Lifestyle modification resolves MASLD, improves adiposity in more PLHIV than standard care

Lifestyle modification induced remission of metabolic dysfunction–associated steatotic liver disease (MASLD) in a higher proportion of people living with HIV (PLHIV) than standard care, according to the first randomized controlled trial (RCT) of its kind conducted by researchers from the Chinese University of Hong Kong (CUHK).

“Due to the toxicity of antiretroviral therapy [ART], HIV infection, as well as dietary and exercise habits, PLHIV are at heightened risk of developing metabolic disorders, including MASLD,” wrote the researchers. “However, the exclusion of PLHIV from pivotal clinical trials and large cohort studies on steatotic liver disease persists. To our knowledge, this is the first RCT to evaluate a dietitian-led lifestyle modification programme in PLHIV on resolution of MASLD.” [Lancet HIV 2025;12:e416-e427]

In the study conducted at the Prince of Wales Hospital, 84 PLHIV with fatty liver who were on ART (male, 88 percent; mean age, 48.2 years; mean BMI, 28.5 kg/m²) were randomly assigned to participate in the lifestyle modification programme (n=43) or to receive standard care (n=41). The lifestyle modification programme consisted of education on the glycaemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating at restaurants, and healthy cooking methods. The participants were to attend dietary consultation sessions weekly in the first 4 months, and monthly in the subsequent 8 months. The control group received standard care, including regular follow-up visits to assess HIV control, adherence to medications and management of comorbidities. All assessments during the 12-month study period were completed by 93 percent of participants.

The primary outcome of MASLD resolution, defined as intrahepatic triglyceride content <5 percent at month 12, was achieved by 28 vs 10 percent of participants in the intervention vs control group (p=0.040 adjusted for baseline diabetes status). Mean reductions in body weight (-2.2 vs 0.8 kg; p=0.0001), BMI (-0.8 vs 0.3 kg/m²; p=0.0002), total body fat (-1.81 vs 0.10 kg; p=0.0005), and trunk fat (-0.97 vs -0.02 kg; p=0.0036) were all significantly greater in the intervention vs control group.

“In our study, the majority of participants in the lifestyle modification programme group had <5 percent weight reduction, and a reduction in liver steatosis but not liver fibrosis was observed. A [study] duration of >12 months might be needed to assess changes in liver fibrosis. A significantly greater reduction in liver stiffness was observed in participants with weight loss of ≥5 percent at month 12,” noted the researchers.

No deaths were reported during the follow-up period. One serious adverse event (AE) (hospitalization due to cellulitis) was reported in the control group and no serious AEs were reported in the intervention group. The occurrence of AEs was similar in the intervention and control groups and the majority of AEs were of mild severity; none were considered to be related to the study intervention.

“The pathogenesis of MASLD among PLHIV is complex, with inflammation, behavioural factors and metabolic complication risks associated with ART contributing to it. These findings can provide more effective and tailored monitoring, interventions and treatment strategies for this population at higher risk of developing liver diseases, further reducing their risks of liver cancer and death,” concluded second author, Professor Vincent Wong of the Division of Gastroenterology and Hepatology at CUHK.