■Cabotegravir(CAB)+利匹韦林(RPV)每月或每2个月给药一次,是维持人类免疫缺陷病毒1型病毒学抑制的完整长效(LA)方案。在第3/3b阶段试验中,最常报告的不良事件是注射部位反应(ISRs).
■我们提供了在FLAIR和ATLAS-2M研究的第96周期间接受CAB+RPVLA的参与者的综合ISR特征和结果,和医疗服务提供者(HCP)注射的调查结果(例如,喷油器)在ATLAS中,FLAIR,和ATLAS-2M研究以确定最佳注射技术。调查是匿名的,自我管理的在线问卷,查询提供者的人口统计数据,注射经验,以及最小化注射前/后不适的技术。使用描述性统计对数据进行汇总。
■总的来说,801名接受≥1次CABLA/RPVLA注射的参与者报告了8453个ISR。大多数ISR的严重程度为轻度至中度(1-2级,99%),中位持续时间为3天(四分位数间距,2-4天),很少导致退出(2%)。调查由113个地点的181个HCP完成。以慢速度推动肌肉注射(66%),使药物达到室温(58%),注射前放松臀肌(53%)被列为有效的预注射/注射程序实践,可最大程度地减少疼痛。大多数注射器(60%)表示俯卧位可提供最佳的患者舒适度,41%的人对注射用药顺序没有偏好。
■放在一起,数据显示,CAB+RPVLA注射剂长期具有良好的耐受性,注射器常规使用的简单技术有助于优化CAB+RPVLA注射剂的给药.
UNASSIGNED: Cabotegravir (CAB) + rilpivirine (RPV) dosed monthly or every 2 months is a complete long-acting (LA) regimen for the maintenance of human immunodeficiency virus type 1 virologic suppression. Across the phase 3/3b trials, the most frequently reported adverse events were injection site reactions (ISRs).
UNASSIGNED: We present pooled ISR characteristics and outcomes for participants receiving CAB + RPV LA through week 96 of the FLAIR and ATLAS-2M studies, and survey results from healthcare providers (HCPs) giving injections (eg, injectors) in the ATLAS, FLAIR, and ATLAS-2M studies to determine optimal injection techniques. Surveys were anonymous, self-administered online questionnaires that queried provider demographics, injection experience, and techniques to minimize pre-/postinjection discomfort. Data were summarized using descriptive statistics.
UNASSIGNED: Overall, 8453 ISRs were reported by 801 participants receiving ≥1 injection of CAB LA/RPV LA. Most ISRs were mild to moderate in severity (grade 1-2, 99%), with a median duration of 3 days (interquartile range, 2-4 days), and rarely led to withdrawal (2%). Surveys were completed by 181 HCPs across 113 sites. Pushing the intramuscular injection at slow speed (66%), bringing the medication to room temperature (58%), and relaxing the gluteus muscle before injecting (53%) were ranked as effective preinjection/injection procedure practices for minimizing pain. Most injectors (60%) indicated that a prone position provided optimal patient comfort, and 41% had no preference on injection medication order.
UNASSIGNED: Taken together, the data demonstrate favorable tolerability with CAB + RPV LA injections over the long term and simple techniques routinely used by injectors to help optimize the administration of CAB + RPV LA injections.