国际视野丨Polin Chan博士：消除乙肝母婴传播的全球模式与实践路径

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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.

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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.

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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.

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