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.
In cohort A, 43 patients who received 200 mg sofosbuvir and 43 patients who received 400 mg sofosbuvir had undetectable HCV RNA at week 12 post-treatment, as did 26 patients in the placebo group. In cohort B, 23 patients had undetectable HCV RNA at week 12 post-treatment. The most common adverse events were fatigue, headache, nausea and chills, which are consistent with adverse events associated with peginterferon and ribavirin.
“Our data suggest further testing of the 400 mg once-daily dose of sofosbuvir in interferon-containing and interferon-free regimens for a total duration of 12 weeks across HCV genotypes, and that these regimens should be testing in a broader population of patients, including those with cirrhosis,” the researchers wrote. “In the ongoing phase 3 study, we are assessing sofosbuvir in combination with peginterferon and ribavirin for 12 weeks in treatment-naïve patients with HCV genotype 1.”
Disclosure: See the study for a list of financial disclosures.