Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal

José Vera; André Gomes; Diana Póvoas; Diana Seixas; Fernando Maltez; Isabel Pedroto; Luís Maia; Margarida Mota; Maria João Vieira; Maria José Manata; Paula Ferreira; Sara Lino; Tiago Pereira Guedes; Vânia Barradas; Nuno Marques

doi:10.20344/amp.19178

Authors

José Vera Centro Hospitalar Barreiro-Montijo. Barreiro.
André Gomes Hospital Garcia de Orta. Almada.
Diana Póvoas Centro Hospitalar Lisboa Central. Lisboa.
Diana Seixas Centro Hospitalar Lisboa Central. Lisboa.
Fernando Maltez Centro Hospitalar Lisboa Central. Lisboa.
Isabel Pedroto Centro Hospitalar Universitário Porto. Porto. https://orcid.org/0000-0001-6573-699X
Luís Maia Centro Hospitalar Universitário Porto. Porto. https://orcid.org/0000-0002-9814-6184
Margarida Mota Centro Hospitalar Vila Nova de Gaia/Espinho. Vila Nova de Gaia.
Maria João Vieira Centro Hospitalar Barreiro-Montijo. Barreiro.
Maria José Manata Centro Hospitalar Lisboa Central. Lisboa.
Paula Ferreira Centro Hospitalar Lisboa Norte. Lisboa.
Sara Lino Centro Hospitalar Lisboa Central. Lisboa.
Tiago Pereira Guedes Centro Hospitalar Universitário Porto. Porto. https://orcid.org/0000-0002-6582-6749
Vânia Barradas Centro Hospitalar Barreiro-Montijo. Barreiro.
Nuno Marques Hospital Garcia de Orta. Almada.

DOI:

https://doi.org/10.20344/amp.19178

Keywords:

Genotype, Glecaprevir, Hepatitis C, Chronic/drug therapy, Pibrentasvir, Portugal, Treatment Outcome

Abstract

Introduction: Information about pan-genotypic treatments for hepatitis in Portugal is scarce. We aimed to evaluate the effectiveness and safety of glecaprevir plus pibrentasvir (GLE/PIB) treatment for hepatitis C virus (HCV) infection in real-world clinical practice.
Methods: An observational prospective study was implemented in six hospitals with 121 adult HCV patients who initiated treatment with GLE/PIB between October 2018 and April 2019, according to clinical practice. Eligible patients had confirmed HCV infection genotype (GT) 1 to 6 and were either treatment-naïve or had experience with interferon-, ribavirin- or sofosbuvir-based regimens, with or without compensated cirrhosis. Baseline sociodemographic and safety data are described for the total population (N = 115). Effectiveness [sustained virologic response 12 weeks after treatment (SVR12)] and patient-reported outcomes are presented for the core population with sufficient follow-up data (n = 97).
Results: Most patients were male (83.5%), aged < 65 years (94.8%), with current or former alcohol consumption (77.3%), illicit drug use (72.6%), and HCV acquisition through intravenous drug use (62.0%). HIV co-infection occurred in 22.6% of patients. The prevalence of each GT was: GT1 51.3%, GT2 1.7%, GT3 30.4%, GT4 16.5%, and GT5.6 0%. Most patients were non-cirrhotic (80.9%) and treatment-naïve (93.8%). The SVR12 rates were 97.9% (95% CI: 92.8 - 99.4), and > 95% across cirrhosis status, GT, illicit drug use, alcohol consumption, and HCV treatment experience. The adverse event rate was 2.6%, and no patient discontinued treatment due to adverse events related to GLE/PIB.
Conclusion: Consistent with other real-world studies and clinical trials, treatment with GLE/PIB showed high effectiveness and tolerability overall and in difficult-to-treat subgroups (ClinicalTrials.gov: NCT03303599).

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