Elbasvir/grazoprevir (EBR/GZR) with or without ribavirin (RBV) appears to be tolerable and effective for achieving a sustained virologic response (SVR) at 12 weeks in certain genotype hepatitis C (HCV) infections, according to study findings published in the Journal of Viral Hepatitis.
In this randomized, open-label trial consisting of treatment-naive, noncirrhotic patients with HCV genotype 2, 4, 5, or 6 infection, investigators assessed the effect of EBR/GZR with or without RBV on SVR. Virologic response at 12 weeks after treatment made up the primary endpoint for this study. In addition, investigators evaluated the treatment’s associated adverse outcomes, including fatigue, headache, asthenia, nausea, and cough.
Those with the HCV genotype 2 infection were randomly assigned to receive GZR 100 mg in addition to RBV ± elbasvir 50 mg for 12 weeks. Participants with HCV genotype 4, 5, or 6 infection received EBR/GZR ± ribavirin for the same period. A SVR response at 12 months was achieved by 80% of participants with genotype 2 infection who were assigned to EBR/GZR plus RBV vs 73% of genotype 2 patients assigned to GZR and RBV.
Rates of SVR were fairly high among patients with HCV genotype 4 infection randomly assigned to EBR/GZR with and without RBV (100% and 90%, respectively). Adding RBV to the EBR/GZR combination therapy improved the 12-week SVR among patients with genotype 5 infection (EBR/GZR [25%] vs EBR/GZR plus RBV [100%]). Approximately 75% of patients with genotype 6 HCV infection in both the EBR/GZR and EBR/GZR plus RBV groups achieved a SVR at follow-up. In addition, patients receiving RBV experienced more frequent adverse events than patients receiving EBR/GZR.
The small number of patients with HCV genotypes 5 and 6 in this analysis limits the ability to draw firm conclusions on treatment “of people infected with these genotypes and the impact [of] resistance associated substitutions.”
Disclosure: This study was funded by Merck & Co., Inc.
Brown A, Hézode C, Zuckerman E, et al; for the C-SCAPE Study Investigators. Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with HCV genotype 2, 4, 5, or 6 infection: the C-SCAPE study [published online November 20, 2017]. J Viral Hepat. doi: 10.1111/jvh.12801