FDA Approves Incivek for Hepatitis C Treatment

yesterday (Monday May 23, 2011) that the U.S. Food and Drug Administration (FDA) has approved Incivek as a treatment for an expansive group of people suffering from genotype 1 chronic Hepatitis C with compensated liver disease, which includes patients with cirrhosis.

The FDA approval of Incivek is based on data from three Phase 3 studies showing that recipients of the drug in combination with pegylated-interferon and ribavirin achieved considerably higher rates of persistent viral response in comparison to patients who received only pegylated-interferon and ribavirin. Prior treatment of the individuals involved had no effect on the outcome of their treatment.

Incivek (telaprevir), developed by Vertex Pharmaceuticals Incorporated, is approved for previously untreated patients as well as for patients who received previous treatment but did not achieve a viral cure.

Of the patients receiving the combined drug therapy in the trials, 79% of those who had never received treatment before achieved a viral cure, in comparison to the 46% of those who received only the pegylated-interferon and ribavirin.

Those who had received previous treatment but had either relapsed (Relapsers), only partially responded to the previous treatment (Partial responders), or did not respond at all (Null responders) also had significantly elevated positive responses to the combination drug therapy. Of these three groups:

• 86% of Relapsers achieved a viral cure versus the 22% of the pegylated-interferon and ribavirin group
• 59% of Partial responders achieved a viral cure versus the 15% of the pegylated-interferon and ribavirin group
• 32% of Null responders achieved a viral cure versus the 5% of the pegylated-interferon and ribavirin group

Incivek is administered as two 375-mg tablets three times daily for twelve weeks. The drug is meant to be given as a cocktail, administered for twelve weeks in combination with pegylated-interferon and ribavirin. Following these initial twelve weeks, all recipients of the concoction discontinue Incivek but maintain treatment with pegylated-interferon and ribavirin for another twelve to thirty-six weeks of treatment.

With Incivek working in conjunction with the pegylated-interferon and ribavirin, more than 60% of sufferers of Hepatitis C treated—those receiving treatment for the first time as well as those who relapsed from previous treatments—are expected to complete all treatment in twenty-four weeks, cutting the time needed for previous treatments relying solely on pegylated-interferon and ribavirin in half. Other patients who do not respond as quickly to the treatment will be given forty-eight weeks of treatment.

The success rate and approval of Incivek is vastly significant, and offers more than just a ray of hope to many sufferers of the debilitating affliction. Ira Jacobson, principal investigator of a Phase 3 study for the drug and Chief of the Division of Gastroenterology and Hepatology at Weill Cornell Medical College, stated that before Incivek, "the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them."

"Today marks a turning point in the fight against Hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex.

"The approval of Incivek was only possible thanks to more than 4,000 people who volunteered for our clinical studies,” continued Emmens, “the doctors, nurses and coordinators who managed the studies, and our own pioneering scientists who have worked for more than fifteen years to bring this new medicine to people with Hepatitis C."

Vertex has also launched a comprehensive financial assistance and patient support program in order to better reach members of the Hepatitis C community and hopefully get Incivek to those who most need it.

The two most serious reported side-effects of Incivek are rash and anemia, but the most common side-effects reported include nausea, fatigue, itching, diarrhea, vomiting, anal/rectal problems, and changes in taste.

Incivek will arrive in pharmacies this week.