The US Food and Drug Administration (FDA) has approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adults.
Zepatier, marketed by Merck, was granted breakthrough therapy designation for the treatment of chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection. This designation expedites the development and review of drugs that are intended to treat a serious condition when preliminary evidence indicates that the drug may demonstrate substantial improvement over an available therapy.
For more on Zepatier, see GI & Hepatology News: http://www.gihepnews.com/specialty-focus/liver-disease/single-article-page/fda-approves-new-treatment-for-chronic-hcv-genotypes-1-and-4/174b52697cbe2b7f82ce4ae71c9128b8.html.