Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Antimicrob Agents Chemother. 2023 Apr 18;67(4):e0005323. doi: 10.1128/aac.00053-23. Epub 2023 Mar 30.
HPTN 083 demonstrated that injectable cabotegravir (CAB) was superior to oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for HIV prevention in cisgender men and transgender women who have sex with men. We previously analyzed 58 infections in the blinded phase of HPTN 083 (16 in the CAB arm and 42 in the TDF-FTC arm). This report describes 52 additional infections that occurred up to 1 year after study unblinding (18 in the CAB arm and 34 in the TDF-FTC arm). Retrospective testing included HIV testing, viral load testing, quantification of study drug concentrations, and drug resistance testing. The new CAB arm infections included 7 with CAB administration within 6 months of the first HIV-positive visit (2 with on-time injections, 3 with ≥1 delayed injection, and 2 who restarted CAB) and 11 with no recent CAB administration. Three cases had integrase strand transfer inhibitor (INSTI) resistance (2 with on-time injections and 1 who restarted CAB). Among 34 CAB infections analyzed to date, diagnosis delays and INSTI resistance were significantly more common in infections with CAB administration within 6 months of the first HIV-positive visit. This report further characterizes HIV infections in persons receiving CAB preexposure prophylaxis and helps define the impact of CAB on the detection of infection and the emergence of INSTI resistance.
HPTN 083 研究表明，在与男性发生性行为的顺性别男性和跨性别女性中，注射用卡替拉韦（CAB）在预防 HIV 方面优于口服替诺福韦二吡呋酯富马酸丙酚替诺福韦（TDF-FTC）。我们之前在 HPTN 083 的盲法阶段分析了 58 例感染（CAB 组 16 例，TDF-FTC 组 42 例）。本报告描述了研究揭盲后 1 年内发生的另外 52 例感染（CAB 组 18 例，TDF-FTC 组 34 例）。回顾性检测包括 HIV 检测、病毒载量检测、研究药物浓度定量检测和耐药性检测。新的 CAB 组感染包括 7 例在首次 HIV 阳性就诊后 6 个月内接受 CAB 治疗（2 例按时注射，3 例至少有 1 次延迟注射，2 例重新开始 CAB 治疗）和 11 例最近未接受 CAB 治疗。有 3 例存在整合酶链转移抑制剂（INSTI）耐药（2 例按时注射，1 例重新开始 CAB 治疗）。在迄今为止分析的 34 例 CAB 感染中，在首次 HIV 阳性就诊后 6 个月内接受 CAB 治疗的感染中，诊断延迟和 INSTI 耐药的情况明显更为常见。本报告进一步描述了接受 CAB 暴露前预防的人群中 HIV 感染的特征，并有助于确定 CAB 对感染检测和 INSTI 耐药的出现的影响。
