Weight and metabolic changes with long-acting cabotegravir and rilpivirine or bictegravir/emtricitabine/tenofovir alafenamide.

Abstract

Background: Modest weight and lipid changes have been observed in cabotegravir plus rilpivirine long-acting (CAB+RPV LA) Phase 3/3b studies. The SOLAR study included standardized evaluations of weight and metabolic changes in people living with HIV switching to CAB+RPV LA dosed every 2 months (Q2M) vs. continuing bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF).

Setting: Phase 3b, randomized, open-label study conducted in 118 centres across 14 countries.

Methods: Participants (n=687) were randomized 2:1; 454 switched to CAB+RPV LA Q2M and 227 continued BIC/FTC/TAF. Participants who started lipid-modifying agents or underwent cosmetic procedures were excluded. We analysed changes in body weight, body mass index (BMI), waist and hip circumferences (WC, HC), waist-to-height ratio (WHtR), waist-to-hip ratio (WHR), muscle mass, body fat, and proportion with insulin resistance or metabolic syndrome at 1 year.

Results: Median (interquartile range) change in body weight from baseline was -0.40 kg (-2.95, +2.10) and +0.05 kg (-2.30, +1.95) in the LA and BIC/FTC/TAF arm, respectively. Median (interquartile range) changes in WC and HC were +0.06 cm (-4.50, 4.00) and +0.00 cm (-4.00, 3.97) in the LA arm, and +1.14 cm (-3.00, 5.09) and +0.13 cm (-3.10, 4.00) in the BIC/FTC/TAF arm. There were no clinically relevant changes in WHtR, WHR, or the proportion with metabolic syndrome or insulin resistance in either arm.

Conclusion: Standardized changes in weight, BMI, and body composition were minor and similar between participant switching to CAB+RPV LA Q2M or continuing BIC/FTC/TAF, with no clinically relevant changes in metabolic syndrome or insulin resistance.