Abstract: Objective The aim of this clinical trial was to compare the virologic response (VR) to elbavir/glarevir therapy in naïve and re-treated patients with chronic hepatitis C (CHC) with HCV genotype 1b infection. Methods 59 naïve and 56 re-treated patients with HCV gene type 1b infected CHC, the latter had failed to response to peg-interferon-α2b treatment, were recruited in our hospital between January 2019 and March 2020, and all patients with CHC were treated by orally elbavir/glarevir for 12 weeks. All the patients were followed-up for 24 weeks. Serum HCV RNA loads were detected by real-time fluorescent quantitative RT-PCR. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TSB), and serum laminin (LN), hyaluronidase (HA), type Ⅲ procollagen N-terminal peptide (PC-Ⅲ) and type Ⅳ collagen (Ⅳ-C) were routinely detected. The rapid virologic response (RVR), end treatment virologic response (ETVR) and sustained virologic response (SVR) were evaluated. Results After treatment, there were no statistical differences as respect to serum ALT, AST and total bilirubin levels between the two groups (P>0.05), and there were also no statistical differences in serum LN, HA, PC-Ⅲ and Ⅳ-C levels between the two groups (P＞0.05); the serum ALT normalization rate and serum HCV RNA loss rate in naïve patients with CHC were 96.6% and 98.3%, both not significantly different as compared to 98.2% and 100.0% in re-treated patients with CHC (P＞0.05); the RVR, ETVR and SVR were 89.8%, 94.9% and 93.2%, not significantly different compared to 91.1%, 98.2% and 98.2%, respectively, in re-treated patients (P＞0.05); there were some cases with headache, dizziness, nausea, vomiting and diarrhoea, which disappeared gradually or after appropriate management, without untoward reactions in our series during the regimen. Conclusion The therapeutic efficacy of elbavir/glarevir is promising in patients with naïve or re-treated CHC, without obvious adverse reactions, and warrants further clinical investigation.

Key words: Hepatitis C, Genotype 1b, Elbavir/glarevir, Naïive, Re-treated, Therapy