Hepmarc: A 96 week randomised controlled feasibility trial of add-on maraviroc in people with HIV and non-alcoholic fatty liver disease

• DOI: 10.1371/journal.pone.0288598
• Publication Date: 2023-07-14T17:35:59Z
• Authors: Daniel Bradshaw; Iga Abramowicz; Stephen Bremner; Sumita Verma; Yvonne Gilleece; Sarah Kirk; Mark Nelson; Rosalie Housman; Helena Miras; Chloe Orkin; Ashini Fox; Michael Curnock; Louise Jennings; Mark Gompels; Emily Clarke; Rachel Robinson; Pauline Lambert; David Chadwick; Nicky Perry
• Keywords: Maraviroc; CCR5 receptor antagonist; Liver disease

Objectives Maraviroc may reduce hepatic inflammation in people with HIV and non-alcoholic fatty liver disease (HIV-NAFLD) through CCR5-receptor antagonism, which warrants further exploration. Methods We performed an open-label 96-week randomised-controlled feasibility trial of maraviroc plus optimised background therapy (OBT) versus OBT alone, a 1:1 ratio, for virologically-suppressed HIV-1 NAFLD without cirrhosis. Dosing followed recommendations the Summary Product Characteristics maraviroc. The primary outcomes were safety, recruitment retention rates, adherence data completeness. Secondary included change Fibroscan-assessed stiffness measurements (LSM), controlled attenuation parameter (CAP) Enhanced Liver Fibrosis (ELF) scores. Results Fifty-three participants (53/60, 88% target) recruited; 23 received OBT; 89% male; 19% had type 2 diabetes mellitus. median baseline LSM, CAP & ELF scores 6.2 (IQR 4.6–7.8) kPa, 325 279–351) dB/m 9.1 8.6–9.6) respectively. Primary outcomes: all individuals eligible after screening randomised; there was 92% (SD 6.6%) to [target >90%]; 83% (95%CI 70%-92%) participant >65%]; 5.5% missing <20%]. There noo Serious Adverse Reactions; mild-moderate intensity Reactions reported by five (5/23, 22% 5%-49%)) <10%]. All resolved. no important differences seen treatment group from or Conclusions This study provides preliminary evidence safety amongst HIV-NAFLD, acceptable recruitment, retention, rates. These support definitive assessing impact on steatosis fibrosis. Trial registration Clinical registry: ISCRTN, number 31461655 .