Gagliardini, R;
Giacomelli, A;
Mussini, C;
Cole, SR;
Edwards, JK;
Pinnetti, C;
Raimondi, A;
... Cozzi-Lepri, A; + view all
(2025)
Effectiveness of dolutegravir-based vs boosted darunavir-based first-line 3-drug regimens in people with HIV with advanced disease: A trial emulation.
International Journal of Infectious Diseases
, 155
, Article 107883. 10.1016/j.ijid.2025.107883.
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Abstract
Background: No randomized comparisons exist between dolutegravir (DTG) and boosted-darunavir (DRV/b) for people initiating treatment with advanced HIV. // Methods: Antiretroviral therapy (ART)-naïve people with HIV (PWH) with CD4 < 200 cells/mm3 or AIDS who started a first-line three-drug regimen with DTG or DRV/b were included. The primary outcome was a composite endpoint of newly diagnosed AIDS, serious non-AIDS events (SNAE), death, virological failure (VF), or discontinuation of the anchor drug due to failure or toxicity. A marginal structural Cox regression model was used to estimate the effect of starting DTG vs DRV/b-based regimens. // Results: A total of 1323 advanced ART-naïve PWH were included, 895 starting DTG and 428 DRV/b. The unweighted risks of the composite endpoint by 48 months were 21.1% (95% CI: 18.1; 24.1%) for DTG vs 37.9% (95% CI: 32.7; 43.2%) for DRV/b (P < 0.001). First-line treatment with DTG showed a lower risk of experiencing the composite endpoint than DRV/b (wHR of DTG vs DRV/b 0.47, 95% CI: 0.35; 0.64, P < 0.001). // Conclusion: Under the stated assumptions, this analysis indicates that in ART-naïve PWH with advanced disease, ART initiation with DTG vs DRV/b-based regimens leads to a 50% reduction in the risk of AIDS/SNAE/death/VF/discontinuation. This observed difference is partly explained by discontinuation of the anchor drug.
| Type: | Article |
|---|---|
| Title: | Effectiveness of dolutegravir-based vs boosted darunavir-based first-line 3-drug regimens in people with HIV with advanced disease: A trial emulation |
| Location: | Canada |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.ijid.2025.107883 |
| Publisher version: | https://doi.org/10.1016/j.ijid.2025.107883 |
| Language: | English |
| Additional information: | Copyright © 2025 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
| Keywords: | ART-naïve; Integrase inhibitors; Antiretroviral therapy; AIDS; Trial emulation |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10208631 |
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