Dolutegravir Monotherapy as Maintenance Strategy: A Meta-Analysis of Individual Participant Data From Randomized Controlled Trials

• Published in: Open forum infectious diseases 2022-06, Vol.9 (6), p.ofac107-ofac107
• Main Authors: Fournier, Anna L, Hocqueloux, Laurent, Braun, Dominique L, Metzner, Karin J, Kouyos, Roger D, Raffi, François, Briant, Anaïs R, Martinez, Esteban, De Lazzari, Elisa, Negredo, Eugenia, Rijnders, Bart, Rokx, Casper, Günthard, Huldrych F, Parienti, Jean-Jacques
• Format: Article
• Language: English
• Subjects: Major
• ISSN: 2328-8957; 2328-8957
• DOI: 10.1093/ofid/ofac107

Abstract Background Dolutegravir monotherapy (DTG-m) results in virological failure (VF) in some people with human immunodeficiency virus (PWH). We sought to identify the independent factors associated with the risk of VF and to explore the effect size heterogeneity between subgroups of PWH enrolled in DTG-m trials. Methods We searched for randomized clinical trials (RCTs) evaluating DTG-m versus combined antiretroviral therapy (cART) among PWH virologically controlled for at least 6 months on cART. We performed an individual participant data meta-analysis of VF risk factors and quantified their explained heterogeneity in random-effect models. Definition of VF was a confirmed plasma human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) >50 copies/mL by week 48. Results Among 416 PWH from 4 RCTs, DTG-m significantly increased the risk of VF (16 of 227 [7%] versus 0 of 189 for cART; risk difference 7%; 95% confidence interval [CI], 1%–2%; P = .02; I2 = 51%). Among 272 participants exposed to DTG-m, VF were more likely in participants with the following: first cART initiated ≥90 days from HIV acute infection (adjusted hazard ratio [aHR], 5.16; 95% 95% CI, 1.60–16.65), CD4 T cells nadir