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Direct-acting antiviral agents in patients with hepatitis C genotype 1-4 infections in a tertiary hospital
J C Del Rio-Valencia1, R Asensi-Diez, L Villalobos-Torres
1Juan Carlos del Rio-Valencia, Hospital Regional Universitario de Málaga. Avenida de Carlos Haya s/n. CP.29010. Málaga. Spain. juancardelrio@telefonica.net.
Insights
Direct antiviral agents (DAAs) demonstrate high sustained virologic response rates (SVR12) in real-world Hepatitis C virus (HCV) patients across genotypes 1-4. Treatment regimens showed significant efficacy, confirming clinical trial data.
Area of Science:
- Hepatology
- Virology
- Clinical Medicine
Background:
- Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease.
- Six HCV genotypes (GT 1-6) exist, with genotype influencing treatment efficacy of direct antiviral agents (DAAs).
Purpose of the Study:
- To describe clinical characteristics of real-world HCV patients.
- To evaluate the effectiveness of various DAA-based treatment regimens.
Main Methods:
- Retrospective, observational study of 515 HCV patients (January 2015-January 2016).
- Patients received 12-week DAA regimens, with or without ribavirin (RBV) or pegylated interferon (Peg-IFN).
- Primary endpoint: sustained virologic response 12 weeks post-treatment (SVR12).
Main Results:
- High SVR12 rates observed across genotypes 1-4 with different DAA combinations.
- Genotype 1: SVR12 rates ranged from 87.5% to 98.82%.
- Genotype 3: SVR12 rates varied from 43.75% to 95% depending on the regimen.
Conclusions:
- Real-world DAA treatment confirms efficacy reported in clinical trials for HCV genotypes 1-4.
- Diverse patient characteristics were managed effectively by the evaluated treatment regimens.
Objective:
Hepatitis C virus (HCV) infection is a major cause of chronic liver disease. Six different genotypes (GT) of HCV (genotypes 1-6) have been identified. The genotype is clinically relevant since the majority of current direct antiviral agents (DAA´s) do not have pangenotypic efficacy. The purpose of this study was to describe the clinical characteristics of real world patients and evaluate the effectiveness of different treatment regimens.
Methods:
Retrospective and observational study carried out in a third level hospital. Study period: January 2015-January 2016. Inclusion criteria: HCV patients of any genotype treated with either DAAs ± rivabirin (RBV) or DAAs + RBV + pegilated interferon (Peg-IFN) regimens for 12 weeks. Exclusion criteria: patients without adequate clinical or analytical information available for further analysis. Patients treated for 24 weeks were excluded. The main endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12), and secondary endpoint was SVR24.
Results:
A total of 515 patients were included (aged 55.52±8.97 years). GT1: patients treated with simeprevir + sofosbuvir (SIM + SOF), ledipavir (LDV)/SOF and paritaprevir/ritonavir/ombitasvir + dasabuvir (PTV/r/OBV + DSV) ± RBV had a SVR12 of 93.59% (190/203), 98.82% (N=84/85), 94.28% (66/70), respectively. Regarding daclatasvir (DCV) + SOF and SIM + DCV, everybody (19/19) and 87.5% (7/8) got SVR12, respectively. GT2: 71.42% (N=10/14) of patients achieved SVR12, concretely, SOF + RBV had a SVR12 75% (N=6/8). GT3: 43.75% (N=7/16), 90% (N=9/10) and 95% (N=19/20) of patients treated with LDV/SOF, LDV/SOF + RBV and SOF + DCV obtained SVR12, respectively. GT4: patients treated with LDV/SOF, SIM + SOF and PTV/r/OBV ± RBV had a SVR12 rate of 100% (21/21), 91.67% (22/24) and 92% (23/25), respectively. All patients that got SVR12 achieved SVR24.
Conclusions:
Our study confirmed the efficacy data reported in clinical trials in a cohort of patients with GT1-4 and a wide range of basal characteristics.
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