Health Analytics and Outcomes Ltd, London, UK.
Hospital Clínico Universitario, Santiago de Compostela, Spain.
AIDS Behav. 2020 Dec;24(12):3533-3544. doi: 10.1007/s10461-020-02929-8.
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.
这两项研究(ATLAS 和 FLAIR)均采用患者报告结局(PRO)工具来衡量治疗满意度(HIVTSQ)和接受度(ACCEPT 一般领域)、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,接受长效(LA)肌内注射卡替拉韦和利匹韦林维持治疗的患者(n=591)与接受当前抗逆转录病毒(CAR)口服治疗的患者(n=591)相比,在治疗满意度(第 44 周,+3.9 比+0.5 HIVTSQ 分;p<0.001)和接受度(第 48 周,+8.8 比+2.0 ACCEPT 分;p<0.001)方面均有更大的平均改善。注射部位反应(PIN)的可接受性从第 5 周(2.10 分)显著改善至第 48 周(1.62 分;p<0.001)。在这两项研究中,≥97%记录数据的 LA 组参与者表示更喜欢 LA 治疗,而不是之前的口服治疗。这些结果进一步支持了每月注射一次的选择对于寻求替代每日口服治疗的 HIV 感染者的潜在应用。