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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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