| Title: |
Hepmarc:A 96 week randomised controlled feasibility trial of add-on maraviroc in people with HIV and non-alcoholic fatty liver disease |
| Authors: |
Bradshaw, Daniel; Abramowicz, Iga; Bremner, Stephen; Verma, Sumita; Gilleece, Yvonne; Kirk, Sarah; Nelson, Mark; Housman, Rosalie; Miras, Helena; Orkin, Chloe; Fox, Ashini; Curnock, Michael; Jennings, Louise; Gompels, Mark; Clarke, Emily; Robinson, Rachel; Lambert, Pauline; Chadwick, David; Perry, Nicky |
| Source: |
Bradshaw, D, Abramowicz, I, Bremner, S, Verma, S, Gilleece, Y, Kirk, S, Nelson, M, Housman, R, Miras, H, Orkin, C, Fox, A, Curnock, M, Jennings, L, Gompels, M, Clarke, E, Robinson, R, Lambert, P, Chadwick, D & Perry, N 2023, 'Hepmarc : A 96 week randomised controlled feasibility trial of add-on maraviroc in people with HIV and non-alcoholic fatty liver disease', PLoS ONE, vol. 18, no. 7, e0288598. https://doi.org/10.1371/journal.pone.0288598 |
| Publication Year: |
2023 |
| Collection: |
King's College, London: Research Portal |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
1932-6203 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37450478; info:eu-repo/semantics/altIdentifier/pissn/1932-6203; info:eu-repo/semantics/altIdentifier/eissn/1932-6203 |
| DOI: |
10.1371/journal.pone.0288598 |
| Availability: |
https://kclpure.kcl.ac.uk/portal/en/publications/8defab15-ffa3-4a30-a539-3c2efc0b33e6; https://doi.org/10.1371/journal.pone.0288598; https://kclpure.kcl.ac.uk/ws/files/354383534/Hepmarc_A_96_week_BRADSHAW_Publishedonline14July2023_GOLD_VoR_CC_BY_.pdf; https://www.scopus.com/pages/publications/85164756845 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.3C45420 |
| Database: |
BASE |