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Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide

Title: Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide
Authors: Tan, Darrell H. S.; Antinori, Andrea; Eu, Beng; Galindo Puerto, María José; Kinder, Clifford; Sweet, Donna; Van Dam, Cornelius N.; Sutton, Kenneth; Sutherland-Phillips, Denise; Berni, Alessandro; Zhang, Feifan; Urbaityte, Rimgaile; Baugh, Bryan; Spreen, William; van Wyk, Jean; Garges, Harmony P.; Patel, Parul; Batterham, Rachel; D'Amico, Ronald
Source: JAIDS Journal of Acquired Immune Deficiency Syndromes ; volume 98, issue 4, page 401-409 ; ISSN 1525-4135 1944-7884
Publisher Information: Ovid Technologies (Wolters Kluwer Health)
Publication Year: 2025
Description: 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 alafenamide (BIC/FTC/TAF). Setting: Phase 3b, randomized, open-label study conducted in 118 centers 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 analyzed changes in body weight, body mass index (BMI), waist circumference (WC), hip circumference (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 to +2.10) and +0.05 kg (−2.30 to +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 to 4.00) and +0.00 cm (−4.00 to 3.97) in the LA arm, and +1.14 cm (−3.00 to 5.09) and +0.13 cm (−3.10 to 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. Conclusions: 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.
Document Type: article in journal/newspaper
Language: English
DOI: 10.1097/qai.0000000000003584
DOI: 10.1097/QAI.0000000000003584
Availability: https://doi.org/10.1097/qai.0000000000003584; https://journals.lww.com/10.1097/QAI.0000000000003584
Rights: http://creativecommons.org/licenses/by-nc-nd/4.0/
Accession Number: edsbas.5ED35974
Database: BASE