Gilead Sciences (GILD: Quote) Tuesday said sofosbuvir, a once-daily therapy for patients with chronic hepatitis C viral infection, met primary end-point in the phase 3 study, named FUSION.
The study evaluated 12 and 16 week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin in patients with genotype 2 or 3 chronic hepatitis C virus infection.
The study demonstrated that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options.
All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures. No patients discontinued sofosbuvir or RBV due to adverse events. The most common adverse events included fatigue, headache, insomnia and nausea.
The primary efficacy endpoint of superiority was met, compared to a predefined historic control sustained virologic response rate of 25 percent.
Looking ahead, with positive results from all the four Phase 3 trials, Gilead is on track to meet its goal of filing regulatory applications in the U.S. and Europe in the second quarter.
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by RTT Staff Writer
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