FDA approves supplemental NDA for Viekira Pak for HCV genotype 1b

AbbVie announced the FDA has approved its supplemental New Drug Application for the use of Viekira Pak without ribavirin for the treatment of adults with genotype 1b chronic hepatitis C virus infection and compensated cirrhosis.

A combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, Viekira Pak (AbbVie) is currently approved for use with or without ribavirin for HCV, but is not recommended for patients with decompensated cirrhosis.

The approval is indicative of results from the TURQUOISE-III clinical trial wherein researchers evaluated the use of Viekira Pak without ribavirin for 12 weeks. Results showed that 100% of enrolled and treated patients with chronic HCV genotype 1b with compensated cirrhosis (n = 60) achieved sustained virologic response at 12 weeks post-treatment, according to a press release.

“This provides a very useful option for people infected with genotype 1b infection and compensated cirrhosis. The ability to cure these individuals with just 12 weeks of treatment and without the need for ribavirin is a great benefit,” Jordan J. Feld, MD, MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada, and HCV Next Editorial Board member, said in the release. “The outstanding 100% cure rate from the study confirms that this is likely to be a very effective strategy.”

Jordan J. Feld

The FDA first approved Viekira Pak for the treatment of HCV in December 2014.

In October 2015, the FDA issued a report warning that the fixed-dose combination could lead to severe liver injury and required AbbVie to update the drug label. In a previous interview, Barry Bernstein, MD, vice president, infectious disease development, AbbVie, told Healio.com/Hepatology that the label updates were “based on post-marketing reports” and the company was in compliance with the FDA’s requests.

The FDA accepted AbbVie’s supplemental new drug application for review of Viekira Pak in December 2015.

The European Committee for Medicinal Products for Human Use granted a positive opinion for the recommendation of Viekirax plus Exviera, without ribavirin, known as Viekira Pak in the U.S., for the treatment of chronic hepatitis C genotype 1b infection with compensated cirrhosis in March.

Disclosure: Feld reports receiving support for research and/or honoraria for scientific consulting for AbbVie, Abbott, Bristol-Myers Squibb, Gilead, Janssen, Merck, Theravance and Trek.