Results Announced for Harvoni in Chronic Hepatitis C Virus Trials

Gilead Sciences announced results from several Phase 2 and Phase 3 studies evaluating the use of Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options, including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant, and patients who failed previous treatment with other direct acting antivirals.

Two prospective analyses from the Phase 2 Study GS-US-337-0123 trial evaluated patients with decompensated cirrhosis and those with HCV recurrence following liver transplantation. In the first subgroup, 108 genotype 1 and 4 infected patients with decompensated cirrhosis, including those with moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Class B) and severe hepatic impairment (CPT Class C), received Harvoni plus RBV for 12 or 24 weeks. Overall, SVR12 rates were 87% (n=45/52) in the 12-week arm and 89% (n=42/47) in the 24-week arm.

The second subgroup evaluated 12 or 24 weeks of Harvoni plus RBV among 223 genotype 1 and 4 patients who developed HCV recurrence following liver transplantation. Among non-cirrhotic patients, SVR12 rates were 96% (n=53/55) and 98% (n=55/56) following 12 and 24 weeks of treatment, respectively. For patients with compensated cirrhosis, SVR12 rates were 96% for both 12 weeks (n=25/26) and 24 weeks (n=24/25) of therapy. SVR12 rates among patients with decompensated cirrhosis were 81% for both 12 weeks (n=25/31) and 24 weeks (n=17/21) of therapy.

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Study GS-US-337-0121 evaluated 155 genotype 1 patients with compensated cirrhosis who had failed prior treatment with pegylated interferon (PegIFN)/RBV and subsequently PegIFN/RBV plus a protease inhibitor. In this study, patients were randomized (1:1) to receive Harvoni plus RBV for 12 weeks or Harvoni alone for 24 weeks. Ninety-six percent (n=74/77) of those receiving Harvoni plus RBV for 12 weeks and 97% (n=75/77) of those receiving Harvoni for 24 weeks achieved SVR12.

In a second study, 51 genotype 1 patients who previously failed SOF/PegIFN/RBV, SOF/RBV or a SOF placebo/PegIFN/RBV treatment regimen received Harvoni plus RBV for 12 weeks. Ninety-eight percent (n=50/51) achieved SVR12 following 12 weeks of treatment with Harvoni plus RBV.

Harvoni is already approved as a once-daily single tablet regimen for the treatment of chronic HCV genotype 1 infection in adults.

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