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

PLoS One. 2023 Jul 14;18(7):e0288598. doi: 10.1371/journal.pone.0288598. eCollection 2023.


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, in a 1:1 ratio, for people with virologically-suppressed HIV-1 and NAFLD without cirrhosis. Dosing followed recommendations for HIV therapy in the Summary of Product Characteristics for maraviroc. The primary outcomes were safety, recruitment and retention rates, adherence and data completeness. Secondary outcomes included the change in Fibroscan-assessed liver stiffness measurements (LSM), controlled attenuation parameter (CAP) and Enhanced Liver Fibrosis (ELF) scores.

Results: Fifty-three participants (53/60, 88% of target) were recruited; 23 received maraviroc plus OBT; 89% were male; 19% had type 2 diabetes mellitus. The median baseline LSM, CAP & ELF scores were 6.2 (IQR 4.6-7.8) kPa, 325 (IQR 279-351) dB/m and 9.1 (IQR 8.6-9.6) respectively. Primary outcomes: all individuals eligible after screening were randomised; there was 92% (SD 6.6%) adherence to maraviroc [target >90%]; 83% (95%CI 70%-92%) participant retention [target >65%]; 5.5% of data were missing [target <20%]. There were noo Serious Adverse Reactions; mild-moderate intensity Adverse Reactions were reported by five participants (5/23, 22% (95%CI 5%-49%)) [target <10%]. All Adverse Reactions resolved. Secondary outcomes: no important differences were seen by treatment group for the change from baseline in LSM, CAP or ELF scores.

Conclusions: This feasibility study provides preliminary evidence of maraviroc safety amongst people with HIV-NAFLD, and acceptable recruitment, retention, and adherence rates. These data support a definitive randomised-controlled trial assessing maraviroc impact on hepatic steatosis and fibrosis.

Trial registration: Clinical trial registry: ISCRTN, registration number 31461655.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Diabetes Mellitus, Type 2* / complications
  • Elasticity Imaging Techniques*
  • Feasibility Studies
  • Female
  • HIV Infections* / complications
  • HIV Infections* / drug therapy
  • HIV Infections* / pathology
  • HIV-1*
  • Humans
  • Liver / pathology
  • Liver Cirrhosis / pathology
  • Male
  • Maraviroc / therapeutic use
  • Non-alcoholic Fatty Liver Disease* / complications
  • Non-alcoholic Fatty Liver Disease* / diagnosis
  • Non-alcoholic Fatty Liver Disease* / drug therapy


  • Maraviroc

Grants and funding

This study was supported by a grant from ViiV Healthcare. The authors of this manuscript were solely responsible for the hypothesis, study design, data analysis, manuscript preparation, and decision to submit the manuscript. ViiV Healthcare provided study drug and, per contract, received serious adverse event (SAE) reports and notification of intent to submit for publication. ViiV Healthcare had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.