96-Week Treatment of Tenofovir Amibufenamide and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients

作者全名："Liu, Zhihong; Jin, Qinglong; Zhang, Yuexin; Gong, Guozhong; Wu, Guicheng; Yao, Lvfeng; Wen, Xiaofeng; Gao, Zhiliang; Huang, Yan; Yang, Daokun; Chen, Enqiang; Mao, Qing; Lin, Shide; Shang, Jia; Gong, Huanyu; Zhong, Lihua; Yin, Huafa; Wang, Fengmei; Hu, Peng; Wu, Qiong; Pan, Chao; Jia, Wen; Li, Chuan; Sun, Chang'a; Niu, Junqi; Hou, Jinlin; TMF Study Grp, T. M. F. Study Group"

作者地址："[Liu, Zhihong; Hou, Jinlin] Southern Med Univ, Nan fang Hosp, Inst Liver Dis Res Guangdong Prov, Dept Infect Dis & Hepat Unit, Guangzhou, Guangdong, Peoples R China; [Jin, Qinglong; Niu, Junqi] First Hosp Jilin Univ, Jilin, Peoples R China; [Zhang, Yuexin] Xinjiang Med Univ, Affiliated Hosp 1, Urumqi, Xinjiang, Peoples R China; [Gong, Guozhong] Cent South Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China; [Wu, Guicheng] Chongqing Univ, Three Gorges Hosp, Chongqing, Peoples R China; [Yao, Lvfeng] Fujian Med Univ, Mengchao Hepatobiliary Hosp, Fuzhou, Fujian, Peoples R China; [Wen, Xiaofeng] Liuzhou Peoples Hosp, Liuzhou, Guangxi, Peoples R China; [Gao, Zhiliang] Zhongshan Univ, Affiliated Hosp 3, Guangzhou, Guangdong, Peoples R China; [Huang, Yan] Cent South Univ, Xiangya Hosp, Changsha, Hunan, Peoples R China; [Yang, Daokun] Xinxiang Med Univ, Affiliated Hosp 1, Xinxiang, Henan, Peoples R China; [Chen, Enqiang] Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China; [Mao, Qing] Southwest Hosp AMU, Chongqing, Peoples R China; [Lin, Shide] Zunyi Med Univ, Affiliated Hosp, Zunyi, Guizhou, Peoples R China; [Shang, Jia] Henan Prov Peoples Hosp, Zhengzhou, Henan, Peoples R China; [Gong, Huanyu] Cent South Univ, Xiangya Hosp 3, Changsha, Hunan, Peoples R China; [Zhong, Lihua] Harbin Med Univ, Affiliated Hosp 4, Harbin, Heilongjiang, Peoples R China; [Yin, Huafa] Anhui Med Univ, Affiliated Hosp 1, Hefei, Anhui, Peoples R China; [Wang, Fengmei] Tianjin Third Cent Hosp, Tianjin, Peoples R China; [Hu, Peng] Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China; [Wu, Qiong; Pan, Chao; Jia, Wen; Li, Chuan; Sun, Chang'a] Jiangsu Hansoh Pharmaceut Grp Co Ltd, Lianyungang, Jiangsu, Peoples R China; [Hou, Jinlin] Southern Med Univ, Nanfang Hosp, Inst Liver Dis Res Guangdong Prov, Dept Infect Dis & Hepatol Unit, 1838 North Guangzhou Ave, Guangzhou 510515, Guangdong, Peoples R China; [Niu, Junqi] First Hospital Jilin Univ, Dept Hepatobiliary & Pancreatol, 71 Xinmin St, Changchun 130021, Jilin, Peoples R China"

通信作者："Hou, JL (通讯作者)，Southern Med Univ, Nanfang Hosp, Inst Liver Dis Res Guangdong Prov, Dept Infect Dis & Hepatol Unit, 1838 North Guangzhou Ave, Guangzhou 510515, Guangdong, Peoples R China.; Niu, JQ (通讯作者)，First Hospital Jilin Univ, Dept Hepatobiliary & Pancreatol, 71 Xinmin St, Changchun 130021, Jilin, Peoples R China."

来源：JOURNAL OF CLINICAL AND TRANSLATIONAL HEPATOLOGY

ESI学科分类：　

WOS号：WOS:000885457800001

JCR分区：Q2

影响因子：3.6

年份：2022

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Hepatitis B; Liver function tests; Viral hepatitis; Liver; Osteoporosis

摘要："Background and Aims: a novel phosphoramidated prodrug of tenofovir with nonin-ferior efficacy and better bone and renal safety to tenofovir disoproxil fumarate (TDF) in 48 weeks of treatment. Here, we update 96-week comparison results. Methods: Patients with chronic hepatitis B were assigned (2:1) to receive ei-ther 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks. The virological suppression was defined as HBV DNA levels <20 IU/mL at week 96. Safety was evaluated thoroughly with focusing on bone, renal, and metabolic pa-rameters. Results: Virological suppression rates at week 96 Tenofovir amibufenamide (TMF) is were similar between TMF and TDF group in both HBeAg-positive and HBeAg-negative populations. Noninferior effi-cacy was maintained in the pooled population, while it was first achieved in patients with HBV DNA >= 7 or 8 log10 IU/mL at baseline. Non-indexed estimated glomerular filtration rate for renal safety assessment was adopted, while a smaller decline of which was seen in the TMF group than in the TDF group (p=0.01). For bone mineral density, patients receiv-ing TMF displayed significantly lower reduction levels in the densities of spine, hip, and femur neck at week 96 than those receiving TDF. In addition, the lipid parameters were stable after week 48 in all groups while weight change still showed the opposite trend. Conclusions: TMF maintained similar ef-ficacy at week 96 compared with TDF with continued superior bone and renal safety profiles (NCT03903796)."

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