Gilead Submits NDA for Sofosbuvir for Hepatitis C
Gilead announced that it has submitted a New Drug Application (NDA) to the FDA for approval of sofosbuvir, a once-daily oral nucleotide analog for the treatment of chronic hepatitis C virus (HCV) infection. If approved, sofosbuvir would shorten HCV therapy to 12–16 weeks and would either eliminate or reduce the duration of peg-IFN injections depending on the genotype. Sofosbuvir interferes directly with the HCV life cycle by suppressing viral replication.
The submission was based on data from four phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV.
The data supports the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
For more information call (800) GILEAD-5 or visit www.gilead.com