ISSUE 1489
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The FDA has approved Zepatier (Merck), a fixed-dose combination of two direct-acting antiviral agents — elbasvir, an NS5A inhibitor, and grazoprevir, an NS3/4A protease inhibitor — for oral treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection.
HCV GENOTYPES — Genotype 1 is responsible for 70-80% of HCV infections in the US. Genotype 4 is uncommon in the US and Canada; it is the most prevalent strain of HCV in Central sub-Saharan Africa, North Africa, and the Middle East.1
FIXED-DOSE COMBINATIONS — Zepatier is the third all-oral, interferon-free, fixed-dose combination to be approved for treatment of infections with HCV genotypes 1 and 4. The combination of ledipasvir/sofosbuvir (Harvoni) was approved for HCV genotype 1 infection in 20142 and for genotypes 4, 5, and 6
... more- JP Messina et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015; 61:77.
- A combination of ledipasvir and sofosbuvir (Harvoni) for hepatitis C. Med Lett Drugs Ther 2014; 56:111.
- In brief: new indications for Harvoni. Med Lett Drugs Ther 2016; 58:6.
- A 4-drug combination (Viekira Pak) for hepatitis C. Med Lett Drugs Ther 2015; 57:15.
- In brief: Technivie for HCV genotype 4 infection. Med Lett Drugs Ther 2015; 57: e162.
- American Association for the Study of Liver Diseases/Infectious Disease Society of America/International Antiviral Society– USA. Recommendations for testing, managing, and treating hepatitis C. December 11, 2015. Available at www. hcvguidelines.org. Accessed February 18, 2016.
- S Zeuzem et al. Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial. Ann Intern Med 2015; 163:1.
- JK Rockstroh et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV 2015; 2:e319.
- P Kwo et al. Efficacy and safety of grazoprevir/elbasvir +/- RBV for 12 or 16 weeks in patients with HCV G1, G4 or G6 infection who previously failed peginterferon/RBV : C-EDGE treatment-experienced. EASL - The International Liver Congress 2015 50th Annual Meeting of the European Association for the Study of the Liver; Vienna, Austria; April 22-26. Available at www.natap. org. Accessed February 18, 2016.
- X Forns et al. Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent. J Hepatol 2015; 63:564.
- M Buti et al. Grazoprevir, elbasvir, and ribavirin for chronic hepatitis C virus genotype 1 infection after failure of pegylated interferon and ribavirin with an earlier-generation protease inhibitor: final 24-week results from C-SALVAGE. Clin Infect Dis 2016; 62:32.
- D Roth et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet 2015; 386:1537.

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