Evidence map›Paper›PMID 37450478›Full record

Trial reportPloS one2023

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

Daniel Bradshaw, Iga Abramowicz, Stephen Bremner, Sumita Verma, Yvonne Gilleece, Sarah Kirk, Mark Nelson, Rosalie Housman, Helena Miras, Chloe Orkin and 9 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Liver disease in people living with HIV infection: a changing landscape.Nature reviews. Gastroenterology & hepatology · 2026
    Review
  2. Review
  3. Article
  4. Review
  5. Fatty Liver Disease: Enter the Metabolic Era.Current HIV/AIDS reports · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 1 country.

Daniel BradshawThe Lawson Unit, University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom.ORCID 0000-0001-7186-2482
Iga AbramowiczBrighton and Sussex Clinical Trials Unit, University of Sussex, Brighton, United Kingdom.
Stephen BremnerBrighton and Sussex Clinical Trials Unit, University of Sussex, Brighton, United Kingdom.
Sumita VermaBrighton and Sussex Medical School, University of Sussex, Brighton, United Kingdom.
Yvonne GilleeceThe Lawson Unit, University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom.
Sarah KirkThe Lawson Unit, University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom.
Mark NelsonDepartment of HIV and Sexual Health, Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.
Rosalie HousmanDepartment of HIV and Sexual Health, Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.
Helena MirasGrahame Hayton Unit, Barts Health NHS Trust, London, United Kingdom.
Chloe OrkinGrahame Hayton Unit, Barts Health NHS Trust, London, United Kingdom.
Ashini FoxDepartment of Genitourinary Medicine and HIV, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.
Michael CurnockDepartment of Genitourinary Medicine and HIV, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.
Louise JenningsDepartment of HIV, North Bristol NHS Trust, Bristol, United Kingdom.
Mark GompelsDepartment of HIV, North Bristol NHS Trust, Bristol, United Kingdom.
Emily ClarkeDepartment of Genitourinary Medicine and HIV, Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.ORCID 0000-0001-9340-1417
Rachel RobinsonDepartment of Genitourinary Medicine and HIV, Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.
Pauline LambertDepartment of Infectious Diseases, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom.
David ChadwickDepartment of Infectious Diseases, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom.
Nicky PerryBrighton and Sussex Clinical Trials Unit, University of Sussex, Brighton, United Kingdom.
Brighton and Sussex Medical School · GBUniversity Hospitals Sussex NHS Foundation Trust · GBBarts Health NHS Trust · GBChelsea and Westminster Hospital NHS Foundation Trust · GBNorth Bristol NHS Trust · GBNottingham University Hospitals NHS Trust · GBSouth Tees Hospitals NHS Foundation Trust · GBUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesMaraviroc may reduce hepatic inflammation in people with HIV and non-alcoholic fatty liver disease (HIV-NAFLD) through CCR5-receptor antagonism, which warrants further exploration.

methodsWe 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.

resultsFifty-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.

conclusionsThis 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 registrationClinical trial registry: ISCRTN, registration number 31461655.

Indexed as

Diabetes Mellitus, Type 2Elasticity Imaging TechniquesHIV-1HIV InfectionsNon-alcoholic Fatty Liver DiseaseFeasibility StudiesFemaleHumansLiverLiver CirrhosisMaleMaravirocMaraviroc

Identifiers

PMID37450478
PMCPMC10348519
OpenAlexW4384282998

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.