Outcome measures
ADVERSE REACTION, RECRUITMENT
The primary objective was to assess the safety, feasibility and acceptability of adding MVC to OBT in HIV-NAFLD. This was assessed through the following outcome measures and minimum target values to indicate feasibility: (1) proportion of eligible individuals who were recruited [target >50%] (2) monthly recruitment rate [>2 individuals per month] (3) retention rate [>65%] (4) proportion of participants with missing data [<80%] (5) proportion of participants with Adverse Reactions (AR) [<10%], which represents the rate observed for a potential alternative agent for treatment of HIV-NAFLD [Secondary outcome measures were: (1) ELF score (2) LSM (3) CAP (4) fasting lipids (5) fasting glucose (6) HbA1c (7) ALT (8) BMI (9) waist circumference (10) CD4 count (11) VL (12) change in the % with a CT liver: spleen attenuation ratio of <1.0 (13) questionnaire-assessed QoL.