Positive Results for Sofosbuvir in Two Phase III Hepatitis Studies
Drug meets efficacy endpoints in both trials (Feb. 4)
Positive results have been reported from two phase III studies that evaluated treatment with the once-daily nucleotide sofosbuvir (Gilead Sciences) in combination with ribavirin (the FISSION trial) and in combination with ribavirin and pegylated interferon (peg-IFN) (the NEUTRINO trial) in treatment-naïve patients with chronic hepatitis C virus (HCV) infection.
In the FISSION trial, 499 patients with genotype 2 or 3 HCV infection were randomly assigned to receive either a 12-week course of sofosbuvir (400 mg once daily) plus ribavirin (1,000 or 1,200 mg/day) (n = 256) or standard of care with 24 weeks of peg-IFN alfa-2a (180 mcg/week) plus ribavirin (800 mg/day) (n = 243). The study met its primary efficacy endpoint of non-inferiority of sofosbuvir plus ribavirin compared with peg-IFN plus ribavirin, with 67% of patients achieving a sustained virologic response (SVR) in the sofosbuvir-plus-ribavirin group versus 67% in those treated with peg-IFN plus ribavirin.
All common adverse events occurred more often in patients receiving peg-IFN and ribavirin compared with those given sofosbuvir and ribavirin. The most common adverse events in patients treated with sofosbuvir plus ribavirin were fatigue, headache, nausea, insomnia, and dizziness.
In the NEUTRINO trial, 327 patients with genotype 1, 4, 5, or 6 HCV infection were treated with a 12-week course of sofosbuvir (400 mg once daily), ribavirin (1,000 or 1,200 mg/day), and peg-IFN (180 mcg/week). This study met its primary efficacy endpoint of superiority compared with a predefined historic control SVR rate of 60%, with 90% of patients achieving SVR12 after completing therapy (P < 0.001). The most common adverse events were fatigue, headache, nausea, insomnia, and anemia.
Source: Gilead Sciences; February 4, 2013.