Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1 from a randomized trial.

IF 3.1 2区医学 Q3 IMMUNOLOGY

AIDS Pub Date : 2025-10-02 DOI:10.1097/QAD.0000000000004367

Andrew Carr, Rosie Mngqibisa, Ilsiyar Khaertynova, Princy N Kumar, Shariq Haider, Ying Zhang, Todd Correll, Ernest Asante-Appiah, Wayne Greaves

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引用次数: 0

Abstract

Objective: This study evaluated the efficacy (Day 8) and safety (Week 49) of doravirine/islatravir (DOR/ISL 100 mg/0.75 mg) plus baseline antiretroviral therapy (ART) and optimized background therapy (OBT) in heavily treatment-experienced (HTE) adults living with detectable HIV-1 RNA.

Design and methods: HTE adults with confirmed plasma viral load >500 copies/mL receiving a stable ART regimen for ≥3 months were randomly assigned 1:2:1:1 to receive once-daily ISL alone, DOR alone, DOR/ISL, or matching placebo for 7 days; at Day 8, baseline ART was optimized and all participants received DOR/ISL and OBT through Week 49. The primary efficacy endpoint was percentage of participants receiving DOR/ISL achieving ≥0.5 log10 decline in viral load from baseline (Day 1) to Day 8. Secondary efficacy endpoints included HIV-1 RNA levels and CD4+ T-cell counts through Week 49.

Results: Thirty-five of the planned 100 participants were enrolled; most were White (57.1%) and male (77.1%) with median age of 50 years. From Day 1 to 8, a ≥1.0 log10 decrease in HIV-1 RNA was achieved in 85.7% of the DOR/ISL group compared with 0% of the placebo group. At Week 49, HIV-1 RNA <50 copies/mL was achieved in 22 participants (71.0%) and the mean increase in CD4+ T-cell count was 87 cells/mm3. Adverse events were reported in 29 participants (82.9%) through Week 49; 9 (25.7%) were considered related to DOR/ISL.

Conclusions: DOR/ISL plus OBT improved HIV-1 suppression in HTE adults living with HIV-1 and was generally well tolerated.

Clinicaltrialsgov: NCT04233216.

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从一项随机试验中，doravirine/islatravir在有大量治疗经验的HIV-1患者中的有效性和安全性

目的：本研究评估了doravirine/islatravir （DOR/ISL 100 mg/0.75 mg）联合基线抗逆转录病毒治疗（ART）和优化背景治疗（OBT）在重度治疗经历（HTE）携带可检测HIV-1 RNA的成人中的疗效（第8天）和安全性（第49周）。设计和方法：接受稳定抗逆转录病毒治疗≥3个月且确认血浆病毒载量为500copies /mL的HTE成人按1:2:1:1随机分配，分别接受每日1次ISL、DOR、DOR/ISL或匹配安慰剂治疗7天；在第8天，基线ART得到优化，所有参与者在第49周接受DOR/ISL和OBT。主要疗效终点是接受DOR/ISL治疗的参与者从基线（第1天）到第8天病毒载量下降≥0.5 log10的百分比。次要疗效终点包括第49周的HIV-1 RNA水平和CD4+ t细胞计数。结果：计划的100名参与者中有35人入选；以白人（57.1%）和男性（77.1%）居多，中位年龄50岁。从第1天到第8天，DOR/ISL组中85.7%的HIV-1 RNA降低≥1.0 log10，而安慰剂组为0%。结论：DOR/ISL加OBT改善了HIV-1感染成人HTE患者的HIV-1抑制，并且通常耐受性良好。Clinicaltrialsgov: NCT04233216。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

AIDS 医学-病毒学

CiteScore

5.90

自引率

5.30%

发文量

478

审稿时长

3 months

期刊介绍： Publishing the very latest ground breaking research on HIV and AIDS. Read by all the top clinicians and researchers, AIDS has the highest impact of all AIDS-related journals. With 18 issues per year, AIDS guarantees the authoritative presentation of significant advances. The Editors, themselves noted international experts who know the demands of your work, are committed to making AIDS the most distinguished and innovative journal in the field. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.