Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study.
Adult
Aged
Aged, 80 and over
Aminoisobutyric Acids
Antiviral Agents
/ therapeutic use
Benzimidazoles
/ therapeutic use
Cyclopropanes
Drug Therapy, Combination
Female
Genotype
Hepacivirus
/ drug effects
Hepatitis C, Chronic
/ drug therapy
Humans
Italy
Lactams, Macrocyclic
Leucine
/ analogs & derivatives
Liver Cirrhosis
/ virology
Longitudinal Studies
Male
Middle Aged
Proline
/ analogs & derivatives
Prospective Studies
Pyrrolidines
Quinoxalines
/ therapeutic use
Substance Abuse, Intravenous
/ complications
Sulfonamides
/ therapeutic use
Sustained Virologic Response
Young Adult
HCV genotype
cirrhosis
direct-acting antiviral
efficacy
substance abuse
Journal
Liver international : official journal of the International Association for the Study of the Liver
ISSN: 1478-3231
Titre abrégé: Liver Int
Pays: United States
ID NLM: 101160857
Informations de publication
Date de publication:
10 2019
10 2019
Historique:
received:
26
02
2019
revised:
30
05
2019
accepted:
03
06
2019
pubmed:
9
6
2019
medline:
22
9
2020
entrez:
9
6
2019
Statut:
ppublish
Résumé
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. This was a prospective, longitudinal study. The outcome variable was the rate of sustained virological response (SVR) at week 12. 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 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.
Sections du résumé
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
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.
Substances chimiques
Aminoisobutyric Acids
0
Antiviral Agents
0
Benzimidazoles
0
Cyclopropanes
0
Lactams, Macrocyclic
0
Pyrrolidines
0
Quinoxalines
0
Sulfonamides
0
pibrentasvir
2WU922TK3L
Proline
9DLQ4CIU6V
Leucine
GMW67QNF9C
glecaprevir
K6BUU8J72P
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1852-1859Informations de copyright
© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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