Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400
mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in
patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study
has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who
received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or
standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for
these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high
response rates, several studies have shown that when these patients had rapid virologic
response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA)
levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment
could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin
for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in
these patients who achieved RVR. While studies showed concordant results in SVR rates for
patients with genotype 3 CHC who received peginterferon plus low dose or weight-based
ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in
patients with genotype 2 CHC who received such treatment. Currently, there are no studies on
the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of
treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to
conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of
peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.
Phase:
Phase 4
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborators:
Department of Health, Executive Yuan, R.O.C. (Taiwan) National Science Council, Taiwan