Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response.

摘要: A recent nonrandomized pilot trial showed that hepatitis C virus (HCV) patients with genotype 2/3 and rapid virological response (RVR) had a 90% sustained (SVR) rate after 14 weeks of treatment. We aimed to assess this concept in randomized controlled trial. In the trial, 428 treatment-naive HCV RNA–positive 2 or 3 were enrolled. Patients RVR (group A) 24 B) treated pegylated interferon α-2b (1.5 μg/kg) subcutaneously weekly ribavirin (800-1400 mg) orally daily. The noninferiority margin was set be 10% between two groups one-sided 2.5% significance level. obtained 302 (71%), 298 these group (n = 148) B 150). intention-to-treat analysis, SVR rates 120 148 (81.1%) 136 150 (90.7%) (difference, 9.6%; 95% confidence interval, 1.7-17.7). Among an RNA test end treatment, 139 (86.3%) achieved compared 146 (93.2%) 6.9%; −0.1 +13.9). Conclusion: cannot formally claim treatment is noninferior However, high, although longer may give slightly better SVR, we believe economical savings fewer side effects make it rational treat for only weeks.