Low Dose Peginterferon and Ribavirin Therapy for Patients With Chronic Hepatitis C Infected With Genotype 2 or 3
Sixty patients with chronic hepatitis C infected with HCV genotype 2 or 3 will be treated
using the combination of either low- or standard dose peginterferon and ribavirin for 24
weeks, with re-treatment using the standard doses and a longer duration (48 weeks) for those
who do not respond to or relapse after initial low dose therapy.
Adult patients with chronic hepatitis C who have HCV genotype 2 or 3 and previously have not
received anti-viral treatment will be given peginterferon alfa-2a (90 or 180 micrograms
weekly by injection) and ribavirin (800 mg daily by mouth). Patients will be monitored at
2- to 4-week intervals for side effects, compliance, complete blood counts, liver
biochemical tests and HCV RNA. Patients becoming HCV RNA negative by week 12 will be
considered on-treatment responders, continue therapy to week 24, and be monitored thereafter
for another 24 weeks. Patients who do not become HCV RNA negative by week 12 as well as
patients who relapse after therapy will be retreated with 180 micrograms of peginterferon
weekly and 800 mg of ribavirin for another 48 weeks.
The primary outcome will be sustained loss of HCV RNA at 24 weeks after low- or
standard-dose combination therapy. Secondary outcomes include viral kinetics and side
effects. Because of preliminary results in the initial 31 patients enrolled in this study,
the dose of peginterferon was changed from 90 to 180 micrograms weekly for the remaining 29
patients to be enrolled, allowing for a direct comparison of efficacy, viral kinetics and
side effects of standard- vs low-dose peginterferon therapy.
This study will evaluate the relative efficacy and safety of the standard versus lower doses
of peginterferon with ribavirin in patients with chronic hepatitis C and HCV genotype 2 or
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Virological Response (Intention to Treat)
Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.
6 months after stopping therapy
United States: Food and Drug Administration
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|