Gilead to submit app for HCV NS5A-nuc combo next year
Gilead Sciences Inc. (NASDAQ:GILD) said it remains on track to submit regulatory applications for its fixed-dose HCV NS5A-nuc combination -- sofosbuvir and GS-5885 -- in 2014. The detail came in an update of its HCV programs on Monday. Gilead is evaluating a fixed-dose combination of sofosbuvir, a single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor, and GS-5885, an HCV NS5A inhibitor, with and without ribavirin for 12 and 24 weeks in the Phase III ION-I trial in treatment-naïve patients with HCV genotype 1 infection; the Phase III ION-2 trial in treatment-experienced patients is slated to start this month.
Gilead also reported additional data from an arm of the Phase IIb ELECTRON trial on Monday showing that all nine null responders with HCV genotype 1 infection receiving sofosbuvir plus GS-5885 and ribavirin for 12 weeks achieved a sustained virologic response (SVR) four weeks after the end of treatment. In November, Gilead reported data showing that all 25 treatment-naïve patients with HCV genotype 1 infection receiving sofosbuvir plus GS-5885 and ribavirin for 12 weeks achieved an SVR4 (see BioCentury Extra, Nov. 12, 2012). ...