Department of Medicine, University of Zimbabwe, Harare, Zimbabwe.
Department of Medicine, University of Stellenbosch, Cape Town, South Africa.
PLoS One. 2023 Feb 14;18(2):e0281279. doi: 10.1371/journal.pone.0281279. eCollection 2023.
In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.
The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.
Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.
In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.
在津巴布韦，接受公共卫生抗逆转录病毒疗法（ART）的儿童、青少年和青年艾滋病毒感染者（CALWH）的病毒载量（VL）抑制不足。我们评估了基于诊所的 VL 监测是否可以降低这些 CALWH 中 12 个月时的病毒学失败率。
该研究已在 ClinicalTrials.gov 上注册：NCT03986099。在长期社区为基础的 ART 中，在 Chidamoyo 基督教医院（CCH）和 8 个农村外展点（ROS）接受护理的 CALWH 按 1:1 随机分配（1:1）接受 COBAS®Ampliprep®/Taqman48® HIV-1 每 6 个月一次的 VL 监测，通过省级转介实验室（PRL）按标准护理（SOC）或通过诊所的 SAMBA II 检测，诊断现实世界，在 CCH。在 12 个月时评估 VL 抑制、VL 结果的周转时间（TAT）、药物转换和二线治疗失败的耐药性。
在纳入的 390 名 CALWH 中，有 347 名（89%）完成了 12 个月的随访。中位（IQR）年龄和 ART 持续时间分别为 14.1（9.7-18.2）和 6.4（3.7-7.9）年，分别。超过一半（57%）的参与者为女性。在入组时，有 78 名（20%）的 VL≥1000 拷贝/ml，VL 抑制率为 80%，12 个月后无变化，SOC（81%）和基于诊所的（80%）手臂之间没有显著差异（p=0.528）。在 CCH 与 PRL 分别确认 VL 结果的中位（IQR）时间分别为 4.0（2.1-4.4）个月和 4.5（3.5-6.3）个月；p=0.027，在 12 个月时。在 26/347（7%）的参与者中记录了药物转换，SOC 与基于诊所的手臂之间在中位（IQR）药物转换时间上没有差异（5.1（3.9-10.0）个月与 4.4（2.5-8.4）个月；p=0.569）。在 24 例确认的二线治疗失败中，只有 4/19（21%）有蛋白酶抑制剂耐药。
在津巴布韦农村地区，基于诊所的 SAMBA II 检测能够比 SOC 在 PRL 更快地提供确认性 VL 结果。然而，这种快速的 TAT 并没有使这些 CALWH 中的药物转换更有效率。
