The US Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for dasabuvir, ombitasvir, paritaprevir and ritonavir (Viekira XT™, AbbVie ) extended-release tablets to treat patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.
The tablets are the first co-formulated three direct-acting antiviral (DAA) treatments for adult patients with GT1 HCV. Given once-daily as three oral tablets and must be taken with a meal, Viekira XT It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients.
There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the United States, accounting for approximately 74% of all cases.1 Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that in the U.S. approximately 2.7 million people are chronically infected with HCV.2
The approval is supported by data from seven phase 3 clinical trials in more than 2,300 patients who received Viekira Pak with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the formulation, according to materials provided by the manufacturer.3
1 Wedemeyer H. Hepatitis C. Chapter 80: In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease. Vol 2. 10th ed. Philadelphia, PA: Saunders Elsevier; 2016.
2 Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for health professionals.http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section1. Accessed June 9, 2016.
3 AbbVie 2016 Impact by the Numbers. http://www.abbvie.com/responsibility/home.html