Switch to a raltegravir‐based antiretroviral regimen in people with HIV and non‐alcoholic fatty liver disease: A randomized controlled trial

Abstract

AbstractIntroductionThe effect of antiretroviral therapy (ART), particularly integrase strand transfer inhibitors (INSTIs), on non‐alcoholic fatty liver disease (NAFLD) in people with HIV remains unclear. We evaluated the effect of switching non‐INSTI backbone antiretroviral medications to raltegravir on NAFLD and metabolic parameters.Materials and MethodsThis was a single‐centre, phase IV, open‐label, randomized controlled clinical trial. People living with HIV with NAFLD and undetectable viral load while receiving a non‐INSTI were randomized 1:1 to the switch arm (raltegravir 400 mg twice daily) or the control arm (continuing ART regimens not containing INSTI). NAFLD was defined as hepatic steatosis by controlled attenuation parameter ≥238 dB/m in the absence of significant alcohol use and viral hepatitis co‐infections. Cytokeratin 18 was used as a biomarker of non‐alcoholic steatohepatitis. Changes over time in outcomes were quantified as standardized mean differences (SMDs), and a generalized linear mixed model was used to compare outcomes between study arms.ResultsA total of 31 people with HIV (mean age 54 years, 74% male) were randomized and followed for 24 months. Hepatic steatosis improved between baseline and end of follow‐up in both the switch (SMD −43.4 dB/m) and the control arm (−26.6 dB/m); the difference between arms was not significant. At the end of follow‐up, aspartate aminotransferase significantly decreased in the switch arm compared with the control arm (SMD −9.4 vs. 5.5 IU/L). No changes in cytokeratin 18, body mass index, or lipids were observed between study arms.DiscussionSwitching to a raltegravir‐based regimen improved aspartate aminotransferase but seemed to have no effect on NAFLD, body weight, and lipids compared with remaining on any other ART.