Lifestyle modification programme for people living with HIV with metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial

Abstract

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a major cause of chronic liver disease among people living with HIV, and preliminary evidence shows that lifestyle modification can reduce liver fat in people living with HIV with MASLD. We aimed to assess a dietitian-led lifestyle modification programme in inducing resolution of MASLD in this population.

Methods: In this single-blind, randomised controlled trial at the Prince of Wales Hospital, Hong Kong, people living with HIV with fatty liver defined by intrahepatic triglyceride content ≥5% on proton magnetic resonance spectroscopy (¹H-MRS) were enrolled if they were aged 18 years or older, were on antiretroviral therapy, and had HIV RNA of ≤50 copies per mL for 6 months or longer. Participants were randomly assigned (1:1) to either receive a dietitian-led lifestyle modification programme or standard care for 12 months. Randomisation was performed using computer-generated random numbers in blocks of 4 stratified by presence or absence of diabetes. The primary outcome, assessed in the intention-to-treat population, was resolution of MASLD, defined as intrahepatic triglyceride content less than 5% at month 12, measured by ¹H-MRS. This trial was registered with ClinicalTrials.gov, NCT03913351, and is completed.

Findings: From May 21, 2019, to March 22, 2022, 203 people were screened for eligibility, of whom 84 were randomly assigned to either the lifestyle modification programme (n=43) or standard care (n=41). 74 (88%) participants were male and ten (12%) were female. 78 participants completed all assessments during the 12-month intervention. In the intention-to-treat analysis, 12 (28%) participants in the intervention group and four (10%) in the control group had resolution of MASLD (p=0·040 adjusted for baseline diabetes status). No deaths were reported during the follow-up period. One serious adverse event (hospitalisation due to cellulitis) was reported in the control group. The occurrence of adverse events was similar in the intervention and control groups. The majority of adverse events were of mild severity, and none were considered to be related to study intervention.

Interpretation: Our findings suggest that a lifestyle modification programme could be a routine behavioural strategy to improve a range of health outcomes in people living with HIV with MASLD.

Funding: Health and Medical Research Fund from the Health Bureau, Hong Kong Special Administrative Region.

Translation: For the Chinese translation of the abstract see Supplementary Materials section.