دورية أكاديمية
Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial
| العنوان: | Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial |
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| المؤلفون: | Hou, J. L., Gao, Z. L., Xie, Q., Zhang, J. M., Sheng, J. F., Cheng, J., Chen, C. W., Mao, Q., Zhao, W., Ren, H., Tan, D. M., Niu, J. Q., Chen, S. J., Pan, C., Tang, H., Wang, H., Mao, Y. M., Jia, J. D., Ning, Q., Xu, M., Wu, S. M., Li, J., Zhang, X. X., Ji, Y., Dong, J. |
| المساهمون: | Hou, JL (reprint author), Southern Med Univ, Nanfang Hosp, Dept Infect Dis, Guangzhou 510515, Guangdong, Peoples R China., Nanfang Hosp, Dept Infect Dis, Guangzhou, Guangdong, Peoples R China., Nanfang Hosp, Hepatol Unit, Guangzhou, Guangdong, Peoples R China., Sun Yat Sen Univ, Affiliated Hosp 3, Dept Infect Dis, Guangzhou 510275, Guangdong, Peoples R China., Ruijin Hosp, Dept Infect Dis, Shanghai, Peoples R China., Huashan Hosp, Dept Infect Dis, Shanghai, Peoples R China., Zhejiang Univ, Coll Med, Affiliated Hosp 1, Dept Infect Dis, Hangzhou 310003, Zhejiang, Peoples R China., Capital Med Univ, Beijing Ditan Hosp, Ctr Liver Dis, Beijing, Peoples R China., Nanjing Mil, Hosp 85, Liver Dis Res Ctr, Shanghai, Peoples R China., Southwest Hosp, Dept Infect Dis, Chongqing, Peoples R China., Second Hosp Nanjing, Dept Liver Dis, Nanjing, Jiangsu, Peoples R China., Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China., Cent S Univ, Xiangya Hosp, Dept Infect Dis, Changsha, Hunan, Peoples R China., Jilin Univ, Affiliated Hosp 1, Dept Hepatol, Changchun 130023, Peoples R China., Jinan Hosp Infect Dis, Dept Liver Dis, Jinan, Peoples R China., Fuzhou Infect Dis Hosp, Dept Hepatol, Fuzhou, Peoples R China., Sichuan Univ, West China Hosp, Ctr Infect Dis, Chengdu 610064, Peoples R China., Peking Univ, Peoples Hosp, Inst Hepatol, Beijing 100871, Peoples R China., Renji Hosp, Dept Gastroenterol, Shanghai, Peoples R China., Capital Med Univ, Beijing Friendship Hosp, Liver Res Ctr, Beijing, Peoples R China., Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Infect Dis, Wuhan 430074, Peoples R China., Guangzhou 8th Peoples Hosp, Dept Liver Dis, Guangzhou, Guangdong, Peoples R China., Shanghai Publ Hlth Clin Ctr, Dept Liver Dis, Shanghai, Peoples R China., Nanjing Med Univ, Affiliated Hosp 1, Dept Infect Dis, Nanjing, Jiangsu, Peoples R China., Zhongshan Hosp, Shanghai, Peoples R China., GlaxoSmithKline R&D China, China Med Dev, Shanghai, Peoples R China., Southern Med Univ, Nanfang Hosp, Dept Infect Dis, Guangzhou 510515, Guangdong, Peoples R China. |
| المصدر: | SCI |
| بيانات النشر: | 病毒性肝炎杂志 |
| سنة النشر: | 2015 |
| المجموعة: | Peking University Institutional Repository (PKU IR) / 北京大学机构知识库 |
| مصطلحات موضوعية: | antiviral therapy, chronic hepatitis B, efficacy, tenofovir disoproxil fumarate, VIRUS, LAMIVUDINE, SUSCEPTIBILITY, RESISTANCE, MUTATIONS, INFECTION, CIRRHOSIS, THERAPY, RISK |
| الوصف: | 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. ; http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000350545800002&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=8e1609b174ce4e31116a60747a720701Test ; Gastroenterology & Hepatology ; Infectious Diseases ; Virology ; SCI(E) ; 0 ; ARTICLE ; jlhousmu@163.com ; 2 ; 85-93 ; 22 |
| نوع الوثيقة: | journal/newspaper |
| اللغة: | English |
| تدمد: | 1352-0504 1365-2893 |
| العلاقة: | JOURNAL OF VIRAL HEPATITIS.2015,22,(2),85-93.; 750565; http://hdl.handle.net/20.500.11897/206395Test; WOS:000350545800002 |
| DOI: | 10.1111/jvh.12313 |
| الإتاحة: | https://doi.org/20.500.11897/206395Test https://doi.org/10.1111/jvh.12313Test https://hdl.handle.net/20.500.11897/206395Test |
| رقم الانضمام: | edsbas.BCAD0DB5 |
| قاعدة البيانات: | BASE |
| تدمد: | 13520504 13652893 |
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| DOI: | 10.1111/jvh.12313 |