New Data Show Efficacy of Combo Therapy Elbasvir/Grazoprevir for Hepatitis C

A new review of clinical trial data show the combination therapy elbasvir/grazoprevir (EBR/GR) has high rates of efficacy for patients with genotypes 1a, 1b, and 4 chronic hepatitis C (HCV) infection.

The US Food and Drug Administration (FDA) approved the fixed-dose oral therapy, which is sold under the brand name Zepatier, back in 2016. The new review, by a team of Japanese researchers, explores the mechanisms behind the drug’s clinical efficacy, as well as some of its limitations.

“The fixed-dose once-daily oral combination regimen of EBR/GZR has beneficial effects in antiviral treatment for HCV [genotype] 1- and 4-infected [treatment-naive] and [treatment-experience] patients, with or without compensated cirrhosis, HIV coinfection, or advanced [chronic kidney disease],” wrote lead author Kenichi Morikawa, MD, PhD, of the Hokkaido University Graduate School of Medicine.

Elbasvir is an HCV nonstructural protein 5A inhibitor, while grazoprevir is an NS3/4A protease inhibitor. In the C-EDGE Trial

of treatment-naive patients, EBR/GZR achieved sustained virological response at 12 weeks (SVR12) in 92% of patients. In that trial, 23% of patients had compensated cirrhosis, but that did not appear to affect whether or not a patient achieved SVR12.

Meanwhile, in the C-EDGE Coinfection

trial, treatment-naive patients who were infected with genotype 1a HCV and also with HIV achieved SVR12 status 97% of the time. Among patients with genotype 1b HCV, the figure was 95%. But investigators noted that patients with baseline NS5A polymorphisms at certain amino acid positions experienced lower rates of efficacy.

Click to continue reading on MD Magazine.