编者按：2025大湾区肝病国际论坛暨消除病毒性肝炎大会在广州成功召开。世界卫生组织（WHO）东南亚区域办事处顾问Polin Chan博士在会上作题为《消除乙肝母婴传播全球模式的转变》的报告。《国际肝病》对她进行了专访，她深入阐述了全球消除乙肝病毒（HBV）母婴传播（MTCT）战略的演变历程，回顾了WHO标准化认证体系的建立过程，剖析了相较于艾滋病和梅毒防控，扩大乙肝干预规模面临的特殊挑战。

《国际肝病》

您在报告中强调了标准化认证体系和全球指南对于验证乙型肝炎病毒（HBV）母婴传播（MTCT）消除的关键作用。能否请您详细阐述这些指导原则如何推动全球消除HBV母婴传播的进程？在全面实施过程中仍面临哪些挑战？

Polin Chan博士：我是WHO东南亚区域办事处（位于印度新德里）的区域顾问，负责肝炎、艾滋病、性传播感染及消除母婴传播事务。我所在的区域覆盖11个国家。

作为全球公共卫生领域的权威机构，WHO始终致力于为成员国制定标准化指南，为实施关键卫生干预措施提供框架。在消除艾滋病、梅毒和乙肝三重母婴传播目标的背景下，WHO多年来发布了多项指南，尤其在检测与治疗领域具有重要指导意义。

2014年，WHO发布了被称为“橙皮书”的《关于消除艾滋病病毒和梅毒母婴传播全球认证和标准的指南》，为各国申请消除母婴传播认证提供规范。该指南最初聚焦艾滋病与梅毒防控，而2021年的更新版本首次纳入乙肝防治标准，这标志着全球消除HBV工作迈出重要一步。

这项全球倡议致力于推动各国阻断病毒垂直传播。截至目前，已有21个国家通过WHO对艾滋病和（或）梅毒母婴传播消除的认证。鉴于乙肝认证标准实施时间较短，目前尚未有国家获得完全认证。值得关注的是，近期非洲某国已达到“消除路径”阶段并取得银级认证，这是向金级认证迈进的重要里程碑。

根据WHO认证体系，各国需依次通过铜级、银级、金级三个递进式评估，最终达到金级标准的国家方可申请全面认证。要实现这一目标，各国面临的核心挑战在于强化乙肝疫苗接种体系——需连续两年保持高水平接种覆盖率：不仅乙肝疫苗全程接种率需达95%以上，新生儿首剂疫苗（出生24小时内接种）的及时接种率也需达到90%。

此外，各国还需证明孕产妇普遍乙肝检测的项目覆盖率，并确保完善的随访及诊疗体系。这不仅包括对孕产妇的健康管理，更需确保新生儿获得规范的医疗照护。

Hepatology Digest: Dr. Chan, your report highlights the critical role of standardized criteria and global guidance in validating the elimination of mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Can you elaborate on how these guidelines have facilitated progress towards eliminating HBV MTCT globally, and what challenges remain in fully implementing them?

Dr. Polin Chan: I am Dr. Polin Chan, Regional Advisor for Hepatitis, HIV, STIs, and Elimination of Mother-to-Child Transmission at the World Health Organization Southeast Asia Regional Office in Delhi, India, which covers 11 countries in the region.

Thank you for your question, it's a very good question. The World Health Organization (WHO) is the leading global public health institution, and our member states look to us for standardized guidelines that provide a framework to implement critical health interventions. In the context of triple elimination of mother-to-child transmission—covering HIV, syphilis, and hepatitis B—WHO has issued several guidelines over the years, particularly related to testing and treatment.

Most notably, since 2014, WHO introduced what we often refer to as the "Orange Book," which contains the criteria for countries to apply for WHO validation of MTCT elimination. Initially, the focus was on HIV and syphilis, but in 2021, the guidelines were updated to include hepatitis B, marking an important step forward for global HBV elimination efforts.

This global initiative encourages countries to aim for the elimination of vertical transmission. So far, WHO has validated 21 countries for achieving elimination of HIV, syphilis, or both. However, since the hepatitis B criteria are relatively new, no country has yet received full validation for HBV MTCT elimination. That said, one country in Africa has recently reached the "path to elimination" stage and achieved the silver tier—an important milestone that reflects progressive achievements toward full validation.

The validation process includes three progress tiers: bronze, silver, and gold. Once a country reaches the gold tier, it becomes eligible to apply for full WHO validation. Looking ahead, one of the key challenges for countries will be strengthening their hepatitis B vaccination programs. To qualify for validation, they must demonstrate at least two years of sustained, high coverage for both the full hepatitis B vaccine series and the timely birth dose administered within 24 hours of birth.

Additionally, countries must show high programmatic coverage of universal hepatitis B testing for pregnant women and ensure adequate follow-up and care. This includes not only managing the health of the mother but also ensuring appropriate outcomes for the infant.

《国际肝病》

您提及的“三重消除倡议”（TEI）旨在消除艾滋病、梅毒及乙肝的母婴传播。相较于艾滋病与梅毒，将乙肝纳入该倡议面临哪些独特挑战？WHO采取何种策略应对这些挑战？

Polin Chan博士：过去三十年间，艾滋病防控获得了大量资源投入，为消除工作奠定了坚实基础。早在2010-2011年，全球通过预防母婴传播（PMTCT）消除艾滋病及梅毒的规划，形成艾滋病与梅毒“双重消除”策略的基础框架。而乙肝作为该倡议的新增目标，其防控体系的构建面临独特挑战。将乙肝母婴传播阻断（EMTCT）纳入该倡议，得益于WHO与成员国特别是中国的开创性合作。

中国通过实施全民乙肝筛查、新生儿乙肝免疫球蛋白（HBIG）接种等国家战略，积累了丰富的防控经验。这些国家级实践经验为区域乃至全球政策制定提供了宝贵的实证依据。WHO消除乙肝母婴传播标准的制定严格遵循循证流程，通过系统性评估真实世界数据确立科学规范。

当前面临的挑战在于如何将这些经验推广至全球范围。虽然中国等国的成功模式已得到验证，特别是在非洲及部分亚洲地区，乙肝疫苗及时首剂接种（出生24小时内）覆盖率仍处于较低水平。非洲多国数据显示，目前仅有不足20%的新生儿能在出生24小时内接种首剂乙肝疫苗，而这一环节对阻断传播至关重要。尽管五联疫苗接种覆盖率相对较高，但及时首剂接种仍是亟待弥补的关键缺口。

尽管存在诸多挑战，我坚信通过区域协作与跨国经验共享，互鉴实践经验，特别是成功经验，我们终将实现下一代免受乙肝威胁的愿景。

Hepatology Digest: You mention the "Triple Elimination Initiative" (TEI), which aims to eliminate MTCT of HIV, syphilis, and HBV. What are the unique challenges associated with including HBV in this initiative, compared to HIV and syphilis, and how is WHO addressing these challenges?

Dr. Polin Chan: This is also another very good question. HIV has received significant investment over the past three decades, which laid a strong foundation for elimination efforts. The global plan to eliminate HIV and later syphilis through prevention of mother-to-child transmission (PMTCT) began as early as 2010–2011. This formed the basis of what we refer to as the dual elimination strategy for HIV and syphilis.

In contrast, hepatitis B elimination through mother-to-child transmission (EMTCT) is a newer addition to the initiative. It was driven in large part by groundbreaking work carried out by WHO in collaboration with governments especially the Government of China. China has a long history of controlling hepatitis B through universal screening and administration of hepatitis B immunoglobulin (HBIG) at birth. This country-level experience provided valuable, practical evidence that informed regional and eventually global policy.

As with all WHO guidance, the development of HBV EMTCT criteria involved systematic reviews and relied heavily on real-world implementation data. The challenge now is scaling these efforts globally—particularly in regions like Africa and parts of Asia, where timely hepatitis B birth dose vaccination remains limited.

In many African countries, for instance, fewer than 20% of newborns receive the hepatitis B vaccine within 24 hours of birth, which is essential to prevent transmission. While pentavalent vaccine coverage is relatively high, timely birth dose delivery is still a major gap.

Despite these challenges, I strongly believe in the power of regional and cross-country collaboration. By learning from each other’s experiences, especially the success stories, we can move closer to a future where the next generation is free from hepatitis B.

《国际肝病》

您在报告中探讨了中国、印度等国采用的次国家层面策略以加速消除HBV母婴传播。能否深入解析这些策略的成功要素？如何将其经验复制或调整应用于其他人口众多且资源有限的中低收入国家？

Polin Chan博士：全球乙肝母婴传播防控领域的首次范式转变，在于认识到单纯依靠免疫策略并不足够。通过应用替诺福韦等抗病毒药物，联合乙肝免疫球蛋白（HBIG）等干预措施，与疫苗接种形成互补，构建起更全面的传播阻断体系。

全球乙肝母婴传播防控经历了两次关键范式转变。第一次转变突破了单纯依赖免疫策略的局限，通过引入替诺福韦等抗病毒药物与乙肝免疫球蛋白（HBIG）联合干预，标志着防控策略的升级。第二次转变聚焦推动消除母婴传播的认证工作，其核心在于次国家策略的应用。正如古语“罗马非一日建成”，实现国家级认证需要时间积累、多方协作与持续努力。

截至目前，仅有中国和巴西两国在“三重消除”框架下实施次国家认证策略。两国在卫生部指导下形成了各具特色的模式。需特别说明的是，WHO仅对国家层面认证进行审核，次国家认证需先由该国自行建立管理体系，待整体达标后方可申请国家级认证。

从中巴两国的实践中，我们提炼出三大核心成功要素：

（1）尽早启动，即刻行动：次国家策略的构建需要时间积淀。必须尽早实现国家战略与省级/州级规划的有效衔接，确保推进步调一致。

（2）强化战略信息系统：建立数据驱动的监测报告体系至关重要。WHO要求提供国家级及次国家级层面的达标证据，包括存在显著城乡差异的疫苗接种覆盖率等关键指标。

（3）构建多方协作机制：国家-省-地方三级联动的协同治理体系同样至关重要。中巴经验表明，政府主导下整合学术机构、社区组织及民间力量的协作模式是成功关键。

对于印度、印尼等人口大国，次国家认证策略展现出特殊优势。其运作逻辑在于：中央政府制定标准框架，省级行政单元（如邦、省、专区）逐级落实目标。特定省份持续达到消除标准后，即可获得国家级认证资质。

值得注意的是，认证并非终点，持续维持防控成效才是重点。以中国广东省为例，在通过认证后仍出现零星传播案例，当地通过建立个案回溯分析机制，将经验教训转化为改进措施，这种动态优化机制为全球实践提供了重要参考。

这种分层认证体系的深层价值在于，次国家认证模式通过整合学术界、医疗机构、政策制定者和社区力量，构建起消除母婴传播的共治体系。因为“三重消除”的终极目标不仅是阻断病毒传播，更是守护下一代免受艾滋病、梅毒和乙肝威胁，构建健康未来。

Hepatology Digest: Your presentation discusses subnational approaches, such as those implemented in China and India, to accelerate the elimination of HBV MTCT. Can you provide insights into the success factors of these approaches and how they can be replicated or adapted in other large, populous low- and middle-income countries (LMICs)?

Dr. Polin Chan: Thank you. The first global paradigm shift in the prevention of mother-to-child transmission of hepatitis B was the recognition that immunization strategies alone were not sufficient. The use of tenofovir and other antivirals, combined with interventions such as hepatitis B immunoglobulin (HBIG), marked an important step forward. These strategies complemented vaccination efforts and formed a more comprehensive approach to interrupt transmission.

The second paradigm shift is the current focus on achieving validation of hepatitis B MTCT elimination, and one key strategy in this effort is the adoption of subnational approaches. These recognize that progress must be incremental, particularly in large, populous countries—and that milestones along the way should be acknowledged and built upon. As the saying goes, Rome wasn’t built in a day. Likewise, validation of elimination requires time, partnership, and sustained collaboration.

To date, only two countries China and Brazil have implemented subnational approaches for triple elimination. Each has adopted different models under the guidance of their respective Ministries of Health. It's important to note that WHO only validates EMTCT at the national level; subnational certification must first be managed internally by the country before it can proceed to seek WHO validation at the national level.

From the experience of China and Brazil, we’ve identified several critical success factors:

Start early, start now: Building a robust subnational approach takes time. It's essential to begin aligning national strategies with those at the provincial or state level to ensure coordinated progress.

Strengthen strategic information systems: A strong, data-driven reporting infrastructure is key. WHO requires clear evidence that EMTCT criteria are met—not only nationally, but also across subnational regions. This includes documenting immunization coverage, which often varies significantly between urban and rural areas.

Foster strong partnerships: Effective collaboration across all levels—national, provincial, and local—is essential. Both China and Brazil have shown that government leadership, coupled with support from academic institutions, communities, and civil society, is critical for success.

In countries like India and Indonesia, subnational strategies are becoming increasingly relevant. National authorities set the standards and criteria, while subnational units—provinces, states, districts—work towards meeting and sustaining these goals. Once the province demonstrates that it has consistently achieved the criteria, the national government can certify it as having reached EMTCT.

Importantly, it's not just about achieving validation, it’s also about maintaining it. We’ve seen examples like the Guangdong province, where a small number of HBV transmissions occurred despite interventions. These cases were reviewed carefully, and the feedback that followed helped improve future efforts. This continuous learning process is vital.

Ultimately, the subnational certification model engages the entire ecosystem—academia, healthcare providers, policymakers, and communities—and builds collective responsibility. Because at its core, triple elimination isn’t only about stopping transmission. It’s about protecting future generations, ensuring they grow up free from HIV, syphilis, and hepatitis B.

（来源：《国际肝病》编辑部）

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