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Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial 期刊论文

编号：

11081929-92a6-4484-b5f9-f5b6fa2353ba
作者：

Hou, J. L.^[1,2] Gao, Z. L.^[3] Xie, Q.^[4] Zhang, J. M.^[5] Sheng, J. F.^[6] Cheng, J.^[7] Chen, C. W.^[8] Mao, Q.^[9] Zhao, W.^[10] Ren, H.^[11] Tan, D. M.^[12] Niu, J. Q.^[13] Chen, S. J.^[14] Pan, C.^[15] Tang, H.^[16] Wang, H.^[17] Mao, Y. M.^[18] Jia, J. D.^[19] Ning, Q.^[20] Xu, M.^[21] Wu, S. M.^[22] Li, J.^[23,25] Zhang, X. X.^[4] Ji, Y.^[24] Dong, J.^[25] Li, J.^[23,25]
语种：

English
期刊：

JOURNAL OF VIRAL HEPATITIS ISSN：1352-0504 2015 年 22 卷 2 期 (85 - 93) ; FEB
收录：
关键词：

antiviral therapy chronic hepatitis B efficacy tenofovir disoproxil fumarate
摘要：

Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China. This study aimed to evaluate the efficacy and safety of TDF compared with adefovir dipivoxil (ADV) in Chinese patients with CHB during 48 weeks of treatment (ClinicalTrial.gov number, NCT01300234). A Phase 3, multicentred, randomized, double-blind, controlled trial compared the efficacy and safety of TDF with ADV in Chinese patients with CHB. The primary endpoint was the proportion of patients with HBV DNA <400 copies/mL in each treatment group at Week 48, using an unpooled Z-test for superiority. Secondary endpoints included viral suppression, serologic response, histological improvement, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations. A total of 509 patients, 202 hepatitis B e antigen (HBeAg)-positive and 307 HBeAg-negative, with HBV DNA >= 10(5) copies/mL received either TDF 300 mg od or ADV 10 mg od. At Week 48, TDF demonstrated superior viral suppression compared with ADV in both HBeAg-positive (76.7% vs 18.2%, P < 0.0001) and HBeAg-negative (96.8% vs 71.2%, P < 0.0001) patients. The majority of patients in both treatment arms achieved ALT normalization (>85%). No resistance to TDF was observed. The frequency of adverse events was comparable between treatment arms (TDF 3.9% vs ADV 4.8%). In this double-blind, randomized, clinical trial, TDF demonstrated superiority over ADV with respect to viral suppression in Chinese patients with CHB at 48 weeks of treatment and without the development of resistance.
推荐引用方式
GB/T 7714：

Hou J. L.,Gao Z. L.,Xie Q., et al. Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial [J].JOURNAL OF VIRAL HEPATITIS,2015,22(2):85-93.
APA：

Hou J. L.,Gao Z. L.,Xie Q.,Zhang J. M.,&Li J..(2015).Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial .JOURNAL OF VIRAL HEPATITIS,22(2):85-93.
MLA：

Hou J. L., et al. "Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial" .JOURNAL OF VIRAL HEPATITIS 22,2(2015):85-93.

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