Feb 4 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
with ribavirin and pegylated interferon for the Neutrino study.
The drugs were tested in patients who have chronic hepatitis
C virus (HCV) infection and have never been treated for it.
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 percent of patients achieved a sustained virologic
response in the sofosbuvir plus RBV treatment group, versus 67
percent 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 percent of patients in the
study group showing a sustain response versus 60 percent in the
The most common adverse events that occurred in bout 20
percent of patients in the Neutrino study were fatigue,
headache, nausea, insomnia and anemia.