课件：替诺福韦进入中国早知道V.ppt

总结 TDF是一种抗HBV活性好、耐药屏障高的核苷(酸)类药物 TDF对于各种CHB患者均有良好的疗效 TDF治疗HBeAg阳性和阴性患者抑制病毒的能力均优于ADV TDF单药或与其他核苷(酸)类药物联合用药对明确的LAM、ADV及ETV等单药、多药应答不佳及耐药者均有效 TDF治疗肝硬化患者亦安全、有效 TDF为妊娠期用药风险分级B级药物 TDF在中国的HIV自费市场已经上市，HBV III期注册临床进展顺利，它将给中国的患者带来新的治疗选择 EndThank You 慢乙肝交叉耐药环境中抗病毒药物耐药类型和途径 * 缩写: I 中度敏感; R 抵抗; S,敏感.以细胞培养和临床应答为基础。 改于 Zoulin Locamini. 2009. Gastroenterol; 127:1593 AND Zoulim Locamini. 2012 J Hepatol(in press) 路径 RT区 氨基酸替代 拉米夫定 替比夫定 恩替卡韦 阿德福韦 替诺福韦 野生株 S S S S S 左旋核酸 (拉米夫定/替比夫定） M204I/V R R I S S 无环磷酸酯 (阿德福韦) N236T S S S R I 共享 (拉米夫定，替比夫定，阿德福韦） A181T/V I/R R S R I 双重 （阿德福韦，替诺福韦） A181T/V +236T R R S R R 环戊烷 (恩替卡韦） L180M+M204V/I ±I168± T184±S202 ±M250 R R R S S * Combined Clinical Summary –Year 6(102; HBeAg- and 103; HBeAg+) Virologic Intention to treat analysis (LTE-TDF): 102 - HBV DNA 400 copies/mL : 81 % (281/345) 103 - HBV DNA 400 copies/mL : 62 % (157/251) On-treatment analysis: 102 - HBV DNA 400 copies/mL : 99.6% (283/284) 103 - HBV DNA 400 copies/mL : 99 % (167/169) Safety Overview 80% of patients entering open label phase remained on the study through year 6 2% of patients discontinued TDF for an AE 7 drug-related SAEs (including 1-mild renal failure [Scr 1.4], 2-osteoporosis, 1-ALT increase) Renal events were uncommon (≤1.5%) No treatment-emergent fractures considered to be related to study drug Serologic HBsAg loss 11% (n=24; Study 103 [KM%]) HBsAg seroconversion 8% (n=18; Study 103 [KM%]) 1 patient had confirmed HBsAg loss/seroconversion at year 5 in Study 102 HBeAg loss 50% (82/163) [on-treatment] HBeAg seroconversion 37% (61/163) [on-treatment] Histology (5 years) Histologic response 87% (304/348) showed histologic improvement Stable fibrosis or regression of fibrosis 96% (335/348) of patient improved or no change Reversal of Cirrhosis (Ishak 5 after cirrhosis at baseline) 74% (71/96) *See following slides for more details Conclusions: TDF demonstrates potent efficacy and a favorable safety profile in treatment-na?ve HBeAg-positive and HBeAg-negativ