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Peginterferon Plus Ribavirin for Certain HCV Patients: Shorter Is Better

A variable-duration regimen for patients with HCV genotype 2 or 3 infections is an effective strategy that reduces costs and improves tolerability.

Among all patients with hepatitis C (HCV) infections, response rate to pegylated interferon-plus-ribavirin regimens is approximately 55%. However, patients with HCV genotype 2 or 3 virus infections have a higher response rate (about 80%) with a shorter duration of therapy — 24 weeks versus the usual 48 weeks for patients with genotype 1 infections. Although effective, combination regimens have substantial side effects, which increase with duration of therapy. In this randomized, multicenter Italian trial, investigators evaluated whether a course of treatment even shorter than 24 weeks is as effective as standard-duration therapy among 283 patients with genotype 2 or 3 infections.

All patients received peginterferon alfa-2b (1.0 µg/kg weekly) plus ribavirin (1000 mg or 1200 mg daily, based on body weight). Seventy patients received 24-week courses (standard-duration group), and 213 patients received variable-duration courses (12-week courses if HCV DNA test results were negative after 4 weeks of treatment or 24-week courses if test results were positive at 4 weeks). The study was designed as a noninferiority trial, with 80% power to detect a 12.5% difference between groups.

In the variable-duration group, 133 patients (62%) had negative HCV DNA tests at week 4 and were treated for 12 weeks. The overall sustained virologic response (24 weeks after treatment ended) was 77% in the variable-duration group and was 76% in the standard-duration group (95% CI for difference between groups, –13% to 10%). Within the variable-duration group, fewer patients who received 12 weeks of therapy than those who received 24 weeks of therapy discontinued treatment because of adverse events (1 vs. 8; P=0.045).

Comment: These results suggest that using a variable-duration regimen for patients with HCV genotype 2 or 3 infections, where patients with early virologic response are treated for only 12 weeks, is an effective strategy that reduces costs and improves tolerability.

— Atif Zaman, MD, MPH

Published in Journal Watch Gastroenterology July 26, 2005

Citation(s):

Mangia A et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med 2005 Jun 23; 352:2609-17.

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