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

ABSTRACT:

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.

SUBMITTER: Li J

PROVIDER: S-EPMC9274559 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: The direct-acting antiviral (DAA) agents are widely used to treat hepatitis C virus (HCV) genotype (GT) 1 infection, while it may cause severe liver damage. The objectives of the study were to evaluate the incidence of drug-induced liver injury (DILI), sustained virologic response at post-treatment week 12 (SVR12), and recurrence rates in HCV GT 1 infection. Methods: This was a retrospective cohort study that included patients diagnosed with HCV GT 1 infection, who had received intervention and treatment with elbasvir/grazoprevir (EBR/GZR) ± ribavirin (RBV) versus ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + dasabuvir ± RBV (as control group) for 12 or 24 weeks at a regional hospital in southern Taiwan between April 2016 and August 2018. The primary outcome of the study was to compare the incidence rate ratio (IRR) of DILI via Poisson regression, and the secondary outcome was to evaluate the effectiveness of two treatment regimens expressed as a percentage. Results: The study included 149 patients in the control group and 105 patients in the intervention group of which 99.33 and 98.1% patients, respectively, achieved SVR12. In the control group, one patient experienced relapse, whereas in the intervention group, two patients relapsed. Furthermore, in the control group, a total of nine patients developed DILI as determined during follow-up care. Of these patients, three were 55-84 years old. In the intervention group, six patients developed DILI. The IRR of DILI caused by EBR/GZR treatment was 2.84 times higher than that caused by the OBV/PTV/r treatment regimen. Conclusion: There was no significant difference between the studied DAA regimens regarding the incidence of DILI and effectiveness during the treatment. DILI occurrence during therapy did not affect the cure rate of medication. The present study results can provide reference data for drug selection among patients with HCV. Trial registration: The study was approved by DMF-CYCH (CYCH IRB No: 2018067).