Journal Article

No changes in weight, body composition or metabolic parameters after the switch to dolutegravir and lamivudine compared to continued treatment with dolutegravir, abacavir and lamivudine for virologically suppressed HIV infection (The AVERTAS trial)

Weis, Nina, Hove, Jens Dahlgaard, Møller, Søren, Kronborg, Gitte, Hansen, Ann-Brit Eg, Gerstoft, Jan, Lindhardt, Magnus Søltoft, Lebech, Anne-Mette, Siebner, Hartwig Roman, Knudsen, Andreas, Meddis, Alessandra, Helweg-Larsen, Jannik, Helms, Morten, Fischer, Christian Philip, Heje, Karen Brorup, Benfield, Thomas, Kirk, Ole

2025

Overview

Background Antiretroviral therapy (ART) in people with HIV (PWH) can lead to weight gain, but the effects of nucleoside reverse transcriptase inhibitors such as abacavir (ABC) are not well understood. In this study, we investigated whether discontinuing ABC would mitigate weight changes and metabolic complications in PWH. Methods In a randomized controlled trial including PWH on dolutegravir, ABC, and lamivudine (DTG/ABC/3TC), participants were randomized 2:1 to either switch to DTG/3TC or continue DTG/ABC/3TC. Data was collected at baseline, week 24, and week 48. This study was powered to detect a difference of 2 kg in weight between groups. Secondary outcomes included body composition, fat and muscle distribution, and metabolic parameters. Weight and metabolic changes were analyzed by linear mixed modeling. Results Eighty-one participants were randomized. Switching from DTG/ABC/3TC to DTG/3TC was not associated with a significant change in weight at 48 weeks in the intention to treat (ITT) analysis (mean difference − 0.5 kg, 95% confidence interval (CI): -2.5 to 1.5, p  = 0.599) or the modified ITT, (-0.1 kg, 95% CI: -1.7 to 1.5, p  = 0.914). In the ITT analysis, the DTG/3TC group gained 0.4 kg ± 5.1 SD ( p  = 0.589) compared to 0.9 kg ± 2.3 SD ( p  = 0.054) in the DTG/ABC/3TC group, while in the modified ITT, the changes were 0.9 ± 3.2 kg ( p  = 0.054) and 0.9 ± 3.6 kg ( p  = 0.071), respectively. The were no differences between groups in secondary outcomes. Conclusion Continuing or discontinuing abacavir for 48 weeks was associated with modest gains in weight that did not differ between groups. Similarly, fat distribution, or metabolic parameters were comparable between groups.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abacavir / Adult / Analysis / Anti-HIV Agents - adverse effects / Anti-HIV Agents - therapeutic use / Antiretroviral agents / Antiretroviral therapy / Antiretroviral therapy, highly active / Antiviral agents / Body composition / Body Composition - drug effects / Body fat / Body weight / Body Weight - drug effects / Cardiovascular disease / Consent / Cyclopropanes / Data collection / Diabetes / Dideoxyadenosine - analogs & derivatives / Dideoxynucleosides - administration & dosage / Dideoxynucleosides - adverse effects / Dideoxynucleosides - therapeutic use / DNA polymerases / Dosage and administration / Drug Combinations / Drug therapy / Female / Health aspects / Heterocyclic Compounds, 3-Ring - administration & dosage / Heterocyclic Compounds, 3-Ring - adverse effects / Heterocyclic Compounds, 3-Ring - therapeutic use / HIV / HIV infection / HIV Infections - drug therapy / HIV Infections - metabolism / Human immunodeficiency virus / Humans / Hypertension / Infections / Infectious Diseases / Internal Medicine / Lamivudine / Lamivudine - administration & dosage / Lamivudine - adverse effects / Lamivudine - therapeutic use / Liver / Male / Medical imaging / Medical Microbiology / Medicine / Medicine & Public Health / Metabolism / Middle Aged / Nucleoside reverse transcriptase inhibitors / Oxazines / Parameters / Parasitology / Patient outcomes / Piperazines / Pyridones / RNA-directed DNA polymerase / Tropical Medicine / Weight / Weight gain