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Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study
Author(s) -
Persico Marcello,
Aglitti Andrea,
Milella Michele,
Coppola Carmine,
Messina Vincenzo,
Claar Ernesto,
Gentile Ivan,
Sogari Fernando,
Pierri Paola,
Surace Lorenzo A.,
Morisco Filomena,
Tundo Paolo,
Brancaccio Giuseppina,
Serviddio Gaetano,
Gatti Pietro,
Termite Antonio P.,
Di Costanzo Giovan G.,
Caroleo Benedetto,
Cozzolongo Raffaele,
Coppola Nicola,
Longo Annamaria,
Fontanella Luca,
Federico Alessandro,
Rosato Valerio,
Terrenato Irene,
Masarone Mario
Publication year - 2019
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14170
Subject(s) - medicine , adverse effect , hepatitis c , cohort , creatinine , prospective cohort study , hepatitis c virus , substance abuse , immunology , virus , psychiatry
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 ( χ 2 < 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.