Objective: To assess the effects of decreased antiretroviral therapy exposure on body fat and metabolic parameters.
Design: Substudy of the Strategies for Management of Anti-Retroviral Therapy study, in which participants were randomized to intermittent CD4-guided [Drug Conservation (DC) group] or to continuous [Viral Suppression (VS) group] antiretroviral therapy.
Methods: Participants at 33 sites were coenrolled in the Strategies for Management of Anti-Retroviral Therapy Body Composition substudy. Regional fat was assessed annually by whole-body dual-energy X-ray absorptiometry and abdominal computed tomography. Fasting metabolic parameters were assessed at months 4, 8, and annually. Treatment groups were compared for changes in fat and metabolic markers using longitudinal mixed models.
Results: Two hundred and seventy-five patients were randomized to the DC (n = 142) or VS (n = 133) group and followed for a median of 2.0 years. By month 12, limb fat (DC-VS difference 9.8%, 95% confidence interval 3.5-16.1; P = 0.003) and subcutaneous abdominal fat (DC-VS difference 14.3 cm, 95% confidence interval -0.1 to 28.7; P = 0.05) increased in the DC group. There was no treatment difference in visceral abdominal fat (DC-VS difference -2.1%, 95% confidence interval -13.5 to 9.4; P = 0.72). Lipids significantly decreased in the DC group by month 4 and treatment differences persisted throughout follow-up (P < or = 0.001). By 12 months, hemoglobin A1C increased in the DC (+0.3%) and remained stable in the VS group (P = 0.003); the treatment difference remained significant throughout follow-up (P = 0.02).
Conclusion: After 12 months, intermittent antiretroviral therapy increased subcutaneous fat, had no effect on visceral abdominal fat, decreased plasma lipids, and increased hemoglobin A1C compared with continuous antiretroviral therapy.