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FDA Committee Unanimously Recommends Telaprevir (Incivek)

The FDA Antiviral Drugs Advisory Committee last week voted 18-0 to recommend approval of the HCV protease inhibitor telaprevir (Incivek) for people with genotype 1 chronic hepatitis C.

By Liz Highleyman

The advent of direct-acting antiviral agents that target different steps of the hepatitis C virus (HCV) lifecycle is expected to revolutionize hepatitis C treatment. While these drugs will initially be used in combination with the current standard of care -- pegylated interferon plus ribavirin -- all-oral combinations are currently under study.

The first drugs out of the pipeline are 2 HCV protease inhibitors, Vertex's telaprevir (now given the brand name Incivek) and Merck's boceprevir (Victrelis). On April 28 the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of telaprevir. The committee also gave a unanimous nod to boceprevir the previous day.

The committee reviewed clinical trial data (including findings from the Phase 3 ADVANCE, ILLUMINATE, and REALIZE studies) showing that combining telaprevir with pegylated interferon/ribavirin produced a higher cure rate -- and in less time -- than standard therapy alone. This improvement is most notable for hard-to-treat patients including those with HCV genotype 1, people with liver cirrhosis, and those who did not respond to a prior course of interferon-based therapy.

The most extensively studied regimen added 750 mg 3-times-daily telaprevir to pegylated interferon/ribavirin for 12 weeks, followed by pegylated interferon/ribavirin alone through 24 or 48 weeks, using a response-guided strategy based on early response. Telaprevir boosted sustained virological response rates to around 70% overall (and 80% for treatment-naive individuals), compared with less than 50% for standard therapy alone.

Telaprevir is generally well-tolerated, but it increases the risk of skin rash and anemia; a small number of people in trials to date have developed severe skin reactions including Stevens-Johnson syndrome. In most cases, however, rash is mild-to-moderate and resolves after telaprevir is discontinued.

The committee recommended further studies looking at people of African descent -- a population that responds more poorly to interferon -- but commended Vertex for already conducting a study of telaprevir in people with HIV/HCV coinfection (reported at this year's Retrovirus conference in February).

The pending approval of telaprevir and boceprevir bring up a host of issues, including how best to use these drugs to avoid development of resistance, the importance of adherence, and whether HCV protease inhibitors should now be considered the comparison standard of care when conducting clinical trials of new agents.

The full FDA is not required to accept committee recommendations, but it usually does so. Agency approval of telaprevir and boceprevir is expected by the end of May, and if that occurs, the drugs will likely be commercially available by the end of the summer.
"Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the committee's unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C," Peter Mueller, PhD, Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex, said in a company press release. "We look forward to working with the FDA as it prepares to make its decision next month."
Briefing materials on telaprevir provided by the FDA and Vertex are available online at [



Vertex Pharmaceuticals. FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C. Press release. April 28, 2011.

E Walker. FDA Panel Endorses Another HCV Drug. MedPage Today. April 28, 2011.























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