Telaprevir for HCV Receives Advisory Panel's Vote of Approval

Emma Hitt, PhD

April 29, 2011

April 29, 2011 — Following in the wake of a unanimous vote for boceprevir yesterday, telaprevir (Vertex Pharmaceuticals, Inc) also received unanimous approval from the Antiviral Drugs Advisory Committee panelists, who voted 18 to 0 that the novel protease inhibitor should receive US Food and Drug Administration (FDA) approval for the treatment of chronic hepatitis C virus (HCV) infection.

The panel voted yes to the question of whether the available data support approval of the telaprevir in combination with other HCV drugs, pegylated interferon and ribavirin. The FDA is expected to make a decision on the approval of telaprevir by May 23, 2011.

The panel reached their decision after reviewing data from phase 3 studies in which telaprevir was given for 12 weeks in combination with pegylated interferon and ribavirin, followed by peginterferon and ribavirin alone, for a total of either 24 or 48 weeks of treatment.

The phase 3 registration studies, ADVANCE, ILLUMINATE, and REALIZE, each evaluated telaprevir at a dose of 750 mg, taken 3 times daily, in combination with peginterferon and ribavirin.

Telaprevir-based combination therapy significantly improved patients' sustained viral response (SVR) compared with 48 weeks of treatment with peginterferon and ribavirin alone, regardless of their experience with prior treatment. In previously untreated patients, 79% achieved SVR compared with 46% receiving peginterferon and ribavirin alone. Rash and anemia were more common with telaprevir compared with peginterferon and ribavirin alone.

Although telaprevir and boceprevir have not been directly compared in clinical trials, the SVR with telaprevir of 79% may translate into higher cure rates than the 66% SVR observed in trials of boceprevir.

Overall, the panel was strongly in favor of telaprevir. "The risks, while they contribute to risk-benefit assessment, are not risks that overrun the benefits by any means," said panelist Susan S. Ellenberg, PhD, from the University of Pennsylvania School of Medicine, in Philadelphia, during the meeting.

"I think this is a long-awaited landmark day for our patients with hepatitis C," said panelist Barbara H. McGovern, MD, from the Tufts University School of Medicine in Boston, Massachusetts.

"We are entering a new era, and telaprevir is a huge advancement in treating hepatitis C," noted panelist Pritybala Valbh, RPh, from PharmaKa Consulting, in Mount Dora, Florida.

The FDA usually, but not always, follows the recommendations of its advisory panels. The FDA is expected to make a decision about boceprevir in mid-May, according to the manufacturer.

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