DOI: 10.25377/sussex.22815686.v1
title: Dataset for Hepmarc: a 96 week randomised controlled feasibility trial of add-on maraviroc in people with HIV and non-alcoholic fatty liver disease

description: Data for paper published in PLOS ONE 14.07.2023 These files were used for the statistical analysis of the <em>hemparc feasibility trial</em> using Stata software verson 17, and are as follows, both Stata format and .csv format as appropriate. The .do file is a simple text file. <br> <strong>hepmarc_data </strong>minimum dataset: .csv, .dta: See doi:10.1136/bmjopen-2019-035596 for study protocol describing all data collected <strong>hepmarc Data dictionary </strong>.xls, .dta; description of each data fields in minimum dataset <strong>hepmarc AE listing</strong>: Adverse events listing .csv, .dta <strong>hepmarc SAP v1.0 240322_</strong>.xls .dta; description of each data fields in minimum dataset <strong>hepmarc data.do </strong>Stata .do file used to perform the analysis <br> Notes: Each particpant's age has been altered by a random amount to preserve anonymity. There are two rows for two of the participants who each reported two adverse reactions. <br> <strong>Abstract</strong> <strong>Objectives</strong> 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. <br> <strong>Methods</strong> 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. <br> <strong>Results</strong> 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. <br> Primary outcomes: all individuals eligible after screening were randomised; there was 92% (SD 6.6%) adherence to maraviroc [target &gt;90%]; 83% (95%CI 70%-92%) participant retention [target &gt;65%]; 5.5% of data were missing [target &lt;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 &lt;10%]. All Adverse Reactionss resolved. Secondary outcomes: no important differences were seen by treatment group for the change from baseline in LSM, CAP or ELF scores <br> <strong>Conclusions</strong> 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. <br> Clinical trial registry: ISCRTN, registration number 31461655.