부산대학교 도서관

Background: Long-acting cabotegravir + rilpivirine (CAB+RPV LA) administered monthly or every 2 months is the first complete LA regimen recommended by treatment guidelines for maintaining HIV-1 virologic suppression. Across Phase 3/3b trials, the most frequently reported adverse events were injection site reactions (ISRs). Here, we present pooled ISR outcomes by regimen, sex, and body mass index (BMI) from the ATLAS-2M and FLAIR studies through Week (W) 96. Methods: Data from participants receiving CAB+RPV LA in ATLAS-2M and FLAIR were pooled and stratified by dosing regimen, sex, and baseline BMI category. Data from ATLAS-2M participants who transitioned from CAB+RPV in ATLAS were excluded. ISR characteristics were evaluated through W96. Results: 920 (Q8W, n=321; Q4W, n=599) participants received ≥1 injection of CAB LA/RPV LA across ATLAS-2M and FLAIR, representing 34,939 injections through W96 (Q8W, n=7954; Q4W, n=26,985) (Table). Overall, 8453 ISRs (Q8W, n=2345; Q4W, n=6108) were reported by 801 participants (Q8W, 89% [n=285]; Q4W, 86% [n=516]). Most were mild to moderate in severity(Grade 1, 83%; Grade 2, 16%; Grade 3, 1%), with a median (interquartile range) duration of 3 days (2–4), and 86% had a duration ≤7 days. The most commonly reported ISRs (% of injections) were pain (20%), nodule (1%), and discomfort (1%). ISRs incidence decreased over time, reported by 71%, 24%, and 15% of participants at W4, W48, and W96, respectively. ISR-related withdrawals were infrequent and comparable between dosing regimens, occurring in 2% (n=20) of participants (majority were injection intolerability [n=10]). ISR profiles over 96 weeks were generally comparable across regimen, sex, and baseline BMI category. Conclusion: The majority of ISRs were mild to moderate in severity, short-lived, and rarely led to treatment discontinuation. Outcomes were comparable by regimen, sex, and BMI category. These data further support the use of CAB+RPV LA as a complete maintenance regimen for HIV-1. [ABSTRACT FROM AUTHOR]