Makerere University - Johns Hopkins University Research Collaboration, P.O. Box 23491, Kampala, Uganda.
Uganda Virus Research Institute, Entebbe, Uganda.
BMC Infect Dis. 2021 Sep 4;21(1):907. doi: 10.1186/s12879-021-06608-4.
Viral load (VL) testing is key in monitoring adherence to antiretroviral therapy (ART) and documenting HIV treatment response. As per HIV treatment guidelines in Uganda, the first VL test is recommended 6 months after initiation of ART. Undetectable VL (uVL) at ART initiation may be helpful in detecting elite controllers in the absence of previous ART use. We investigated viral suppression at ART initiation among a cohort of HIV-positive pregnant women enrolled in the Friends for Life Circles (FLC) for Option B+ randomized controlled trial (RCT).
Pregnant women ≥ 18 years of age testing positive for HIV at their first antenatal care visit and starting on ART Option B+ as per the National PMTCT Program guidelines were enrolled into the FLC for Option B+ RCT in urban Kampala and rural Mityana districts of Uganda. Each participant had whole blood samples collected at enrolment to assess baseline VL. Plasma HIV-1 RNA was quantified using COBAS Ampliprep /COBAS Taqman. Baseline VL below 400 RNA copies/ml was considered as viral suppression while baseline VL below 20 RNA copies/ml was considered uVL.
The mean duration from the date of ART initiation to time of sample collection for baseline VL assessment was 4.4 days (SD 3.6). Of the 532 HIV-positive pregnant women enrolled in the FLC for Option B+ study and newly starting Option B+ without a self-reported history of prior ART use, 29 (5.5%) had uVL and 113 (21.4%) had suppressed VL at baseline. There was no association between participants' age, gravidity, marital status, mean monthly income, educational level, disclosure of HIV status to partner, and uVL or viral suppression at baseline. However, non-disclosure of HIV status to any other person was associated with decreased odds of viral suppression at baseline (OR 0.640; 0.416-0.982).
Twenty-one percent of HIV-positive Ugandan pregnant women initiating ART (Option B+) showed virological suppression at baseline and were presumed to be "elite controllers" or to have misreported being ART-naive. Further studies are needed to better understand the biologic mechanisms of elite controllers among pregnant women as well as to differentiate elite controllers from concealed ART use. Trial Registration The trial was registered as NCT02515370 (04/08/2015) on Clinicaltrials.gov.
病毒载量（VL）检测是监测抗逆转录病毒治疗（ART）依从性和记录 HIV 治疗反应的关键。根据乌干达的 HIV 治疗指南，建议在开始 ART 后 6 个月进行首次 VL 检测。在没有先前使用过 ART 的情况下，开始 ART 时检测到不可检测的 VL（uVL）可能有助于发现精英控制者。我们调查了在参与“朋友生命圈（FLC）B 方案+ 随机对照试验（RCT）的 HIV 阳性孕妇队列中，开始 ART 时的病毒抑制情况。
在乌干达城市坎帕拉和农村米蒂亚纳地区，首次产前保健就诊时检测出 HIV 阳性并根据国家预防母婴传播规划指南开始接受 B 方案+ ART 的≥18 岁孕妇被纳入 FLC B 方案+ RCT。每位参与者在入组时采集全血样本，以评估基线 VL。使用 COBAS Ampliprep/COBAS Taqman 定量检测血浆 HIV-1 RNA。基线 VL 低于 400 RNA 拷贝/ml 被认为是病毒抑制，而基线 VL 低于 20 RNA 拷贝/ml 被认为是 uVL。
从开始 ART 日期到采集基线 VL 评估样本的时间的平均持续时间为 4.4 天（SD 3.6）。在参与 FLC B 方案+研究并新开始 B 方案+且无先前使用 ART 的自我报告史的 532 名 HIV 阳性孕妇中，29 名（5.5%）有 uVL，113 名（21.4%）有基线 VL 抑制。参与者的年龄、孕次、婚姻状况、月平均收入、教育水平、向伴侣披露 HIV 状况以及基线时的 uVL 或病毒抑制均无相关性。然而，向任何其他人隐瞒 HIV 状况与基线时病毒抑制的几率降低有关（OR 0.640；0.416-0.982）。
21%的开始 ART（B 方案+）的乌干达 HIV 阳性孕妇在基线时表现出病毒学抑制，被认为是“精英控制者”或错误报告为未经 ART 治疗。需要进一步研究以更好地了解孕妇中精英控制者的生物学机制，并将精英控制者与隐匿性 ART 使用区分开来。
该试验于 2015 年 4 月 8 日（04/08/2015）在 Clinicaltrials.gov 上注册为 NCT02515370。
