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

• Published in: Liver international Vol. 39; no. 10; pp. 1852 - 1859
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.10.2019
• Subjects: Adult; Aged; Aged, 80 and over; Antiviral agents; Antiviral Agents - therapeutic use; Benzimidazoles - therapeutic use; cirrhosis; Correlation analysis; Creatinine; direct‐acting antiviral; Drug abuse; Drug Therapy, Combination; Effectiveness; efficacy; Epidemics; Female; Fibrosis; Genotype; Genotypes; HCV genotype; Hepacivirus - drug effects; Hepacivirus - genetics; Hepatitis; Hepatitis C; Hepatitis C, Chronic - drug therapy; Humans; Italy; Kidney diseases; Liver Cirrhosis - virology; Longitudinal Studies; Male; Medical treatment; Middle Aged; Patients; Prospective Studies; Quinoxalines - therapeutic use; Subgroups; substance abuse; Substance Abuse, Intravenous - complications; Substance use; Sulfonamides - therapeutic use; Sustained Virologic Response; Viruses; Young Adult; Italy; direct-acting antiviral; substance abuse; cirrhosis; efficacy; HCV genotype
• ISSN: 1478-3223; 1478-3231; 1478-3231
• DOI: 10.1111/liv.14170

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.