Gilead Sciences’ sofosbuvir and ribavirin cured participants who had genotype 2 or 3 of hepatitis C virus (HCV) at rates in the mid-70 percent range in two new Phase III studies, although results were better for those with genotype 2, aidsmap reports. Results were presented at the International Liver Congress, the 48th annual meeting of the European Association for the Study of the Liver (EASL) in Amsterdam.
The blinded, placebo-controlled POSITRON trial compared a 12-week regimen of sofosbuvir and ribavirin (given to 207 participants) with a placebo (given to 71 participants) in those with genotype 2 or 3 of the virus who had previously discontinued interferon-based therapy because of side effects, who had a medical condition that was incompatible with interferon treatment, or who had chosen not to take the drug. About 20 percent had evidence of compensated cirrhosis. The rate of sustained virologic response (SVR, considered a cure) 12 weeks after therapy among the group taking the active drugs was 78 percent compared with 0 percent taking the placebo.
The blinded, active-control FUSION trial included participants with genotype 2 or 3 who had not responded to previous interferon therapy. About 30 percent had evidence of compensated cirrhosis. Among them, 103 took the regimen for 12 weeks and 98 for 16 weeks. The SVR rate for the 12-week group was 50 percent, compared with 73 percent for the 16-week group.
Those with genotype 3 experienced lower response rates in both studies than those with genotype 2, as did those with cirrhosis as compared to those without.
The most common adverse side effects were headache, fatigue, nausea and insomnia. About 1 to 2 percent of those taking sofosbuvir discontinued the therapy.
To read the aidsmap story, click here.
To read the study, click here.
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