FDA approves Technivie (ombitasvir + paritaprevir + ritonavir) with ribavirin for Hepatitis C- AbbVie

The FDA has approved Technivie (ombitasvir, paritaprevir, and ritonavir tablets), from AbbVie, in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. Technivie is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection.

Approval of Technivie is based on data from the PEARL-I study, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received Technivie and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that evaluated the efficacy and safety of Technivie in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking Technivie without RBV. In the treatment-naive group without RBV, on-treatment virologic breakthrough was reported in one patient (two percent), and two patients (five percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms. There were no discontinuations due to adverse events in these patients.

Comment: The combination of (ombitasvir + paritaprevir + ritonavir) with ribavirin was EU approved in January 2015 as Viekirax and approved in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.