Procedures
NAFLD, AIDS toxicity
INFECTIOUS DISEASES, ADVERSE EVENT, ALLERGY, LIVER FIBROSIS, CHRONIC LIVER DISEASE
MVC was prescribed twice daily at the licensed dose for HIV-1 therapy, adjusted according to co-medications according to the Summary of Product Characteristics. Participants attended every 24 weeks for 96 weeks plus a week 4 safety visit for those receiving maraviroc. All participants received advice on lifestyle and dietary modifications as standard of care interventions for HIV-NAFLD. Supplementary Table S1 in In brief, the screening visit included history-taking, physical examination, height and weight measurement, laboratory investigations for eligibility, ECG, LSM and Controlled Attenuation Parameter (CAP) score measured by Fibroscan, and hepatic ultrasound scan. Fibroscan readings, HbA1c, CD4 T-lymphocyte count, and VL from screening were used as the baseline measures. This visit was performed by the site investigator or sub-investigator, who also confirmed eligibility. The baseline assessment included diet and exercise history, fasting bloods for glucose and lipids, Enhanced Liver Fibrosis (ELF) score and proviral DNA co-receptor tropism. There was an optional CT scan liver and spleen, and this was only offered at one site. Participants additionally completed questionnaires to evaluate quality of life (QoL): chronic liver disease questionnaire for NAFLD (CLDQ-NAFLD) [Assessments performed each 24 weeks were review of symptoms and Adverse Events (AE), examination, weight, VL, full blood count, routine serum chemistries and urinalysis. Additional assessments performed every 48 weeks were diet and exercise history, questionnaire completion, CD4 count, fasting glucose and lipids, HbA1c, ELF score, Fibroscan. An optional CT scan of liver and spleen was performed at 96 weeks. Self-reported adherence noted on diary cards and pill counts by the pharmacist of returned MVC doses were recorded every visit. AE severity and laboratory abnormalities was assessed using the National Institute of Allergy and Infectious Diseases Division of AIDS toxicity grading scale [The first participant was enrolled on 24/07/18 and the final participant completed the last study assessment on 08/11/21.