3. BACKGROUND Hepatitis C related chronic liver disease is common and may result in devastating outcome. The standard treatment World wide is Interferon and Ribavirin combination.
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5. HYDROLYTIC ENZYMES + RUTOSID … .a new perspective in the management of Hepatitis C viral infections
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9. Phlogenzym ® with INTERFERON+RIBAVIRIN; a comparative study of efficacy and tolerability in patients with HCV infection
10. OBJECTIVE To compare the efficacy & tolerability of Phlogenzym ® vs standard therapy (Interferon & Ribavirin) in patients with HCV infections. Phlogenzym ® vs INTERFERON+RIBAVIRIN
11. STUDY OVERVIEW Idea Conceived In July 2003 Principal Investigator Identified 05-01-04 IRB –Approval 18-05-04 MoH Approval 25-03-05
12. STUDY OVERVIEW Study Began 25-01-05 Patients Screened 12-02-05 First Patient enrolled(V0) 27-03-05 First Patient completed(V6) 28-09-05 Study Presentation on 25-03-06
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16. Study Design Phlogenzym ® vs INTERFERON+RIBAVIRIN For 6-months For 9-months Conventional Dosage 2 Tablets,3-times a day ½ hr before meals 30-patients recruited; 22-patients completed 39-patients recruited; 30 -patients completed. Interferon+Ribavirin Phlogenzym ®
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19. Genotype Distribution in recruited patients Phlogenzym ® vs INTERFERON+RIBAVIRIN 1 0 1 2 2 3 17 25 3 6 4 Interferon Arm (Reference Drug) 6 6 Phlogenzym Arm (Test Drug) Untypable 3 Description
20. Phlogenzym ® vs INTERFERON+RIBAVIRIN Genotype Distribution in recruited patients
21. Previous Medical History in Recruited Patients Phlogenzym ® vs INTERFERON+RIBAVIRIN 30 0 Interferon Arm (Reference Drug) 32 7 Phlogenzym Arm (Test Drug) Naive Non Responders to Interferon Description
23. COMPLIANCE STATUS Phlogenzym ® vs INTERFERON+RIBAVIRIN 8 22 Interferon Arm (Reference Drug) 9 30 Phlogenzym Arm (Test Drug) Dropped Out Trial Completed Description
24. DETAILS OF INTERFERON ARM DROP OUT PATIENTS Phlogenzym ® vs INTERFERON+RIBAVIRIN Withdraw due to decrease TLC after 1 month of therapy 1 High grade fever after 1 month of therapy 1 Epistaxis after 1 month of therapy 1 H. Zoster after 4 months of therapy 1 Changed Physician after 1 month of therapy 4 REASONS ‘ n’
25. DETAILS OF Phlogenzym ® ARM DROP OUT PATIENTS Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
26. GENDER DISTRIBUTION IN PATIENTS WHO COMPLETED THERAPY Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’ 14 8 Interferon Arm (Reference Drug) 13 17 Phlogenzym ® Arm (Test Drug) Female Male Description
27. Phlogenzym ® vs INTERFERON+RIBAVIRIN GENOTYPE DISTRIBUTION IN PATIENTS WHO COMPLETED THERAPY Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’ 2 2 3 12 20 3 5 3 Interferon Arm (Reference Drug) 4 4 Phlogenzym ® Arm (Test Drug) Untypable 3 Description
28. Phlogenzym ® vs INTERFERON+RIBAVIRIN GENOTYPE DISTRIBUTION IN PATIENTS WHO COMPLETED THERAPY Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
29. PREVIOUS MEDICAL HISTORY IN PATIENTS WHO COMPLETED THERAPY Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’ 22 0 Interferon Arm (Reference Drug) 26 4 Phlogenzym ® Arm (Test Drug) Naive Non Responders to Interferon Description
30. Phlogenzym ® vs INTERFERON+RIBAVIRIN PREVIOUS MEDICAL HISTORY IN PATIENTS WHO COMPLETED THERAPY Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
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32. PCR –VE PATIENTS DISTRIBUTION Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
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34. Comparison of Change in ALT values Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
35. TOLERANCE JUDGMENT BY PATIENTS IN BOTH GROUPS Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
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38. Comparison of change in PCR at 9 months Phlogenzym ® vs INTERFERON+RIBAVIRIN p-value (two-tailed) .8743 t 0.16 df 50 n 22 30 std. dev. 0.63 0.60 mean 1.27 1.30 Interferon Phlogenzym ®
39. Changes in PCR with Phlogenzym ® Phlogenzym ® vs INTERFERON+RIBAVIRIN p-value (two-tailed) .0001 t 4.10 df 58 n 30 30 std. dev. 0.00 0.49 mean 1.00 1.37 PCR at VO PCR_V9
40. Plogenzym ® vs INTERFERON+RIBAVIRIN Changes in PCR with INTERFERON p-value (two-tailed) .0006 t 3.74 df 40 n 22 20 std. dev. 0.00 0.50 mean 1.00 1.40 V0 V9
41. Plogenzym ® vs INTERFERON+RIBAVIRIN Changes in ALT with Phlogenzym ® p-value (two-tailed) .6375 t 0.47 df 58 n 30 30 std. dev. 64.24 54.74 mean 92.3 43.7 ALT_V0 ALT_V9
42. COMPARISON WITH INTERFERON+RIBAVIRIN Phlogenzym ® vs INTERFERON+RIBAVIRIN Phlogenzym ® Interferons Ribavirin Subjective symptoms CICs Inflammation Kill the Virus
43. Phlogenzym ® vs INTERFERON+RIBAVIRIN Changes in ALT with INTERFERON p-value (two-tailed) .0002 t 4.06 df 42 n 22 22 std. dev. 39.49 31.38 mean 83.4 27.6 V0 V9
44. Comparison of Well Being Parameters at Visit 9 in both groups Phlogenzym ® vs INTERFERON+RIBAVIRIN 0.004 0.12 0.02 0 0.002 0.08 0.23 V6 0.45 0.32 0.34 0.19 0.23 0.03 0.42 V4 6.11 4.25 0.32 5.76 0.16 0.21 0.41 V0 Cumulative Score Weight Loss Fever Jaundice Fatigue Vomiting Anorexia
45. Cost Comparison of Phlogenzym ® & INTERFERON 9- Months Treatment Period COST BENEFIT OF PLHOGENZYM TREATMENT OVER INTERFERON TREATMENT (74%) Phlogenzym ® vs INTERFERON+RIBAVIRIN Mild diarrhea, irritation or itching 3 No follow-up after 2 months of therapy 1 No follow-up after 3 months of therapy 1 No follow-up after 1 month of therapy 4 Reasons ‘ n’
46. CONCLUSION Phlogenzym ® is as effective as Interferon +Ribavirin for HCV patients. End of Treatment Response was 40 % Phlogenzym ® vs INTERFERON+RIBAVIRIN
47. Phlogenzym ® vs INTERFERON+RIBAVIRIN Phlogenzym ® is very well tolerated & is associated with significant improvement in feeling of well being in majority of patients.
48. Phlogenzym ® Managing Hepatitis C with Efficacy, Safety & Economy
