Gilead reports data for sofosbuvir/NS5A combo

Next quarter, Gilead Sciences Inc. (NASDAQ:GILD) plans to submit an NDA to FDA and an MAA to EMA for an oral, once-daily, fixed-dose combination of the company's Sovaldi sofosbuvir ( GS-7977) and ledipasvir ( GS-5885) to treat chronic HCV genotype 1 infection. Gilead disclosed the plans after reporting data on Wednesday for three Phase III trials evaluating the fixed-dose combo, which has breakthrough therapy designation in the U.S. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir is an HCV NS5A protein inhibitor. Earlier this month, FDA approved Sovaldi for HCV infection. An MAA for Sovaldi is under accelerated assessment by EMA for HCV infection, with a decision expected next quarter (see BioCentury Extra, Dec. 6).

In 431 evaluable treatment-naive patients with chronic HCV genotype 1 infection in ION-1, sofosbuvir plus ledipasvir with ribavirin for 12 weeks produced a sustained virologic response (SVR) 12 weeks after the end of treatment in 97.2% of patients, with an SVR12 rate of 97.7% in patients receiving the combo without ribavirin. In 440 treatment-experienced patients with chronic HCV genotype 1 infection in ION-2, the fixed-dose combo with ribavirin for 12 weeks led to an SVR12 rate of 96.4% and the regimen without ribavirin for 12 weeks led to an SVR12 rate of 93.6%. The fixed-dose combo both with and without ribavirin for 24 weeks led to an SVR12 rate of 99.1%. In 647 non-cirrhotic, treatment-naive patients with chronic HCV genotype 1 infection in ION-3, the fixed-dose combo with ribavirin for eight weeks led to an SVR12 rate of 93.1% and the combo with ribavirin for 12 weeks led to an SVR12 rate of 95.4%. The fixed-dose combo without ribavirin for eight weeks led to an SVR12 rate of 93.1%. ...