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).
Highlights
Ombitasvir (OBV), an antiviral agent used for the treatment of hepatitis C virus (HCV) infection, acts as an inhibitor of the non-structural protein 5A (NS5A) inhibitor
The incidence rate ratio (IRR) of drug-induced liver injury (DILI) caused by EBR/GZR treatment was 2.84 times higher than that caused by the OBV/PTV/r treatment regimen
There was no significant difference between the studied direct-acting antiviral (DAA) regimens regarding the incidence of DILI and effectiveness during the treatment
Summary
Ombitasvir (OBV), an antiviral agent used for the treatment of hepatitis C virus (HCV) infection, acts as an inhibitor of the non-structural protein 5A (NS5A) inhibitor. Paritaprevir (PTV) acts as an HCV NS3/4A protease inhibitor, and ritonavir acts as a CYP3A inhibitor When these drugs are administered in combination as the OBV/ PTV/r regimen, they serve as effective direct-acting antiviral (DAA) agents for the treatment of HCV infection. Ribavirin (RBV) in combination with daclatasvir (DSV), an HCV non-nucleoside NS5B palm domain polymerase inhibitor, can be used for the treatment of adult patients with chronic HCV genotype (GT) 1 or 4 infection (Product Information, 2015). 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
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