Three Phase II trials of Sovaldi for HCV report positive results - Gilead

Gilead Sciences has announced data from two Phase II studies and a compassionate access study in which a regimen containing once-daily Sovaldi (sofosbuvir) administered for the treatment of chronic Hepatitis C virus (HCV) infection in patients with advanced liver disease. Study GS-US-334-0125 is an ongoing open-label trial evaluating HCV patients with cirrhosis and portal hypertension, with or without decompensation. Of the 22 patients who completed 24 weeks of therapy, 95% achieved virologic suppression on treatment. Additionally, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared to patients in the observation arm. Sovaldi-based therapy was well tolerated in the study, and only one patient discontinued treatment due to an adverse event.

Study GS-US-334-0126 was a single-arm open-label trial in which patients with established recurrent HCV infection following liver transplantation received up to 24 weeks of therapy with Sovaldi plus RBV. The majority of patients had genotype 1-HCV infection. Seventy percent of patients in this study achieved SVR12. The most common adverse events occurring in more than 20% of patients were fatigue, headache, arthralgia (joint pain) and diarrhea. There were no deaths, graft losses or episodes of organ rejection.

A third, compassionate access study evaluated Sovaldi therapy among 104 post-transplant patients with severe recurrent HCV, including fibrosing cholestatic hepatitis, who had exhausted all other treatment options and received pre-approval access to Sovaldi via Gilead�s compassionate use program. Overall, 62% of patients achieved SVR12. Sovaldi-based therapy was well tolerated. Data are being presented at the 49th Annual Meeting of the European Association for the Study of the Liver.