Merck: Hepatitis C Treatment Shows 95% Cure Rate -- Update

By Lisa Beilfuss 

Merck & Co. said Friday that its experimental drug combination for treating chronic hepatitis C patients demonstrated a 95% effective rate in a late-stage study.

The study combined grazoprevir and elbasvir in a once-daily tablet and was administered to previously untreated patients, some of whom also had HIV and liver cirrhosis, for 12 weeks. The treatment is for patients with genotypes 1 and 4. In the U.S., genotype one is the most common variant, while genotype 4 is prevalent in Egypt, the Middle East and Africa. According to the National Center for Biotechnology Information, though, the epidemiology of genotype 7 has changed and has begun to cross borders and spread to several regions in Europe through immigration and injection drug use.

"Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options," said Dr. Eric Lawitz, vice president at the Texas Liver Institute.

A Merck spokesperson said the company remains on track to submit a New Drug Application with the U.S. Food and Drug Administration in the first half of this year.

The combined tablet from Merck poses a potential threat to Gilead Sciences Inc.

This week, Gilead announced results from a midstage study that combined its blockbuster drugs Harvoni and Sovaldi to treat patients with advanced liver disease. Its study showed an 86% effective rate in pretransplant patients, and a 96% cure rate in post-transplant noncirrhotic patients with recurrent hepatitis C. Harvoni treats genotype 1 while Sovaldi treats genotypes 1 through 4.

The two drugs represented more than half of Gilead's 2014 revenue.

Also on Friday, AbbVie Inc. said the FDA had granted priority review status for its drug to treat adult patients with chronic genotype 4 hepatitis C.

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