink eye.” Rash occurred more often in patients taking taking PREZISTA® or any other medicines without first talking to your PREZISTA® and raltegravir together than with either drug separately, healthcare professional but was generally mild You are encouraged to report negative side effects of Who should not take PREZISTA®? prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. • Do not take PREZISTA® if you are taking the following 28PRZDTC0288R8 medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45, ® Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI) Embolex, Migranal ), ergonovine, ergotamine (Cafergot, Ergomar ®), ® ® ® for additional information on precautionary measures. methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral Please read accompanying Patient Information for PREZISTA® midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort and discuss any questions you have with your doctor. (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
  • 3. IS THE PREZISTA ® EXPERIENCE RIGHT FOR YOU? There is no other person in the world who is exactly like you. And no HIV treatments are exactly alike, either. That’s why you should ask your healthcare professional about PREZISTA® (darunavir). Once-Daily PREZISTA® taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control over the long term. In a clinical study* of almost 4 years (192 weeks), 7 out of 10 adults who had never taken HIV medications before maintained undetectable† viral loads with PREZISTA® plus ritonavir and Truvada.® Find out if the PREZISTA® EXPERIENCE is right for you. Ask your healthcare professional and learn more at DiscoverPREZISTA.com Please read the Important Safety Information and Patient Information on adjacent pages. Snap a quick pic of our logo to show your doctor and get the conversation started. *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346). †Undetectable was defined as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners. Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2012 06/12 28PRZ12036G
  • 4. IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) • o not have any kind of sex without protection. Always practice D (darunavir) safe sex by using a latex or polyurethane condom to lower the Oral Suspension chance of sexual contact with semen, vaginal secretions, or blood. PREZISTA (pre-ZIS-ta) Ask your healthcare provider if you have any questions on how to (darunavir) prevent passing HIV to other people. Tablets Who should not take PREZISTA? Read this Patient Information before you start taking PREZISTA and Do not take PREZISTA with any of the following medicines: each time you get a refill. There may be new information. This • lfuzosin (Uroxatral®) a information does not take the place of talking to your healthcare • ihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, d provider about your medical condition or your treatment. ergotamine (Cafergot®, Ergomar®) methylergonovine Also read the Patient Information leaflet for NORVIR® (ritonavir). • isapride c What is the most important information I should • imozide (Orap®) p know about PREZISTA? • ral midazolam, triazolam (Halcion®) o • REZISTA can interact with other medicines and cause serious P • he herbal supplement St. John’s Wort (Hypericum perforatum) t side effects. It is important to know the medicines that should not be • he cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, t taken with PREZISTA. See the section “Who should not take Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) PREZISTA?” • ifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) r • REZISTA may cause liver problems. Some people taking PREZISTA P • ildenafil (Revatio®) only when used for the treatment of pulmonary s in combination with NORVIR® (ritonavir) have developed liver arterial hypertension. problems which may be life-threatening. Your healthcare provider Serious problems can happen if you take any of these medicines with should do blood tests before and during your combination treatment PREZISTA. with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often What should I tell my doctor before I take PREZISTA? because you have an increased chance of developing liver problems. PREZISTA may not be right for you. Before taking PREZISTA, tell your • ell your healthcare provider if you have any of the below signs and T healthcare provider if you: symptoms of liver problems. • ave liver problems, including hepatitis B or hepatitis C h • ark (tea colored) urine D • re allergic to sulfa medicines a • ellowing of your skin or whites of your eyes y • ave high blood sugar (diabetes) h • ale colored stools (bowel movements) p • ave hemophilia h • ausea n • re pregnant or planning to become pregnant. It is not known if a • omiting v PREZISTA will harm your unborn baby. • ain or tenderness on your right side below your ribs p Pregnancy Registry: You and your healthcare provider will need to • oss of appetite l decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how PREZISTA may cause severe or life-threatening skin reactions or rash. you can be included in the Antiretroviral Pregnancy Registry. The Sometimes these skin reactions and skin rashes can become severe purpose of the registry is follow the health of you and your baby. and require treatment in a hospital. You should call your healthcare • re breastfeeding or plan to breastfeed. Do not breastfeed. We do a provider immediately if you develop a rash. However, stop taking not know if PREZISTA can be passed to your baby in your breast PREZISTA and ritonavir combination treatment and call your healthcare milk and whether it could harm your baby. Also, mothers with HIV-1 provider immediately if you develop any skin changes with symptoms should not breastfeed because HIV-1 can be passed to the baby in below: the breast milk. • fever Tell your healthcare provider about all the medicines you take including • iredness t prescription and nonprescription medicines, vitamins, and herbal • uscle or joint pain m supplements. Using PREZISTA and certain other medicines may affect • listers or skin lesions b each other causing serious side effects. PREZISTA may affect the way • mouth sores or ulcers other medicines work and other medicines may affect how PREZISTA • ed or inflamed eyes, like “pink eye” (conjunctivitis) r works. Rash occurred more often in patients taking PREZISTA and raltegravir Especially tell your healthcare provider if you take: together than with either drug separately, but was generally mild. • edicine to treat HIV m See “What are the possible side effects of PREZISTA?” for more • strogen-based contraceptives (birth control). PREZISTA might e information about side effects. reduce the effectiveness of estrogen-based contraceptives. You What is PREZISTA? must take additional precautions for birth control such as a condom. PREZISTA is a prescription anti-HIV medicine used with ritonavir and • edicine for your heart such as bepridil, lidocaine (Xylocaine m other anti-HIV medicines to treat adults with human immunodeficiency Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a Cardarone®), digoxin (Lanoxin ®), flecainide (Tambocor ®), protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune propafenone (Rythmol®) Deficiency Syndrome). • arfarin (Coumadin®, Jantoven®) w • edicine for seizures such as carbamazepine (Carbatrol®, Equetro®, m When used with other HIV medicines, PREZISTA may help to reduce Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell • edicine for depression such as trazadone and desipramine m which help fight off other infections. Reducing the amount of HIV and (Norpramin®) increasing the CD4 (T) cell count may improve your immune system. • larithromycin (Prevpac®, Biaxin®) c This may reduce your risk of death or infections that can happen when • edicine for fungal infections such as ketoconazole (Nizoral®), m your immune system is weak (opportunistic infections). itraconazole (Sporanox®, Onmel®), voriconazole (VFend®) PREZISTA does not cure HIV infection or AIDS and you may continue to • olchicine (Colcrys®, Col-Probenecid®) c experience illnesses associated with HIV-1 infection, including • ifabutin (Mycobutin®) r opportunistic infections. You should remain under the care of a doctor • edicine used to treat blood pressure, a heart attack, heart failure, m when using PREZISTA. or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Avoid doing things that can spread HIV-1 infection. Combigan®) • Do not share needles or other injection equipment. • idazolam administered by injection m • o not share personal items that can have blood or body fluids on D • edicine for heart disease such as felodipine (Plendil®), nifedipine m them, like toothbrushes and razor blades. (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
  • 5. IMPORTANT PATIENT INFORMATION • teroids such as dexamethasone, fluticasone (Advair Diskus®, s • Changes in your immune system (Immune Reconstitution Syndrome) Veramyst®, Flovent®, Flonase®) can happen when you start taking HIV medicines. Your immune • bosentan (Tracleer®) system may get stronger and begin to fight infections that have been • medicine to treat chronic hepatitis C such as boceprevir hidden in your body for a long time. Call your healthcare provider (VictrelisTM), telaprevir (IncivekTM) right away if you start having new symptoms after starting your HIV • medicine for cholesterol such as pravastatin (Pravachol®), medicine. atorvastatin (Lipitor®), rosuvastatin (Crestor®) • ncreased bleeding for hemophiliacs. Some people with hemophilia I • edicine to prevent organ transplant failure such as cyclosporine m have increased bleeding with protease inhibitors including (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus PREZISTA. (Rapamune®) The most common side effects of PREZISTA include: • almeterol (Advair®, Serevent®) s • diarrhea • headache • medicine for narcotic withdrawal such as methadone (Methadose®, • nausea • abdominal pain Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®) • rash • vomiting • edicine to treat schizophrenia such as risperidone (Risperdal®), m Tell your healthcare provider if you have any side effect that bothers thioridazine you or that does not go away. • edicine to treat erectile dysfunction or pulmonary hypertension m These are not all of the possible side effects of PREZISTA. For more such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), information, ask your health care provider. tadalafil (Cialis®, Adcirca®) Call your doctor for medical advice about side effects. You may report • edicine to treat anxiety, depression or panic disorder such as m side effects to the FDA at 1-800-FDA-1088. sertraline (Zoloft®), paroxetine (Paxil®) How should I store PREZISTA? This is not a complete list of medicines that you should tell your • tore PREZISTA oral suspension and tablets at room temperature S healthcare provider that you are taking. Ask your healthcare provider [77°F (25°C)]. or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your • Do not refrigerate or freeze PREZISTA oral suspension. doctor or pharmacist when you get a new medicine. Do not start any • Keep PREZISTA away from high heat. new medicines while you are taking PREZISTA without first talking with • REZISTA oral suspension should be stored in the original container. P your healthcare provider. Keep PREZISTA and all medicines out of the reach of children. How should I take PREZISTA? General information about PREZISTA • ake PREZISTA every day exactly as prescribed by your healthcare T provider. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a • ou must take ritonavir (NORVIR®) at the same time as PREZISTA. Y condition for which it was not prescribed. Do not give PREZISTA to • o not change your dose of PREZISTA or stop treatment without D other people even if they have the same condition you have. It may talking to your healthcare provider first. harm them. • Take PREZISTA and ritonavir (NORVIR®) with food. This leaflet summarizes the most important information about • wallow PREZISTA tablets whole with a drink. If you have difficulty S PREZISTA. If you would like more information, talk to your healthcare swallowing PREZISTA tablets, PREZISTA oral suspension is also provider. You can ask your healthcare provider or pharmacist for available. Your health care provider will help determine whether PREZISTA tablets or oral suspension is right for you. information about PREZISTA that is written for health professionals. • REZISTA oral suspension should be given with the supplied oral P For more information, call 1-800-526-7736. dosing syringe. Shake the suspension well before each usage. What are the ingredients in PREZISTA? • f you take too much PREZISTA, call your healthcare provider or go I Active ingredient: darunavir to the nearest hospital emergency room right away. Inactive ingredients: What should I do if I miss a dose? PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline People who take PREZISTA one time a day: cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric • f you miss a dose of PREZISTA by less than 12 hours, take your I acid monohydrate, sucralose, masking flavor, strawberry cream flavor, missed dose of PREZISTA right away. Then take your next dose of hydrochloric acid (for pH adjustment), purified water. PREZISTA at your regularly scheduled time. PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, • f you miss a dose of PREZISTA by more than 12 hours, wait and then I crospovidone, magnesium stearate, microcrystalline cellulose. The film take the next dose of PREZISTA at your regularly scheduled time. coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl People who take PREZISTA two times a day alcohol-partially hydrolyzed, talc, titanium dioxide). • f you miss a dose of PREZISTA by less than 6 hours, take your I PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, missed dose of PREZISTA right away. Then take your next dose of crospovidone, magnesium stearate, microcrystalline cellulose. The film PREZISTA at your regularly scheduled time. coating contains: OPADRY® Orange (FD&C Yellow No.  6, polyethylene • f you miss a dose of PREZISTA by more than 6 hours, wait and then I glycol 3350, polyvinyl lcohol-partially hydrolyzed, talc, titanium dioxide). a take the next dose of PREZISTA at your regularly scheduled time. This Patient Information has been approved by the U.S Food and Drug If a dose of PREZISTA is skipped, do not double the next dose. Do not Administration. take more or less than your prescribed dose of PREZISTA at any one time. Manufactured by: What are the possible side effects of PREZISTA? PREZISTA Oral Suspension Janssen Pharmaceutica, N.V. PREZISTA can cause side effects including: Beerse, Belgium • ee “What is the most important information I should know about S PREZISTA?” PREZISTA Tablets • iabetes and high blood sugar (hyperglycemia). Some people who D Janssen Ortho LLC, Gurabo, PR 00778 take protease inhibitors including PREZISTA can get high blood Manufactured for: sugar, develop diabetes, or your diabetes can get worse. Tell your Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ healthcare provider if you notice an increase in thirst or urinate 08560 often while taking PREZISTA. NORVIR® is a registered trademark of its respective owner. • hanges in body fat. These changes can happen in people who take C antiretroviral therapy. The changes may include an increased PREZISTA® is a registered trademark of Janssen Pharmaceuticals amount of fat in the upper back and neck (“buffalo hump”), breast, © Janssen Pharmaceuticals, Inc. 2006 and around the back, chest, and stomach area. Loss of fat from the Revised: June 2012 986588P legs, arms, and face may also happen. The exact cause and long- term health effects of these conditions are not known.
  • 6. 5537 N. Broadway St. Chicago, IL 60640 phone: (773) 989–9400 fax: (773) 989–9494 email: inbox@tpan.com www.positivelyaware.com editor-in-Chief Jeff Berry associate editor Enid Vázquez copy Editors Sue Saltmarsh, Jason Lancaster Web Master Joshua Thorne EXCLUSIVELY ON www.positivelyaware.com Creative director Rick Guasco contributing writers Keith R. Green, Liz Highleyman, Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp Surface vs. substance A website—and app—that encourages truth in Internet dating photographers www.positivelyaware.com/2012/12_06/mister.shtml Chris Knight, Joshua Thorne Additional conference coverage from AIDS 2012 www.positivelyaware.com/2012/12_06/aids2012.shtml Medical advisors Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA Follow us We read you Joel Gallant, MD on Facebook and on comment on our articles Swarup Mehta, PharmD TwitteR (@posaware) at POSITIVELYAWARE.COM © 2012. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network advertising inquiries (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing Lorraine Hayes information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, contact Sue Saltmarsh. Six l.hayes@tpan.com issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute. We accept contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or distribution Manager decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use Bradley P Mazzie your actual name or a pseudonym for publication, but please include your name and phone number. distribution@tpan.com Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician. POSITIVELY AWARE A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively IS PUBLISHED BY Aware, association with TPAN, or contributions to this journal. Distribution of Positively Aware is supported in part through an unrestricted grant from ViiV Healthcare. 4 SEPTE MB E R +O C TO B ER 201 2 P os i t i v e lyAware .com
  • 7. SEP+OCT 2012 VOLUME 24 NUMBER 6 D e pa r t m e n t s 6 In Box 6 Readers’ poll 7 editor’s Note What is a woman? 13 Briefly FDA approves Truvada for HIV prevention. Rapid home HIV test approved. Initial study results find dolutegravir/Epzicom is superior to Atripla. 34 Conference Update News from the XIX International AIDS Conference in Washington, D.C. 44 ask the HIV specialist Safe sex is for seniors, too. 45 WHOLISTIC PICTURE Battle of the sexes? c o v e r F e at u r e s 22 Securing care for HIV-positive women Challenges and solutions for women living with HIV. 26 Black women, society, and HIV An expert talks about the context of infection. 28 ‘Everyone needs a support system’ How one therapist helps HIV-positive women learn to take care of themselves. 30 Nine months to birth day HIV and pregnancy—keeping yourself and your baby healthy. F e at u r e 41 The mirror has two faces A personal account of using facial filler for lipoatrophy. On the cover and this page: Tamara wilson, HIV-Positive since 1999, photographed by chris Knight P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 2 01 2 5
  • 8. In Box join the conversation: inbox@tpan.com and @posaware Readers’ poll In the JULY+AUGUST issue, we asked HIV testing in prison? Before you tested HIV-positive, did you think you were at risk? First let me say this is I had no idea that anyone strictly my opinion in has the same problems as No. I didn’t answer to your reader’s me. The issue touched me 8% think poll question concern- deeply. about it. ing HIV testing in prison. Simply knowing you’re 16% Yes, but I I believe it should be there, that I can reach out practiced required upon entering to someone for information safer sex. and leaving prison. seems to make everything a 24% Yes, but I Prior to my incarcera- little bit better. I’m not sure thought I was at low risk. tion, I worked at Prevention how to receive future issues, Point Philadelphia (a needle but put me on your mailing Yes, but I 33% didn’t care. exchange program), the Gay list if at all possible! 19% & Lesbian AIDS Education —Dwayne E. Initiative, and I spoke at various events Florida about HIV/AIDS in the prison system. I’ve been positive for 18 years and for the last Good wishes Your comments: 11 years I’ve been trying to get as many Comment on July+August Editor’s Note: “I barebacked all the way after my first people tested as possible. Thank you for the uplifting article, “Wish encounter—I have no one to blame but At present, I have three and a half years HIV Away.” Though easier said than done, I myself and my lack of self-esteem.” left on my sentence. During my incarcera- know that I’ll be able to pick my head up in tion, I have been a Peer Educator teaching the morning and continue on with a posi- “After I found out, I wanted to kill myself— a class called Positive Voices behind the tive outlook on the day. I’m not at the stage my partner never told me he had HIV.” Walls (a little plug never hurts!) and an yet where people can know, only because advocate for testing. I’m open about my I’m just two months into this disease, but I “Before I tested positive, I always HIV status, so HIV can have a “face” that know I will get there (fingers crossed). practiced safe sex. But I also remember defies the expectations of some of the —Steven feeling like no matter how much of a men in here. via thebody.com good boy I was, HIV was going to get me.” After taking my class for 16 weeks, I have seen men’s attitudes change com- Hidden no more “I practiced safer sex until depression pletely because they see me living healthy, I have to let you guys know how much and drugs got in my way.” happy, with a loving family, and looking I appreciated the article, “The Hidden forward to a long life. People,” in your January+February 2012 “I never thought about it. I suspect I So, yes, testing should be mandatory, issue. I would love to have the Muslim was infected in 1986. At that time, there along with education and good informa- brothers come to Memphis to speak in the wasn’t much information available tion about prevention. very near future. My southern hat goes off about infection and I had no idea what —Larry to the writer Sue Saltmarsh for the article. behavior was risky and what wasn’t.” White Deer, Pennsylvania And love to Karim Rush, Shadeed Jenkins, and Iman Boyd. “I thought those who caught HIV led You’re not the only one Great job, POSITIVELY AWARE! You reckless lives, taking drugs and hav- Finally, I’ve found relief! On May 21st, I guys rock! ing many anonymous partners and read my first ever issue of Positively  —Anthony Hardaway unprotected sex. I was naïve to believe Aware—the March+April Drug Guide. via the Internet I would be OK if I limited myself to one casual partner every few months.” Do the write thinG. Positively Aware treats all communications (letters, e-mail, etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for this issue’s poll question: length, style, or clarity. Unless you tell us not to, we will use your name and city. Who is more stigmatized because of HIV? Positively aware We read you. 5537 N. Broadway St. SHare your comments Chicago, IL 60640 about our articles at cast your vote at inbox@tpan.com POSITIVELYAWARE.COM positivelyaware.com 6 SEPTE M B E R +O C TO B ER 201 2 P os i t i v e lyAware .com
  • 9. Editor’s NOTE Jeff Berry @PAeditor What is a woman? I’ve had many teachers in life, including women up of mostly women, HIV-positive There are who have taught me particularly important lessons about educator and activist Linda Scruggs countless said it best by stating she wasn’t examples in courage, strength, resilience, caring, and compassion. going to ask for anything, because our culture of women have been asking to be strong, coura- Cindy, the oldest of my three sisters, realized at an counted in for the last two decades. “Today I stand here geous women early age that it was her job to help look after the other to give you some directions. We’ve decided to stop ask- and their four kids in the Berry clan. My sister Barb became a ing, and maybe you just need the recipe.” many accom- veterinarian, the first doctor in our family. The one who Scruggs called for meaningful involvement of women plishments was closest to me in age, Wendy, became my best friend at every level, from the government to local communities and contribu- growing up. My mother Norma went back to work when and organizations, and also made it clear that women are tions to the I started preschool in the early 1960’s, and continued not just asking for male-run organizations that “tolerate” a world. So why working as a schoolteacher and elementary school prin- women’s program. “We need the support and resources… is it that so cipal until she retired. And my grandmother, Ruby, lived to give us the power to heal our sisters, to change our many women to be 101, and would often recount to us colorful stories men. We are the mothers of the earth.” who are in from her life, such as the one about traveling all day in In her talk, Scruggs also shared part of what she says positions a covered wagon to see the Wright Brothers perform got her to the stage that day. She learned she was HIV- of power breathtaking feats in their amazing flying machines. positive while visiting a perinatal clinic and was 13-weeks and leader- All these women and others demonstrated to me pregnant, and had to decide whether to terminate the ship appear wonderful qualities that I respected and admired, and pregnancy and live five years, or have the baby and pos- threatening sought to emulate and incorporate into my own sense sibly live three. She says she’s glad that day the doctor to so many of values and ideals. There are countless examples in was wrong, and her son, Isaiah, was born free of HIV, who live in our culture of strong, courageous women and their and he just recently turned 21. our male- many accomplishments and contributions to the world. “I could’ve made the decision to have an abortion. dominated So why is it that so many women who are in positions An abortion would not have been the first one I had had, society? of power and leadership appear threatening to so many but I had an experience with God. I had an experience who live in our male-dominated society? that…made me really look and reflect about women. A recurring theme at this year’s International AIDS After all, what is a woman who thinks she’s ugly? What Conference was the role of women in ending the is a woman who feels she has no self-value? What is a epidemic. In her address at the conference opening woman who allows not one, but two men to rape her in plenary, Secretary of State Hillary Clinton talked about silence? What is a woman who allows an uncle to molest the essential role of communities, especially people liv- her and others and still be silent?... What is a woman ing with HIV, in turning the tide on the epidemic. “And it who feels that she’s been broken and voiceless? What is will come as no surprise to you,” Clinton told the packed a woman who’s afraid of understanding herself? What audience, “that I would like to highlight the particular is a woman who spent a lifetime trying to be someone role that women play.” other than herself? Clinton pointed out that in Sub-Saharan Africa “I’ll tell you, that cold November day, that woman women account for 60% of people living with HIV. was me, but it was through the support of this commu- “Women want to protect themselves, and they want nity that I was able to find a voice and a place, that PHOTO: Chris Knight adequate health care, and we need to answer their call,” I could be just who I say I am. I am a woman.” said Clinton. “Every woman should be able to decide when and whether to have children. This is true if she is Take care of yourself, and each other. HIV-positive or not. Women need and deserve a voice in the decisions that affect their lives.” In a lively morning plenary session by a panel made P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 2 01 2 7
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  • 15. BRIEFLY Enid Vázquez FDA approves Truvada for PrEP The Food and Drug Administration (FDA) reduction counseling, consistent and participants who in July approved Truvada as the first correct condom use, regular HIV testing, took Truvada in the medication to help prevent HIV infec- and screening for and treatment of other prescribed once- tion. As expected, the approval came sexually-transmitted infections, stating daily dose. with restrictions. that “Truvada is not a substitute for safer “The Partners Truvada, a combination of tenofovir sex practices.” PrEP trial was conducted (Viread) and emtricitabine (Emtriva), is Truvada now carries a Boxed Warning in 4,758 heterosexual couples, one of the most prescribed medications on its drug label alerting health care where one partner was HIV-infected and for HIV in this country. For HIV preven- professionals and uninfected individuals the other was not (serodiscordant cou- tion, the use of Truvada is called “PrEP,” that Truvada for PrEP must only be used ples),” the press release continued. “The for “pre-exposure prophylaxis.” by people confirmed to be HIV-negative trial evaluated the efficacy and safety of “[We] commend the FDA’s approval of before being prescribed the drug and [both] Truvada and [Viread] tenofovir [Truvada] for the use of [PrEP] to prevent tested at least every three months dur- versus placebo in preventing HIV infection HIV transmission. This approach can ing use to reduce the risk of developing in the uninfected male or female partner. prevent many new infections and could drug resistance. Both the antiviral and the Results showed Truvada reduced the risk dramatically impact HIV transmission PrEP dose is one pill taken once daily. of becoming infected by 75% compared worldwide,” said Kenneth H. Mayer, MD, Truvada maker Gilead Sciences worked with placebo. Medical Research Director and Co-chair with the FDA to create a Risk Evaluation “No new side effects were identified of The Fenway Institute at Fenway Health. and Mitigation Strategy (REMS) for in the clinical trials evaluating Truvada “My colleagues and I are delighted to have Truvada PrEP. The REMS focuses on a pre- for the PrEP indication. The most com- helped to demonstrate the utility of this scriber training and education program mon side effects reported with Truvada promising approach for HIV prevention.” in counseling and managing individuals include diarrhea, nausea, abdominal David Ernesto Munar, President/CEO who are taking or considering Truvada for pain, headache, and weight loss. Serious of the AIDS Foundation of Chicago, said, PrEP. The REMS looks at the elements of adverse events in general, as well as “Our challenge now is to implement PrEP a comprehensive HIV prevention strategy, those specifically related to kidney or as strategically as possible, and to ensure the importance of adhering to the recom- bone toxicity, were uncommon.” the people who need it most, those who mended daily dosing regimen, and the As a condition of approval, Gilead are most at risk for HIV, have access.” serious risks of taking Truvada for PrEP if Sciences is required to collect and “This is an enormous turning point, a already infected with HIV or of becoming analyze samples from individuals who real game changer, in the fight against infected while taking it. become infected with HIV while taking HIV,” said Jim Pickett, AFC’s Director According to the press release, Truvada to see if they’ve developed drug of Prevention Advocacy and Gay Men’s “Truvada’s safety and efficacy for PrEP resistance. The company is also required Health. “The toolbox we have now has were demonstrated in two large, random- to collect data on women who become Truvada as PrEP. We can look forward to ized, double-blind, placebo-controlled pregnant while taking Truvada for PrEP more sex acts being protected, especially clinical trials. The iPrEx trial evaluated and to conduct other research. among individuals who have already Truvada in 2,499 HIV-negative men “Today’s decision is the culmination chosen, for whatever reason, to not use or transgender women who have sex of almost 20 years of research involving condoms consistently.” with men and with evidence of high investigators, academic and medical According to a press release from the risk behavior for HIV infection... Results institutions, funding agencies, and nearly Photo: Joshua Thorne FDA, “Truvada is to be used for [PrEP] in showed Truvada was effective in reduc- 20,000 trial participants around the combination with safer sex practices to ing the risk of HIV infection by 42% com- world, and Gilead is proud to have been prevent sexually-acquired HIV infection in pared with placebo in this population. a partner in this effort,” said Norbert adults at high risk.” Efficacy was strongly correlated with Bischofberger, PhD, Executive Vice The FDA said Truvada for PrEP should drug adherence in this trial.” President, Research and Development be used as part of a comprehensive It was also shown in iPrEX that there and Chief Scientific Officer, Gilead HIV prevention plan that includes risk was a 92% reduction of risk for HIV in Sciences. >> P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 201 2 13
  • 16. BRIEFLY Enid Vázquez in the greatest expansion of HIV preven- Rapid home Moises Agosto tion tools than at any other time in the history of this epidemic. Coupled with the HIV test approved reforms included in the Patient Protection and Affordable Care Act, as well as the In June, the Food and Drug National HIV/AIDS Strategy, we are in a Administration (FDA) approved the position for the first time in over three OraQuick In-Home HIV Test, an HIV decades to finally end this epidem- self-test kit that does not require sending ic. Today’s decision is another important a sample to a laboratory for analysis. The step in realizing that goal.” kit, which tests a swab from your mouth, is approved for sale in stores and online Dolutegravir/Epzicom to anyone age 17 and older. (Although HIV is not found in saliva, evidence of superior to Atripla? exposure to the virus—called HIV anti- bodies—is found in the mouth and indi- Shionogi-ViiV Healthcare LLC announced cates infection.) A positive result at home that initial results from its Phase 3 study must then be followed up with a confir- SINGLE (ING114467) show superiority of matory blood test from a laboratory. its investigational HIV medication dolute- The FDA said the test can be falsely >> The following is from a statement gravir plus Epzicom over Atripla, one of negative for reasons that include the from Moises Agosto, Director of the most widely prescribed antiviral med- occurrence of HIV infection within three Treatment Education, Adherence, and ications in the country. At 48 weeks, 88% months before testing. People who Mobilization for the National Minority of study participants on the dolutegravir engage in behaviors that put them at AIDS Council (NMAC): regimen achieved undetectable viral increased risk of getting HIV—including load (less than 50 copies/mL) vs. 81% of having unprotected sex with new part- “While PrEP shows substantial promise as those on Atripla, a statistically significant ners, or injecting illegal drugs—should be a supplement to current HIV prevention difference. The company said the dif- re-tested on a regular basis. They should efforts, it is by no means a panacea and ference was primarily driven by a higher not interpret a negative test to indicate is only effective when used in conjunction rate of discontinuation due to adverse that engaging in high risk behavior is with traditional prevention and risk reduc- events in the Atripla arm. All individuals safe. tion strategies, such as condom usage. in the study were taking antiviral therapy “Anti-retroviral medications, like for the first time, a group that does the Truvada, are extremely powerful drugs best in HIV treatment. There were 414 with the potential for serious side individuals put on dolutegravir and 419 effects. As such, PrEP should only be put on Atripla. Overall, 2% of those on the used by individuals who are highly vul- dolutegravir-based regimen discontinued nerable to HIV infection, including those due to adverse events vs. 10% of those in sero-discordant couples, sex workers, receiving the Atripla regimen. The most and gay men. Its efficacy is also directly common adverse events while on Atripla related to an individual’s adherence to were neurological (reported by 41% of a regimen, and should only be used by Atripla recipients vs. 15% of participants those who can commit to taking it regu- receiving the dolutegravir), while the larly. Finally, use of PrEP by individuals most common drug-related adverse who may already be HIV-positive could events with dolutegravir were in the gas- increase the risk of drug resistance. trointestinal system (reported by 22% of “In recent years, there have been a people on dolutegravir vs. 22% of those number of promising developments in given Atripla). biomedical interventions—from treat- Dolutegravir is an investigational ment as prevention and pre-exposure integrase inhibitor (INSTI), the same class prophylaxis to microbicides and vaccine as Isentress, the only INSTI currently on research. These advances have resulted the market. 14 SEP TE M B E R +O C TO BER 201 2 P os i t i v e lyAware .com
  • 17. E-NEWS | Sign up for the weekly email newsletter of positively aware. go to positivelyaware.com From the Weekly E-News is an important step forward in our fight Studies find against the disease.” once-daily ‘Quad’ Website offers ViiV Healthcare is the first pharma- ceutical company to support the program is safe and effective access to HIV meds with HIV/AIDS medications and funding. for uninsured The goal of HarborPath is to get all HIV/AIDS medications into the program The findings of two large international randomized studies published in The HarborPath, a new non-profit organiza- and serve uninsured individuals with: Lancet medical journal indicate that the tion, has been established to create a new once-daily pill combining three program that offers a single place where n An easy-to-use website with a single antiretrovirals and a booster molecule is uninsured HIV-positive people who portal to determine eligibility for the a safe and effective alternative to two otherwise qualify for manufacturer- program and to fill prescriptions for widely used drug regimens for newly sponsored patient assistance programs participating companies’ HIV/AIDS diagnosed HIV-positive adults who have (PAPs) can apply for and receive their medications. had no previous treatment. The study medications. The “one stop shop” portal n Automatic notifications for both the results also indicate that the new “Quad” will provide a streamlined, online process individual and the case manager of pill is faster acting, doesn’t have the neu- to qualify individuals and deliver the qualification for the program. ropsychiatric side effects associated with donated medications through a mail- n A pharmacy that ships a 3-month sup- other combinations, and could improve order pharmacy. HarborPath will pilot the ply of all participating medications in compliance with treatment. program in states with high need, includ- one package within two business days “Patient adherence to medication is ing Alabama, Texas, and Virginia. of final approval and confirms delivery vital, especially for patients with HIV, To create the portal, HarborPath of the medications. where missed doses can quickly lead to worked closely with the National Alliance n Renewal reminders to individuals and the virus becoming resistant to medica- of State and Territorial AIDS Directors case managers to improve medication tion. Older HIV treatment regimens (NASTAD) and the Clinton Health Access adherence. involve taking several pills multiple times Initiative (CHAI), which provided the seed n A fully automated portal that case a day,” explains Paul Sax from Brigham funding for the organization. On World managers can access at any time and Women’s Hospital, Harvard Medical AIDS Day 2011, President Bill Clinton noted for up-to-the-minute status of an School, lead author of the first study. the need to fight HIV/AIDS in the U.S. individual’s application or shipment. If “Our results provide an additional highly “I am proud that my foundation is needed, live support is also available potent, well-tolerated treatment option, partnering with NASTAD and other through a toll-free call center. and highlight the simplicity of treatment pharmaceutical manufacturers to make resulting from combining several anti- sure Americans living with HIV have Murray Penner, Deputy Executive retrovirals in a single pill. Studies have access to the life-saving medications Director at NASTAD, said, “Under the cur- shown that single pill treatments improve they need,” said President Clinton. “This rent PAP process, an individual or their both adherence and patient satisfaction, case manager has to apply and help prevent prescription errors, separately to each com- thereby reducing the likelihood of treat- pany’s program for these ment failure and drug resistance.” medications, which can be The first study randomly assigned complex and time-consum- 700 patients from centers across North ing. Missing doses or failing America to start treatment with two to fill prescriptions because different single tablet regimens—either of complications sometimes the Quad, combining the new integrase associated with these pro- inhibitor elvitegravir (EVG) boosted with cesses may result in serious cobicistat (a new pharmacoenhancer; health consequences, or COBI) plus emtricitabine/tenofovir even death, in addition to (Emtriva/Viread), or Atripla (efavirenz/ increased transmission of emtricitabine/tenofovir), the current gold the virus. HarborPath is standard regimen approved by the FDA designed to address this in 2006. urgent need in the U.S.” After 48 weeks of treatment, 88% >> P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 201 2 15
  • 18. BRIEFLY Enid Vázquez of patients given the Quad had sup- was reached by 90% of people in the first conference to be held in the U.S. pressed viral loads (less than 50 copies/ Quad group compared with 87% in the since President Obama lifted the travel mL), compared with 84% in the Atripla atazanavir/ritonavir/emtricitabine/teno- ban on HIV-positive people, his anticipa- group. fovir group. tion of such events as displays of the Adverse events that led to patients The safety of the two regimens was AIDS Memorial Quilt, a planned march discontinuing treatment were infrequent also similar. and demonstration, the performance and similar in both groups. Mild nausea of the Tony Award-winning play The was more common with the Quad, but patients were less likely to have dizziness, PA’s editor debuts Normal Heart, as well as the many global leaders in AIDS policy, advocacy, and abnormal dreams, insomnia, and rash blog on HuffPo treatment advances that presented at the compared with the Atripla regimen. conference. The second trial included 708 Positively Aware editor Jeff Berry has treatment-naïve adults from 146 medical joined other AIDS activists and journalists centers across Australia, Europe, North America, and Thailand. Patients were such as The Body’s Kellee Turrell, the AIDS Foundation of Chicago’s David Ernesto Did he get infected? randomly assigned to receive a once-daily Munar, and others in becoming a blogger In the July+August issue of Positively Quad or a popular and recommended published by The Huffington Post. Aware, a young man in Chicago, Chris, twice-daily combination of Norvir- In advance of the upcoming AIDS 2012 was anxiously awaiting the results of his boosted Reyataz (atazanavir/ritonavir) World AIDS Conference, Berry wrote HIV tests following a potential exposure plus Truvada (emtricitabine/tenofovir). “Reflections from an Epidemic: Carrying through sex (“PrEPing,” July+August). The primary endpoint, to achieve viral the Torch to AIDS 2012.” In it, he talks Two months later, he remains levels below 50 copies/mL by week 48, about the significance of this being the HIV-negative. Simplify your life. Turn your assorted prescription medicine bottles into single-dose packs. Easy to remember. Easy to take. Each pack contains all the pills of a single dose. Free FedEx shipping anywhere in the continental U.S. J Discount Pharmacy Call to place your first order: (773) 278-5337 16 SE P TE M B E R +O C TO BER 201 2 P os i t i v e lyAware .com
  • 19. TPAN, publisher of Positively Aware, is commemorating 25 years of service to Chicago’s HIV community. Join Jamar Rogers, of NBC’s “The Voice,” for a special performance. October 4, 2012 5:30–8:30 PM | Chicago Cultural center Tickets available at www.tpan.com Event sponsors ANNIVERSARY PARTNERS $100,000 AND ABOVE $50,000 AND ABOVE Alphawood Foundation Janssen Therapeutics Photo: Matthew Garsteck Bristol-Myers Squibb $25,000 AND ABOVE $10,000 AND ABOVE Abbott Virology AIDS Foundation of Chicago EMD Serono Blue Cross and Blue Shield Lloyd A. Fry Foundation of Illinois ViiV Healthcare Cheetah Gyms Walgreens Gilead Sciences, Inc. Macy’s MillerCoors Steamworks
  • 20. COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others. one The for me Patient model. Pill shown is not actual size. INDICATION Do not take COMPLERA if you are taking the following medicines: • other HIV medicines (COMPLERA provides a complete treatment for HIV infection.) COMPLERA (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate ® • the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®, 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), (emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) phenytoin (Dilantin®, Dilantin-125®, Phenytek®) combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before. Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®) COMPLERA does not cure HIV and has not been shown to prevent passing HIV • a proton pump inhibitor medicine for certain stomach or intestinal problems, to others. It is important to always practice safer sex, use latex or polyurethane including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), condoms to lower the chance of sexual contact with any body fluids, and to never omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®) re-use or share needles. Do not stop taking COMPLERA unless directed by your • more than 1 dose of the steroid medicine dexamethasone or dexamethasone healthcare provider. See your healthcare provider regularly. sodium phosphate • St. John’s wort (Hypericum perforatum) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) IMPORTANT SAFETY INFORMATION • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®, Contact your healthcare provider right away if you get the following side effects Epivir® or Epivir-HBV®, Epzicom®, Trizivir®) or conditions while taking COMPLERA: • rilpivirine (Edurant™) • Nausea, vomiting, unusual muscle pain, and/or weakness. These may be • adefovir (HEPSERA®) signs of a buildup of acid in the blood (lactic acidosis), which is a serious In addition, also tell your healthcare provider if you take: medical condition • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • Light-colored stools, dark-colored urine, and/or if your skin or the whites of your carbonate. Take antacids at least 2 hours before or at least 4 hours after you eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), take COMPLERA with liver enlargement (hepatomegaly), and fat in the liver (steatosis) • a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine • If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without medicines at least 12 hours before or at least 4 hours after you take COMPLERA first talking to your healthcare provider. Your healthcare provider will monitor • the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, your condition Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®) COMPLERA may affect the way other medicines work, and other medicines may • an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazole affect how COMPLERA works, and may cause serious side effects. (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®), voriconazole (Vfend®) • methadone (Dolophine®) This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
  • 21. Save up to You may be able to save on the co-pay for 200 your COMPLERA prescription with a Gilead $ HIV Co-pay Assistance Card. Call 1-877-505-6986 for more information per month or visit www.COMPLERA.com.* COMPLERA. A complete HIV treatment in only 1 pill a day. Ask your healthcare provider if it’s the one for you. Before taking COMPLERA, tell your healthcare provider if you: Common side effects associated with COMPLERA: • have liver problems, including hepatitis B or C virus infection • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, • have kidney problems nausea, rash, tiredness, and depression • have ever had a mental health problem Other side effects associated with COMPLERA: • have bone problems • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm and pain your unborn child • are breastfeeding; women with HIV should not breast-feed because they can pass Tell your healthcare provider if you have any side effect that bothers you or that HIV through their milk to the baby does not go away. These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider Contact your healthcare provider right away if you experience any of the for medical advice about side effects. following serious or common side effects: You are encouraged to report negative side effects of prescription drugs to the Serious side effects associated with COMPLERA: • New or worse kidney problems can happen in some people who take COMPLERA. FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you have had kidney problems in the past or take other medicines that can cause Take COMPLERA exactly as your healthcare provider tells you to take it kidney problems, your healthcare provider may need to do blood tests to check your • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to kidneys during your treatment with COMPLERA help get the right amount of medicine in your body. A protein drink does not replace • Depression or mood changes can happen in some people who take COMPLERA. a meal Tell your healthcare provider right away if you have any of the following symptoms: • Stay under the care of your healthcare provider during treatment with feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of COMPLERA and see your healthcare provider regularly hurting yourself (suicide) or have tried to hurt yourself • Bone problems can happen in some people who take COMPLERA. Bone problems Please see Patient Information for COMPLERA on the following pages. include bone pain, softening or thinning (which may lead to fractures). Your *The co-pay program covers up to $200 per month for 1 year from card activation or until the healthcare provider may need to do additional tests to check your bones card expires, up to $2400 in a calendar year. The program is subject to change or cancellation • Changes in body fat can happen in people taking HIV medicine. These changes at any time. may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine Learn more at www.COMPLERA.com