Hep C Update: Vertex, Merck and Gilead

Researchers are presenting the boceprevir data on Monday and Tuesday, which will hopefully shed light on why the analysis summarized in the Merck press release appears to exclude certain patients.

Boceprevir's overall cure rate for treatment-naive Hep C patients ranged from 63-66%, with the proportion of patients eligible for shortened therapy 44%. The cure rate was high (87% for African-American/Blacks and 97% for non-African Americans) for those patients that did receive shortened therapy due to an early and robust response to boceprevir.

Merck is also presenting data at AASLD from a study of boceprevir in patients who were not cured by previous treatments. When these "treatment resistant" patients were re-treated with boceprevir, cure rates ranged from 59% to 66% compared to 21% of patients re-treated with just standard of care.

Vertex has data on telaprevir in similar hard-to-treat patients that is superior to boceprevir, with cure rates of 65% overall that included patients much more resistant to therapy than those enrolled in Merck's boceprevir study. When similar treatment-resistant patients are compared across both studies, boceprevir's 66% cure rate falls short of telaprevir's 78% cure rate.

Vertex is not presenting its telaprevir data in treatment resistant patients at this year's AASLD meeting.

Gilead Sciences(GILD): The HIV drug powerhouse should be a major player in developing new Hep C therapies because the viral diseases share similar traits. Yet Gilead has fumbled early Hep C drug development efforts, forcing the company to rethink strategy as competitors surged ahead.

In June, Gilead lured Duke University's Dr. John McHutchison, a leading Hep C researcher, to join the company and take over its R&D push into liver disease. On Saturday night, Gilead held a coming-out party for McHutchison, who gave investors a detailed look at the company's revamped Hep C drug development efforts.

Companies like Vertex are early winners for combining powerful, new oral drugs like telaprevir to the standard of care in Hep C -- injectable interferons and oral ribavirin. Gilead isn't trying to compete here; instead the company is taking a page from its HIV playbook, believing that the long-term future of Hep C treatment will be in developing combination of oral drugs --each acting against the Hep C virus in different ways -- that can eliminate the need for injectable interferon and perhaps even ribavirin, both of which can cause nasty side effects.

Just like Gilead sells a Atripla for HIV treatment -- a single, daily pill that combines three different medicines -- the company would like to one day develop a single, multi-drug pill for Hep C, said McHutchison.