The FDA approved Incivek (telaprevir, Vertex, J&J) by its PDUFA due date on 23 May, 2011. The drug was approved fot the treatment of chronic hepatitis C infection in treatment naïve, null or partial responders or relapsed patients. The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.
The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care. The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.
Incivek is a pill taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
FDA approves Incivek for hepatitis C http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm Full U.S. Prescribing Information (PDF) http://www.incivek.com/ Financial Assistance and Patient Support Program for INCIVEK Incivek (telaprevir) For Patients With Hepatitis C Approved By FDA Medical News Today - 37 minutes ago Patients with genotype 1 chronic hepatitis C with functioning but damaged livers (compensated liver disease), including cirrhosis may now be prescribed Incivek (telaprevir), which was approved today for such indications by the FDA (Food and Drug ...