CHMP recommends Solvadi for Chronic Hepatitis C- Gilead Sciences

On 21 November 2013 the CHMP recommended the granting of marketing authorisation for Solvadi (sofosbuvir), 400mg film coated tablet from Gilead Sciences for the treatment of chronic Hepatitis C. Solvadi provides the first interferon free treatment option for chronic Hepatitis C. In patients where interferon is still needed for efficacy Solvadi enables a shorter duration of treatment compared to current standard of care. Solvadi also can prevent graft re-infection in patients with HCV.

The MAA for sofosbuvir is supported primarily by data from four Phase III 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 (were HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. During the European review, data from two additional Phase III studies, VALENCE and PHOTON-1 were filed to the MAA. In the VALENCE study, patients with genotype 3 HCV infection were treated with sofosbuvir and RBV for 24 weeks. The PHOTON-1 study evaluated sofosbuvir and RBV for 12 weeks in patients with genotype 2 HCV infection co-infected with HIV-1 and for 24 weeks in patients with genotypes 1 or 3 HCV co-infected with HIV-1. In all Phase III studies of sofosbuvir, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.

Sofosbuvir received FDA Antiviral Drugs Advisory Committee recommendation in the US on 26 October 2013.