PWE-129 Pegylated Interferon Alfa, Nitazoxanide, Telaprevir, Ribavirin, in Genotype 1 Undergoing Prior Experienced Chc-A Randomized Placebo Control Clinical Pilot Trial (Intrigue-C)

Abstract

Aim: 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 utilized NTZ and Telapravir; 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 for12 weeks Group C (n= 26) control. All received peg interferon alfa 2a 180 mcg SQ QOWwith 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, 7 th day, 14 th day, 4 weeks, 12 th, 24 weeks and 48 th weeks SVR. Viral kinetics was analyzed. 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 anemia, 8% for thrombocytopenia and 7% for nutropenia. 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 anemia, major depression, renal failure, prior severe skin rash, active drug and alcohol abuse. Results: In group A the Undetectable, NR, PR, AVR, VRVR, RVR, EVR, ETVR and SVR were 9/12 (75%), 1/12 (8%), 1/12 (8%), 11/12 (92%), 11/12 (92%), 9/12 (75%), 9/12 (75%), 9/12 (75%) and 8/12 (67%) respectively. In group B the undetectable, NR, PR, AVR, VRVR, RVR, EVR, ETVR and SVR were 1012(83%), 2/12 (16%), 12/12 (100%), 12/12 (100%), 10/12 (83%), 10/12 (83%), 10/12 (83%), 10/12 (83%) and 8/12 (67%) respectively. In Group C the Undetectable, NR, PR, AVR, VRVR, RVR, EVR, ETVR and SVR were 16/26 (62%), 4/26 (15%), 3/26 (11%), 20/26 (77%), 22/26 (84%), 18/26 (70%), 16/26 (62%), 16/26 (62%) and 15/26 (58%) respectively. Conclusion: This quadruple 24 weeks regimen has excelled the RVR, EVR, and ETVT over SOC with DAAs over 11%, with SVR 67%. Needs a larger trial for validation.