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Technivie (Ombitasvir, Paritaprevir, Ritonavir) Wins FDA Approval for Treatment of Patients With Genotype-4 HCV Infection

First all-oral, interferon-free therapy for this indication

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

The FDA granted “priority review” status to Technivie. This designation is given to investigational therapies that are designed to treat a serious condition and to provide significant improvements in safety or efficacy. This designation shortened the regulatory review period from the normal 10 months to 6 months. Technivie also received a “breakthrough therapy” designation from the FDA in 2014. This status is given to investigational treatments for serious or life-threatening conditions that have preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared with available therapy.

The FDA’s approval of Technivie was based on data from the PEARL-I trial, which demonstrated a 100% sustained virologic response rate at 12 weeks post-treatment (SVR12) in patients who received Technivie and RBV for 12 weeks. PEARL-I was an open-label, phase IIb study that evaluated the efficacy and safety of Technivie in chronic GT4 HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n = 42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n =49). In addition, 91% (40/44) of patients who were new to therapy achieved SVR12 after being treated with Technivie without RBV. In the treatment-naive group without RBV, on-treatment virologic breakthrough was reported in one patient (2%), and two patients (5%) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.

The investigators reported no discontinuations due to adverse events. The most commonly reported treatment-emergent adverse events (greater than 10% in any group) observed in patients receiving Technivie alone or Technivie with RBV were asthenia (25% vs. 29%, respectively), fatigue (7% vs. 15%), nausea (9% vs. 14%) and insomnia (5% vs. 13%). Four patients who received Technivie and RBV experienced decreased hemoglobin levels (anemia), which required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. All of the patients treated with Technivie and RBV achieved SVR12.

Technivie is an all-oral antiviral treatment consisting of a fixed-dose combination of paritaprevir/ritonavir (150/100 mg) co-formulated with ombitasvir (25 mg) dosed once daily and taken with a meal, which is co-administered with weight-based RBV (1,000 or 1,200 mg in divided doses, twice daily), taken with food. The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.

Source: AbbVie; July 24, 2015.

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