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news.Gilead Sciences has announced that two Phase 3 studies, FISSION and NEUTRINO, of Sofosbuvir conducted for a period of 12 weeks in hepatitis C virus (HCV) infected patients met the primary endpoints.
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The once-daily nucleotide sofosbuvir plus ribavirin (RBV) was assessed in FISSION study while sofosbuvir plus ribavirin and pegylated interferon was assessed in NEUTRINO study in chronic HCV infected patients who were new to the treatment.
Gilead chief scientific officer and research and development executive vice president Norbert Bischofberger said the data support positive clinical profile of sofosbuvir as potent, safe and well-tolerated HCV therapy.
"The sofosbuvir regimens in these trials allowed us to shorten the duration of effective hepatitis C therapy to just 12 weeks for treatment-naïve patients with genotypes 1 through 6," Bischofberger added.
Sustained virologic response (SVR) rate of 67% was achieved in the sofosbuvir plus RBV treatment group when compared to 67% in the pegylated interferon alfa-2a (peg-IFN) RBV treatment group in the FISSION study thus demonstrating the non-inferiority of sofosbuvir plus RBV to peg-IFN plus RBV.
The most common adverse events associated with FISSION study in the sofosbuvir plus RBV arm include fatigue, headache, nausea, insomnia and dizziness.
NEUTRINO study reported 90% SVR12 in patients after completing the therapy, thus meeting the primary efficacy endpoint of superiority compared to a predefined historic control SVR rate of 60%.
Fatigue, headache, nausea, insomnia and anemia were the most common adverse events associated with the NEUTRINO study.