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WHO:慢性乙型肝炎感染者的预防、诊断、护理和治疗指南(2024)

制定者:
世界卫生组织(WHO,The World Health Organization)

2024年3月28日

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中英对照

Hepatitis B virus (HBV) infection is a major public health problem and cause of chronic liver disease that led to an estimated 820,000 deaths in 2019, mainly due to cirrhosis and liver cancer. In 2019, WHO estimated that 296 million people were chronically infected and living with hepatitis B, with a disproportionately high burden in low- and middle-income countries. The WHO African region, together with the South-East Asia Region and Western Pacific Region account for 88% of the global burden. Most of the global burden of chronic hepatitis B (CHB) can be attributed to mother-to-child transmission at the time of or shortly after birth, and such perinatal infections lead to a high rate of chronicity. Considerable progress has been made towards eliminating the perinatal transmission of HBV through universal infant HBV immunization, including the timely hepatitis B birth dose, which has been highly effective in reducing new infections among children. However, in 2022 hepatitis B birth-dose coverage was only 45% globally, with the lowest coverage (18%) in the WHO African Region. For people with CHB infection, nucleoside analogue treatment with currently recommended tenofovir and entecavir is highly effective and can delay the progression of cirrhosis, reduce the incidence of hepatocellular carcinoma (HCC) and improve long-term survival. However, a major testing and treatment gap remains. In 2019, only 10% of the estimated 296 million people with CHB had been diagnosed and 2% had been treated. Scaling up testing and treatment towards the elimination goals will require a radical simplification of treatment criteria and care pathways to overcome barriers in access to hepatitis B testing and treatment.

In 2015, WHO issued the first comprehensive guidelines on prevention, care and treatment for people with CHB, followed in 2017 with guidelines on testing for viral hepatitis B and C and in 2021 with WHO guidelines on preventing the mother-to-child transmission of HBV using antiviral prophylaxis in pregnancy. Several significant developments have occurred since the 2015 guidelines were published. These include new study data on the following: diagnostic performance of non-invasive tests for staging of liver disease and cut-off thresholds for diagnosing significant fibrosis or cirrhosis; natural history of CHB in different regions and antiviral therapy effectiveness according to different HBV DNA and ALT levels; comparison of the effectiveness and safety of dual combination of tenofovir + lamivudine or emtricitabine and also tenofovir alafenamide fumarate (TAF), a prodrug of tenofovir compared to tenofovir; diagnostic performance and impact of HBV DNA point-of-care viral load testing technologies; testing for hepatitis D virus coinfection (who to test and how to test), and impact of reflex testing approaches for HBV DNA and hepatitis D infection; and evaluation of impact of different service delivery models for care and treatment of CHB on outcomes across the cascade of care. In addition, there are opportunities to further expand use of antiviral prophylaxis to prevent mother-to-child transmission linked with the global initiative for triple elimination of HIV, hepatitis B and syphilis.

The objective of the 2024 guidelines is to provide updated evidence-informed recommendations on key priority topics. These include expanded and simplified treatment criteria for adults but now also for adolescents; expanded eligibility for antiviral prophylaxis for pregnant women to prevent mother-to-child transmission of HBV; and improving HBV diagnostics through use of point-of-care HBV DNA viral load and reflex approaches to HBV DNA testing; and who to test and how to test for HDV infection.

乙型肝炎病毒(HBV)感染是一个重大公共卫生问题,也是慢性肝病的病因2019年导致约82万人死亡的疾病,主要死于肝硬化和肝癌。2019年,WHO估计有2.96亿人慢性感染并感染肝炎B、中低收入国家负担不成比例地高。WHO非洲地区,连同东南亚区域和西太平洋地区占88%的全球负担。全球慢性乙型肝炎(CHB)的大部分负担可归因于出生时或出生后不久的母婴传播,此类围产期感染导致以高慢性化率。在消除围产期方面取得了相当大的进展。通过婴儿HBV普遍免疫传播HBV,包括及时接种乙型肝炎病毒出生剂量,在减少儿童新发感染方面非常有效。然而,2022年全球乙肝出生剂量覆盖率仅为45%,覆盖率最低(18%)在WHO非洲区域。对于CHB感染患者,核苷类似物治疗与目前推荐的替诺福韦和恩替卡韦高效,可延缓进展的肝硬化,降低肝细胞癌(HCC)的发生率和改善远期生存。然而,仍存在重大检测和治疗差距。2019年,仅为估计的10%已确诊CHB患者2.96亿人,2%接受过治疗。规模放大试验实现消除目标的治疗需要彻底简化治疗克服乙型肝炎检测和治疗障碍的标准和护理路径。

2015年,WHO发布了关于预防、护理和治疗的第一份综合指南,CHB患者,2017年遵循乙型和丙型肝炎病毒检测指南2021年WHO关于使用抗病毒药物预防HBV母婴传播的指南妊娠期预防。自2015年以来发生了几项重大发展指南已发表。其中包括以下方面的新研究数据:诊断性能的非侵入性检测用于肝病分期和诊断显著的临界值阈值纤维化或肝硬化;不同地区CHB的自然史和抗病毒治疗的有效性根据不同HBVDNA和ALT水平;比较有效性和安全性的替诺福韦+拉米夫定或恩曲他滨与替诺福韦艾拉酚胺的双重联合富马酸盐(TAF),替诺福韦与替诺福韦相比的前体药物;诊断性能和影响的HBVDNA床旁病毒载量检测技术;检测丁型肝炎病毒合并感染(检测人员和检测方法)以及HBVDNA和肝炎反射检测方法的影响D感染;评价护理和治疗的不同服务提供模式的影响的CHB对整个护理级联结局的影响。此外,还有机会进一步扩大抗病毒预防的使用,以预防与全球有关的母婴传播三重消除艾滋病毒、乙型肝炎和梅毒的倡议。

2024年指南的目标是提供最新的循证建议。关于关键优先级主题。包括扩大和简化的成人治疗标准但目前也适用于青少年;扩大孕妇抗病毒预防的资格,以预防HBV母婴传播;通过使用床旁检测改善HBV诊断HBVDNA病毒载量和HBVDNA检测的反射方法;以及检测对象和检测方法对于HDV感染。

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WHO:慢性乙型肝炎感染者的预防、诊断、护理和治疗指南(2024)
发布时间:  2024年3月28日
制定者:  
世界卫生组织(WHO,The World Health Organization)

195人浏览

0收藏

5次下载

摘要

Hepatitis B virus (HBV) infection is a major public health problem and cause of chronic liver disease that led to an estimated 820,000 deaths in 2019, mainly due to cirrhosis and liver cancer. In 2019, WHO estimated that 296 million people were chronically infected and living with hepatitis B, with a disproportionately high burden in low- and middle-income countries. The WHO African region, together with the South-East Asia Region and Western Pacific Region account for 88% of the global burden. Most of the global burden of chronic hepatitis B (CHB) can be attributed to mother-to-child transmission at the time of or shortly after birth, and such perinatal infections lead to a high rate of chronicity. Considerable progress has been made towards eliminating the perinatal transmission of HBV through universal infant HBV immunization, including the timely hepatitis B birth dose, which has been highly effective in reducing new infections among children. However, in 2022 hepatitis B birth-dose coverage was only 45% globally, with the lowest coverage (18%) in the WHO African Region. For people with CHB infection, nucleoside analogue treatment with currently recommended tenofovir and entecavir is highly effective and can delay the progression of cirrhosis, reduce the incidence of hepatocellular carcinoma (HCC) and improve long-term survival. However, a major testing and treatment gap remains. In 2019, only 10% of the estimated 296 million people with CHB had been diagnosed and 2% had been treated. Scaling up testing and treatment towards the elimination goals will require a radical simplification of treatment criteria and care pathways to overcome barriers in access to hepatitis B testing and treatment.

In 2015, WHO issued the first comprehensive guidelines on prevention, care and treatment for people with CHB, followed in 2017 with guidelines on testing for viral hepatitis B and C and in 2021 with WHO guidelines on preventing the mother-to-child transmission of HBV using antiviral prophylaxis in pregnancy. Several significant developments have occurred since the 2015 guidelines were published. These include new study data on the following: diagnostic performance of non-invasive tests for staging of liver disease and cut-off thresholds for diagnosing significant fibrosis or cirrhosis; natural history of CHB in different regions and antiviral therapy effectiveness according to different HBV DNA and ALT levels; comparison of the effectiveness and safety of dual combination of tenofovir + lamivudine or emtricitabine and also tenofovir alafenamide fumarate (TAF), a prodrug of tenofovir compared to tenofovir; diagnostic performance and impact of HBV DNA point-of-care viral load testing technologies; testing for hepatitis D virus coinfection (who to test and how to test), and impact of reflex testing approaches for HBV DNA and hepatitis D infection; and evaluation of impact of different service delivery models for care and treatment of CHB on outcomes across the cascade of care. In addition, there are opportunities to further expand use of antiviral prophylaxis to prevent mother-to-child transmission linked with the global initiative for triple elimination of HIV, hepatitis B and syphilis.

The objective of the 2024 guidelines is to provide updated evidence-informed recommendations on key priority topics. These include expanded and simplified treatment criteria for adults but now also for adolescents; expanded eligibility for antiviral prophylaxis for pregnant women to prevent mother-to-child transmission of HBV; and improving HBV diagnostics through use of point-of-care HBV DNA viral load and reflex approaches to HBV DNA testing; and who to test and how to test for HDV infection.

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