Tolerability of four-drug antiretroviral combination therapy in primary HIV-1 infection.

Tolerability of four-drug antiretroviral combination therapy in primary HIV-1 infection.
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HIV - 1原发性感染中四药抗逆转录病毒联合疗法的耐受性。

DOI:
10.1111/hiv.13118
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发表时间:
2021-09
期刊:
影响因子:
3
通讯作者:
Fidler S
Fidler S
中科院分区:
医学4区
文献类型:
--
作者:
Burns JE;Stöhr W;Kinloch-De Loes S;Fox J;Clarke A;Nelson M;Thornhill J;Babiker A;Frater J;Pett SL;Fidler S

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快速开始抗逆转录病毒治疗(ART)对于基线病毒载量高的个体很重要,例如原发性HIV‐1感染(PHI)。有时会考虑四种药物方案;然而,缺乏耐受性的数据。我们的目的是评估在HIV - 1病毒库根除研究(RIVER)中使用的四种药物方案的耐受性。在入组时,ART‐naïve成年参与者或新开始ART治疗的参与者在PHI的4周内开始或加强到四种药物治疗方案。快速启动定义为确诊前或确诊后≤7天。主要和次要结果分别是患者报告的依从性,通过7天回忆和在入组和随机化之间的方案切换来衡量。总共纳入54名男性:72.2%为白人,中位年龄为32岁,42.6%的病毒载量≥100,000 HIV‐1 RNA拷贝/mL, 92.6%的男性是通过性行为感染HIV‐1的。20名(37%)患者开始了四种药物治疗方案,34名(63%)患者强化治疗。快速开始抗逆转录病毒治疗的发生率为28%,100%在≤4周内开始治疗。到第4、12和24周,分别有37.0%、69.0%和94.0%的病毒无法检测到(病毒载量< 50拷贝/mL)。在第4、12、22和24周的依从率分别为88.9%、87.0%、82.4%和94.1%。5名患者切换到3种药物,4名患者改变了他们的方案成分,2名患者在随机化后切换。总体而言,四种药物方案具有良好的耐受性和高水平的依从性。虽然与三种药物方案相比,它们的益处尚不明确,但我们的研究结果应该为临床表明临时强化方案有助于促进治疗提供了保证。
Rapid initiation of antiretroviral therapy (ART) is important for individuals with high baseline viral loads, such as in primary HIV‐1 infection (PHI). Four‐drug regimens are sometimes considered; however, data are lacking on tolerability. We aimed to evaluate the tolerability of four‐drug regimens used in the Research in Viral Eradication of HIV‐1 Reservoirs (RIVER) study. At enrolment, ART‐naïve adult participants or those newly commenced on ART were initiated or intensified to four‐drug regimens within 4 weeks of PHI. Rapid start was defined as pre‐confirmation or ≤ 7 days of confirmed diagnosis. Primary and secondary outcomes were patient‐reported adherence measured by 7‐day recall and regimen switches between enrolment and randomization, respectively. Overall, 54 men were included: 72.2% were of white ethnicity, with a median age of 32 years old, 42.6% had a viral load of ≥ 100 000 HIV‐1 RNA copies/mL, and in 92.6% sex with men was the mode of acquisition of HIV‐1. Twenty (37%) started a four‐drug regimen and 34 (63%) were intensified. Rapid ART initiation occurred in 28%, 100% started in ≤ 4 weeks. By weeks 4, 12, and 24, 37.0%, 69.0%, and 94.0% were undetectable (viral load < 50 copies/mL), respectively. Adherence rates of 100% at weeks 4, 12, 22 and 24 were reported in 88.9%, 87.0%, 82.4% and 94.1% of participants, respectively. Five individuals switched to three drugs, four changed their regimen constituents, and two switched post‐randomization. Overall, four‐drug regimens were well tolerated and had high levels of adherence. Whilst their benefit over three‐drug regimens is lacking, our findings should provide reassurance if a temporarily intensified regimen is clinically indicated to help facilitate treatment.
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