Safety and efficacy of elbasvir/grazoprevir for the treatment of chronic hepatitis C: current evidence

• Published in: Drug design, development and therapy development and therapy, 2018-01, Vol.12, p.2749-2756
• Main Authors: Morikawa, Kenichi, Nakamura, Akihisa, Shimazaki, Tomoe, Sakamoto, Naoya
• Format: Article
• Language: English
• Subjects: Acids; Antiviral agents; Antiviral Agents - adverse effects; Antiviral Agents - chemistry; Antiviral Agents - therapeutic use; Antiviral drugs; Benzofurans - adverse effects; Benzofurans - chemistry; Benzofurans - therapeutic use; Boceprevir; Chronic kidney failure; Cirrhosis; CKD; Clinical trials; Combination drug therapy; Comorbidity; compensated LC; Complications and side effects; DAAs; Drug therapy; Effectiveness; Elbasvir; Gastroenterology; Genotype & phenotype; Genotypes; HCV; HCV/HIV; Hepacivirus - drug effects; Hepatitis; Hepatitis C; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Hepatology; HIV; Human immunodeficiency virus; Humans; Imidazoles - adverse effects; Imidazoles - chemistry; Imidazoles - therapeutic use; Infections; Interferon; Kidney diseases; Life cycles; Liver cirrhosis; Medical research; Mode of action; Molecular Conformation; Patients; Pharmacokinetics; Pharmacology; Populations; Protease inhibitors; Proteases; Proteinase inhibitors; Quinoxalines - adverse effects; Quinoxalines - chemistry; Quinoxalines - therapeutic use; Review; Ribavirin; Safety; Systematic review; Telaprevir; Therapeutic applications; Transplants & implants; Viruses
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S133697

Treatments for hepatitis C virus (HCV) have advanced greatly, becoming more efficacious with fewer adverse events, due to the availability of direct-acting antiviral agents, which target specific steps in the HCV life cycle. Recently, a combination regimen consisting of the HCV nonstructural protein 5A inhibitor elbasvir (EBR) and the HCV NS3/4A protease inhibitor grazoprevir (GZR) was approved for the treatment of patients with chronic HCV and genotypes (Gts) 1 and 4 in various countries. In Phase III trials, the combination of EBR/GZR (fixed-dose combination table or single agent) for 12 or 16 weeks of treatment with or without ribavirin resulted in a high sustained virological response at 12 weeks in treatment-naïve and treatment-experienced patients with HCV Gt 1a, 1b, 4, or 6, including special populations, such as individuals with advanced chronic kidney disease, HCV-HIV coinfection, and compensated cirrhosis. In this review, we focus on the mode of action, pharmacokinetics, clinical applications, efficacy, and safety profile of EBR/GZR, including special populations who have been considered refractory from the extensive evidence of clinical trials.