MAVMET trial: maraviroc and/or metformin for metabolic dysfunction associated fatty liver disease in adults with suppressed HIV.
AIDS
; 38(10): 1513-1522, 2024 Aug 01.
Article
em En
| MEDLINE
| ID: mdl-38819839
ABSTRACT
OBJECTIVE:
Metabolic dysfunction associated fatty liver disease (MAFLD) is over-represented in people with HIV (PWH). Maraviroc (MVC) and/or metformin (MET) may reduce MAFLD by influencing inflammatory pathways and fatty acid metabolism.DESIGN:
Open-label, 48-week randomized trial with a 2âxâ2 factorial design.SETTING:
Multicenter HIV clinics.PARTICIPANTS:
Nondiabetic, virologically suppressed PLWH, aged at least 35âyears, with confirmed/suspected MAFLD (≥1âbiochemical/anthropometric/radiological/histological features). INTERVENTION Adjunctive MVC; MET; MVC+MET vs. antiretroviral therapy (ART) alone. PRIMARYOUTCOME:
Change in liver fat fraction (LFF) between baseline and week-48 using magnetic resonance proton density fat fraction (MR PDFF).RESULTS:
Six sites enrolled 90 participants (93% male; 81% white; median age 52 [interquartile range, IQR 47-57] years) between March 19, 2018, and November 11, 2019. Seventy percent had imaging/biopsy and at least one 1 MAFLD criteria. The analysis included 82/90 with week-0 and week-48 scans. Median baseline MR PDFF was 8.9 (4.6-17.1); 40, 38, 8, and 14% had grade zero, one, two, and three steatosis, respectively. Mean LFF increased slightly between baseline and follow-up scans 2.22% MVC, 1.26% MET, 0.81% MVC+MET, and 1.39% ART alone. Prolonged intervention exposure (delayed week-48 scans) exhibited greater increases in MR PDFF (estimated difference 4.23% [95% confidence interval, 95% CI 2.97-5.48], P â<â0.001). There were no differences in predicted change for any intervention compared to ART alone MVC (-0.42% [95% CI -1.53 to 0.68, P â=â0.45]), MET (-0.62 [-1.81 to 0.56, P â=â0.30]), and MVC+MET (-1.04 [-2.74 to 0.65, P â=â0.23]). Steatosis grade remained unchanged in 55% and increased in 24%.CONCLUSION:
Baseline levels of liver fat were lower than predicted. Contrary to our hypothesis, neither MVC, MET, or the combination significantly reduced liver fat as measured by MRPDFF compared to ART alone.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecções por HIV
/
Maraviroc
/
Metformina
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
AIDS
Assunto da revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Ano de publicação:
2024
Tipo de documento:
Article