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 hepatitis C infection, including a major complication, cirrhosis of the liver.
Some 3.2 million Americans are infected with the viral disease, which can lead to complications including reduced liver function, liver failure or liver cancer, the FDA said in a news release. Most infected people have no symptoms before onset of liver damage.
Without proper treatment, 15 percent to 30 percent will develop advanced liver disease known as cirrhosis, the agency said.
The combination pack's safety and effectiveness were evaluated in clinical studies involving more than 2,300 people with chronic hepatitis C, with and without cirrhosis. The most common side effects included fatigue, itching, weakness, lack of energy, nausea and trouble sleeping.
Viekira Pak is marketed by AbbVie Inc., based in North Chicago.
Visit the FDA to learn more.