FDA approves Technivie for treatment of hepatitis C virus genotype 4 infections

FDA has approved ombitsavir, paritaprevir and ritonavir (Technivie, AbbVie) for the treatment of hepatitis C virus genotype 4 infections.

Hepatitis C is inflammation of the liver due to infection caused by the hepatitis C virus (HCV). The Centers for Disease Control (CDC) estimates that 2.7 million people in the United States currently have chronic HCV. There are 6 major genotypes of HCV (GT1-6) and genotype 4 (GT4), which accounts for approximately 1.1% of HCV infections, has historically been considered difficult-to-treat.

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Technivie is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the United States for the treatment of adults with GT4 chronic HCV infection without cirrhosis. Technivie is an all-oral antiviral treatment containing the fixed-dose combination of paritaprevir/ritonavir (1050 mg/100 mg) with ombitasvir (25 mg) dosed once daily with a meal. It is coadministered with ribavirin (RBV). Each of the antivirals has a distinct mechanism of action, which allows the drugs to work together to inhibit specific HCV proteins in the viral replication process.

"Physicians have previously had limited options when it comes to treating people living with GT4 chronic hepatitis C," said Tarek Hassanein, MD, professor of medicine, University of California San Diego School of Medicine. "The approval of TECHNIVIE in combination with ribavirin is important for these patients who now have an approved all-oral, interferon-free treatment option that provides a high probability of a cure."

FDA granted the manufacturer priority review as well as breakthrough therapy designation for Technivie.

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The approval of Technivie is based on data from the PEARL-I study, which included 135 participants with chronic HCV GT4 infections without cirrhosis. Ninety-one people received Technivie plus RBV once daily and 44 participants received Technivie once daily without RBV, each for 12 weeks. The study demonstrated 100% sustained virologic response rates, defined as when the virus is no longer detectable in the patient’s blood 12 weeks after treatment, in the patients treated with Technivie plus RBV.

Technivie is not recommended for use in patients with moderate hepatic impairment (Child Pugh B). Common side effects associated with the use of Technivie include weakness, fatigue, tiredness, nausea, and sleep problems.

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