Department of Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Department of Medicine, Jos University Teaching Hospital, Jos, Nigeria.
Clin Infect Dis. 2023 Feb 8;76(3):e671-e680. doi: 10.1093/cid/ciac609.
Human immunodeficiency virus (HIV) viral load (VL) monitoring is critical for antiretroviral therapy (ART) management. Point-of-care (POC) VL testing has been reported to be feasible and preferred over standard-of-care (SOC) testing in many low- and middle-income country settings where rapid results could improve patient outcomes.
The timeliness of receipt of VL results was evaluated in an open-label, randomized, controlled trial among patients newly initiating ART. Clinical outcomes with POC VL monitoring using Cepheid Xpert vs SOC VL at Jos University Teaching Hospital and Comprehensive Health Centre Zamko in Nigeria were assessed. We determined time between specimen collection and recording of VL in patient charts, receipt of results, and ART switch for those who met virologic failure criteria.
Between April 2018 and October 2019, we screened 696 ART-naive individuals; 273 were randomized to POC and 268 to SOC HIV-1 VL testing. Participants in the POC arm received VL results significantly faster than those in the SOC arm (0.1 median days, interquartile range [IQR], 0.1-0.2 vs 143.1 days, IQR, 56.0-177.1, respectively; P < .0001). Participants in the POC arm with confirmed virologic failure vs those in the SOC arm were switched more rapidly to a second-line regimen (0 median days, IQR, 0-28 vs 66 days, IQR, 63-123, respectively; P = .03).
POC VL testing resulted in significant improvement in the timeliness of VL result receipt by patients and use for effective HIV clinical management. In patients experiencing VL failure, POC monitoring enabled prompt switching to second-line ART regimens.
NCT03533868.
人类免疫缺陷病毒 (HIV) 病毒载量 (VL) 监测对于抗逆转录病毒疗法 (ART) 管理至关重要。在许多中低收入国家，即时检测 (POC) 已被报道为可行的，并优于标准护理 (SOC) 检测，因为快速的结果可以改善患者的预后。
在一项新启动 ART 的患者中进行的开放性、随机、对照试验中，评估了 VL 结果的及时性。在尼日利亚的乔斯大学教学医院和综合卫生中心 Zamko 中，使用 Cepheid Xpert 进行 POCT 监测与使用 SOC VL 的临床结果进行了评估。我们确定了从标本采集到患者病历中记录 VL 的时间、结果的获得时间以及那些符合病毒学失败标准的患者的 ART 转换时间。
2018 年 4 月至 2019 年 10 月，我们筛选了 696 名初治的 ART 个体；其中 273 名被随机分配到 POCT 组，268 名被分配到 SOC HIV-1 VL 检测组。POC 组的参与者比 SOC 组更快地获得 VL 结果（0.1 天中位数，四分位距 [IQR]，0.1-0.2 对 143.1 天，IQR，56.0-177.1；P <.0001）。POC 组中确诊病毒学失败的参与者比 SOC 组更快地转换为二线方案（0 天中位数，IQR，0-28 对 66 天，IQR，63-123；P =.03）。
POC VL 检测显著提高了患者获得 VL 结果的及时性，并用于有效的 HIV 临床管理。在经历 VL 失败的患者中，POC 监测可实现快速切换至二线 ART 方案。
NCT03533868。
