Gilead Sciences (GILD), Tuesday revealed positive results from a fourth late-stage study of its experimental once-daily nucleotide sofosbuvir in Hepatitis C patients who failed prior treatment.
The fourth Phase-3 study, called FUSION, evaluated 12- and 16-week courses of therapy with sofosbuvir plus standard care ribavirin in patients with genotype 2 or 3 chronic hepatitis C virus infection who failed prior treatment.
Results showed that 50 percent of the patients in the 12-week arm and 73 percent in the 16-week arm could suppress the virus. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response rate of 25 percent.
The most common advere events were fatigue, headache, insomnia and nausea.
"With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter," said Norbert Bischofberger, Gilead' Chief scientific officer.
Gilead recently said the drug combination also achieved main goals set in two other late-stage trials of treating patients who have chronic hepatitis C virus infection and have never been treated for it.
Sofosbuvir also showed promise in another late-stage study called Positron in patients who were unable or unwilling to take interferon - a standard hepatitis C drug known for its unpleasant side effects.
Gilead will present full data from the four studies at a future scientific conference.
Gilead is trading at $42.20, up 1.44%, on a volume of 5.6 million shares on the Nasdaq.
by RTT Staff Writer
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