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

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

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.

Afiliação

Liu Z; Department of Infectious Diseases and Hepatology Unit, Institutes of Liver Diseases Research of Guangdong Province, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Jin Q; The First Hospital of Jilin University, Changchun, Jilin, China.
Zhang Y; The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.
Gong G; The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Wu G; Chongqing University Three Gorges Hospital, Chongqing, China.
Yao L; Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, China.
Wen X; Liuzhou People's Hospital, Liuzhou, Guangxi, China.
Gao Z; The Third Affiliated Hospital of Zhongshan University, Guangzhou, Guangdong, China.
Huang Y; Xiangya Hospital of Central South University, Changsha, Hunan, China.
Yang D; The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China.
Chen E; West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Mao Q; The Southwest Hospital of AMU, Chongqing, China.
Lin S; Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
Shang J; Henan Provincial People's Hospital, Zhengzhou, Henan, China.
Gong H; The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
Zhong L; The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Yin H; The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Wang F; Tianjin Third Central Hospital, Tianjin, China.
Hu P; The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Wu Q; Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Lianyungang, Jiangsu, China.
Pan C; Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Lianyungang, Jiangsu, China.
Jia W; Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Lianyungang, Jiangsu, China.
Li C; Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Lianyungang, Jiangsu, China.
Sun C; Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Lianyungang, Jiangsu, China.
Niu J; The First Hospital of Jilin University, Changchun, Jilin, China.
Hou J; Department of Infectious Diseases and Hepatology Unit, Institutes of Liver Diseases Research of Guangdong Province, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.

J Clin Transl Hepatol ; 11(3): 649-660, 2023 Jun 28.

Article em En | MEDLINE | ID: mdl-36969889

ABSTRACT

ABSTRACT

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 (21) 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.