On July 2015, the US Food and Drug Administration granted final approval of AbbVie’s TECHNIVIE (ombitasvir, paritaprevir and ritonavir), a fixed-dose combination drug classified as a hepatitis C virus NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor in one. It is indicated as a combination treatment with ribavirin for patients diagnosed with genotype 4 hepatitis C virus without cirrhosis.
TECHNIVIE with ribavirin is the first HCV infection treatment that has successfully demonstrated favorable safety and efficacy profiles, without necessitating co-administration with interferon. The drug, however, is not recommended for patients with moderate liver impairment (Child-Pugh B), and is not to be administered in patients with severe impairment (Child-Pugh C).
The drug is administered once daily, in the form of two oral tablets, together with the patient’s standard meal, and is meant to be taken with ribavirin for 12 weeks. Patients who have no history of receiving treatment for HCV, or cannot tolerate ribavirin may receive monotherapy with TECHNIVIE.
TECHNIVIE’s safety and efficacy profiles were derived from a study involving 135 patients with known chronic HCV genotype 4, without cirrhosis, and were either treatment-naive or have not responded to pegylated interferon/ribavirin. Participants were also screened against exposure to direct-acting antivirals. According to this study’s findings, 100% of participants who were treated with TECHNIVIE and ribavirin achieved a sustained virologic response. The same was observed in 91% of those who received TECHNIVIE alone.
The approved product label will soon be available at http://dailymed.nlm.nih.gov/dailymed/.
The recently approved Viekira, with or without ribavirin (RBV), is an oral interferon-free treatment for patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infections; those with compensated cirrhosis are also included. Viekira is the only approved regimen that consists of three different mechanism of action: a non-nucleoside NS5B polymerase inhibitor, a NS3/4A protease inhibitor and a NS5A inhibitor. These mechanisms work together to attack the virus in three stages of its life-cycle so that it is prevented from continuing to reproduce.