FDA Green Lights Viekira Pak For Patients With Chronic HCV Genotype 1b

Officials with AbbVie have announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the use of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets (Viekira Pak) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis. 

The Centers for Disease Control and Prevention estimates that in the United States, approximately 2.7 million people are chronically infected with HCV.1 Genotype 1 is the most common HCV in the United States.¹ Of the total U.S. population with GT1 HCV infection, approximately 77% are genotype 1a (GT1a) and 23% are GT1b.¹

In a study of the medication, dubbed TURQUOISE-III, researchers demonstrated 100% (N=60/60) sustained virologic response at 12 weeks post-treatment (SVR12). Patients who achieve SVR12 are considered cured of HCV, as the virus is no longer detectable in the blood. No patients discontinued treatment due to adverse events. The most commonly-reported adverse events were fatigue, diarrhea, headache, arthralgia, dizziness, insomnia, and pruritus.²

References

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. Feld JJ et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks. J Hepatol (2015), http://dx.doi.org/10.1016/j.jhep.2015.10.005