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'an; Niu, Junqi; Hou, Jinlin"

作者地址："[Liu, Zhihong; Hou, Jinlin] Southern Med Univ, Inst Liver Dis Res Guangdong Prov, Nanfang Hosp, Dept Infect Dis & Hepatol Unit, Guangzhou, Guangdong, Peoples R China; [Jin, Qinglong; Niu, Junqi] First Hosp Jilin Univ, Changchun, Jilin, Peoples R China; [Jin, Qinglong; Niu, Junqi] First Hosp Jilin Univ, Changchun, Jilin, Peoples R China; [Gong, Guozhong] Cent South Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China; [Wu, Guicheng] Chongqing Univ, Gorges Hosp 3, Chongqing, Peoples R China; [Yao, Lvfeng] Fujian Med Univ, Mengchao Hepatobil 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'an] Jiangsu Hansoh Pharmaceut Grp Co Ltd, Lianyungang, Jiangsu, Peoples R China"

通信作者："Hou, JL (通讯作者)，Southern Med Univ, Inst Liver Dis Res Guangdong Prov, Nanfang Hosp, Dept Infect Dis & Hepatol Unit, 1838 North Guangzhou Ave, Guangzhou 510515, Guangdong, Peoples R China.; Niu, JQ (通讯作者)，First Hosp Jilin Univ, Dept Hepatobil & 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:001047508100016

JCR分区：Q2

影响因子：3.1

年份：2023

卷号：11

期号：3

开始页：649

结束页：660

文献类型：Article

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

摘要："Background and Aims: Tenofovir amibufenamide (TMF) is a novel phosphoramidated prodrug of tenofovir with noninferior 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 either 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 parameters. Results: Virological suppression rates at week 96 were similar between TMF and TDF group in both HBeAg-positive and HBeAg-negative populations. Noninferior efficacy 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 receiving 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 efficacy at week 96 compared with TDF with continued superior bone and renal safety profiles (NCT03903796)."

基金机构："Hansoh Pharmaceuticals Co., Ltd."

基金资助正文："This study was funded by Hansoh Pharmaceuticals Co., Ltd."