Gilead Sciences, Inc. (GILD) announced pooled data from certain phase II and phase III studies evaluating Harvoni for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options including patients with decompensated cirrhosis and patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals. These data will be presented at the 65th annual meeting of the American Association for the Study of Liver Diseases.
In the pooled analysis, HCV infected patients with compensated cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or 24 weeks, achieved sustained virologic response (SVR12) of 96%. SVR12 rates using Harvoni plus RBV were 96% for genotype 1 and 4 patients who developed HCV recurrence following liver transplantation. SVR12 rates were also impressive in genotype 1 HCV patients with compensated cirrhosis who had failed prior treatment with pegylated interferon and RBV and subsequently pegylated interferon /RBV plus a protease inhibitor.
Harvoni is a once daily fixed-dose combination of ledipasvir and Gilead’s blockbuster drug, Sovaldi. It was approved by the FDA in Oct 2014, making it the first once-daily single tablet regimen for the treatment of chronic HCV genotype 1 infection.
Meanwhile, the company also announced data from three phase II open-label studies evaluating the safety and efficacy of an all-oral regimen – Sovaldi plus GS-5816 – for the treatment of chronic HCV infection. SVR12 rates were between 88% – 100% in these studies.
Earlier this month, Johnson & Johnson (JNJ) announced that the FDA has approved its HCV drug Olysio in combination with Sovaldi as an all-oral, interferon- and ribavirin-free treatment for genotype 1 chronic hepatitis C infection in adults.
Gilead holds a Zacks Rank #2 (Buy). Equally well-ranked stocks in the health care space include Allergan (AGN) and AbbVie (ABBV).
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