Mngqibisa Rosie, Singh Yashna, Orrell Catherine, Lombaard Johan, Griffith Sandy, Harrington Conn, D'Amico Ronald, Spreen William, St Clair Marty, Latham Christine, Garside Louise, Van Solingen-Ristea Rodica, Van Eygen Veerle, Boateng Fafa Addo, Crauwels Herta, Eneh Prosperity, Eshun-Wilsonova Ingrid
Ward D1, Enhancing Care Foundation, Wentworth Hospital, Durban, South Africa.
Desmond Tutu HIV Centre, Institute of Infectious Diseases and Molecular Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.
South Afr J HIV Med. 2025 Jul 22;26(1):1709. doi: 10.4102/sajhivmed.v26i1.1709. eCollection 2025.
Evaluating long-term efficacy, safety and pharmacokinetics of long-acting cabotegravir + rilpivirine (CAB+RPV LA) in sub-Saharan African populations is important because of the region's unique demographics and antiretroviral therapy resistance patterns.
To describe the 96-week efficacy, safety and pharmacokinetics of CAB+RPV LA in South African participants from the pooled FLAIR and ATLAS-2M Phase 3/3b randomised studies.
Primary endpoint: proportion of participants with plasma HIV-1 RNA levels ≥ 50 copies/mL at Week 96. Secondary endpoints: proportion of participants with plasma HIV-1 RNA levels < 50 copies/mL, confirmed virological failure (CVF; two consecutive plasma HIV-1 RNA ≥ 200 copies/mL), adverse events and pharmacokinetics.
Sixty-six participants were included, (CAB+RPV LA, = 49; current oral antiretroviral regimen [CAR], = 17). Forty-five (92%) on CAB+RPV LA and 15 (88%) on CAR maintained HIV-1 RNA levels < 50 copies/mL. At Week 96, two participants, one in each arm, had CVF. Ninety per cent on CAB+RPV LA and 76% on CAR of participants experienced an adverse event; six (12%) of which were drug-related (CAB+RPV LA: = 6). Injection-site reactions were common (78% [Grade 1: 80%; Grade 2: 20%]). CAB and RPV trough plasma concentrations remained above respective in vitro protein-adjusted 90% inhibitory concentrations following all doses.
This subgroup analysis of South African participants demonstrated durable efficacy, acceptable safety profile and pharmacokinetics of injectable CAB+RPV LA up to 96 weeks, consistent with long-term data from other regions and studies.
鉴于撒哈拉以南非洲地区独特的人口统计学特征和抗逆转录病毒疗法耐药模式，评估长效卡博特韦+利匹韦林（CAB+RPV LA）在该地区人群中的长期疗效、安全性和药代动力学具有重要意义。
描述在汇总的FLAIR和ATLAS-2M 3期/3b期随机研究中，CAB+RPV LA在南非参与者中的96周疗效、安全性和药代动力学。
主要终点：第96周时血浆HIV-1 RNA水平≥50拷贝/mL的参与者比例。次要终点：血浆HIV-1 RNA水平<50拷贝/mL的参与者比例、确诊的病毒学失败（CVF；连续两次血浆HIV-1 RNA≥200拷贝/mL）、不良事件和药代动力学。
纳入66名参与者（CAB+RPV LA组，n = 49；当前口服抗逆转录病毒方案[CAR]组，n = 17）。CAB+RPV LA组45名（92%）和CAR组15名（88%）的HIV-1 RNA水平维持在<50拷贝/mL。在第96周时，两组各有1名参与者出现CVF。CAB+RPV LA组90%和CAR组76%的参与者经历了不良事件；其中6例（12%）与药物相关（CAB+RPV LA组：n = 6）。注射部位反应常见（78%[1级：80%；2级：20%]）。所有剂量后，CAB和RPV血浆谷浓度均保持在各自体外蛋白校正的90%抑制浓度以上。
对南非参与者的这一亚组分析表明，注射用CAB+RPV LA在长达96周的时间里具有持久疗效、可接受的安全性和药代动力学，与其他地区和研究的长期数据一致。
