AbbVie Gets FDA Approval Of Viekira Pak sNDA For HCV Genotype 1b
AbbVie (ABBV) has announced U.S. Food and Drug Administration (FDA) approval for a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® without ribavirin in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
The FDA accepted the application under Priority Review in January. This designation is given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness. The European Medicines Agency‘s Ad Comm committee backed approval in February.
Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie, said:
“We are constantly striving to advance clinical care for patients living with chronic hepatitis C. This approval is especially significant because patients with chronic HCV with compensated cirrhosis are among the tough to treat, and in our study VIEKIRA PAK demonstrated 100 percent cure rates in GT1b patients without the use of ribavirin.”
VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), is a prescription medicine used with or without ribavirin to treat adults with genotype 1 (GT1) chronic HCV infection, and can be used in people who have a certain type of cirrhosis (compensated). VIEKIRA PAK is not for people with advanced cirrhosis (decompensated).
The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. Although it was originally used to predict mortality during surgery, it is now used to determine the prognosis, as well as the required strength of treatment and the necessity of liver transplantation.
According to estimates from The Centers for Disease Control and Prevention, in the United States, approximately 2.7 million people are chronically infected with HCV.1 Genotype 1 is the most common HCV in the U.S. Of the total U.S. population with GT1 HCV infection, approximately 77 percent are genotype 1a (GT1a) and 23 percent are GT1b.
TURQUOISE-III lead investigator Jordan J. Feld, MD, MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada, said:
“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. The outstanding 100 percent cure rate from the study confirms that this is likely to be a very effective strategy.”
TURQUOISE-III 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 hepatitis C virus infection and compensated liver cirrhosis 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).