Sovaldi Approved for Chronic Hepatitis C Infection
Sovaldi is indicated specifically for hepatitis C virus (HCV) genotypes 1, 2, 3, or 4 infection, including patients with hepatocellular carcinoma meeting Milan criteria and those with HCV/HIV-1 co-infection.
Sofosbuvir is an oral nucleotide analog polymerase inhibitor of the HCV NS5B polymerase enzyme, which plays an important role in HCV replication. Sovaldi is a direct-acting agent that interferes with the HCV life cycle by suppressing viral replication.
The efficacy of Sovaldi is primarily based on data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, which evaluated 12 or 16 weeks of treatment with Sovaldi combined with either RBV or RBV + peg-IFN.
In these trials, Sovaldi-based therapy was found to be superior to historical controls (NEUTRINO and FUSION) or to placebo (POSITRON), or non-inferior to currently available treatment options (FISSION) 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.
Sovaldi will be available in 400mg strength tablets in 28-count bottles.
For more information call (800) GILEAD-5 or visit Gilead.com.