Technivie Approved for Hepatitis C
For people with a genetic subtype of the liver infection
FRIDAY, July 24, 2015 (HealthDay News) -- Technivie (ombitasvir, paritaprevir and ritonavir) has been approved by the U.S. Food and Drug Administration, in tandem with ribavirin, to treat hepatitis C genotype 4 infection among people without poor liver function (cirrhosis) and without scarring.
Some 2.7 million Americans have hepatitis C, and genotype 4 is among the least common genetic subtypes, the agency said.
Technivie is the first drug to be sanctioned to treat genotype 4 hepatitis C infection without requiring co-use of the drug interferon, the agency said Friday in a news release.
Infection with the hepatitis C virus causes liver inflammation that may lead to cirrhosis or liver failure. Most infected people don't develop symptoms until liver damage has already occurred, the FDA said.
Symptoms of cirrhosis may include a yellowing of the eyes and skin called jaundice, abdominal fluid retention and liver cancer.
The Technivie/ribavirin combination was evaluated in a clinical study involving some 135 people. The most commonly reported side effects included fatigue, weakness, nausea, insomnia, itching and other skin reactions.
Technivie's label includes a warning of the possibility of elevated liver enzymes, a result that occurred most often among women who took contraceptives containing ethinyl estradiol. Such contraceptives should be discontinued before these women take Technivie, the FDA advised.
Technivie is marketed by AbbVie, based in North Chicago, Ill.
Visit the FDA to learn more.