Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, 615 E Charles Young Drive S, Los Angeles, CA, 90095, USA.
Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
BMC Infect Dis. 2022 Sep 1;22(1):719. doi: 10.1186/s12879-022-07697-5.
Oral daily preexposure prophylaxis (PrEP) using emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is recommended as standard of care for prevention in individuals at high risk for HIV infection, including pregnant and postpartum cisgender women. FTC/TDF is also active against hepatitis B virus (HBV); however, concern has been raised that providing PrEP to individuals infected with HBV could lead to hepatitis flares and liver injury, especially in the setting of suboptimal PrEP use.
We conducted a cross-sectional analysis of baseline data from the PrEP in pregnant and postpartum women (PrEP-PP) cohort study from February 2020-March 2022 in one antenatal care clinic in Cape Town, South Africa (SA) to evaluate: (1) the field performance of a point of care test (POCT) (Determine II, Abbott Inc., Japan) for diagnosis of hepatitis B surface antigen (HBsAg) in a maternity setting, (2) the prevalence of HBV in a cohort of pregnant women not living with HIV.
We enrolled 1194 HIV sero-negative pregnant women at their first antenatal visit. Median age was 26 years (IQR = 22-31 years); 52% were born before 1995 (before universal HBV vaccination had started in South Africa). Median gestational age was 22 weeks (IQR = 16-30 weeks). There were 8 POCT and laboratory confirmed HBV cases among 1194 women. The overall prevalence of 0.67% (95% CI = 0.34-1.32%). In women born before 1995, 8 of 622 women were diagnosed with HBsAg; the prevalence was 1.29% (95% CI = 0.65-2.52%), and in women born in 1995 or after (n = 572); the prevalence was 0% (95% CI = 0.0-0.67%). We confirmed the test results in 99.8% of the rapid HBsAg (Determine II). Sensitivity was 100% (95% CI = 68-100%). Specificity was 100% (95% CI = 99.67-100%).
The prevalence of HBV was very low in pregnant women not living with HIV and was only in women born before the HBV vaccine was included in the Expanded Program of Immunization. The Determine II POCT HBsAg showed excellent performance against the laboratory assay. HBV screening should not be a barrier to starting PrEP in the context of high HIV risk communities.
口服每日暴露前预防（PrEP）使用恩曲他滨（FTC）/替诺福韦二吡呋酯（TDF）被推荐作为预防 HIV 感染高危人群（包括孕妇和产后跨性别女性）的标准护理。FTC/TDF 也对乙型肝炎病毒（HBV）有效；然而，有人担心向 HBV 感染者提供 PrEP 可能导致肝炎发作和肝损伤，尤其是在 PrEP 使用不理想的情况下。
我们对 2020 年 2 月至 2022 年 3 月在南非开普敦一家产前保健诊所进行的孕妇和产后 PrEP（PrEP-PP）队列研究的基线数据进行了横断面分析，以评估：（1）在产科环境中用于诊断乙型肝炎表面抗原（HBsAg）的即时检测（POCT）（ Abbott Inc.，日本的 Determine II）的现场性能；（2）在未感染 HIV 的孕妇队列中 HBV 的流行情况。
我们在第一次产前就诊时招募了 1194 名 HIV 血清阴性孕妇。中位年龄为 26 岁（IQR=22-31 岁）；52%的人出生于 1995 年之前（南非开始普遍接种乙型肝炎疫苗之前）。中位孕龄为 22 周（IQR=16-30 周）。在 1194 名妇女中，有 8 例经 POCT 和实验室确认的 HBV 病例。总患病率为 0.67%（95%CI=0.34-1.32%）。在 1995 年之前出生的妇女中，622 名妇女中有 8 名被诊断为 HBsAg；患病率为 1.29%（95%CI=0.65-2.52%），而在 1995 年或之后出生的妇女（n=572）中，患病率为 0%（95%CI=0.0-0.67%）。我们确认了快速 HBsAg（Determine II）的检测结果的 99.8%。灵敏度为 100%（95%CI=68-100%）。特异性为 100%（95%CI=99.67-100%）。
未感染 HIV 的孕妇中 HBV 的患病率非常低，仅在乙型肝炎疫苗纳入扩大免疫规划之前出生的妇女中发现。Determine II POCT HBsAg 对实验室检测表现出优异的性能。在 HIV 高风险社区中，不应因 HBV 筛查而成为开始 PrEP 的障碍。
