Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis. Issue 2 (13th July 2021)

• Record Type: Journal Article
• Authors: Dunn, Keith; Rogers, Rachel; Simonson, Richard Bruce; Luo, Donghan; Sheng, Shubin; Kassam, Purnima T.; Seyedkazemi, Sareh; Hardy, Hélène
• Is Part Of: HIV research & clinical practice. Volume 22:Issue 2(2021)
• Page Start: 55
• Page End: 61
• Publication Date: 2021-07-13
• Subjects: HIV-1 -- acute HIV-1 infection -- early HIV-1 infection -- rapid initiation -- darunavir; HIV Infections -- therapy; Acquired Immunodeficiency Syndrome -- therapy; Clinical Trials as Topic; Clinical Medicine; AIDS (Disease) -- Treatment -- Periodicals; AIDS (Disease) -- Treatment; Periodicals; Periodical; 616.9792
• DOI: 10.1080/25787489.2021.1915652
• Languages: English
• ISSNs: 2578-7489

Abstract

Abstract : Background: Treatment during acute or early human immunodeficiency virus (HIV)-1 infection is associated with immunologic and virologic benefits. Objective: To evaluate darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) efficacy/safety among patients with acute or early HIV-1 infection who rapidly initiate treatment. Methods: DIAMOND (ClinicalTrials.gov Identifier: NCT03227861), a phase 3 study, evaluated the efficacy/safety of D/C/F/TAF 800/150/200/10 mg in rapid initiation. Adults aged ≥18 years began D/C/F/TAF within 14 days of diagnosis, prior to the availability of screening/baseline laboratory results. In this subgroup analysis, virologic response (HIV-1 RNA <50 copies/mL) was assessed at Week 48 by intent-to-treat FDA snapshot (ITT-FDA snapshot) and observed (excluding patients with missing data) analyses in patients with acute (HIV-1 antibody negative and HIV-1 RNA positive/p24 positive) or early (HIV-1 antibody positive and suspected infection ≤6 months before screening/baseline) infection. Results: Among 109 patients, 13 had acute and 43 had early HIV-1 infection. High rates of virologic response were demonstrated at Week 48 by ITT-FDA snapshot (acute: 10/13 [76.9%]; early: 37/43 [86.0%]) and observed (acute: 10/11 [90.9%]; early: 37/38 [97.4%]) analyses. No patients discontinued or required regimen change due to baseline resistance or lack of efficacy, or developed protocol-defined virologic failure. Through Week 48, 7 (53.8%) acute and 22 (51.2%) early infection patients had a D/C/F/TAF-related adverse event (AE); none had a D/C/F/TAF-related grade 4 or serious AE. Conclusions: High rates of viral suppression during acute/early infection were achieved with D/C/F/TAF rapid initiation, no treatment-emergent resistant mutations were observed, and D/C/F/TAF was safe and well tolerated.