FDA Committee Unanimously Recommends Hep C Patients Take Teleprevir Despite SJS Warnings

The FDA Antiviral Drugs Advisory Committee voted last week on whether to approve the HCV protease inhibitor telaprevir (Incivek) for those people suffering from genotype 1 chronic hepatitis C. They voted unanimously (18-0) in favor of the drug. However, the drug is also linked to the rare skin disease Stevens-Johnson syndrome (SJS).

Now that drug makers have come up with direct-acting antiviral drugs agents that target Hepatitis C in its different stages, it is expected that this move could become a revolutionary step in the treatment of the disease. While these drugs will start out being used in combination with treatments that are already in use, including pegylated interferon plus ribavirin, the other combinations are still being studied.

In the first line of new drugs, drug makers are promoting 2 HCV protease inhibitors, which are Vertex’s telaprevir (brand name Incivek) and Merck’s boceprevir (Victrelis). The telaprevir was approved for this use on April 28 unanimously. The committee had already given another unanimous vote for the drug boceprevir the day before. The vote was unanimous regardless of the increased risk of patients developing SJS.

The committee reached its decision by reviewing clinical trial data. The clinical trial information on teleprevir showed that “combining telaprevir with pegylated interferon/ribavirin produced a higher cure rate in less time than standard therapy alone.”

For the hard-to-treat Hep C patients (even the patients with HCV genetype 1), this improvement is significant and will be a boon to those patients who are suffering from cirrhosis of the liver and patients who didn’t respond well to previous courses of interferon-based therapy. However, the fact that teleprevir comes with an SJS warning could leave some patients susceptible to the disease.

If you or someone you love develops SJS after taking teleprevir, contact attorney Greg Jones today for a free consultation. I am an experienced SJS attorney and I will fight hard to help you recover money for your pain and suffering.

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