AbbVie announced that the Food and Drug Administration (FDA) has approved Technivie (ombitasvir, paritaprevir, ritonavir) tablets in combination with ribavirin for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. Technivie is the first all-oral, interferon-free, direct-acting antiviral treatment approved for adults with GT4 chronic HCV infection.
The FDA approval was based on results form the PEARL-I study, a Phase 2b, open-label study that evaluated the efficacy and safety of Technivie in GT4 chronic HCV patients without cirrhosis. It included patients who were new to therapy or who had failed previous treatment with pegylated interferon (pegIFN) and ribavirin. Results showed 100% sustained virologic response rates at 12 weeks post-treatment when patients took Technivie and ribavirin. Further, 91% of patients who were new to therapy achieved sustained virologic response at 12 weeks after receiving Technivie without ribavirin. In the treatment-naive group without ribavirin, virologic breakthrough was reported in 1 patient.
Technivie combines ombitasvir, a hepatitis C virus NS5A inhibitor; paritaprevir, a hepatitis C virus NS3/4A protease inhibitor; and ritonavir, a CYP3A inhibitor.
Technivie was granted priority review and was designated a Breakthrough Therapy by the FDA. It will be available as a 12.5mg/75mg/50mg fixed-dose strength in monthly cartons for a total of 28 day supply.
For more information call (800) 633-9110 or visit AbbVie.com.