Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial |
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| Authors: | J L Hou Z L Gao Q Xie J M Zhang J F Sheng J Cheng C W Chen Q Mao W Zhao H Ren D M Tan J Q Niu S J Chen C Pan H Tang H Wang Y M Mao J D Jia Q Ning M Xu S M Wu J Li X X Zhang Y Ji J Dong J Li |
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| Institution: | 1. Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Guangzhou, China;2. Department of Infectious Disease, Third Affiliated Hospital of Sun Yat‐sen University, Guangzhou, China;3. Department of Infectious Disease, Ruijin Hospital, Shanghai, China;4. Department of Infectious Disease, Huashan Hospital, Shanghai, China;5. Department of Infectious Disease, First Affiliated Hospital of College of Medicine Zhejiang University, Hangzhou, China;6. Center of Liver Disease, Beijing Ditan Hospital, Capital Medical University, Beijing, China;7. Liver Diseases Research Center, 85 Hospital Affiliated to Nanjing Military, Shanghai, China;8. Department of Infectious Disease, Southwest Hospital, Chongqing, China;9. Department of Liver Disease, Second Hospital of Nanjing, Nanjing, China;10. Department of Infectious Disease, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China;11. Department of Infectious Disease, Xiangya Hospital of Central‐South University, Changsha, China;12. Department of Hepatology, First Affiliated Hospital of Jilin University, Changchun, China;13. Department of Liver Disease, Ji'nan Hospital for Infectious Diseases, Ji'nan, China;14. Department of Hepatology, Fuzhou Infectious Diseases Hospital, Fuzhou, China;15. Center of Infectious Diseases, Sichuan University West China Hospital, Chengdu, China;16. Hepatology Institute, Peking University People's Hospital, Beijing, China;17. Department of Gastroenterology, Renji Hospital, Shanghai, China;18. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China;19. Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China;20. Department of Liver Disease, Guangzhou 8th People's Hospital, Guangzhou, China;21. Department of Liver Disease, Shanghai Public Health Clinical Centre, Shanghai, China;22. Department of Infectious Diseases, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China;23. Zhongshan Hospital, Shanghai, China;24. China Medicine Development, GlaxoSmithKline R&D China, Shanghai, China |
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| Abstract: | 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 ≥105 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. |
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| Keywords: | antiviral therapy chronic hepatitis B efficacy tenofovir disoproxil fumarate |
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