Zhu Weiming, Delaney Kevin, Huang Ya-Lin A, Patel Rupa R, Kourtis Athena P, Hoover Karen W
Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Clin Infect Dis. 2025 Apr 3. doi: 10.1093/cid/ciaf173.
People who use long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) can have ambiguous HIV test results if HIV is acquired during its use. The 2021 CDC PrEP guidelines recommend both HIV antigen/antibody (Ag/Ab) and RNA testing at CAB-LA initiation and follow-up.
We conducted a cohort study using the HealthVerity database to evaluate the utilization of HIV testing among people who use CAB-LA PrEP. We identified and adjudicated HIV Ag/Ab and RNA tests with a positive result, and estimated the incidence of breakthrough HIV infection or long-acting early viral inhibition (LEVI) syndrome. Testing agreement, false positive test rates, and positive predictive value were explored.
Among 384 people who use CAB-LA PrEP with both HIV Ag/Ab and RNA testing with a median follow-up time of 4.2 months, we found one discordant pair with Ag/Ab(-) and RNA(+), and one with Ag/Ab(+) and RNA(-). Among four users with a positive Ag/Ab or RNA test, we identified one who acquired HIV before CAB-LA initiation with both Ag/Ab(+) and RNA(+), one likely false RNA(+), one likely false Ag/Ab(+), and one inconclusive Ag/Ab(+) due to insufficient follow-up. We identified no persons with confirmed breakthrough HIV infection or LEVI syndrome, or with RNA testing resulting in an earlier HIV diagnosis compared with Ag/Ab testing alone.
The frequency of breakthrough HIV infection or LEVI syndrome in this real-world cohort was low during initial three to seven months of injectable PrEP use. Ongoing assessment of the added value of HIV RNA testing for monitoring during CAB-LA PrEP use is warranted.
使用长效注射用卡博特韦（CAB-LA）进行暴露前预防（PrEP）的人群，如果在使用期间感染了HIV，其HIV检测结果可能会不明确。2021年美国疾病控制与预防中心（CDC）的PrEP指南建议在开始使用CAB-LA及随访时同时进行HIV抗原/抗体（Ag/Ab）检测和RNA检测。
我们使用HealthVerity数据库进行了一项队列研究，以评估使用CAB-LA PrEP的人群中HIV检测的使用情况。我们对HIV Ag/Ab和RNA检测结果为阳性的情况进行了识别和判定，并估计了突破性HIV感染或长效早期病毒抑制（LEVI）综合征的发生率。探讨了检测一致性、假阳性率和阳性预测值。
在384名同时进行HIV Ag/Ab和RNA检测且使用CAB-LA PrEP的人群中，中位随访时间为4.2个月，我们发现1对结果不一致的情况，即Ag/Ab（-）和RNA（+），以及1对Ag/Ab（+）和RNA（-）。在4名Ag/Ab或RNA检测呈阳性的使用者中，我们确定1名在开始使用CAB-LA之前感染了HIV，其Ag/Ab（+）和RNA（+）；1名可能是RNA假阳性；1名可能是Ag/Ab假阳性；还有1名因随访不足而Ag/Ab结果不确定（+）。我们未发现确诊的突破性HIV感染或LEVI综合征患者，也未发现与单独进行Ag/Ab检测相比，RNA检测能更早诊断出HIV的情况。
在注射用PrEP使用的最初三到七个月期间，这一真实队列中突破性HIV感染或LEVI综合征的发生率较低。有必要持续评估HIV RNA检测在CAB-LA PrEP使用期间监测中的附加价值。
