Friday, February 15, 2013

FDA adds indication for prior null responders to Victrelis label

FDA adds indication for prior null responders to Victrelis label

February 15, 2013
The FDA recently announced revisions to the labeling for protease inhibitor Victrelis, expanding its indication to include previous null responders to interferon-based therapy.

The update indicates that combination therapy with Victrelis (boceprevir, Merck) should continue through 48 weeks in null responders with or without HCV RNA detected at week 8, and without detectable RNA at week 24. The labeling also now includes a warning to discontinue the entire drug regimen should pegylated interferon and/or ribavirin be permanently discontinued.

The null responder addition follows results from the ongoing, open-label PROVIDE study, in which participants with chronic HCV genotype 1 received 800 mg three times daily, in addition to 1.5 mcg peginterferon alfa-2b per kg of body weight weekly and a divided daily dose of 600 mg ribavirin to 1,400 mg ribavirin, for 44 weeks. All participants were nonresponsive members of the control arms that did not receive Victrelis in previous studies. Among patients who received a 4-week lead-in period with peginterferon and ribavirin, sustained virologic response occurred in 38% and relapse occurred in 14%.

This update to the Victrelis labeling follows an addition in November 2012 warning of the potential for an acute hypersensitivity reaction, and an update in August 2012 on drug-drug interactions between Victrelis and atorvastatin, cyclosporine, escitalopram, pravastatin and tacrolimus.
Victrelis is intended for adult patients with chronic HCV genotype 1 who are either treatment-naive or experienced relapse or null or partial response to previous treatment with interferon and ribavirin.

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