Interpretation of the update points on guideline for the prevention and treatment of chronic hepatitis B (2022)_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

HAN Ning ^1,2 , YAN Libo ^1,2 ,  TANG Hong ^1,2

1. Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. Division of Infectious Diseases, State Key Laboratory of Biotherapy, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

TANG Hong, Email: htang6198@hotmail.com

Keywords：

chronic hepatitis B; guideline; update point; interpretation

DOI：

10.7507/1007-9424.202309028

Video：

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In order to provide more standardized guidance for the management of patients with chronic hepatitis B (CHB) in China and to achieve the World Health Organization’s goal of “eliminating viral hepatitis as public health threats by the year 2030”, the Hepatology and Infectious Diseases Societies of the Chinese Medical Association organized experts to update the guideline for the prevention and treatment of CHB, emphasizing more extensive screening for hepatitis B virus (HBV) markers in the general population and more active antiviral treatment for HBV-infected patients. This article introduced and studied the key update points of the new guideline.

Citation： HAN Ning, YAN Libo, TANG Hong. Interpretation of the update points on guideline for the prevention and treatment of chronic hepatitis B (2022). CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2023, 30(11): 1301-1307. doi: 10.7507/1007-9424.202309028 Copy

1.	中华医学会肝病学分会, 中华医学会感染病学分会. 慢性乙型肝炎防治指南 (2022年版). 中华肝脏病杂志, 2022, 30(12): 1309-1331.
2.	World Health Organization. Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021: accountability for the global health sector strategies 2016–2021: actions for impact: web annex 2: data methods. 2021-07-14. (2023-08-20). https://apps.who.int/iris/handle/10665/342813.
3.	Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol, 2018, 3(6): 383-403.
4.	中华医学会感染病学分会, 中华医学会肝病学分会. 慢性乙型肝炎防治指南 (2019年版). 中华肝脏病杂志, 2019, 27(12): 938-961.
5.	Péneau C, Imbeaud S, La Bella T, et al. Hepatitis B virus integrations promote local and distant oncogenic driver alterations in hepatocellular carcinoma. Gut, 2022, 71(3): 616-626.
6.	Erken R, Loukachov V, van Dort K, et al. Quantified integrated hepatitis B virus is related to viral activity in patients with chronic hepatitis B. Hepatology, 2022, 76(1): 196-206.
7.	Tong S, Revill P. Overview of hepatitis B viral replication and genetic variability. J Hepatol, 2016, 64(1 Suppl): S4-S16.
8.	Huang DQ, Li X, Le MH, et al. Natural history and hepatocellular carcinoma risk in untreated chronic hepatitis B patients with indeterminate phase. Clin Gastroenterol Hepatol, 2022, 20(8): 1803-1812.
9.	Yao K, Liu J, Wang J, et al. Distribution and clinical characteristics of patients with chronic hepatitis B virus infection in the grey zone. J Viral Hepat, 2021, 28(7): 1025-1033.
10.	Lin N, Ye A, Lin J, et al. Diagnostic value of detection of pregenomic RNA in sera of hepatitis B virus-infected patients with different clinical outcomes. J Clin Microbiol, 2020, 58(2): e01275-e01219.
11.	Adraneda C, Tan YC, Yeo EJ, et al. A critique and systematic review of the clinical utility of hepatitis B core-related antigen. J Hepatol, 2023, 78(4): 731-741.
12.	Carey I, Gersch J, Wang B, et al. Pregenomic HBV RNA and hepatitis B core-related antigen predict outcomes in hepatitis B e antigen-negative chronic hepatitis B patients suppressed on nucleos(T)ide analogue therapy. Hepatology, 2020, 72(1): 42-57.
13.	Mak LY, Cloherty G, Wong DK, et al. HBV RNA profiles in patients with chronic hepatitis B under different disease phases and antiviral therapy. Hepatology, 2021, 73(6): 2167-2179.
14.	Seto WK, Liu KS, Mak LY, et al. Role of serum HBV RNA and hepatitis B surface antigen levels in identifying Asian patients with chronic hepatitis B suitable for entecavir cessation. Gut, 2021, 70(4): 775-783.
15.	Li J, Mao RC, Li XL, et al. A novel noninvasive index for the prediction of moderate to severe fibrosis in chronic hepatitis B patients. Dig Liver Dis, 2018, 50(5): 482-489.
16.	Li J, Gong QM, Xie PL, et al. Prognostic value of anti-HBc quantification in hepatitis B virus related acute-on-chronic liver failure. J Gastroenterol Hepatol, 2021, 36(5): 1291-1299.
17.	Kong Y, Sun Y, Zhou J, et al. Early steep decline of liver stiffness predicts histological reversal of fibrosis in chronic hepatitis B patients treated with entecavir. J Viral Hepat, 2019, 26(5): 576-585.
18.	中国肝炎防治基金会, 中华医学会感染病学分会, 中华医学会肝病学分会和中国研究型医院学会肝病专业委员会. 瞬时弹性成像技术诊断肝纤维化专家共识 (2018年更新版). 中华肝脏病杂志, 2019, 27(3): 182-191.
19.	Wang H, Wen B, Chang X, et al. Baveno Ⅵ criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol, 2021, 74(3): 584-592.
20.	Wang Q, Zhao H, Deng Y, et al. Validation of Baveno Ⅶ criteria for recompensation in entecavir-treated patients with hepatitis B-related decompensated cirrhosis. J Hepatol, 2022, 77(6): 1564-1572.
21.	Chayanupatkul M, Omino R, Mittal S, et al. Hepatocellular carcinoma in the absence of cirrhosis in patients with chronic hepatitis B virus infection. J Hepatol, 2017, 66(2): 355-362.
22.	Choi GH, Kim GA, Choi J, et al. High risk of clinical events in untreated HBeAg-negative chronic hepatitis B patients with high viral load and no significant ALT elevation. Aliment Pharmacol Ther, 2019, 50(2): 215-226.
23.	Wang F, Mubarik S, Zhang Y, et al. Long-term trends of liver cancer incidence and mortality in China 1990-2017: a joinpoint and age-period-cohort analysis. Int J Environ Res Public Health, 2019, 16(16): 2878. doi: 10.3390/ijerph16162878.
24.	Garrido A, Djouder N. Cirrhosis: a questioned risk factor for hepatocellular carcinoma. Trends Cancer, 2021, 7(1): 29-36.
25.	Alshuwaykh O, Daugherty T, Cheung A, et al. Incidence of hepatocellular carcinoma in chronic hepatitis B virus infection in those not meeting criteria for antiviral therapy. Hepatol Commun, 2022, 6(11): 3052-3061.
26.	Lee MH, Yang HI, Liu J, et al. Prediction models of long-term cirrhosis and hepatocellular carcinoma risk in chronic hepatitis B patients: risk scores integrating host and virus profiles. Hepatology, 2013, 58(2): 546-554.
27.	Wu Z, Ma AL, Xie Q, et al. Significant histological changes and satisfying antiviral efficacy in chronic hepatitis B virus infection patients with normal alanine aminotransferase. Antiviral therapy decision in chronic HBV patients with normal ALT. Clin Res Hepatol Gastroenterol, 2021, 45(2): 101463.
28.	Duan M, Chi X, Xiao H, et al. High-normal alanine aminotransferase is an indicator for liver histopathology in HBeAg-negative chronic hepatitis B. Hepatol Int, 2021, 15(2): 318-327.
29.	Kao JH, Hu TH, Jia J, et al. East Asia expert opinion on treatment initiation for chronic hepatitis B. Aliment Pharmacol Ther, 2020, 52(10): 1540-1550.
30.	Hou JL, Zhao W, Lee C, et al. Outcomes of long-term treatment of chronic HBV infection with entecavir or other agents from a randomized trial in 24 countries. Clin Gastroenterol Hepatol, 2020, 18(2): 457-467.
31.	Marcellin P, Gane E, Buti M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet, 2013, 381(9865): 468-475.
32.	Byun KS, Choi J, Kim JH, et al. Tenofovir alafenamide for drug-resistant hepatitis B: a randomized trial for Switching from tenofovir disoproxil fumarate. Clin Gastroenterol Hepatol, 2022, 20(2): 427-437.
33.	Liu Z, Jin Q, Zhang Y, et al. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther, 2021, 54(9): 1134-1149.
34.	Liu Z, Jin Q, Zhang Y, et al. 96-week treatment of tenofovir amibufenamide and tenofovir disoproxil fumarate in chronic hepatitis B patients. J Clin Transl Hepatol, 2023, 11(3): 649-660.
35.	Wu D, Wang P, Han M, et al. Sequential combination therapy with interferon, interleukin-2 and therapeutic vaccine in entecavir-suppressed chronic hepatitis B patients: the Endeavor study. Hepatol Int, 2019, 13(5): 573-586.
36.	Chan HLY, Chan FWS, Hui AJ, et al. Switching to peginterferon for chronic hepatitis B patients with hepatitis B e antigen seroconversion on entecavir - a prospective study. J Viral Hepat, 2019, 26(1): 126-135.
37.	Hall SAL, Vogrin S, Wawryk O, et al. Discontinuation of nucleot(s)ide analogue therapy in HBeAg-negative chronic hepatitis B: a meta-analysis. Gut, 2022, 71(8): 1629-1641.
38.	Fan R, Papatheodoridis G, Sun J, et al. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol, 2020, 73(6): 1368-1378.
39.	Sun Y, Wu X, Zhou J, et al. Persistent low level of hepatitis B virus promotes fibrosis progression during therapy. Clin Gastroenterol Hepatol, 2020, 18(11): 2582-2591.
40.	Zhang Q, Peng H, Liu X, et al. Chronic hepatitis B infection with low level viremia correlates with the progression of the liver disease. J Clin Transl Hepatol, 2021, 9(6): 850-859.
41.	韩宁, 严丽波, 唐红. 慢性乙型肝炎治疗过程中低病毒血症的临床意义和管理策略. 中华肝脏病杂志, 2021, 29(12): 1139-1143.
42.	Paul S, Dickstein A, Saxena A, et al. Role of surface antibody in hepatitis B reactivation in patients with resolved infection and hematologic malignancy: a meta-analysis. Hepatology, 2017, 66(2): 379-388.
43.	Lau G, Yu ML, Wong G, et al. APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy. Hepatol Int, 2021, 15(5): 1031-1048.
44.	朱世殊, 董漪, 徐志强, 等. 1~7岁慢性乙型肝炎HBeAg阳性儿童经抗病毒治疗HBsAg清除率的回顾性研究. 中华肝脏病杂志, 2016, 24(10): 738-743.
45.	朱世殊, 董漪, 张鸿飞, 等. 慢性乙型肝炎儿童免疫耐受期随机对照干扰素序贯联合拉米夫定抗病毒治疗的疗效影响因素研究. 中华肝脏病杂志, 2019, 27(8): 604-609.
46.	Jonas MM, Lok AS, McMahon BJ, et al. Antiviral therapy in management of chronic hepatitis B viral infection in children: a systematic review and meta-analysis. Hepatology, 2016, 63(1): 307-318.

1. 中华医学会肝病学分会, 中华医学会感染病学分会. 慢性乙型肝炎防治指南 (2022年版). 中华肝脏病杂志, 2022, 30(12): 1309-1331.
2. World Health Organization. Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021: accountability for the global health sector strategies 2016–2021: actions for impact: web annex 2: data methods. 2021-07-14. (2023-08-20). https://apps.who.int/iris/handle/10665/342813.
3. Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol, 2018, 3(6): 383-403.
4. 中华医学会感染病学分会, 中华医学会肝病学分会. 慢性乙型肝炎防治指南 (2019年版). 中华肝脏病杂志, 2019, 27(12): 938-961.
5. Péneau C, Imbeaud S, La Bella T, et al. Hepatitis B virus integrations promote local and distant oncogenic driver alterations in hepatocellular carcinoma. Gut, 2022, 71(3): 616-626.
6. Erken R, Loukachov V, van Dort K, et al. Quantified integrated hepatitis B virus is related to viral activity in patients with chronic hepatitis B. Hepatology, 2022, 76(1): 196-206.
7. Tong S, Revill P. Overview of hepatitis B viral replication and genetic variability. J Hepatol, 2016, 64(1 Suppl): S4-S16.
8. Huang DQ, Li X, Le MH, et al. Natural history and hepatocellular carcinoma risk in untreated chronic hepatitis B patients with indeterminate phase. Clin Gastroenterol Hepatol, 2022, 20(8): 1803-1812.
9. Yao K, Liu J, Wang J, et al. Distribution and clinical characteristics of patients with chronic hepatitis B virus infection in the grey zone. J Viral Hepat, 2021, 28(7): 1025-1033.
10. Lin N, Ye A, Lin J, et al. Diagnostic value of detection of pregenomic RNA in sera of hepatitis B virus-infected patients with different clinical outcomes. J Clin Microbiol, 2020, 58(2): e01275-e01219.
11. Adraneda C, Tan YC, Yeo EJ, et al. A critique and systematic review of the clinical utility of hepatitis B core-related antigen. J Hepatol, 2023, 78(4): 731-741.
12. Carey I, Gersch J, Wang B, et al. Pregenomic HBV RNA and hepatitis B core-related antigen predict outcomes in hepatitis B e antigen-negative chronic hepatitis B patients suppressed on nucleos(T)ide analogue therapy. Hepatology, 2020, 72(1): 42-57.
13. Mak LY, Cloherty G, Wong DK, et al. HBV RNA profiles in patients with chronic hepatitis B under different disease phases and antiviral therapy. Hepatology, 2021, 73(6): 2167-2179.
14. Seto WK, Liu KS, Mak LY, et al. Role of serum HBV RNA and hepatitis B surface antigen levels in identifying Asian patients with chronic hepatitis B suitable for entecavir cessation. Gut, 2021, 70(4): 775-783.
15. Li J, Mao RC, Li XL, et al. A novel noninvasive index for the prediction of moderate to severe fibrosis in chronic hepatitis B patients. Dig Liver Dis, 2018, 50(5): 482-489.
16. Li J, Gong QM, Xie PL, et al. Prognostic value of anti-HBc quantification in hepatitis B virus related acute-on-chronic liver failure. J Gastroenterol Hepatol, 2021, 36(5): 1291-1299.
17. Kong Y, Sun Y, Zhou J, et al. Early steep decline of liver stiffness predicts histological reversal of fibrosis in chronic hepatitis B patients treated with entecavir. J Viral Hepat, 2019, 26(5): 576-585.
18. 中国肝炎防治基金会, 中华医学会感染病学分会, 中华医学会肝病学分会和中国研究型医院学会肝病专业委员会. 瞬时弹性成像技术诊断肝纤维化专家共识 (2018年更新版). 中华肝脏病杂志, 2019, 27(3): 182-191.
19. Wang H, Wen B, Chang X, et al. Baveno Ⅵ criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol, 2021, 74(3): 584-592.
20. Wang Q, Zhao H, Deng Y, et al. Validation of Baveno Ⅶ criteria for recompensation in entecavir-treated patients with hepatitis B-related decompensated cirrhosis. J Hepatol, 2022, 77(6): 1564-1572.
21. Chayanupatkul M, Omino R, Mittal S, et al. Hepatocellular carcinoma in the absence of cirrhosis in patients with chronic hepatitis B virus infection. J Hepatol, 2017, 66(2): 355-362.
22. Choi GH, Kim GA, Choi J, et al. High risk of clinical events in untreated HBeAg-negative chronic hepatitis B patients with high viral load and no significant ALT elevation. Aliment Pharmacol Ther, 2019, 50(2): 215-226.
23. Wang F, Mubarik S, Zhang Y, et al. Long-term trends of liver cancer incidence and mortality in China 1990-2017: a joinpoint and age-period-cohort analysis. Int J Environ Res Public Health, 2019, 16(16): 2878. doi: 10.3390/ijerph16162878.
24. Garrido A, Djouder N. Cirrhosis: a questioned risk factor for hepatocellular carcinoma. Trends Cancer, 2021, 7(1): 29-36.
25. Alshuwaykh O, Daugherty T, Cheung A, et al. Incidence of hepatocellular carcinoma in chronic hepatitis B virus infection in those not meeting criteria for antiviral therapy. Hepatol Commun, 2022, 6(11): 3052-3061.
26. Lee MH, Yang HI, Liu J, et al. Prediction models of long-term cirrhosis and hepatocellular carcinoma risk in chronic hepatitis B patients: risk scores integrating host and virus profiles. Hepatology, 2013, 58(2): 546-554.
27. Wu Z, Ma AL, Xie Q, et al. Significant histological changes and satisfying antiviral efficacy in chronic hepatitis B virus infection patients with normal alanine aminotransferase. Antiviral therapy decision in chronic HBV patients with normal ALT. Clin Res Hepatol Gastroenterol, 2021, 45(2): 101463.
28. Duan M, Chi X, Xiao H, et al. High-normal alanine aminotransferase is an indicator for liver histopathology in HBeAg-negative chronic hepatitis B. Hepatol Int, 2021, 15(2): 318-327.
29. Kao JH, Hu TH, Jia J, et al. East Asia expert opinion on treatment initiation for chronic hepatitis B. Aliment Pharmacol Ther, 2020, 52(10): 1540-1550.
30. Hou JL, Zhao W, Lee C, et al. Outcomes of long-term treatment of chronic HBV infection with entecavir or other agents from a randomized trial in 24 countries. Clin Gastroenterol Hepatol, 2020, 18(2): 457-467.
31. Marcellin P, Gane E, Buti M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet, 2013, 381(9865): 468-475.
32. Byun KS, Choi J, Kim JH, et al. Tenofovir alafenamide for drug-resistant hepatitis B: a randomized trial for Switching from tenofovir disoproxil fumarate. Clin Gastroenterol Hepatol, 2022, 20(2): 427-437.
33. Liu Z, Jin Q, Zhang Y, et al. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther, 2021, 54(9): 1134-1149.
34. Liu Z, Jin Q, Zhang Y, et al. 96-week treatment of tenofovir amibufenamide and tenofovir disoproxil fumarate in chronic hepatitis B patients. J Clin Transl Hepatol, 2023, 11(3): 649-660.
35. Wu D, Wang P, Han M, et al. Sequential combination therapy with interferon, interleukin-2 and therapeutic vaccine in entecavir-suppressed chronic hepatitis B patients: the Endeavor study. Hepatol Int, 2019, 13(5): 573-586.
36. Chan HLY, Chan FWS, Hui AJ, et al. Switching to peginterferon for chronic hepatitis B patients with hepatitis B e antigen seroconversion on entecavir - a prospective study. J Viral Hepat, 2019, 26(1): 126-135.
37. Hall SAL, Vogrin S, Wawryk O, et al. Discontinuation of nucleot(s)ide analogue therapy in HBeAg-negative chronic hepatitis B: a meta-analysis. Gut, 2022, 71(8): 1629-1641.
38. Fan R, Papatheodoridis G, Sun J, et al. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol, 2020, 73(6): 1368-1378.
39. Sun Y, Wu X, Zhou J, et al. Persistent low level of hepatitis B virus promotes fibrosis progression during therapy. Clin Gastroenterol Hepatol, 2020, 18(11): 2582-2591.
40. Zhang Q, Peng H, Liu X, et al. Chronic hepatitis B infection with low level viremia correlates with the progression of the liver disease. J Clin Transl Hepatol, 2021, 9(6): 850-859.
41. 韩宁, 严丽波, 唐红. 慢性乙型肝炎治疗过程中低病毒血症的临床意义和管理策略. 中华肝脏病杂志, 2021, 29(12): 1139-1143.
42. Paul S, Dickstein A, Saxena A, et al. Role of surface antibody in hepatitis B reactivation in patients with resolved infection and hematologic malignancy: a meta-analysis. Hepatology, 2017, 66(2): 379-388.
43. Lau G, Yu ML, Wong G, et al. APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy. Hepatol Int, 2021, 15(5): 1031-1048.
44. 朱世殊, 董漪, 徐志强, 等. 1~7岁慢性乙型肝炎HBeAg阳性儿童经抗病毒治疗HBsAg清除率的回顾性研究. 中华肝脏病杂志, 2016, 24(10): 738-743.
45. 朱世殊, 董漪, 张鸿飞, 等. 慢性乙型肝炎儿童免疫耐受期随机对照干扰素序贯联合拉米夫定抗病毒治疗的疗效影响因素研究. 中华肝脏病杂志, 2019, 27(8): 604-609.
46. Jonas MM, Lok AS, McMahon BJ, et al. Antiviral therapy in management of chronic hepatitis B viral infection in children: a systematic review and meta-analysis. Hepatology, 2016, 63(1): 307-318.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Interpretation of the update points on guideline for the prevention and treatment of chronic hepatitis B (2022)

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