Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study

Marcello Persico, Andrea Aglitti, Michele Milella, Carmine Coppola, Vincenzo Messina, Ernesto Claar, Ivan Gentile, Fernando Sogari, Paola Pierri, Lorenzo A. Surace, Filomena Morisco, Paolo Tundo, Giuseppina Brancaccio, Gaetano Serviddio, Pietro Gatti, Antonio P. Termite, Giovan G. Di Costanzo, Benedetto Caroleo, Raffaele Cozzolongo, Nicola CoppolaAnnamaria Longo, Luca Fontanella, Alessandro Federico, Valerio Rosato, Irene Terrenato, Mario Masarone

Research output: Contribution to journalArticlepeer-review

Abstract

Background and aims: It is paramount to identify predictors of treatment failure with direct antiviral agents in ‘field-practice’ patients, including people who inject drugs (PWID). Data on the efficacy of glecaprevir/pibrentasvir (GLE/PIB) in a field-practice scenario are scant. The multicentre MISTRAL study enrolled 1177 patients, including PWID, to assess real-life efficacy and safety of GLE/PIB and to identify the predictive factors for this treatment. Methods: This was a prospective, longitudinal study. The outcome variable was the rate of sustained virological response (SVR) at week 12. Results: A total of 123 patients (10%) were infected from hepatitis C virus (HCV) 3. METAVIR fibrosis score was F4 in 104 subjects (9%); 118 patients (10%) were PWID. Overall, 1163/1177 (99%) patients achieved SVR. The baseline clinical factors discriminating between treatment success and treatment failure were age at treatment (P = 0.031) and creatinine level (P = 0.034). SVR rates were not influenced by gender, substance abuse, previous treatment, treatment duration, fibrosis or chronic kidney disease stage. Compared with non-substance users, the 118 PWID exhibited a significantly different genotype pattern distribution (χ2 < 0.001). A total of 40/118 (33.9%) of substance users were HCV3 compared to 83/1056 (7.9%) non-substance users. Only 6 patients (0.5%) reported a serious adverse event. Conclusions: The MISTRAL study provides evidence of GLE/PIB efficacy in a field-practice scenario in a highly epidemic HCV area in southern Italy; it unveiled significant differences in genotype distribution among the most underserved and difficult-to-treat patient subgroups including PWID.

Original languageEnglish
Pages (from-to)1852-1859
Number of pages8
JournalLiver International
Volume39
Issue number10
DOIs
Publication statusPublished - Oct 1 2019

Keywords

  • cirrhosis
  • direct-acting antiviral
  • efficacy
  • HCV genotype
  • substance abuse

ASJC Scopus subject areas

  • Hepatology

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