Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Alessio Aghemo, Alfredo Alberti, Alessia Alberti, Pietro Andreone, Mario Angelico, Maurizia Rossana Brunetto, Luchino Chessa, Alessia Ciancio, Antonio Craxì, Giovanni Battista Gaeta, Massimo Galli, Antonio Gasbarrini, Alessia Giorgini, Elisabetta Grilli, Pietro Lampertico, Miriam Lichtner, Michele Milella, Filomena Morisco, Marcello Persico, Mario PirisiMassimo Puoti, Giovanni Raimondo, Antonietta Romano, Maurizio Russello, Vincenzo Sangiovanni, Monica Schiavini, Gaetano Serviddio, Erica Villa, Maria Vinci, Maria Rosaria Vinci, Antonella De Michina, Valentina Gallinaro, Giuliana Gualberti, Antonio Saverio Roscini, Anna Linda Zignego

Research output: Contribution to journalArticle

Abstract

Background and Aims: The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and Methods: Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naïve and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. Results: The SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. Conclusion: Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.
Original languageEnglish
Pages (from-to)612-619
Number of pages8
JournalDigestive and Liver Disease
Volume53
DOIs
Publication statusPublished - 2021

Keywords

  • Adult
  • Aged
  • Antiviral Agents
  • Benzimidazoles
  • Drug Combinations
  • Female
  • GLE/PIB
  • HCV
  • Hepatitis C, Chronic
  • Humans
  • Italy
  • Male
  • Middle Aged
  • PWUD
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Pyrrolidines
  • Quality of Life
  • Quinoxalines
  • Sulfonamides
  • Sustained Virologic Response
  • elderly

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