Gilead Sciences, Inc. GILD and Bristol-Myers Squibb Company BMY announced encouraging results from their respective studies on hepatitis C virus (HCV).
Gilead, a familiar name in the biotech space, announced results from two studies – the phase III BOSON study and a phase II study on Sovaldi and Harvoni-based regimens in chronic HCV patients with genotypes 2, 3, 4 and 5. The company intends to present these data at the annual meeting of the European Association for the Study of the Liver.
We note that both Sovaldi and Harvoni are approved in the U.S. for the treatment of chronic HCV infection. While Harvoni is indicated for patients with genotype 1, Sovaldi is used in combination with other agents and its efficacy has been established in patients with genotypes 1, 2, 3 and 4.
Results from the BOSON study, evaluating the safety and efficacy of Sovaldi plus ribavirin for 16 or 24 weeks compared to Sovaldi plus pegylated interferon/ribavirin for 12 weeks, revealed that Sovaldi in both the combinations showed high cure rates among all patients with genotypes 2 and 3. The other study, an open-label phase II study on Harvoni, showed high sustained virologic response rates (SVR) in both treatment-naïve and treatment-experienced patients suffering from chronic HCV genotypes 4 or 5 infection.
In a separate announcement, Bristol-Myers, another pharma/biotech company, announced positive results from its late-stage HCV study. The phase III ALLY-1 study is evaluating a 12-week regimen of daclatasvir in combination with Sovaldi once-daily with ribavirin for the treatment of HCV patients with either advanced cirrhosis or post-liver transplant recurrence of HCV.
Results revealed that 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis under the combination of daclatasvir and Sovaldi achieved SVR 12 weeks after treatment. This was also the primary endpoint of the study.
We note that last month, Bristol-Myers resubmitted the new drug application for daclatasvir for use in combination with Sovaldi for the treatment of chronic HCV genotype 3. A final decision from the FDA is expected by September this year.
The highly lucrative HCV market has been the focus area for most of the big biotech companies for the last couple of years. Pricing competition among the approved products is also intense. We expect the segment to remain in focus in the coming quarters as well.
Both Gilead and Bristol-Myers hold a Zacks Rank #3 (Hold). Biogen BIIB and Actelion Ltd. ALIOF are two better-ranked stocks in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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