Technivie is an all-oral, interferon-free, direct-acting antiviral treatment consisting of the fixed-dose combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily and taken with a meal, which is co-administered with weight-based RBV taken with food.
The approval of Technivie marks an important advancement in providing HCV patients an opportunity for a cure.
Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient’s blood 12 weeks after treatment (SVR12).
The company noted that Technivie is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B).
AbbVie Research and Development executive vice-president and chief scientific officer Michael Severino said: "As demonstrated by the PEARL-I study results, Technivie delivers on AbbVie’s ongoing commitment to provide curative therapies for HCV patients who have historically been considered difficult-to-treat."
The approval of Technivie is based on data from an open-label Phase II trial (PEARL-I), which showed 100% sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received Technivie and RBV for 12 weeks.
The trial evaluated the efficacy and safety of Technivie in GT4 chronic HCV patients without cirrhosis.