Gilead Sciences has announced data from a Phase 2 study evaluating once-daily Sovaldi (sofosbuvir) 400mg for the treatment of chronic hepatitis C virus (HCV) infection in patients with advanced liver disease. The study results will be presented at the International Liver Congress 2014.
In Study GS-US-334-0125, an ongoing open-label Phase 2 clinical trial, HCV patients with cirrhosis and portal hypertension, with or without decompensation participated in the 24-week evaluation. Patients were randomized to receive one-daily Sovaldi and ribavirin (RBV) for 48 weeks (n=25) or to receive this combination after a 24-week observation period. Ninety-five percent of those who completed 24 weeks of therapy (n=22) achieved virologic suppression. Both patient groups will continue to be evaluated for 12-week sustained virologic response rates (SVR12) after 48 weeks of the combination treatment.
In Study GS-US-334-0126, a single-arm open-label Phase 2 trial, patients with recurrent HCV infection following liver transplantation received up to 24 weeks of therapy with Sovaldi plus RBV (starting at 400mg/day). Data showed 70% (n=28/40) of patients in this study achieved SVR12.
In a compassionate access study (Oral #62), Sovaldi was evaluated among 104 post-transplant patients with severe recurrent HCV, including fibrosing cholestatic hepatitis, who had received pre-approval access via Gilead’s compassionate use program. Patients received up to 48 weeks of Sovaldi plus RBV, with some patients also receiving pegylated interferon (peg-IFN) (180μg/week) at their physician’s discretion. Overall, 62% of patients achieved SVR12 and therapy was well tolerated.
Sovaldi is currently indicated as a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection in adults ≥18 years of age.
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