FDA Approves Expanded Use of AbbVie's V-Pak for HCV-1b

Global pharmaceutical company, AbbVie, announced the approval of a supplemental new drug application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in chronic hepatitis C patients with genotype 1b (HCV-1b) and compensated cirrhosis. Approval for this drug comes after results of the TURQUOISE-III study showed 100% sustained virologic response (SVR), 12 weeks post-treatment in all of the patients in the study, indicating the patients were cured of HCV-1b as the virus was no longer detectable in the blood.

Hepatitis C (HCV) is one of the most common hepatitis infections in the United States. According to a recent National Academies of Sciences, Engineering, and Medicine report, between 2.5 million and 4.7 million Americans are battling chronic HCV, and around 20,000 Americans die of chronic hepatitis B and HCV every year in the United States.

Executive vice president, research and development and chief scientific officer of AbbVie stated in the press release that, “we are constantly striving to advance clinical care for patients living with chronic hepatitis C. This approval is especially significant because patients with chronic hepatitis C with compensated cirrhosis are among the tough to treat, and in our study VIEKIRA PAK demonstrated 100 percent cure rates in [HCV-1b] patients without the use of ribavirin."

TURQUOISE-III study lead investigator, Jordan J. Feld, MD, MPH, research director and clinical scientist, Toronto Center for Liver Disease, Toronto, Canada, added, “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 [and] the outstanding 100 percent cure rate from the study confirms that this is likely to be a very effective strategy."

The TURQUOISE-III study “is a multi-center, open-label, single-arm Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRA PAK without ribavirin in adult patients (N=60) with genotype 1b chronic HCV infection and compensated liver cirrhosis (Child-Pugh A) who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).”