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B 型肝炎治療新知

B 型肝炎治療新知. 台大醫院內科部 陳健弘. B 型肝炎的 流行病學. 台灣成人每五人中 ， 就有一人是 B 型肝炎帶原者 ， 全國約有 300 萬 (20%) B 型肝炎帶原者. 每 5 人就有 1 人有 B 型肝炎. 20 years after mass HBV vaccination. Year 2004 17,637 healthy individuals (M/F, 9785:7852), <20 y/o 1142 individuals (M/F, 693:449) aged between 20 and 30 years

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B 型肝炎治療新知

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  1. B型肝炎治療新知 台大醫院內科部 陳健弘

  2. B型肝炎的 流行病學

  3. 台灣成人每五人中，就有一人是B型肝炎帶原者，全國約有300萬(20%) B型肝炎帶原者 每5人就有1人有B型肝炎

  4. 20 years after mass HBV vaccination

  5. Year 2004 • 17,637 healthy individuals (M/F, 9785:7852), <20 y/o • 1142 individuals (M/F, 693:449) aged between 20 and 30 years • from schools, institutes, or workplaces in Taipei City, HBsAg(+): 1.2%

  6. HBV vaccination reduce HCC incidence

  7. P<0.001

  8. Natural course of CHB

  9. Natural course of CHB Liaw YF and Chu CM. Lancet 2009; 373: 582–92

  10. HBV DNA • IU/mL • copies/mL • pg/mL

  11. REVEAL-HBV Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer– Hepatitis B Virus

  12. HBV DNA as a risk for cirrhosis

  13. HBV DNA Associated With Increased Risk of Liver cirrhosis REVEAL: Long-term follow-up of untreated HBsAg positive individuals in Taiwan Cumulative Incidence of cirrhosis at Year 13 Follow-up[1] (N = 3582) 50 40 36.2 30 Patients (%) 23.5 20 9.8 10 5.9 4.5 0 ≥ 1 million < 300 100,000- 999,999 300- 9999 10,000- 99,999 Baseline HBV DNA (copies/mL) ILOEJE UH et al., GASTROENTEROLOGY 2006;130:678–686

  14. HBV DNA as a risk for HCC

  15. HBV DNA Associated With Increased Risk of HCC REVEAL: Long-term follow-up of untreated HBsAg positive individuals in Taiwan Cumulative Incidence of HCC at Year 13 Follow-up[1] (N = 3653) 14.9 15 12.2 12 Median age: 45 HBeAg(-): 85% ALT<45:94% 9 Patients (%) 6 3.6 3 1.3 1.4 0 300- 999 1000- 9999 10,000- 99,999 < 300 ≥ 100,000 Baseline HBV DNA (copies/mL) Chen CJ et al., JAMA. 2006;295:65-73

  16. Risks of HCC in HBV carriers

  17. Risk factors associated with HCC in HBV carriers • Male • Increasing age • High ALT level • Alcohol consumption • HBeAg (+) • High HBV DNA • Genotype C • Presence of cirrhosis • ….

  18. AUC: 0.851 AUC: 0.852 Yang HI et al., J Clin Oncol 2010;28:2437-2444

  19. Initial evaluation

  20. 當病人說他有B肝時，必須釐清是否是HBsAg(+)，如果無書面資料，建議check HBsAg來證實

  21. HBsAg HBeAg AST, ALT, AFP Ultrasound

  22. 慢性B型肝炎 • e抗原陽性慢性B型肝炎 • e抗原陰性慢性B型肝炎

  23. B肝病人， 誰需要治療？

  24. 案例 21歲男性 HBsAg(+)，ALT: 24 U/L，HBeAg(-) HBV DNA: 100 IU/mL， 上網找到資料，B肝帶原者日後得到肝癌的機會較大。 問題︰要不要治療以便終止帶原狀態？

  25. Inactive HBsAg carrier 25. In patients with inactive HBsAg carrier state antiviral treatment is not indicated, but these patients should be monitored (see Recommendation 12). (II-2)

  26. 案例 21歲男性， HBsAg(+)，ALT: 60 U/L， HBeAg(+) HBV DNA: 3x109 IU/mL，上網找到資料，HBV DNA愈高則日後得到肝癌的機會愈大。 問題︰要不要治療？

  27. HBeAg(+) CH-B 15b. ALT persistently normal or <2 X ULN. These patients generally should not be initiated on treatment. (I) • Liver biopsy may be considered in patients with fluctuating or minimally elevated ALT levels especially in those above 40 years of age. (II-3) • Treatment may be initiated if there is moderate or severe necroinflammation or significant fibrosis on liver biopsy. (I)

  28. 案例 25歲男性 HBsAg(+) ALT: 150 U/L HBeAg(+) HBV DNA: 3x109 IU/mL 問題︰要不要治療？

  29. HBeAg(+) CH-B 15a. ALT ≧ 2 x ULN or moderate/severe hepatitis on biopsy, and HBV DNA >20,000 IU/ml. These patients should be considered for treatment. (I)

  30. 案例 40歲男性 HBsAg(+) ALT: 150 U/L HBeAg(-) HBV DNA: 7x106 IU/mL 問題︰要不要治療？

  31. HBeAg(-) CH-B 16. Patients with HBeAg(-) chronic hepatitis B (serum HBV DNA >20,000 IU/ml and elevated ALT>2 x ULN) should be considered for treatment.(I) APASL: HBV DNA > 2000 IU/mL

  32. 案例 45歲男性 HBsAg(+) ALT: 50 U/L HBeAg(-) HBV DNA: 3x103 IU/mL 超音波: liver cirrhosis + splenomegaly 問題︰要不要治療？

  33. Compensated liver cirrhosis 23. Patients with compensated cirrhosis — Treatment should be considered for patients with ALT >2 UNL, and for patients with normal or minimally elevated ALT if serum HBV DNA levels are high (>2,000 IU/ml). (II-2) • Patients with compensated cirrhosis are best treated with NAs because of the risk of hepatic decompensation associated with IFNa–related flares of hepatitis. In view of the need for long-term therapy, tenofovir or entecavir is preferred. (II-3) 建議轉給 hepatologist

  34. 案例 45歲男性 HBsAg(+) ALT: 50 U/L, Bilirubin: 5 mg/dL HBeAg(-) HBV DNA: 3x103 IU/mL 超音波: liver cirrhosis + splenomegaly + massive ascites 問題︰要不要治療？

  35. Decompensated liver cirrhosis 24. Patients with decompensated cirrhosis - Treatment should be promptly initiated with a NA that can produce rapid viral suppression with low risk of drug resistance. (II-1) 盡快轉給 hepatologist

  36. 治療B型肝炎的藥物 • 傳統型干擾素 • 長效型干擾素 • 干安能 (lamivudine, Zeffix) • 干適能 (adefovir, Hepsera) • 貝樂克 (entecavir, Baraclude) • 喜必福 (telbivudine, Sebivo) • tenofovir

  37. 要治療多久

  38. 案例 25歲男性 HBsAg(+), ALT: 150 U/L, HBeAg(+), HBV DNA: 3x109 IU/mL 使用抗病毒藥治療1年後 ALT: 30 U/L, HBeAg(+) HBV DNA: 測不到 問題︰可不可以停藥？

  39. Duration of nucleoside analogue treatment- HBeAg(+) 32a. HBeAg(+) chronic hepatitis B — Treatment should be continued until the patient has achieved HBeAg seroconversion and completed at least 6 months of additional treatment after appearance of anti-HBe. (I) • Close monitoring for relapse is needed after withdrawal of treatment. (I)

  40. 案例 40歲男性 HBsAg(+), ALT: 150 U/L, HBeAg(-) HBV DNA: 7x106 IU/mL 使用抗病毒藥治療1年後 ALT: 30 U/L, HBV DNA: 300 IU/mL 治療2年後 ALT: 30 U/L, HBV DNA: 測不到 問題︰可不可以停藥？

  41. Duration of nucleoside analogue treatment- HBeAg(-) 32b. HBeAg(-) chronic hepatitis B — Treatment should be continued until the patient has achieved HBsAg clearance. (I) 在亞太地區，做不到

  42. Recommendation 9 (II) For oral antiviral agents: In HBeAg-negative patients, it is not clear how long this treatment should be continued, but treatment discontinuation can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart. (II). 2008 APASL consensus statement

  43. 案例 45歲男性 HBsAg(+), ALT: 50 U/L, HBeAg(-) HBV DNA: 3x103 IU/mL 超音波: liver cirrhosis + splenomegaly 使用抗病毒藥治療1年後 ALT: 30 U/L, HBV DNA: 測不到 治療3年後 ALT: 32 U/L, HBV DNA: 測不到 問題︰需要繼續用藥嗎？健保給付嗎？

  44. Duration of nucleoside analogue treatment- Compensated cirrhosis 32c. Compensated cirrhosis — These patients should receive long-term treatment. However, treatment may be stopped in HBeAg(+) patients if they have confirmed HBeAg seroconversion and have completed at least 6 months of consolidation therapy and in HBeAg(-) patients if they have confirmed HBsAg clearance. (II-3) • Close monitoring for viral relapse and hepatitis flare is mandatory if treatment is stopped. (II-3)

  45. Duration of nucleoside analogue treatment- Decompensated cirrhosis 32d. Decompensated cirrhosis and recurrent hepatitis B post-liver transplantation - Life-long treatment is recommended. (II-3)

  46. 特殊族群

  47. 案例 45歲男性 HBsAg(+), ALT: 20 U/L, HBeAg(-) HBV DNA:測不到 惡性淋巴瘤，準備做化學治療 問題︰要不要治療？

  48. Treatment of Hepatitis B carriers Who Require Immunosuppressive or Cytotoxic Therapy 39. HBsAg testing should be performed in patients who are at high risk of HBV infection (see recommendation number 1), prior to initiation of chemotherapy or immunosuppressive therapy. (II-3)

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