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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