Safety and efficacy of switching to 4-weekly albuvirtide plus daily dolutegravir in virologically suppressed HIV-1 adults: a 24-week study.

IF 3.1 2区医学 Q3 IMMUNOLOGY AIDS Pub Date : 2025-06-01 Epub Date: 2025-01-24 DOI:10.1097/QAD.0000000000004130

Xiaoxin Xie, Yanhua Fu, Lin Gan, Xiaoyan Yang, Yebing Song, Chunli Song, Fangfang Sun, Lei Guo, Hai Long

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Abstract

Objectives: Albuvirtide (ABT) is a long-acting fusion inhibitor. This study assessed switching to ABT 640 mg every 4 weeks plus daily dolutegravir (DTG) in virologically suppressed adults with HIV-1.

Design and methods: In this open-label, single-arm study, 10 participants with HIV-1 RNA less than 50 copies/ml switched to ABT plus DTG for 24 weeks. Safety, pharmacokinetics, viral load, and CD4 + T cell counts were assessed.

Results: No serious adverse events occurred. Albuvirtide's steady-state trough concentration was 31.1 times higher than PA-IC90. All participants maintained virological suppression. CD4 + T-cell counts increased significantly after 24 weeks ( P = 0.0462).

Conclusion: Switching to 4-weekly ABT plus daily DTG demonstrated good safety, favorable pharmacokinetics, maintained virological suppression, and improved immune recovery. These findings support ABT's potential as a long-acting agent for simplifying HIV treatment.

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在病毒学抑制的HIV-1成人中，转换为4周albuvirtide +每日dolutegravir的安全性和有效性：一项为期24周的研究

目的：Albuvirtide （ABT）是一种长效融合抑制剂。该研究评估了病毒学抑制的HIV-1成年患者每4周改用ABT 640 mg加每日多鲁特格拉韦（DTG）的情况。设计和方法：在这项开放标签、单臂研究中，10名携带HIV-1 RNA的参与者结果：未发生严重不良事件。Albuvirtide的稳态谷浓度比PA-IC90高31.1倍。所有参与者都保持病毒学抑制。24周后CD4+ t细胞计数明显升高（P = 0.0462）。结论：转为4周ABT +每日DTG具有良好的安全性，良好的药代动力学，维持病毒学抑制，改善免疫恢复。这些发现支持ABT作为一种简化HIV治疗的长效药物的潜力。

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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.