Department of Infectious Diseases, University Medical Center Utrecht, Utrecht, Netherlands.
Stichting HIV Monitoring, Amsterdam, Netherlands; Amsterdam UMC, Location University of Amsterdam, Department of Infectious Diseases, Amsterdam, Netherlands; Amsterdam Institute for Immunology & Infectious diseases, Infectious Diseases Program, Amsterdam, Netherlands.
Lancet HIV. 2024 Sep;11(9):e576-e585. doi: 10.1016/S2352-3018(24)00150-4.
Currently, real-world data on doravirine are scarce. In a national prospective cohort, we assessed the effectiveness and tolerability of switching to doravirine-based antiretroviral therapy (ART) in people with HIV.
We did a nationwide, matched, prospective cohort study of people with HIV without previous virological failure and stable for at least 12 months on non-doravirine-containing triple or dual ART switching to doravirine before Sept 1, 2020 (exposed group). Participants in the exposed group were matched 1:2 to individuals continuing stable non-doravirine-containing ART, on age, sex, HIV acquisition category, time since ART initiation, calendar time, pre-ART CD4-count, pre-ART plasma viral load (PVL) and anchor drug class before switching. The primary outcome was protocol-defined virological failure (PDVF; PVL of ≥200 copies per mL) in the intention-to-treat (ITT) population at week 104, with participants modifying their regimen or becoming lost to follow-up considered as PDVF (non-inferiority margin +5%). In contrast, in the on-treatment population, those who modified their regimen or became lost to follow-up were censored from that moment onwards. Tolerability was a secondary outcome.
In total, 590 participants in the exposed group and 1180 participants in the unexposed group (of whom 55·3% used integrase strand transfer inhibitor-based regimens) were included. In the ITT analysis, PDVF occurred in 135 (22·9%) exposed participants and in 295 (25·0%) unexposed participants (risk difference -2·12%, upper limit of the one-sided 95% CI +1·40%). In the on-treatment analysis, 10 (2·2%) of 455 non-censored exposed participants and 26 (2·9%) of 885 non-censored unexposed participants had PDVF (risk difference -0·70%, upper limit of the one-sided 95% CI +0·73%). All exposed participants with a PVL of 200 copies or more per mL resuppressed without regimen modification: no confirmed virological failure (two consecutive PVLs of ≥200 copies per mL) was observed. 104 (17·6%) exposed participants and 211 (17·9%) unexposed participants modified their regimen. 73 (12.4%) exposed participants discontinued doravirine due to adverse events: abnormal dreams (1·7%) and insomnia (1·5%) were most common.
Switching to doravirine in well suppressed people with HIV without previous virological failure was non-inferior compared with continuing non-doravirine-containing regimens after 2 years in a real-world setting.
None.
目前，多尔韦林的真实世界数据有限。在一项全国性前瞻性队列研究中，我们评估了在未发生病毒学失败且至少稳定接受非多尔韦林三联或双联抗逆转录病毒治疗（ART）治疗 12 个月的 HIV 感染者中，切换至含多尔韦林的 ART 治疗的疗效和耐受性。
我们对未发生病毒学失败且稳定接受非多尔韦林三联或双联 ART 治疗的 HIV 感染者进行了全国性、匹配、前瞻性队列研究，在 2020 年 9 月 1 日之前切换至含多尔韦林的 ART（暴露组）。在暴露组中，按照年龄、性别、HIV 感染途径、ART 开始时间、日历时间、ART 前 CD4 计数、ART 前血浆病毒载量（PVL）和切换前的锚定药物类别，1：2 匹配继续稳定接受非多尔韦林含 ART 治疗的个体。主要结局是在 104 周时在意向治疗（ITT）人群中发生协议定义的病毒学失败（PDVF；PVL≥200 拷贝/ml），调整方案或失访的参与者被视为 PDVF（非劣效性边界+5%）。相比之下，在治疗人群中，那些调整方案或失访的参与者从那一刻起被删失。耐受性是次要结局。
共有 590 名暴露组参与者和 1180 名未暴露组参与者（其中 55.3%使用整合酶抑制剂为基础的方案）被纳入研究。在 ITT 分析中，135 名（22.9%）暴露组参与者和 295 名（25.0%）未暴露组参与者发生 PDVF（风险差-2.12%，单侧 95%CI 的上限+1.40%）。在治疗人群分析中，455 名未删失的暴露组参与者中有 10 名（2.2%）和 885 名未删失的未暴露组参与者中有 26 名（2.9%）发生 PDVF（风险差-0.70%，单侧 95%CI 的上限+0.73%）。所有 PVL 为 200 拷贝/ml 或更高的暴露参与者均未通过调整方案而重新抑制：未观察到确认的病毒学失败（连续两次 PVL≥200 拷贝/ml）。104 名（17.6%）暴露组参与者和 211 名（17.9%）未暴露组参与者调整了方案。73 名（12.4%）暴露组参与者因不良事件停止使用多尔韦林：最常见的是异常梦境（1.7%）和失眠（1.5%）。
在真实世界环境中，在未发生病毒学失败且稳定接受非多尔韦林含 ART 治疗至少 12 个月的 HIV 感染者中，切换至含多尔韦林的 ART 治疗与继续接受非多尔韦林含 ART 治疗相比，在 2 年时非劣效。
无。
