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PWE-129 Pegylated Interferon Alfa, Nitazoxanide, Telaprevir, Ribavirin, in Genotype 1 Undergoing Prior Experienced Chc-A Randomized Placebo Control Clinical Pilot Trial (Intrigue-C)
  1. P Basu1,
  2. N J Shah2,
  3. S Farhat3,
  4. R Siriki1,
  5. K Mittimanj1,
  6. M Rahaman1,
  7. S Atluri1
  1. 1Forest Hills Hospital, Hofstra North Shore-LIJ School of Medicine
  2. 2James J Peters VA Medical Center, Mount Sinai School of Medicine, New York
  3. 3Columbia School of Physicians and Surgeons, NY, New York, United States

Abstract

Introduction Chronic Hepatitis C is a global challenge with End stage liver disease and rising Hepatocellular Carcinoma. Peg Interferon Alfa and Ribavirin was the backbone of therapy. Recently introduced Directly Acting Antivirals (DAAs)-protease inhibitors have escalated Sustained Viral Response (SVR) in Response guided therapy in non responders, partial responders and relapsers. This study utilised NTZ & Telaprevir; with SOC for 24 weeks in treatment experienced patients.

Methods Fifty (n = 50) patients were divided into GroupA (n = 12) NTZ 500 mg three times for 12 weeks, Group B (n = 12) NTZ, BID for 12 weeks Group C (n = 26) control. All received Peg Interferon Alfa 2a 180 mcg SQ QOW with fixed dose of Ribavirin 1200 mg daily for 24 weeks and Telaprevir 750 mg three times daily for 12 weeks. Viral load was obtained at day 0, 7th day, 14thday, 4 weeks, 12th, 24 weeks and 48th weeks SVR. Viral kinetics was analysed. In Group A, B and C: 5/12(42%), 5/12(42%), 10/26(38%) Non Responder, 6/12(50%), 6/12 (50%),4/26(15%) partial responder, and 2/12(16%), 1/12 relapsers (8%), 4/26(15%) relapsers, 2/26(8%) unknown. Use of Growth factors-12% for severe anaemia, 8% for thrombocytopenia and 7% for neutropenia. Skin rash was 29%. Rectalgia was 11%. 3/50(6%) drop out, 2/50(4%) fell in futility law. Exclusion; Decompensated liver disease. HCC, poor controlled DM, severe CAD, Hemolytic anaemia, Major depression, Renal failure, Prior severe skin rash, active drug and alcohol abuse.

Abstract PWE-129 Table

Conclusion This quadruple 24 weeks regimen has excelled the RVR, EVR, ETVT over SOC with DAAs over 11%, with SVR 67%. Needs a larger trial for validation

Disclosure of Interest None Declared.

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