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Can we end the HIV/AIDS
epidemic?
Josip Begovac
University Hospital for Infectious Diseases, Zagreb,
Croatia
7th Regional HIV and AIDS Conference
Sarajevo, 28th - 29th May 2015
Outline
• Epidemiology
• The concept of ending AIDS
• Antiretrovirals for HIV Prevention
– Pre-exposure prophylaxis
HIV in Europe in 2013
• 136 235 new HIV infections were diagnosed in 51
of the 53 countries of the WHO European Region
• 56 507 were officially reported to ECDC/WHO
Regional Office for Europe by 50 countries
• 29 157 infections from the European Union and
European Economic Area (EU/EEA)
• 79 728 infections was published by the Russian
Federal Scientific and Methodological Centre for
Prevention and Control of AIDS
ECDC: HIV surveillance in Europe 2013
HIV in Europe 2013
WHO Region EU/EEC Including Russia
Rate of HIV 7.8 5.7 15.7
AIDS cases 15 789 4 369
Rate of AIDS 2.2 0.9
Rate per 100 000 population
ECDC: HIV surveillance in Europe 2013
Male-to-female ratio in new HIV diagnoses, by country, Centre, 2013 (n=4 166)
ECDC: HIV surveillance in Europe 2013
End of AIDS?
Choosing a future… The End of AIDS
• “The End of AIDS” is an aspirational vision
• Epidemiological concepts of elimination and eradication
not readily applicable to AIDS as millions are living with
HIV and no cure available
• Key step to “The End of AIDS” is epidemic control
– Epidemic control - Reduction of disease incidence, prevalence,
morbidity or mortality to a locally acceptable level as a result of
deliberate intervention measures
– Point where HIV no longer represents a public health threat and
no longer among the leading causes of country’s disease burden
– Mathematically defined as the point at which the reproductive
rate of infection (R0) is below 1
Source: Cremin I. et al. AIDS 2013
Status quo
+ 100% ART at CD4 200
+ Circumcision
+ Early ART
+ PrEP
Is HIV epidemic control achievable?
Without a vaccine or cure?
Yes, HIV epidemic control is achievable!
However, a vaccine or cure is essential for elimination
Ambitious, but achievable, new target
The result
= a three-fold increase
over current estimates
72%
of people living with
HIV will be virally
suppressed
3
The objective
“Maximize the effectiveness of existing tools
to virtually eliminate progression to AIDS,
premature death and HIV transmission, and
thereby transform the HIV/AIDS pandemic into a
low level sporadic endemic.”
Antiretrovirals for HIV prevention
Role of antiretrovirals in prevention of HIV
transmission
• Antiretrovirals for HIV negative individuals
– Before exposure (pre-exposure prophylaxis)
• Oral medication
• Micobicides
– After exposure (post-exposure prophylaxis)
• Widely used for prophylaxis post-needlesticks (poor evidence
base), now being used post-sexual exposure
• Antiretrovirals for HIV infected individuals
– Prevention of MTCT
– Prevention of sexual transmission
Antiretrovirals for HIV negative
individuals
18
What is pre-exposure prophylaxis
(PrEP)?
• Pre
 Before (and after)
• Exposure
 When a fluid containing HIV comes into contact with
mucous membranes or non-intact skin
• Prophylaxis
 An action taken to prevent infection or disease
19
19
What is PrEP to prevent HIV
infection?
• The ongoing use of one or two antiretrovirals by HIV-negative
individuals starting before an exposure and continuing afterwards
– A potential option to prevent infection from ongoing
exposures to HIV during periods of risk
• A recently proven strategy still being studied
• PrEP is currently unapproved in Europe
•20
Potential types of PrEP
How are the antiretrovirals
used?
• Oral pill
• Topical gel (microbicide)
•Rectal
•Vaginal
• Injection
• Intravaginal ring
How often are the
antiretrovirals used?
• Daily
• Intermittently
• Coitally (before/sex)
How many antiretrovirals are
used?
• Single
• Combination
What antiretrovirals are used? • Over 25 available
TDF Concentrates 10-100x More in Rectal
Tissue than in Cervico-vaginal Tissues
Days post single-dose
Patterson KB et al. Sci Transl Med. 2011.
22
On Demand PrEP
with Oral TDF/FTC in MSM Results of the
ANRS Ipergay Trial
Molina JM, Capitant C, Spire B, Pialoux G, Chidiac C,
Charreau I, Tremblay C, Meyer L, Delfraissy JF, and the ANRS Ipergay Study
Group
Hospital Saint-Louis and University of Paris 7, Inserm SC10-US019
Villejuif, Hospital Tenon, Paris, Hospital Croix-Rousse, Lyon, UMR912
SEAS Marseille, France, CHUM, Montreal, Canada
and ANRS, Paris, France
Study Design
• HIV negative high risk MSM
• Condomless anal sex
with > 2 partners within 6 m
• eGFR > 60 mL/mn
Full prevention services*
TDF/FTC before and after sex
Full prevention services*
Placebo before and after sex
* Counseling, condoms and gels, testing and treatment for STIs, vaccination for HBV and HAV, PEP
 End-point driven study : with 64 HIV-1 infections, 80% power to detect a 50% relative
decrease in HIV-1 incidence with TDF/FTC (expected incidence: 3/100 PY with placebo)
 Follow-up visits: month 1, 2 and every two months thereafter
www.ipergay.fr
Double-Blinded Randomized Placebo-Controlled Trial
Friday Saturday Sunday Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Ipergay : Event-Driven iPrEP
 2 tablets (TDF/FTC or placebo)
2-24 hours before sex
 1 tablet (TDF/FTC or placebo)
24 hours later
 1 tablet (TDF/FTC or placebo)
48 hours after first intake
KM Estimates of Time to
HIV-1 Infection (mITT Population)
Mean follow-up of 13 months: 16 subjects infected
14 in placebo arm (incidence: 6.6 per 100 PY), 2 in TDF/FTC arm (incidence: 0.94 per 100 PY)
86% relative reduction in the incidence of HIV-1 (95% CI: 40-99, p=0.002)
NNT for one year to prevent one infection : 18
Pragmatic Open-Label
Randomised Trial of Pre-Exposure
Prophylaxis: the PROUD study
http://www.proud.mrc.ac.uk/
Sexual health service in England
• ~220 sexual health clinics, linked
through professional guidelines
• Accessed by 110,000 HIV negative
gay men per year
• Diagnoses made and services
provided reported to Public Health
England
PROUD Pilot
GMSM reporting UAI last/next 90days; 18+;
and willing to take a pill every day
Risk reduction includes
Truvada AFTER 12M
Randomize HIV negative MSM
(exclude if treatment for HBV/Truvada contra-indicated)
Main endpoints in Pilot: recruitment and retention
From April 2014: HIV infection in first 12 months
Follow 3 monthly for up to 24 months
Risk reduction includes
Truvada NOW
545 enrolled
269 assigned to
DEFERRED
276 assigned to
IMMEDIATE
Participant randomization
HIV Incidence
Efficacy =86% (90% CI: 58 – 96%)
P value =0.0002
Rate Difference =7.6 (90% CI: 4.1 – 11.2)
Number Needed to Treat =13 (90% CI: 9 – 25)
Group No. of
infections
Follow-
up (PY)
Incidence
(per 100 PY)
90% CI
Overall 22 453 4.9 3.4–6.8
Immediate 3 239 1.3 0.4–3.0
Deferred 19 214 8.9 6.0–12.7
PrEP guidelines
US CDC: PreP for Prevention of HIV infection in te US 2014 A
Clinical Practice Guidelines
http://www.cdc.gov/hiv/prevention/research/prep/
IAS-USA: JAMA 2014;312:320.
BHIVA: Position statement on PrEP in the UK 2012
WHO: Consolidated guidelines on HIV prevention, diagnosis,
treatment and care for key populations, July 2014
ECDC: EU Members States should give consideration to
integrating PrEP into their existing HIV prevention package
for those most at-risk of HIV infection, starting with MSM.
ECDC April 30, 2015.
USA Guidelines
• Offer PrEP to:
– Persons with high risks based on
• Background HIV incidence > 2%
• Recent diagnosis of STI
• Using PEP more then 2x per year
–Injection drug use
• Who share injection equipment
• Inject ≥1 day
• Inject cocaine or methamphetamine
WHO PrEP Guidelines July 2014
• Recommended for MSM with a
comprehensive prevention package
• Consider for discordant couples where
additional HIV prevention choices are
needed
Treatment for HIV infected patients
also called treatment as prevention
HPTN 052: HIV Transmission Reduced
by 96% in Serodiscordant Couples
Single transmission in patient in
immediate ART arm believed
to have occurred close to time
therapy began and prior to HIV-1 RNA
suppression
Total HIV-1 Transmission Events: 39
(4 in immediate arm and
35 in delayed arm; P < .0001)
Linked
Transmissions: 28
Unlinked or TBD
Transmissions: 11
P < .001
Immediate
Arm: 1
Delayed
Arm: 27
Cohen MS, et al. IAS 2011. Abstract MOAX0102.
Cohen MS, et al. N Engl J Med. 2011;[Epub ahead of print].
Note: PMTCT, Screening transfusions, Harm reduction, Universal precautions, etc. have not been included – this is on sexual transmission
Behavioural
Intervention
- Abstinence
- Be Faithful
HIV Counselling
and Testing
Coates T, Lancet 2000
Sweat M, Lancet 2011
Male Condoms
Female Condoms
Treatment of
STIs
Grosskurth H, Lancet 2000
Male
circumcision
Auvert B, PloS Med 2005
Gray R, Lancet 2007
Bailey R, Lancet 2007
Treatment for
prevention
Cohen M, NEJM, 2011
Donnell D, Lancet 2010
Tanser, Science 2013
Microbicides
for women
Abdool Karim Q, Science 2010
Grant R, NEJM 2010 (MSM)
Baeten J , NEJM 2012 (Couples)
Paxton L, NEJM 2012 (Heterosexuals)
Choopanya K, Lancet 2013 (IDU)
Oral pre-exposure
prophylaxis
Post Exposure
prophylaxis (PEP)
Scheckter M, 2002
ARV
prophylaxis
HIV
PREVENTION
Stigma: Major impediment to HIV prevention
and treatment
Source: UNAIDS Together we will end AIDS 2012
Stigma, discrimination & legislative hurdles
Challenges for achieving
90%-90%-90%
What about low-prevalence countries?
• The definition of „epidemiologic control”
should include the absence of an increasing
trend over time
Undetectable
In care Diagnosed
• How to increase early HIV diagnosis?
– Targeted testing for key populations
– Community based testing
– Testing in health care settings, particularly in STI
clinics
– Fighting stigma
Challenges for achieving
90%-90%-90%
STOP

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Can we end the HIV/AIDS epidemic? Josip begovac

  • 1. Can we end the HIV/AIDS epidemic? Josip Begovac University Hospital for Infectious Diseases, Zagreb, Croatia 7th Regional HIV and AIDS Conference Sarajevo, 28th - 29th May 2015
  • 2. Outline • Epidemiology • The concept of ending AIDS • Antiretrovirals for HIV Prevention – Pre-exposure prophylaxis
  • 3. HIV in Europe in 2013 • 136 235 new HIV infections were diagnosed in 51 of the 53 countries of the WHO European Region • 56 507 were officially reported to ECDC/WHO Regional Office for Europe by 50 countries • 29 157 infections from the European Union and European Economic Area (EU/EEA) • 79 728 infections was published by the Russian Federal Scientific and Methodological Centre for Prevention and Control of AIDS ECDC: HIV surveillance in Europe 2013
  • 4. HIV in Europe 2013 WHO Region EU/EEC Including Russia Rate of HIV 7.8 5.7 15.7 AIDS cases 15 789 4 369 Rate of AIDS 2.2 0.9 Rate per 100 000 population ECDC: HIV surveillance in Europe 2013
  • 5.
  • 6.
  • 7. Male-to-female ratio in new HIV diagnoses, by country, Centre, 2013 (n=4 166) ECDC: HIV surveillance in Europe 2013
  • 9. Choosing a future… The End of AIDS • “The End of AIDS” is an aspirational vision • Epidemiological concepts of elimination and eradication not readily applicable to AIDS as millions are living with HIV and no cure available • Key step to “The End of AIDS” is epidemic control – Epidemic control - Reduction of disease incidence, prevalence, morbidity or mortality to a locally acceptable level as a result of deliberate intervention measures – Point where HIV no longer represents a public health threat and no longer among the leading causes of country’s disease burden – Mathematically defined as the point at which the reproductive rate of infection (R0) is below 1
  • 10. Source: Cremin I. et al. AIDS 2013 Status quo + 100% ART at CD4 200 + Circumcision + Early ART + PrEP Is HIV epidemic control achievable? Without a vaccine or cure? Yes, HIV epidemic control is achievable! However, a vaccine or cure is essential for elimination
  • 12.
  • 13. The result = a three-fold increase over current estimates 72% of people living with HIV will be virally suppressed 3
  • 14. The objective “Maximize the effectiveness of existing tools to virtually eliminate progression to AIDS, premature death and HIV transmission, and thereby transform the HIV/AIDS pandemic into a low level sporadic endemic.”
  • 16. Role of antiretrovirals in prevention of HIV transmission • Antiretrovirals for HIV negative individuals – Before exposure (pre-exposure prophylaxis) • Oral medication • Micobicides – After exposure (post-exposure prophylaxis) • Widely used for prophylaxis post-needlesticks (poor evidence base), now being used post-sexual exposure • Antiretrovirals for HIV infected individuals – Prevention of MTCT – Prevention of sexual transmission
  • 17. Antiretrovirals for HIV negative individuals
  • 18. 18 What is pre-exposure prophylaxis (PrEP)? • Pre  Before (and after) • Exposure  When a fluid containing HIV comes into contact with mucous membranes or non-intact skin • Prophylaxis  An action taken to prevent infection or disease
  • 19. 19 19 What is PrEP to prevent HIV infection? • The ongoing use of one or two antiretrovirals by HIV-negative individuals starting before an exposure and continuing afterwards – A potential option to prevent infection from ongoing exposures to HIV during periods of risk • A recently proven strategy still being studied • PrEP is currently unapproved in Europe
  • 20. •20 Potential types of PrEP How are the antiretrovirals used? • Oral pill • Topical gel (microbicide) •Rectal •Vaginal • Injection • Intravaginal ring How often are the antiretrovirals used? • Daily • Intermittently • Coitally (before/sex) How many antiretrovirals are used? • Single • Combination What antiretrovirals are used? • Over 25 available
  • 21. TDF Concentrates 10-100x More in Rectal Tissue than in Cervico-vaginal Tissues Days post single-dose Patterson KB et al. Sci Transl Med. 2011.
  • 22. 22
  • 23. On Demand PrEP with Oral TDF/FTC in MSM Results of the ANRS Ipergay Trial Molina JM, Capitant C, Spire B, Pialoux G, Chidiac C, Charreau I, Tremblay C, Meyer L, Delfraissy JF, and the ANRS Ipergay Study Group Hospital Saint-Louis and University of Paris 7, Inserm SC10-US019 Villejuif, Hospital Tenon, Paris, Hospital Croix-Rousse, Lyon, UMR912 SEAS Marseille, France, CHUM, Montreal, Canada and ANRS, Paris, France
  • 24. Study Design • HIV negative high risk MSM • Condomless anal sex with > 2 partners within 6 m • eGFR > 60 mL/mn Full prevention services* TDF/FTC before and after sex Full prevention services* Placebo before and after sex * Counseling, condoms and gels, testing and treatment for STIs, vaccination for HBV and HAV, PEP  End-point driven study : with 64 HIV-1 infections, 80% power to detect a 50% relative decrease in HIV-1 incidence with TDF/FTC (expected incidence: 3/100 PY with placebo)  Follow-up visits: month 1, 2 and every two months thereafter www.ipergay.fr Double-Blinded Randomized Placebo-Controlled Trial
  • 25. Friday Saturday Sunday Monday Tuesday Wednesday Thursday Friday Saturday Sunday Ipergay : Event-Driven iPrEP  2 tablets (TDF/FTC or placebo) 2-24 hours before sex  1 tablet (TDF/FTC or placebo) 24 hours later  1 tablet (TDF/FTC or placebo) 48 hours after first intake
  • 26. KM Estimates of Time to HIV-1 Infection (mITT Population) Mean follow-up of 13 months: 16 subjects infected 14 in placebo arm (incidence: 6.6 per 100 PY), 2 in TDF/FTC arm (incidence: 0.94 per 100 PY) 86% relative reduction in the incidence of HIV-1 (95% CI: 40-99, p=0.002) NNT for one year to prevent one infection : 18
  • 27. Pragmatic Open-Label Randomised Trial of Pre-Exposure Prophylaxis: the PROUD study http://www.proud.mrc.ac.uk/
  • 28. Sexual health service in England • ~220 sexual health clinics, linked through professional guidelines • Accessed by 110,000 HIV negative gay men per year • Diagnoses made and services provided reported to Public Health England
  • 29. PROUD Pilot GMSM reporting UAI last/next 90days; 18+; and willing to take a pill every day Risk reduction includes Truvada AFTER 12M Randomize HIV negative MSM (exclude if treatment for HBV/Truvada contra-indicated) Main endpoints in Pilot: recruitment and retention From April 2014: HIV infection in first 12 months Follow 3 monthly for up to 24 months Risk reduction includes Truvada NOW
  • 30. 545 enrolled 269 assigned to DEFERRED 276 assigned to IMMEDIATE Participant randomization
  • 31. HIV Incidence Efficacy =86% (90% CI: 58 – 96%) P value =0.0002 Rate Difference =7.6 (90% CI: 4.1 – 11.2) Number Needed to Treat =13 (90% CI: 9 – 25) Group No. of infections Follow- up (PY) Incidence (per 100 PY) 90% CI Overall 22 453 4.9 3.4–6.8 Immediate 3 239 1.3 0.4–3.0 Deferred 19 214 8.9 6.0–12.7
  • 32. PrEP guidelines US CDC: PreP for Prevention of HIV infection in te US 2014 A Clinical Practice Guidelines http://www.cdc.gov/hiv/prevention/research/prep/ IAS-USA: JAMA 2014;312:320. BHIVA: Position statement on PrEP in the UK 2012 WHO: Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, July 2014 ECDC: EU Members States should give consideration to integrating PrEP into their existing HIV prevention package for those most at-risk of HIV infection, starting with MSM. ECDC April 30, 2015.
  • 33. USA Guidelines • Offer PrEP to: – Persons with high risks based on • Background HIV incidence > 2% • Recent diagnosis of STI • Using PEP more then 2x per year –Injection drug use • Who share injection equipment • Inject ≥1 day • Inject cocaine or methamphetamine
  • 34. WHO PrEP Guidelines July 2014 • Recommended for MSM with a comprehensive prevention package • Consider for discordant couples where additional HIV prevention choices are needed
  • 35. Treatment for HIV infected patients also called treatment as prevention
  • 36. HPTN 052: HIV Transmission Reduced by 96% in Serodiscordant Couples Single transmission in patient in immediate ART arm believed to have occurred close to time therapy began and prior to HIV-1 RNA suppression Total HIV-1 Transmission Events: 39 (4 in immediate arm and 35 in delayed arm; P < .0001) Linked Transmissions: 28 Unlinked or TBD Transmissions: 11 P < .001 Immediate Arm: 1 Delayed Arm: 27 Cohen MS, et al. IAS 2011. Abstract MOAX0102. Cohen MS, et al. N Engl J Med. 2011;[Epub ahead of print].
  • 37. Note: PMTCT, Screening transfusions, Harm reduction, Universal precautions, etc. have not been included – this is on sexual transmission Behavioural Intervention - Abstinence - Be Faithful HIV Counselling and Testing Coates T, Lancet 2000 Sweat M, Lancet 2011 Male Condoms Female Condoms Treatment of STIs Grosskurth H, Lancet 2000 Male circumcision Auvert B, PloS Med 2005 Gray R, Lancet 2007 Bailey R, Lancet 2007 Treatment for prevention Cohen M, NEJM, 2011 Donnell D, Lancet 2010 Tanser, Science 2013 Microbicides for women Abdool Karim Q, Science 2010 Grant R, NEJM 2010 (MSM) Baeten J , NEJM 2012 (Couples) Paxton L, NEJM 2012 (Heterosexuals) Choopanya K, Lancet 2013 (IDU) Oral pre-exposure prophylaxis Post Exposure prophylaxis (PEP) Scheckter M, 2002 ARV prophylaxis HIV PREVENTION
  • 38. Stigma: Major impediment to HIV prevention and treatment Source: UNAIDS Together we will end AIDS 2012
  • 39. Stigma, discrimination & legislative hurdles
  • 40. Challenges for achieving 90%-90%-90% What about low-prevalence countries? • The definition of „epidemiologic control” should include the absence of an increasing trend over time Undetectable In care Diagnosed
  • 41. • How to increase early HIV diagnosis? – Targeted testing for key populations – Community based testing – Testing in health care settings, particularly in STI clinics – Fighting stigma Challenges for achieving 90%-90%-90%
  • 42. STOP