Ge Ying, Li Deming, Fan Yunming, Yang Haihong, Lyu Wei, Fan Hongwei, Zhou Baotong, Liu Xiaoqing, Liu Zhengyin
Department of Internal Medicine, Common Hospital Centre S.Januario, Macau, China. Email:
Department of Infectious Disease, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China. Email:
Zhonghua Nei Ke Za Zhi. 2014 Sep;53(9):697-700.
To evaluate the efficacy of tenofovir (TDF) 300 mg/d, comparing with entecavir (ETV), in adults with chronic HBV infection who had previously virologic failure with lamivudine(LAM) and failed with rescue treatment of LAM combined adefovir(ADV).
Fifty-seven patients of chronic hepatitis B on rescue treatment with TDF were analyzed retrospectively. The serum HBV DNA levels, HBeAg, ALT and serum creatinine (Cr) were detected after treatment for 12, 24 and 48 weeks respectively. In addition, data of 40 cases treated with ETV 1 mg per day as a control group were also collected.
The baseline characteristics including HBV viral loads, median age, serum levels of ALT and Cr were compatible between TDF group and ETV group. At the time point of 24 weeks, there was only one patient (2.5%) in ETV group with HBV DNA<100 IU/ml, which means negative viral replication, while 49 patients in TDF group reached HBV negativity (86.0% vs 2.5%, χ(2) = 22.26, P < 0.001). At the time point of 48 weeks, the proportion of patients with HBV DNA<100 IU/ml in TDF group was significantly higher than that in ETV group (87.7% vs 12.5%,χ(2) = 24.17, P < 0.001). The ratios of ALT normalization (84.2% vs 77.5%, P = 0.431) and HBeAg seroconversion were similar in both groups. Elevated Cr was not found in both cohorts at the end of treatment.
Tenofovir (300 mg/d) is an effective and safe rescue therapy in chronic hepatitis B patients who failed initial treatment with LAM and secondary treatment of LAM plus ADV.
评估300mg/d替诺福韦(TDF)与恩替卡韦(ETV)相比,对既往拉米夫定(LAM)治疗病毒学失败且拉米夫定联合阿德福韦(ADV)挽救治疗失败的慢性HBV感染成人患者的疗效。
回顾性分析57例接受TDF挽救治疗的慢性乙型肝炎患者。分别在治疗12、24和48周后检测血清HBV DNA水平、HBeAg、ALT和血清肌酐(Cr)。此外,还收集了40例每天服用1mg ETV作为对照组的数据。
TDF组和ETV组的基线特征包括HBV病毒载量、中位年龄、ALT和Cr血清水平具有可比性。在24周时,ETV组仅有1例患者(2.5%)HBV DNA<100IU/ml,即病毒复制阴性,而TDF组有49例患者达到HBV阴性(86.0%对2.5%,χ²=22.26,P<0.001)。在48周时,TDF组HBV DNA<100IU/ml的患者比例显著高于ETV组(87.7%对12.5%,χ²=24.17,P<0.001)。两组的ALT正常化率(84.2%对77.5%,P=0.431)和HBeAg血清学转换率相似。治疗结束时两组均未发现Cr升高。
替诺福韦(300mg/d)对初始LAM治疗及LAM加ADV二线治疗失败的慢性乙型肝炎患者是一种有效且安全的挽救治疗方法。