FDA Approves Antiviral Combination for Hepatitis C

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FDA Approves Antiviral Combination for Hepatitis C
FDA Approves Antiviral Combination for Hepatitis C

MONDAY, Dec. 22, 2014 (HealthDay News) -- Viekira Pak, a combination of four antiviral drugs (ombitasvir, paritaprevir, ritonavir, and dasabuvir), has been approved by the U.S. Food and Drug Administration to treat chronic hepatitis C virus genotype 1 infection, including hepatitis C virus infection with cirrhosis of the liver.

The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 mg/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily. The combination pack can be used with or without ribavirin, the agency said in a news release, but it is not recommended for patients whose liver is unable to function properly, such as those with decompensated cirrhosis.

The combination pack's safety and effectiveness were evaluated in clinical studies involving 2,308 people with chronic hepatitis C virus infection, with and without cirrhosis. The most common side effects included fatigue, itching, weakness, lack of energy, nausea, and trouble sleeping.

"The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease," Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens."

Viekira Pak is marketed by AbbVie Inc., based in North Chicago.

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