Incidence of Metabolic syndrome in people with HIV without experienCe to antiretroviral Therapy who start doLutegravir based-regimen compared with bictegrAvir based-regimeN after 48 weeks (MICTLAN trial).

Objective: Evidence suggests that patients initiating a second-generation INSTI-based regimen may have a higher risk of developing metabolic syndrome (MetS) compared to those on other antiretroviral classes. This study aimed to describe the incidence of MetS at 48 weeks, based on ATP III criteria, in people with HIV (PWH) who started antiretroviral therapy (ART) with a DTG/ABC/3TC-based regimen compared to those receiving a BIC/TAF/FTC-based regimen.

Design: A randomized, open-label clinical trial was conducted in PWH with no prior exposure to ART.

Methods: Participants were randomized to receive either BIC/TAF/FTC or DTG/ABC/3TC. Anthropometric measurements, including weight, height, blood pressure, waist circumference, bioelectrical impedance analysis, and visceral fat assessment via ultrasonography, were performed at baseline, 24 weeks, and 48 weeks. Metabolic parameters were evaluated at each visit.

Results: Out of 378 subjects, 311 provided informed consent and were included. Of these, 276 completed 48 weeks of follow-up. The incidence of MetS was 6 (3.9%) and 10 (6.3%) in BIC/TAF/FTC and DTG/ABC/3TC arms, respectively, with no significant difference between groups. In the BIC/TAF/FTC group, 24 patients (9%) experienced a weight gain of ≥10%, compared to 16 patients (6%) in the DTG/ABC/3TC group (p = 0.72). Risk factors for MetS were age ≥40 years old, baseline BMI ≥25 kg/m2, and baseline visceral fat ≥5 cm prior to ART initiation.

Conclusion: Incidence of MetS among PWH receiving an INSTI-based regimen was high, with no difference between BIC/TAF/FTC and DTG/ABC/3TC groups. Age, overweight and elevated visceral fat at baseline were all associated with MetS.