Efficacy and safety of elbasvir/grazoprevir treatment for Chinese patients with hepatitis C virus genotype 1b: a retrospective study.

OBJECTIVES

To determine the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) treatment in Chinese patients with GT1b chronic hepatitis virus C (HCV) infections.

METHODS

In this retrospective study, 49 treatment-naive patients with chronic GT1b HCV infection were treated with GZR (100 mg) plus EBR (50 mg) for 12 weeks. The viral response was the primary endpoint and fibrosis stage changes during and after treatment, as well as the incidence of treatment-emergent adverse events (TEAE) were secondary endpoints.

RESULTS

After 2-week EBR/GZR treatment, the virologic response rate was 85.1% (80/94) and reached 100% (94/94) after 8 and 12 weeks of therapy. Sustained virologic response (SVR) rates were 100% at the 12, 24 and 48-week follow-ups. Multivariate analysis revealed that the baseline viral load of HCV RNA may affect the rapid 2-week virologic response (OR: 0.36, 95% CI: 0.14-0.92, P=0.034), but did not influence efficacy during further treatment or follow-ups. Fifteen patients with ≥1 TEAE (16.0%) were observed and 7 (7.4%) and 8 (8.5%) patients had mild ALT or AST elevations (1.1-2.5× BL), but no serious drug-related AEs occurred. Liver stiffness measurement (LSM), the AST to platelet ratio index (APRI) and the fibrosis index based on 4 factor (FIB4) scores were consistently reduced, especially in patients with high baseline assessments after 12 weeks' treatment and during follow-ups.

CONCLUSIONS

A 12-week EBR/GZR regimen shows high efficacy and safety in Chinese patients with GT1b HCV infections.