Gilead Sciences GILD today announced topline results from the Phase 3
POSITRON study examining a 12-week course of once-daily sofosbuvir plus
ribavirin (RBV) in patients with genotype 2 or 3 chronic hepatitis C virus
(HCV) infection who are not candidates to take interferon (IFN). The study
found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12
weeks after completing therapy (SVR12). The safety profile of sofosbuvir was
similar to that observed in previous studies, and there were few treatment
discontinuations due to adverse events.
POSITRON is the first of three Phase 3 studies to be completed that are
evaluating sofosbuvir therapy in HCV genotype 2 or 3 infected patient
populations.
In POSITRON, HCV genotype 2 or 3 patients who were interferon intolerant,
interferon ineligible or unwilling to take interferon were randomized (3:1) to
receive 12 weeks of either sofosbuvir 400 mg once daily plus weight-based RBV
twice daily (n=207) or matching placebo (n=71). Of the 207 patients randomized
to the sofosbuvir/RBV arm, 15 percent had compensated cirrhosis (more advanced
liver disease) and 53 percent were infected with genotype 2. SVR12 rates were
93 percent in genotype 2 and 61 percent in genotype 3. In the small percentage
of patients with cirrhosis at baseline who received sofosbuvir/RBV, 61 percent
achieved SVR12. All patients receiving sofosbuvir/RBV became HCV RNA negative
on treatment and relapse accounted for all virologic failures. No patient in
the placebo group achieved an SVR12. The most common adverse events reported
in greater than 10 percent of patients in the study were fatigue, nausea,
headache, insomnia, pruritis and anemia.
Full data from the study will be submitted for presentation at a future
scientific conference.
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