FDA Sanctions New Drug for Hepatitis C Virus

First Posted: Nov 23, 2013 06:42 AM EST

The U.S. Food and Drug Administration approved a new treatment for chronic hepatitis C virus infection.

The FDA approved Olysio (simeprevir), a new treatment to cure the viral disease hepatitis C that damages the liver, on Friday.  Olysio is a protease inhibitor that blocks a key protein used by hepatitis C virus from multiplying.

Known to cause inflammation of the liver, hepatitis C infection can even lead to liver failure. People infected with this disease show no symptoms until the liver is considerably damaged and this   process may take several years. This further leads to chronic hepatitis C. Compilations of the disease include bleeding, jaundice and excess fluid accumulation in the stomach and infection of liver or even cancer. A Centers for Disease Control and Prevention report states that nearly 3.2 American are infected with the hepatitis C virus.

The new treatment will be used as a combination antiviral treatment regimen. The safety of the treatment was evaluated using it in combination with two drugs called peginterferon-alfa and ribavirin, both used to treat the viral disease.

This treatment is for adults who have a diseased but functioning liver(compensated liver). It is also meant for cirrhosis, for people who have not received any treatment for the disease (treatment naive) and those who haven't benefited from previous treatments.

"Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Five clinical studies were done to evaluate the effectiveness and safety of the drug. The participants were randomly given either Olysio along with peginterferon-alfa and ribavirin or they were given a placebo with peginterferon-alfa and ribavirin.

The participants were then checked for the virus after 12 weeks of treatment. They noticed that 80 percent of the treatment naive patients who were given Olysio plus peginterferon-alfa and ribaviri, achieved a virologic response, whereas just 50 percent of the control group benefited from it. In one of the studies where infection returned, 79 percent achieved virologic response compared to 37 percent in the control group.

The effectiveness of Olysio was lowered in those with genotype1a hepatitis C virus with an NS3Q80K polymorphism, a strain of hepatitis C commonly found in America.

During the course of treatment the patients are advised to limit sun exposure and use sun screen.

The common side effects include nausea, itching and rash.

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