Drug & Device Development

Two hepatitis C drug trials meet study goals

Last Updated: 2013-02-04 13:10:21 -0400 (Reuters Health)

(Reuters) - Gilead Sciences on Monday said two late-stage hepatitis studies have met their goals.

The studies, dubbed Fission and Neutrino, evaluated a 12-week course of once-daily nucleotide sofosbuvir in combination with ribavirin for the Fission study, and in combination with ribavirin and pegylated interferon for the Neutrino study.

The drugs were tested in patients with previously untreated chronic hepatitis C virus (HCV) infection.

In the Fission study, patients with HCV infection were selected at random to receive either a 12-week course of sofosbuvir plus ribavirin (RBV), or standard of care with 24 weeks of pegylated interferon alfa-2a (peg-IFN) plus RBV.

The study met its primary goal showing that the treatment was just as good as sofosbuvir plus RBV to peg-IFN plus RBV. In the study, 67% of patients achieved a sustained virologic response in the sofosbuvir plus RBV treatment group, versus 67% in the peg-IFN plus RBV treatment group.

Common adverse events - fatigue, headache, nausea, insomnia and dizziness - occurred more frequently in patients receiving peg-IFN and RBV compared with sofosbuvir and RBV.

In the Neutrino study, patients were given a 12-week course of sofosbuvir, RBV and peg-IFN. This study met its primary goal of achieving superiority, with 90% of patients in the study group showing a sustain response versus 60% in the control group.

The most common adverse events that occurred in about 20% of patients in the Neutrino study were fatigue, headache, nausea, insomnia and anemia.