Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial.

Novel STRs are therefore needed.

因此，需要开发新型的STRs。

We aimed to evaluate the efficacy and safety of a novel STR, bictegravir-lenacapavir, in people with HIV-1.

我们旨在评估一种新型整合酶抑制剂（STR），bictegravir-lenacapavir，在HIV-1感染者中的疗效和安全性。

Methods

ARTISTRY-1 was a randomised, open-label, active-controlled, non-inferiority phase 3 trial conducted at hospitals and clinics across 15 countries that enrolled people with HIV-1 with virological suppression on complex regimens.

ARTISTRY-1是一项随机、开放标签、活性对照、非劣效性第3期试验，该试验在15个国家的医院和诊所进行，招募了在复杂方案下实现病毒学抑制的HIV-1感染者。

Participants were randomly assigned (using interactive technology, 2:1, stratified by geographical region) to switch to once-daily oral bictegravir-lenacapavir 75 mg/50 mg STR or continued complex regimen.

参与者通过交互技术以2:1的比例随机分配（按地理区域分层），切换至每日一次口服bictegravir-lenacapavir 75 mg/50 mg单片复合制剂（STR）或继续使用复杂的治疗方案。

The primary outcome was the proportion of participants with an HIV-1 RNA viral load of 50 copies per mL or higher at week 48 (US Food and Drug Administration Snapshot algorithm), assessed in all randomly assigned participants who received any dose of assigned treatment.

主要结果是48周时，HIV-1 RNA病毒载量≥50拷贝/毫升的参与者比例（美国食品药品监督管理局Snapshot算法），在所有接受任何剂量指定治疗的随机分配参与者中进行评估。

This trial (active; enrolment complete) was registered with ClinicalTrials.gov (NCT05502341).

这项试验（正在进行中；招募已完成）已在ClinicalTrials.gov上注册（NCT05502341）。

Results

Between Jan 29 and Sept 26, 2024, 729 participants were screened; 557 were randomly assigned and treated (bictegravir-lenacapavir n=371; complex regimen n=186).

在2024年1月29日至9月26日期间，共有729名参与者接受了筛查；其中557人被随机分配接受治疗（bictegravir-lenacapavir组371人；复杂方案组186人）。

At baseline, median age was 60 years (range 22-84), HIV treatment duration was 28 years (IQR 22-32); participants were taking a median of three antiretroviral pills per day (range 2-11).

基线时，中位年龄为60岁（范围22-84岁），HIV治疗持续时间为28年（四分位数间距22-32年）；参与者每天中位服用三种抗逆转录病毒药物（范围2-11种）。

At week 48, an HIV-1 RNA viral load of 50 copies per mL or higher was observed in three (1%) participants receiving bictegravir-lenacapavir and two (1%) receiving a complex regimen (difference -0·3%; 95·002% CI -2·3 to 1·8), meeting the non-inferiority margin of 4%.

在第48周，接受bictegravir-lenacapavir治疗的参与者中有三人（1%）和接受复杂方案治疗的参与者中有两人（1%）观察到HIV-1 RNA病毒载量为50拷贝/毫升或更高（差异-0.3%；95.002%置信区间-2.3至1.8），满足非劣效性边界为4%。

No resistance emerged.

未出现耐药性。

Adverse eventrates were similar between groups.

两组之间的不良事件发生率相似。

Six (2%) participants discontinued bictegravir-lenacapavir and one (1%) discontinued their complex regimen due to adverse events.

有六名（2%）参与者因不良事件停止使用bictegravir-lenacapavir治疗，另有1名（1%）因不良事件停止使用他们的复杂治疗方案。

There were five deaths in the bictegravir-lenacapavir group, none of which were deemed related to study drug.

bictegravir-lenacapavir组中有五例死亡，均被认为与研究药物无关。

Participants reported increased treatment satisfaction after switching to bictegravir-lenacapavir.

参与者报告在改用比克替拉韦-雷尼卡韦后治疗满意度有所提高。

interpretation

Bictegravir-lenacapavir STR demonstrated non-inferior efficacy to complex regimens, with a similar safety profile and increased treatment satisfaction.

比克替拉韦-雷尼卡韦单片复方制剂显示出与复杂方案相当的非劣效性疗效，具有相似的安全性特征，并且提高了治疗满意度。

Bictegravir-lenacapavir offers new opportunities for HIV-1 treatment optimisation for people taking complex regimens.

比克替拉韦-雷纳卡帕韦为正在接受复杂方案治疗的人群提供了HIV-1治疗优化的新机会。

funding

Gilead Sciences.

吉利德科学公司。