Today, Gilead Sciences announced positive results for the company’s Phase III FUSION study evaluating its hepatitis C treatment.
The FUSION study evaluated 12 and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment. It met its primary efficacy endpoint of superiority when compared to a predefined historic controlled sustained virologic response (SVR) rate of 25 percent.
The found that 50 percent of patients in the group receiving therapy for 12 weeks 50 percent of patients achieved SVR12 and 73 percent of patients in the 16 week treatment group achieved SVR12.
“This study demonstrates 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,” Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer said in a statement. “With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and in Europe in the second quarter.”
In the FUSION study, patients received a 12 or 16 week course of sofosbuvir 400 mg once-daily plus RBV. There were 63 percent patients with genotype 3. For the group receiving the 12-week course, 86 percent of genotype 2 patients and 30 percent of genotype 3 patients achieved SVR12. For the group receiving the 16-week course, 94 percent of genotype 2 patients and 62 percent of genotype 3 patients achieved SVR12.
There were no discontinuations of treatment due to adverse events, however the most common reported by patients were fatigue, headache, insomnia and nausea.
According to the company, full results from the studies will be presented at a future scientific conference.
Source: Gilead Sciences
Last Updated: 2/19/13; 2:30PM EST