Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 – 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation.
- To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance
- To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.
Chronic Hepatitis C, HCV Genotype 1
Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication|
- Sustained virological response (HCV RNA negative) 6 months post-treatment cessation
- Hepatic and serum HCV RNA levels as a predictor for treatment duration
- HCV-specific T-cell reactivity as a predictor for treatment duration
|Study Start Date:||April 2002|
Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment.
Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.
|University College London Hospital, London, United Kingdom, WC1E 6HX|
|Principal Investigator:||Nikolai V. Naoumov, MD||Institute of Hepatology, University College London|