BACKGROUND & AIMS: Patients infected with hepatitis C virus (HCV) genotype 1, body weights >/=85 kg and high baseline viral loads respond poorly to standard doses of peginterferon and ribavirin. We evaluated the effects of intensified therapy with peginterferon alfa-2a plus ribavirin.
METHODS: We performed a double-blind, randomized trial of outpatients from hepatology clinics who were infected with HCV genotype 1. Patients in the study had body weights >/=85 kg and HCV RNA titers >/=400,000 IU/mL. Patients were randomized to 180 mug/week peginterferon alfa-2a for 48 weeks in combination with 1200 mg/day ribavirin (standard of care) (group A, N=191) or 1400/1600 mg/day ribavirin (group B, N=189). Additional groups included those who received 360 mug/week peginterferon alfa-2a for 12 weeks and then 180 mug/week peginterferon alfa-2a for 36 weeks, combined with 1200 mg/day ribavirin (group C, N=382) or 1400/1600 mg/day ribavirin (group D, N=383). All patients were followed for 24 weeks after treatment.
RESULTS: Sustained virologic response rates (HCV RNA <15 IU/mL at the end of the follow-up period) in groups A, B, C, and D were 38%, 43%, 44%, and 41%, respectively. There were no significant differences among the 4 groups or between pooled peginterferon alfa-2a regimens (A+B vs. C+D: odds ratio [OR]=1.08, 95% confidence interval [CI]=0.83-1.39, P=0.584) or pooled ribavirin regimens (A+C vs. B+D: OR=1.00, 95% CI=0.79-1.28, P=0.974).
CONCLUSIONS: In patients infected with HCV genotype 1 who are difficult to treat (high viral load and body weight >/=85 kg), a 12-week induction regimen of peginterferon alfa-2a and/or higher-dose ribavirin is not more effective than the standard regimen.