Data from a phase 2 trial suggest that adding 12 weeks of sofosbuvir
to peginterferon alfa-2a and ribavirin may be beneficial in
non-cirrhotic, treatment-naive patients with genotypes 1, 2 and 3
hepatitis C virus infection.
In the two-cohort trial, patients with HCV genotype 1, 2 or 3 from 22
centers in the United States were recruited from Aug. 16 to Dec. 13,
2010. The 122 patients with HCV genotype 1 were allocated to cohort A.
These patients were randomly assigned to 200 mg sofosbuvir
(Gilead Sciences), 400 mg sofosbuvir or placebo for 12 weeks, with
peginterferon and ribavirin. Depending on viral response, the patients
continued peginterferon and ribavirin for an additional 12 weeks or 36
weeks. The 25 patients with genotypes 2 or 3 comprised cohort B. These
patients all received 400 mg sofosbuvir plus peginterferon and ribavirin
for 12 weeks.