Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment‐naïve (AMBER) and virologically suppressed (EMERALD) participants with neurological and/or psychiatric comorbidities: Week 96 subgroup analysis. Issue 3 (15th August 2022)

• Record Type: Journal Article
• Authors: Dunn, Keith; Bushen, Jennifer; Luo, Donghan; Cai, Jiyun; Simonson, Richard Bruce; Anderson, David
• Is Part Of: HIV medicine. Volume 24:Issue 3(2023)
• Page Start: 279
• Page End: 289
• Publication Date: 2022-08-15
• Subjects: antiretroviral agents -- darunavir -- HIV‐1 -- neurological -- psychiatric; HIV infections -- Treatment -- Periodicals; HIV-positive persons -- Periodicals; HIV infections -- Treatment -- Decision making -- Periodicals; 616.9792
• DOI: 10.1111/hiv.13377
• Languages: English
• ISSNs: 1464-2662

Abstract

Abstract: Objective: Our objective was to evaluate the prevalence of pre‐existing neurological and/or psychiatric comorbidities (NPCs) and efficacy/safety outcomes for participants with versus without baseline NPCs in AMBER and EMERALD. Methods: AMBER (treatment‐naïve population) and EMERALD (virologically suppressed population) were phase III randomized studies of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg. The primary objective of this post hoc analysis was to assess virological response (HIV‐1 RNA <50 copies/mL) at week 48 by intent‐to‐treat US Food and Drug Administration snapshot analysis comparing participants with and without baseline NPCs. Results: Among participants in AMBER, 88/362 (24%) in the D/C/F/TAF arm and 99/363 (27%) in the control arm had baseline NPCs; in EMERALD, 294/763 (39%; D/C/F/TAF) and 166/378 (44%; control) participants had baseline NPCs. At baseline, psychiatric NPCs were more common than neurological NPCs in both studies; the most common of each type were depression and headache, respectively. High virological response rates were achieved with D/C/F/TAF across studies regardless of baseline NPCs at weeks 48 (range 86%–95%) and 96 (range 80%–91%). No participants in either study with a baseline NPC prematurely discontinued because of a study drug–related neurological or psychiatric adverse event. Conclusion: D/C/F/TAF may be a suitable treatment option for individuals with HIV‐1 and NPCs.