Université Paris Cité and Université Sorbonne Paris Nord, Inserm, IAME, F-75018 Paris, France.
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, UK.
J Hepatol. 2023 May;78(5):937-946. doi: 10.1016/j.jhep.2022.12.032. Epub 2023 Jan 18.
BACKGROUND & AIMS: HCV test and treat campaigns currently exclude pregnant women. Pregnancy offers a unique opportunity for HCV screening and to potentially initiate direct-acting antiviral treatment. We explored HCV screening and treatment strategies in two lower middle-income countries with high HCV prevalence, Egypt and Ukraine.
Country-specific probabilistic decision models were developed to simulate a cohort of pregnant women. We compared five strategies: S0, targeted risk-based screening and deferred treatment (DT) to after pregnancy/breastfeeding; S1, World Health Organization (WHO) risk-based screening and DT; S2, WHO risk-based screening and targeted treatment (treat women with risk factors for HCV vertical transmission [VT]); S3, universal screening and targeted treatment during pregnancy; S4, universal screening and treatment. Maternal and infant HCV outcomes were projected.
S0 resulted in the highest proportion of women undiagnosed: 59% and 20% in Egypt and Ukraine, respectively, with 0% maternal cure by delivery and VT estimated at 6.5% and 7.9%, respectively. WHO risk-based screening and DT (S1) increased the proportion of women diagnosed with no change in maternal cure or VT. Universal screening and treatment during pregnancy (S4) resulted in the highest proportion of women diagnosed and cured by delivery (65% and 70%, respectively), and lower levels of VT (3.4% and 3.6%, respectively).
This is one of the first models to explore HCV screening and treatment strategies in pregnancy, which will be critical in informing future care and policy as more safety/efficacy data emerge. Universal screening and treatment in pregnancy could potentially improve both maternal and infant outcomes.
In the context of two lower middle-income countries with high HCV burdens (Egypt and Ukraine), we designed a decision analytic model to explore five different HCV testing and treatment strategies for pregnant women, with the assumption that treatment was safe and efficacious for use in pregnancy. Assuming direct-acting antiviral treatment during pregnancy would reduce vertical transmission, our findings indicate that the provision of universal (rather than risk-based targeted) screening and treatment would provide the greatest maternal and infant benefits. While future trials are needed to assess the safety and efficacy of direct-acting antivirals in pregnancy and their impact on vertical transmission, there is increasing recognition that the elimination of HCV cannot leave entire subpopulations of pregnant women and young children behind. Our findings will be critical for policymakers when developing improved screening and treatment recommendations for pregnant women.
目前，丙型肝炎病毒（HCV）检测和治疗活动将孕妇排除在外。怀孕为 HCV 筛查和潜在的直接作用抗病毒治疗提供了独特的机会。我们在两个丙型肝炎病毒流行率较高的中低收入国家——埃及和乌克兰，探索了 HCV 筛查和治疗策略。
针对两国情况，我们建立了特定的概率决策模型，以模拟孕妇队列。我们比较了五种策略：S0，基于风险的目标性筛查和产后/哺乳期延迟治疗（DT）；S1，世界卫生组织（WHO）基于风险的筛查和 DT；S2，WHO 基于风险的筛查和针对特定人群的治疗（对有 HCV 垂直传播风险因素的妇女进行治疗）；S3，妊娠期间进行普遍筛查和针对特定人群的治疗；S4，妊娠期间进行普遍筛查和治疗。预测了母婴 HCV 结局。
S0 导致未确诊的妇女比例最高：埃及和乌克兰分别为 59%和 20%，分娩时母亲的 HCV 治愈率均为 0%，垂直传播的估计值分别为 6.5%和 7.9%。WHO 基于风险的筛查和 DT（S1）增加了诊断出的妇女比例，但不改变母亲的治愈率或垂直传播率。妊娠期间进行普遍筛查和治疗（S4）使分娩时诊断出和治愈的妇女比例最高（分别为 65%和 70%），并且垂直传播率较低（分别为 3.4%和 3.6%）。
这是首次在妊娠期间探索 HCV 筛查和治疗策略的模型之一，随着更多安全性/疗效数据的出现，该模型将为未来的护理和政策提供重要信息。妊娠期间的普遍筛查和治疗可能会改善母婴结局。
在两个中低收入国家（埃及和乌克兰）中，HCV 负担较高，我们设计了一个决策分析模型，以探索针对孕妇的五种不同的 HCV 检测和治疗策略，假设在妊娠期间使用直接作用抗病毒治疗是安全有效的。假设直接作用抗病毒治疗可降低垂直传播的风险，我们的研究结果表明，提供普遍（而非基于风险的目标性）筛查和治疗将为母婴带来最大的益处。尽管未来需要进行临床试验来评估妊娠期间直接作用抗病毒药物的安全性和疗效及其对垂直传播的影响，但越来越多的人认识到，消除 HCV 不能将整个孕妇和儿童亚群排除在外。在制定针对孕妇的改进筛查和治疗建议时，我们的研究结果对政策制定者来说至关重要。
