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Sofosbuvir/ribavirin effectively treated patients with HCV genotype 2, 3

Therapy combining sofosbuvir and ribavirin safely and effectively treated patients with chronic hepatitis C virus genotype 2 or 3 who either were unresponsive to or for whom pegylated interferon and ribavirin were not an option in a recent study.

Researchers conducted two multicenter, randomized phase 3 trials of patients with hepatitis C virus (HCV) genotype 2 or 3 infection to test the efficacy of sofosbuvir administered with ribavirin. In the first trial (POSITRON), the cohort included patients (n=207) who received sofosbuvir/ribavirin or matching placebo (n=71) for 12 weeks because peginterferon was not an option due to psychiatric disorders (57%) and autoimmune disorders (19%) among patients.

The other trial (FUSION) included 195 evaluable patients who did not have a response to previous interferon therapy. The cohort received sofosbuvir/ribavirin for either 12 (n=100) or 16 weeks (n=95). Primary endpoint was sustained virologic response (SVR) 12 weeks after therapy.

In the POSITRON trial, SVR was 78% (95% CI, 72-83) for patients assigned to sofosbuvir/ribavirin compared with 0% among patients assigned placebo (P<.001). Among FUSION patients, SVR was 50% (95% CI, 40-60) and 73% (95% CI, 63-81) in the 12-week and 16-week cohorts, respectively (P<.001 for each).

In subgroup analysis, researchers determined that SVR among both trials was greater for patients with genotype 2 infection compared with those with genotype 3. In addition, patients with genotype 3 who had cirrhosis displayed lower SVR than those who were noncirrhotic.

Adverse events included fatigue, headache, nausea and insomnia; overall discontinuation rates for sofosbuvir were 1% to 2%.

“Our findings suggest that 12 weeks of treatment with sofosbuvir and ribavirin can be an effective option for patients with HCV genotype 2 infection,” the researchers wrote about the study, which will be presented at the International Liver Congress in Amsterdam. “However, for patients with genotype 3 infection, particularly those who have cirrhosis or who have not had a response to prior treatment with interferon, extending the duration of treatment to 16 weeks may provide an additional benefit.”

Disclosure: See the study for a full list of relevant disclosures.