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1、HBV Treatment: What to Start? HBV感染的首选治疗？,This program is supported by educational grants from,何生松 教授,About These Slides,The full program accompanying these slides is available on the Clinical Care Options Hepatitis Web site: Users are encouraged to use these slides in their own noncommercial prese
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4、 been approved by the United States Food and Drug Administration. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or using any therapies described in these materials.,内容,HB
5、V治疗目标 已批准的HBV治疗药物 病人资格 初始治疗: Interferon Based vs Nucleos(t)ide 核苷类似物的选择 干扰素疗法的选择 其他,HBV 治疗目标、病人评价和资格审查,HBV治疗目标,HBV 感染不能被完全清除和“治愈” HBV临床治疗目标 预防并逆转并发症，预防肝脏疾病进展导致的死亡 HBeAg-阳性 and HBeAg-阴性 病人 持续抑制病毒复制使HBV DNA 10-15 IU/mL 生化缓解，防止进一步肝损伤,HBV 的治疗目标,HBeAg-阳性 病人 (cont) HBeAg 消失或血清转换是一个次级治疗目标 伴随临床结局的长期改善 在HBeA
6、g-阳性 和 HBeAg-阴性 病人 HBsAg 消失和血清转换是治疗的终极目标 病毒持久抑制的最好预测指标 最好临床结局的最强指标, 肝硬化肝癌的风险最低 大多数病人都不能达到,Interferon alfa-2b,Lamivudine,Adefovir,Peginterferon alfa-2a,Telbivudine,Tenofovir,1990,1998,2002,2005,2006,2008,Entecavir,获批准的HBV治疗,HBeAg-阳性病人的初始治疗建议,1. Lok A, et al. Hepatology. 2007;45:507-539. 2. Keeffe EB,
7、 et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. 3. EASL HBV Guidelines. J Hepatology. 2009;50:227-242.,*Persistent ( 3-6 mos). TDF not FDA approved at time of publication.,HBV DNA, ALT 和组织学必须全部满足条件 否则, 建议观察，根据患者年龄、健康状况和疾病的阶段给于适当的治疗,HBeAg-阴性 病人的初始治疗建议,*Persistent ( 3-6 mos). TDF not FDA approve
8、d at time of publication. Consider liver biopsy if 2000 IU/mL and treat if moderate/severe inflammation and/or fibrosis found.,HBV DNA, ALT 和组织学必须全部满足条件 否则, 建议观察，根据患者年龄、健康状况和疾病的阶段给于适当的治疗,1. Lok A, et al. Hepatology. 2007;45:507-539. 2. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341.
9、3. EASL HBV Guidelines. Journal of Hepatology. 2009;50:227-242.,特殊人群乙肝的治疗,不考虑HBV DNA and ALT水平 肝功能迅速恶化的病人 代偿性肝硬化 DNA 2,000 IU/mL, 不考虑 ALT水平 失代偿性肝硬化 (如果没有禁忌) 移植后再感染 HBV 携带者接受免疫抑制剂或细胞毒药物,Lok A, et al. Hepatology. 2007;45:507-539. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. EASL HBV
10、 Guidelines. Journal of Hepatology. 2009;50:227242. Sorrell MF, et al. Ann Intern Med. 2009;150:104-110.,HBV治疗反应受 HBeAg 状态影响,*血清转换后.,一线治疗的选择 核苷（酸）类似物 vs. 干扰素,*Prolonged treatment not feasible. Newer vs older nucles(t)ides.,一线核苷（酸）类似物的选择,以下情形选择核苷（酸）类似物 作为初始治疗,好的应答预期 高ALT 低HBV DNA (基线和治疗中) 特殊病人的人口学因素
11、老年患者 患者的偏好 HIV和并感染 没有HCV共感染,效能 (潜能),耐药屏障 (持久性),选择初始核苷的决定因素,安全性,抗病毒活性 (潜能),*治疗一年 HBV DNA 检测不出率,*By PCR-based assay (LLD 50 IU/mL) except for some LAM studies.,Lok A, et al. Hepatology. 2007;45:507-539. EASL HBV Guidelines. Journal of Hepatology. 2009;50:227-242.,Not head-to-head trials; different pat
12、ient populations and trial designs,HBeAg Positive,HBeAg Negative,Undetectable* HBV DNA (%),100,80,60,40,20,0,LAM,ADV,ETV,LdT,TDF,40-44,13-21,67,60,76,60-73,51-63,90,88,91,100,80,60,40,20,0,LAM,ADV,ETV,LdT,TDF,HBeAg阳性病人治疗一年 HBeAg 阴转和血清转换率,HBeAg Loss/Seroconversion (%),Lau GK, et al. N Engl J Med. 200
13、5;352:2682-2695. Marcellin P, et al. N Engl J Med. 2003;348:808-816 Chang TT, et al. N Engl J Med. 2006;354:1001-1010. Lai CL, et al. N Engl J Med. 2007;357:2576-2588. Marcellin P, et al. N Engl J Med. 2008;359:2442-2455.,Not head-to-head trials; different patient populations and trial designs,HBeAg
14、 转阴,HBeAg 转换,100,80,60,40,20,0,LAM,ADV,ETV,LdT,TDF,32,24,22,26,22,12-18,21,23,21,100,80,60,40,20,0,LAM,ADV,ETV,LdT,TDF,NR,Years of Therapy,Patients (%),HBeAg阳性病人长期治疗 HBeAg 阴转和血清转换率 *,*With sustained undetectable HBV DNA.,Chang TT, et al. N Engl J Med. 2006;354:1001-1010. Lai CL, et al. N Engl J Med.
15、 2007;357:2576-2588. Marcellin P, et al. N Engl J Med. 2003;348:808-816. Marcellin P, et al. N Engl J Med. 2008;359:2442-2455. Lok AS, et al. Gastroenterology. 2003;125:1714-1722. Leung NW, et al. Hepatology. 2001;33:1527-1532. Dienstag JL, et al. Hepatology. 2003;37:748-755. Marcellin P, et al. Hep
16、atology. 2008;48:750-758. Liaw YF, et al. Gastroenterology. 2009;136:486-495. Gane E, et al. AASLD 2008. Abstract 729. Heathcote E, et al. AASLD 2008. Abstract 158.,Not head-to-head trials; different patient populations and trial designs,100,80,60,40,20,0,1,2,3,4,5,22,12,21,23,21,29,31,29,27,40,37,47,50,48,LAM,ADV,ETV,LdT,TDF,HBeAg阳性病人长期治疗 HBs
