TY - JOUR
T1 - Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection
T2 - The MISTRAL study
AU - Persico, Marcello
AU - Aglitti, Andrea
AU - Milella, Michele
AU - Coppola, Carmine
AU - Messina, Vincenzo
AU - Claar, Ernesto
AU - Gentile, Ivan
AU - Sogari, Fernando
AU - Pierri, Paola
AU - Surace, Lorenzo A.
AU - Morisco, Filomena
AU - Tundo, Paolo
AU - Brancaccio, Giuseppina
AU - Serviddio, Gaetano
AU - Gatti, Pietro
AU - Termite, Antonio P.
AU - Di Costanzo, Giovan G.
AU - Caroleo, Benedetto
AU - Cozzolongo, Raffaele
AU - Coppola, Nicola
AU - Longo, Annamaria
AU - Fontanella, Luca
AU - Federico, Alessandro
AU - Rosato, Valerio
AU - Terrenato, Irene
AU - Masarone, Mario
PY - 2019/10/1
Y1 - 2019/10/1
N2 - 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.
AB - 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.
KW - cirrhosis
KW - direct-acting antiviral
KW - efficacy
KW - HCV genotype
KW - substance abuse
UR - http://www.scopus.com/inward/record.url?scp=85068518984&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068518984&partnerID=8YFLogxK
U2 - 10.1111/liv.14170
DO - 10.1111/liv.14170
M3 - Article
C2 - 31175707
AN - SCOPUS:85068518984
VL - 39
SP - 1852
EP - 1859
JO - Liver International
JF - Liver International
SN - 1478-3223
IS - 10
ER -