Gilead announced that the FDA has approved Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C infection as part of a combination antiviral treatment regimen. 

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.

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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