A Retrospective Cohort Study: Safety and Effectiveness of Elbasvir/Grazoprevir ± Ribavirin Compared With Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir ± Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection

Hsuan-Yu Hung; Chung-Yu Chen; Yi-Hsiang Liao

doi:10.3389/fphar.2021.640317

A Retrospective Cohort Study: Safety and Effectiveness of Elbasvir/Grazoprevir ± Ribavirin Compared With Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir ± Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection

Front Pharmacol. 2021 Sep 9:12:640317. doi: 10.3389/fphar.2021.640317. eCollection 2021.

Authors

Hsuan-Yu Hung¹, Chung-Yu Chen^{2

3

4}, Yi-Hsiang Liao⁵

Affiliations

¹ Department of Pharmacy, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi, Taiwan.
² Master Program in Clinical Pharmacy, School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
³ Department of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
⁴ Department of Medical Research, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
⁵ Chinese Medical Department, Park One International Hospital, Kaohsiung, Taiwan.

Abstract

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).

Keywords: DILI; drug-induced liver injury; hepatitis C virus; viekirax; zepatier.