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Gilead's Sovaldi Shows Efficacy & Safety In Chronic Hepatitis C Patients

Gilead Sciences, Inc. (GILD) reported data from two Phase 2 studies and a compassionate access study, wherin a regimen containing once-daily Sovaldi 400 mg was administered to treat chronic hepatitis C virus or HCV infection in patients with advanced liver disease.

The first study, named Study GS-US-334-0125, is an ongoing open-label Phase 2 trial assessing HCV patients with cirrhosis and portal hypertension, with or without decompensation, who were randomized 1:1 to an immediate treatment arm in which Sovaldi and ribavirin or RBV was administered for 48 weeks or to a deferred treatment arm in which this regimen was started after a 24-week observation period.

Out of the 22 patients who completed 24 weeks of therapy, 95 percent achieved virologic suppression on treatment. Further, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared to patients in the observation arm; and 80% of participants were treatment-experienced

Study GS-US-334-0126, was a single-arm open-label Phase 2 study 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 and 88 percent were treatment-experienced. According to the company, seventy percent of patients in this study achieved SVR12.

by RTT Staff Writer

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