Gilead Sciences GILD today announced topline results from two Phase 3
studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily
nucleotide sofosbuvir in combination with ribavirin (FISSION) and in
combination with ribavirin and pegylated interferon (NEUTRINO) among
treatment-naïve patients with chronic hepatitis C virus (HCV) infection.
In the FISSION study, patients with genotype 2 or 3 HCV infection were
randomized 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 efficacy endpoint of
non-inferiority of sofosbuvir plus RBV to peg-IFN plus RBV, with 67 percent
(170/253) of patients achieving a sustained virologic response (SVR) in the
sofosbuvir plus RBV treatment group versus 67 percent (162/243) in the peg-IFN
plus RBV treatment group (95 percent CI for the difference: -7.5 to +8.0
percent for sofosbuvir plus RBV versus peg-IFN plus RBV; predefined criterion
for non-inferiority was a lower bound of a two sided 95 percent CI of -15
percent). All common adverse events (≥10 percent in any group) occurred more
frequently in subjects receiving peg-IFN and RBV as compared to sofosbuvir and
RBV. The most common adverse events in the sofosbuvir plus RBV arm occurring
in ≥10 percent of the patients were fatigue, headache, nausea, insomnia and
dizziness.
In the NEUTRINO study, patients with genotype 1, 4, 5 or 6 HCV infection were
treated with a 12-week course of sofosbuvir, RBV and peg-IFN. This study met
its primary efficacy endpoint of superiority compared to a predefined historic
control SVR rate of 60 percent with 90 percent (295/327) of patients achieving
SVR12 after completing therapy (P<0.001).
In the NEUTRINO study the most common adverse events that occurred in ≥20
percent of patients were fatigue, headache, nausea, insomnia and anemia.
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