AN INNOVATIVE APPROACH TOWARDS THE TREATMENT of HEPATITIS C

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Lecture on Hepatitis C by Dr. Aftab Mohsin during the 6th International Infection Control Conference 2006

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AN INNOVATIVE APPROACH TOWARDS THE TREATMENT of HEPATITIS C

  1. 1. AN INNOVATIVE APPROACH TOWARDS THE TREATMENT of HEPATITIS C Prof. Dr. Aftab Mohsin Medical Unit III Services Hospital, Lahore.
  2. 2. Pakistan: A Cirrhotic State
  3. 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.
  4. 4. A PARADIGM SHIFT ! <ul><li>Enhancing endogenous immunity, increasing Interferons to kill an old enemy HCV. </li></ul><ul><li>Recently ( Nov; 2006) Liver meeting in Boston, USA dedicated presentations on agents that will enhance / augment immunity. </li></ul>
  5. 5. HYDROLYTIC ENZYMES + RUTOSID … .a new perspective in the management of Hepatitis C viral infections
  6. 6. HYDROLYTIC ENZYMES +RUTOSID BIOLOGICAL RESPONSE MODIFIER <ul><li>Known Biochemical Substances. </li></ul><ul><li>They have in vitro & vivo effects upon immune competent cells. </li></ul><ul><li>Even after prolonged use are not immuno-suppressive. </li></ul><ul><li>Neither teratogenic nor carcinogenic. </li></ul><ul><li>Jager H. et al; Hydrolytic Enzymes as BRM in Medical Virology, </li></ul><ul><li>Immunology & Oncology, Vol. 1: 44, Oxford, Newyork,Tokyo,1988. </li></ul>
  7. 7. HYDROLYTIC ENZYMES +RUTOSID BIOLOGICAL RESPONSE MODIFIER <ul><li>BRMs can be produced by body itself like cytokines. </li></ul><ul><li>Hydrolytic Enzymes + Rutosid combination is highly capable of boosting normal immune functions. </li></ul>
  8. 8. HYDROLYTIC ENZYMES +RUTOSID BIOLOGICAL RESPONSE MODIFIER <ul><li>Increases activity of Macrophages and NK-cells, enhancing the endogenous Interferon production. </li></ul><ul><li>Breaks down circulating immune complexes that block the activity </li></ul><ul><li>of Macrophages & NK Cells. </li></ul>
  9. 9. Phlogenzym ® with INTERFERON+RIBAVIRIN; a comparative study of efficacy and tolerability in patients with HCV infection
  10. 10. OBJECTIVE To compare the efficacy & tolerability of Phlogenzym ® vs standard therapy (Interferon & Ribavirin) in patients with HCV infections. Phlogenzym ® vs INTERFERON+RIBAVIRIN
  11. 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. 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
  13. 13. Phlogenzym ® vs INTERFERON+RIBAVIRIN <ul><li>PATIENTS’ INCLUSION CRITERIA </li></ul><ul><li>Age over 18 years. </li></ul><ul><li>Chronic active Hepatitis C. </li></ul><ul><li>PCR Positive. </li></ul><ul><li>Liver biopsy reveal chronic active hepatitis (optional; required in cases where AST / ALT normal & PCR positive). </li></ul>
  14. 14. Phlogenzym ® vs INTERFERON+RIBAVIRIN <ul><li>PATIENTS’ EXCLUSION CRITERIA </li></ul><ul><li>Hepatitis B or any other Liver Disease. </li></ul><ul><li>Pregnant women or nursing mothers. </li></ul><ul><li>Females in child bearing age without sufficient contraception during study. </li></ul><ul><li>Known intolerance against active ingredients of Phlogenzym. </li></ul><ul><li>Current participation in a clinical study within the last 3-months. </li></ul>
  15. 15. <ul><li>STUDY DESIGN </li></ul><ul><li>Open randomized pilot study </li></ul><ul><li>96-patients were screened </li></ul><ul><li>69-pts enrolled in 2-parallel groups </li></ul><ul><li>Conducted from Feb 05 – Aug 06 </li></ul>Phlogenzym ® vs INTERFERON+RIBAVIRIN
  16. 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 ®
  17. 17. b <ul><li>CRITERIA FOR EFFICACY </li></ul><ul><li>Normalization of LFTs </li></ul><ul><li>-ve HCV RNA by PCR </li></ul>Phlogenzym ® vs INTERFERON+RIBAVIRIN
  18. 18. <ul><li>CRITERIA FOR SAFETY </li></ul><ul><li>Platelet Count </li></ul><ul><li>Complete Blood Count </li></ul><ul><li>Abdominal Ultrasonography </li></ul>Phlogenzym ® vs INTERFERON+RIBAVIRIN
  19. 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. 20. Phlogenzym ® vs INTERFERON+RIBAVIRIN Genotype Distribution in recruited patients
  21. 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
  22. 22. Previous Medical History in Recruited Patients Phlogenzym ® vs INTERFERON+RIBAVIRIN
  23. 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. 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. 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. 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. 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. 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. 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. 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’
  31. 31. END OF TREATMENT RESPONSE <ul><li>In Phlogenzym® Group </li></ul><ul><li>12 Patients become HCV –ve </li></ul><ul><li>Response Rate is 40% </li></ul><ul><li>In INTERFERON+RIBAVIRIN Group </li></ul><ul><li>11-Patients become HCV –ve </li></ul><ul><li>Response Rate is 50% </li></ul>Phlogenzym ® vs INTERFERON+RIBAVIRIN
  32. 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’
  33. 33. <ul><li>END OF TREATMENT RESPONSE </li></ul><ul><ul><li>12 Patients are PCR -ve in Phlogenzym ® Group </li></ul></ul><ul><ul><li>End of Treatment Response Rate was 40% </li></ul></ul>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’
  34. 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. 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’
  36. 36. 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’ <ul><li>Minor allergic reactions </li></ul><ul><li>Harmless alteration in the consistency, colour and odor of the stool. </li></ul><ul><li>GI disturbances </li></ul><ul><li>Feeling of fullness </li></ul><ul><li>No such complaints. </li></ul><ul><li>Haemolytic anemia </li></ul><ul><li>Fatigue </li></ul><ul><li>Irritability </li></ul><ul><li>Skin rash </li></ul><ul><li>Anorexia </li></ul><ul><li>GI upsets </li></ul><ul><li>Flu like symptoms </li></ul><ul><li>Psychosis </li></ul><ul><li>Aggravation of all subjective symptoms. </li></ul><ul><li>Flu like feelings </li></ul><ul><li>Tiredness </li></ul><ul><li>Fatigue </li></ul><ul><li>Poor appetite </li></ul><ul><li>Nausea </li></ul><ul><li>Stomach pain </li></ul><ul><li>Diarrhoea </li></ul><ul><li>Fever </li></ul><ul><li>Liver pain </li></ul><ul><li>Muscle and joint pains </li></ul>Phlogenzym ® INTERFERON AND RIBAVIRIN SIDE EFFECTS SUBJECTIVE SYMPTOMS
  37. 37. <ul><li>STUDY OVERVIEW </li></ul><ul><li>SCREENING </li></ul><ul><li>11- VISITS </li></ul><ul><li>9- VISITS: V0- V9 at monthly interval </li></ul><ul><li>ETR at V6 & V9 </li></ul><ul><li>10- VISITS </li></ul><ul><li>6- months for PROPOSED SVR at V12. </li></ul>Phlogenzym ® vs INTERFERON+RIBAVIRIN
  38. 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. 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. 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. 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. 42. COMPARISON WITH INTERFERON+RIBAVIRIN Phlogenzym ® vs INTERFERON+RIBAVIRIN     Phlogenzym ®   Interferons  Ribavirin Subjective symptoms  CICs Inflammation Kill the Virus
  43. 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. 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. 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. 46. CONCLUSION Phlogenzym ® is as effective as Interferon +Ribavirin for HCV patients. End of Treatment Response was 40 % Phlogenzym ® vs INTERFERON+RIBAVIRIN
  47. 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. 48. Phlogenzym ® Managing Hepatitis C with Efficacy, Safety & Economy
  49. 49. THANKS

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