AbbVie, a global, research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Technivie (ombitasvir, paritaprevir and ritonavir tablets) 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. The approval of Technivie marks an important advancement in providing this historically difficult-to-treat population of 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). Technivie is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B).

"Physicians have previously had limited options when it comes to treating people living with GT4 chronic hepatitis C," said Tarek Hassanein, M.D., professor of medicine, University of California San Diego School of Medicine. "The approval of Technivie in combination with ribavirin is important for these patients who now have an approved all-oral, interferon-free treatment option that provides a high probability of a cure." 

The FDA granted priority review to AbbVie for Technivie, a designation granted to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness. This designation shortened the regulatory review period from the normal 10 months to six months. Technivie was also granted a Breakthrough Therapy designation by the FDA in 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.

For more details, go to: http://abbvie.mediaroom.com/2015-07-24-TECHNIVIE-ombitasvir-paritaprevir-and-ritonavir-tablets-Receives-FDA-Approval-as-the-First-and-Only-All-Oral-Interferon-Free-Treatment-for-Genotype-4-Chronic-Hepatitis-C-in-the-U-S