Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
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.

 Objectives:

 1. 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

 2. 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.
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 treatment week 12 and they will be withdrawn from the study protocol.
Inclusion Criteria:

 -  Age 18 - 65

 -  HCV RNA positive

 -  HCV genotype 1

 -  Histologically proven chronic hepatitis

 -  No previous antiviral treatment

 Exclusion Criteria:

 -  Liver histology showing cirrhosis

 -  Decompensated liver function

 -  WCC < 1500/mm3 or platelet count <90,000/mm3

 -  Co-infection with HIV or HBV/HAV

 -  Alcohol intake greater than 40 units/week

 -  Current intravenous drug dependence

 -  Pregnancy or breast feeding of infants

 -  Inadequate contraception

 -  Neuropsychiatric disorder

 -  Neoplastic disease

 -  Other significant medical problems