William F. Balistreri, MD

Disclosures

March 22, 2016

In This Article

Grazoprevir/Elbasvir for HCV Genotypes 1, 4, and 6

The fixed-dose combination of GZR/EBR—an interferon-free, RBV-free once-daily tablet—has shown robust efficacy and safety in diverse populations.

Rockstroh and colleagues[6] evaluated GZR/EBR among treatment-naive HIV/HCV-coinfected patients with HCV genotype 1, 4, or 6. All patients were receiving stable antiretroviral therapy and then were given open-label GZR/EBR (100 mg/50 mg) for 12 weeks. SVR12 was achieved in 95% of patients, including 100% of those with cirrhosis.

Jacobson and colleagues[7] analyzed the efficacy and safety of 12-16 weeks of therapy with GZR/EBR among patients with compensated cirrhosis (HCV genotype 1, 4, and 6).Treatment-naive and treatment-experienced patients with compensated cirrhosis received GZR/EBR with and without RBV for 12-18 weeks in six studies. Among treatment-experienced patients, 51% had a prior null response to pegylated RBV, and therapy had failed in 15%.

In phase 2 and 3 studies, GZR/EBR for 12 weeks resulted in high SVR rates among treatment-naive and treatment-experienced patients who had cirrhosis and were infected with HCV genotype 1b. For treatment-experienced patients with HCV genotype 1a, 4, or 6, a 16- to 18-week regimen with or without RBV was highly effective. The GZR/EBR combination regimen was generally well tolerated among patients with cirrhosis as well. [Editor's note: The US Food and Drug Administration (FDA) approved the combination drug EBR/GZR (Zepatier™, Merck) for HCV genotype 1 and 4 on January 28, 2016.]

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