for HCV Wins Unanimous FDA Committee Recommendation
FDA Antiviral Drugs Advisory Committee voted 18-0 to recommend
approval of protease inhibitor boceprevir (Victrelis) for
people with hard-to-treat HCV genotype 1.
advent of direct-acting antiviral agents that target different
steps of the hepatitis C virus (HCV) lifecycle is expected to
revolutionize hepatitis C treatment. These drugs will initially
be used in combination with pegylated
interferon and ribavirin -- increasing the cure rate and potentially
allowing shorter therapy -- but combinations of all oral drugs
are currently under study.
first drugs out of the pipeline are 2 HCV protease inhibitors,
and Vertex's telaprevir.
On Wednesday (April 27), the Antiviral Drugs Advisory Committee
of the U.S. Food and Drug Administration (FDA) gave a unanimous
recommendation for approval of boceprevir.
committee hearing for telaprevir was underway on Thursday, as
HIVandHepatitis.com was preparing
for publication, and it too will likely be recommended for approval.
Wednesday the committee reviewed clinical trial data showing that
boceprevir added to pegylated interferon plus ribavirin cured
more patients -- and in less time -- than standard therapy alone.
The improvement in response rates was particularly notable for
people with HCV genotype 1 and those who did not respond or relapsed
with a prior course of standard treatment.
virological response rates for genotype 1 prior non-responders
were around 60% with boceprevir plus pegylated interferon/ribavirin,
compared with about 20% for standard therapy alone. For treatment-naive
patients, cure rates approached 70% with boceprevir compared with
about 40% for standard treatment.
is generally well-tolerated, but it increases the risk of developing
anemia (already a concern with ribavirin). Studies also showed
an increase in reports of suicidal or homicidal ideation, but
the committee said it was "difficult to make any meaningful
clinical conclusions" based on this.
the committee voted 18 to 0 in favor of approval, it did recommend
further studies looking at how to improve response in difficult-to-treat
groups such as people of African descent and patients with liver
cirrhosis. It also remains unclear how well "null responders"
who do not experience substantial HCV viral load reduction during
the early weeks of therapy will fare, and how best to use response-guided
positive recommendation brings us one step closer to bringing
Victrelis to men and women who need it, and reinforces our ongoing
commitment to developing innovative therapies to treat chronic
hepatitis C," said Merck Research Laboratories president
Peter Kim, PhD, in a company press release. "We're pleased
with the panel's decision and look forward to working with the
FDA as it continues to evaluate the application for Victrelis."
full FDA is not required to accept committee recommendations,
but it typically does so. Agency approval of boceprevir is expected
by the end of May, and the drug should be commercially available
by the end of the summer.
materials on boceprevir provided by the FDA and Merck are available
Victrelis (boceprevir) Unanimously Recommended for Approval by
FDA Advisory Committee for Treatment of Chronic HCV Genotype 1
Infection. Press release. April 27, 2011.
Walker. FDA Panel Endorses Boceprevir for Hepatitis C. MedPage
Today. April 27, 2011.