A Randomized Study of Extended Treatment With Peginterferon α-2b Plus Ribavirin Based on Time to HCV RNA Negative-Status in Patients With Genotype 1b Chronic Hepatitis C

OBJECTIVES: The treatment of patients with hepatitis C virus (HCV) genotype 1 with peginterferon plus ribavirin treatment for more than 48 weeks demonstrated high sustained virological response (SVR) rates. Although many studies extended the duration of therapy from 48 weeks to 72 weeks, the optimal duration has not yet been determined. METHODS: A total of 113 genotype 1b patients with high viral load were randomized at baseline to the standard (n = 56) or extended (n = 57) treatment group. The standard group patients received 48 weeks of peginterferon plus ribavirin treatment. In the extended group, the treatment was performed for 44 weeks after patients became negative for HCV RNA (total duration 48-68 weeks). RESULTS: The SVR rate of the standard and extended group was 36 % (20 of 56) and 53 % (30 of 57; P = 0.07). However, the extended group patients who became negative for HCV RNA between weeks 16 and 24 had a significantly higher SVR rate (78 %; 7 of 9) than that of standard group (9 %, 1 of 11; P = 0.005). The predictive factors for the SVR were the treatment regimen (the standard vs. extended treatment) and the time to HCV RNA negative-status. CONCLUSIONS: The extended treatment significantly increased the SVR rate in patients who were HCV RNA negative at 16-24 weeks.