Cabotegravir and rilpivirine for treatment of HIV infection in Africa: week 96 results from the phase 3b randomized, open-label, noninferiority CARES trial.

In a multicenter, open-label phase 3b trial, 512 African adults with HIV-1, stable on first-line oral therapy, with screening plasma viral load (VL) <50 copies ml-1 and without past virologic failure were randomized (1:1) to continue oral therapy or switch to cabotegravir (600 mg) and rilpivirine (900 mg) intramuscular injections every 8 weeks (optional 4-week oral lead-in).

在一个多中心、开放标签的3b期试验中，512名HIV-1成人患者，他们在一线口服治疗下病情稳定，筛选时血浆病毒载量（VL）<50拷贝/ml，且没有过去的病毒学失败，被随机分为（1:1）继续口服治疗或改用卡博特韦（600毫克）和利匹韦林（900毫克）肌肉注射，每8周一次（可选的4周口服引导期）。

VL was monitored every 24 weeks.

每24周监测一次病毒载量。

Here the primary outcome for our analysis up to 96 weeks was VL <50 copies ml-1, using the Food and Drug Administration snapshot algorithm (noninferiority margin 10%) in the intention-to-treatexposed population.

在我们的分析中，主要结果是96周内病毒载量小于50拷贝/毫升，使用美国食品药品监督管理局的快照算法（非劣效性边界为10%），在意向治疗人群中进行评估。

At 96 weeks, 247/255 (97%) in the long-acting group and 250/257 (97%) in the oral therapy group had VL <50 copies ml-1 (difference -0.4%; 95% confidence interval-3.1% to 2.0%), demonstrating noninferiority.

在96周时，长效组的247/255（97%）和口服治疗组的250/257（97%）的病毒载量（VL）低于50拷贝/毫升（差异-0.4%；95%置信区间-3.1%至2.0%），显示出非劣效性。

Adverse events of severity grade ≥3 occurred in 41/255 (16%) in the long-acting group and in 22/257 (9%) in the oral therapy group, mostly considered unrelated to the study drug; only one treatment-related adverse eventin the long-acting group led to a decision to discontinue treatment (injection-site abscess).

在长效组中，有41/255（16%）的患者发生了3级或更高级别的不良事件，在口服治疗组中，有22/257（9%）的患者发生了类似不良事件，大多数被认为与研究药物无关；仅有一例与治疗相关的不良事件导致长效组决定停药（注射部位脓肿）。

Cabotegravir and rilpivirine long-acting therapy produced durable virologic suppression, met the prespecified noninferiority endpoint compared with oral therapy and demonstrated an acceptable safety and tolerability profile.

卡博特韦和利匹韦林长效疗法实现了持久的病毒抑制，达到了与口服疗法相比的预定非劣效性终点，并显示出可接受的安全性和耐受性特征。

Long-acting therapy may be considered for use in African treatment programs.

长效疗法可以考虑用于非洲的治疗计划。

PACTR registration: 202104874490818.

PACTR 注册号：202104874490818。