Simeprevir Approved to Treat Chronic Hepatitis C

November 22, 2013

The US Food and Drug Administration (FDA) approved the protease inhibitor simeprevir (Olysio, Janssen Pharmaceuticals) to treat chronic hepatitis C infections, the agency announced today.

Simeprevir is the third protease inhibitor for hepatitis C to hit the market. Boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex Pharmaceuticals) received FDA approval in 2011.

The new drug is indicated for adults with compensated liver disease, including cirrhosis, who have yet to receive treatment for hepatitis C, or who have not responded well to previous treatments. The FDA said simeprevir is designed as one component of a combination antiviral therapy regimen.

The Centers for Disease Control and Prevention puts the number of Americans infected with the hepatitis C virus at 3.2 million. The infection usually goes undetected until liver damage occurs. Many infected patients progress to a chronic infection, which can ultimately lead to liver cancer or liver failure.

Last month, an FDA advisory committee unanimously recommended approval of simeprevir on the basis of clinical trials in which both treatment-naïve and treatment-experienced patients with chronic hepatitis C received the drug in combination with 2 antivirals, ribavirin and peginterferon-alfa. Researchers measured whether a patient's hepatitis C virus could no longer be detected in the bloodstream at least 12 weeks following the course of treatment.

"We clearly need better drugs, and the evidence is strong that this (simeprevir) is a better drug than we have," said committee member Curt Hagedorn, MD, medicine-service chief at Central Arkansas Veterans Healthcare Service, in Little Rock, Arkansas.

Simeprevir's effectiveness was diminished, however, in patients infected with the genotype 1a hepatitis C virus with an NS3 Q80K polymorphism. The FDA recommends that clinicians screen patients for this common strain of the virus before prescribing simeprevir, and consider an alternative treatment if they find this variant.

Rash, itching, and nausea were the most common adverse events to emerge in the clinical trials. Some patients experienced serious photosensitivity reactions that landed them in the hospital.

More information on today's announcement is available at the FDA Web site.


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