Background

In 2020, WHO recommended the addition of peripartum antiviral prophylaxis (PAP) to hepatitis B birth dose vaccination (HepB-BD) and hepatitis B infant vaccination (HepB3) to reduce mother-to-child transmission of hepatitis B virus (HBV) infection in pregnant women who have a marker of high infectivity (ie, HBV DNA ≥200 000 international units per mL or HBeAg-positive). We aimed to evaluate the impact and cost-effectiveness of this recommendation and of a theoretical simplified strategy whereby PAP is given to all pregnant women who are HBsAg-positive without risk stratification.

Methods

This modelling study used a dynamic simulation model of the HBV epidemic in 110 countries in all WHO regions, structured by age, sex, and country. We assessed three strategies of scaling up PAP for pregnant women: PAP for those with high viral load (PAP-VL); PAP for those who are HBeAg-positive (PAP-HBeAg); and PAP for all pregnant women who are HBsAg-positive (PAP-universal), in comparison with neonatal vaccination alone (HepB-BD). We investigated how different diagnostic and antiviral drug costs affected the cost-effectiveness of the strategies evaluated. Using a health-care provider perspective, we calculated incremental cost-effectiveness ratios in cost (US$) per disability-adjusted life-year (DALY) averted in each country's population and compared these with country-specific cost-effectiveness thresholds. We also calculated new neonatal infections averted for each of the strategies.

Findings

Adding PAP-VL to HepB-BD could avert around 1·1 million (95% uncertainty interval 1·0 million–1·2 million) new neonatal infections by 2030 and around 3·2 million (95% uncertainty interval 3·0 million–3·4 million) new neonatal infections and approximately 8·8 million (7·8 million–9·7 million) DALYs by 2100 across all the countries modelled. This strategy would probably be cost-effective up to 2100 in 28 (26%) of 106 countries analysed (which included some of the countries that have the greatest HBV burden) if costs are as currently expected to be, and in 74 (70%) countries if diagnostic and monitoring costs were lowered (by about 60–75%). The relative cost-effectiveness of PAP-VL and PAP-HBeAg was finely balanced and depended on the respective diagnostic and monitoring costs. The PAP-universal strategy could be more cost-effective than either of these strategies in most countries, but the use of antiviral treatment could be five times as high than with PAP-VL.

Interpretation

PAP can provide substantial health benefits, and, although the current approach might already be cost-effective in some high-burden settings, decreased diagnostic costs would probably be needed for PAP to be cost-effective in most countries. Therefore, careful consideration needs to be given about how such a strategy is implemented, and securing reduced costs for diagnostics should be a priority. The theoretical strategy of offering PAP to all women who are HBsAg-positive (eg, if diagnostic tests to identify mothers at risk of transmission are not available) could be a cost-effective alternative, depending on prevailing costs of diagnostics and antiviral therapy.

Funding

UK Medical Research Council, UK National Institute for Health and Care Research, and the Vaccine Impact Modelling Consortium.

中文翻译：

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妊娠期乙型肝炎病毒预防的影响和成本效益：动态模拟模型研究

 背景

2020年，世界卫生组织建议在乙型肝炎出生剂量疫苗接种（HepB-BD）和乙型肝炎婴儿疫苗接种（HepB3）的基础上增加围产期抗病毒预防（PAP），以减少乙型肝炎病毒（HBV）感染的母婴传播。具有高传染性标志的孕妇（即 HBV DNA ≥200 000 国际单位/mL 或 HBeAg 阳性）。我们的目的是评估该建议以及理论上的简化策略的影响和成本效益，即对所有 HBsAg 阳性孕妇进行 PAP，无需进行风险分层。

 方法

这项建模研究使用了世卫组织所有区域 110 个国家的 HBV 流行动态模拟模型，按年龄、性别和国家/地区构建。我们评估了三种扩大孕妇 PAP 的策略： 高病毒载量人群的 PAP (PAP-VL)； HBeAg 阳性者进行 PAP（PAP-HBeAg）；与仅新生儿疫苗接种 (HepB-BD) 相比，针对所有 HBsAg 阳性孕妇（PAP 通用）进行 PAP 接种。我们研究了不同的诊断和抗病毒药物成本如何影响所评估策略的成本效益。我们从卫生保健提供者的角度出发，计算了每个国家人口可避免的每残疾调整生命年 (DALY) 的成本增量成本效益比（美元），并将其与特定国家的成本效益阈值进行比较。我们还计算了每种策略避免的新新生儿感染。

 发现

到 2030 年，将 PAP-VL 添加到 HepB-BD 可以避免约 1·1 百万（95% 不确定性区间 1·0 百万–1·2 百万）新新生儿感染，以及约 3·2 百万（95% 不确定性区间 3·0 百万）到 2100 年，所有建模国家中将有 3·400 万）新的新生儿感染和约 8·800 万（7·800 万至 9·700 万）伤残调整生命年。如果成本按照目前的预期，在 2100 年之前，在所分析的 106 个国家中的 28 个国家（其中包括一些乙肝病毒负担最重的国家）中，这一策略可能具有成本效益，而在 74 个国家中（70%） ）国家如果诊断和监测成本降低（约 60-75%）。 PAP-VL 和 PAP-HBeAg 的相对成本效益得到了很好的平衡，并且取决于各自的诊断和监测成本。在大多数国家，PAP 通用策略可能比这两种策略都更具成本效益，但抗病毒治疗的使用可能是 PAP-VL 的五倍。

 解释

PAP 可以提供巨大的健康益处，尽管目前的方法在一些高负担环境中可能已经具有成本效益，但在大多数国家，PAP 可能需要降低诊断成本才能具有成本效益。因此，需要仔细考虑如何实施这一策略，并优先考虑降低诊断成本。向所有 HBsAg 阳性女性提供 PAP 的理论策略（例如，如果无法进行诊断测试来识别有传播风险的母亲）可能是一种具有成本效益的替代方案，具体取决于诊断和抗病毒治疗的普遍成本。

 资金

英国医学研究委员会、英国国家健康与护理研究所和疫苗影响模型联盟。