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Patient-Reported Outcomes in ATLAS and FLAIR Participants on Long-Acting Regimens of Cabotegravir and Rilpivirine Over 48 Weeks.
AIDS and Behavior ( IF 2.7 ) Pub Date : 2020-05-23 , DOI: 10.1007/s10461-020-02929-8
Miranda Murray 1 , Antonio Antela 2 , Anthony Mills 3 , Jenny Huang 4 , Hans Jäger 5, 6 , Enrique Bernal 7 , Johan Lombaard 8 , Harold Katner 9 , Sharon Walmsley 10 , Marie-Aude Khuong-Josses 11 , Krischan Hudson 12 , David Dorey 4 , Sandy Griffith 12 , William Spreen 12 , Simon Vanveggel 13 , Mark Shaefer 12 , David Margolis 12 , Vasiliki Chounta 14
Affiliation  

The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p < 0.001) and acceptance (Week 48, +8.8 vs. +2.0 ACCEPT-points; p < 0.001). The acceptability of injection site reactions (PIN) significantly improved from week 5 (2.10 points) to week 48 (1.62 points; p < 0.001). In both studies, ≥ 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results further support the potential of a monthly injectable option for people living with HIV seeking an alternative to daily oral treatment.

中文翻译:

ATLAS和FLAIR参加者在48周内对长效治疗Cabotegravir和Rilpivirine的患者报告的结果。

ATLAS和FLAIR的3期研究表明,长效(LA)肌内Cabotegravir和rilpivirine维持治疗的疗效不亚于目前的抗逆转录病毒(CAR)口服疗法。两项研究均使用“患者报告的结果”工具来衡量治疗满意度(HIVTSQ)和接受度(ACCEPT一般范围),健康状况(SF-12),注射耐受性/接受度(PIN)和治疗偏好。在汇总分析中,接受LA治疗的患者(n = 591)在治疗满意度方面较CAR组(n = 591)表现出比基线水平更高的平均改善率(第44周,+ 3.9 vs. + 0.5 HIVTSQs-点; p <0.001)和接受度(第48周,+ 8.8与+2.0 ACCEPT点; p <0.001)。注射部位反应(PIN)的可接受性从第5周(2.10点)显着提高到第48周(1.62点; p <0.001)。在两项研究中,与先前的口服治疗相比,有97%记录数据的LA组参与者更倾向于LA治疗。这些结果进一步为寻求替代日常口服治疗的艾滋病毒感染者提供了每月可注射选择的潜力。
更新日期:2020-05-23
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