PMID- 36177347
OWN - NLM
STAT- MEDLINE
DCOM- 20221003
LR  - 20221003
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 16
DP  - 2022
TI  - Non-Inferior Efficacy of Tenofovir Disoproxil to Tenofovir Disoproxil Fumarate in 
      Virologically Suppressed Chronic Hepatitis B Patients.
PG  - 3263-3274
LID - 10.2147/DDDT.S376821 [doi]
AB  - PURPOSE: Tenofovir disoproxil (TD), modified from tenofovir disoproxil fumarate 
      (TDF), was developed as a salt-free formulation, removing fumarate to improve the 
      ease of oral intake by reducing the tablet's size. We evaluated the maintenance 
      of antiviral effects and overall safety profile of TD 245 mg after switching from 
      TDF 300 mg in patients with chronic hepatitis B (CHB). PATIENTS AND METHODS: CHB 
      patients with HBV-DNA <69 IU/mL after >/=24 weeks of TDF therapy were enrolled. The 
      primary efficacy endpoint was the HBV-DNA suppression rate (HBV-DNA <69 IU/mL) at 
      week 48; We evaluated the non-inferiority (10% margin) of TD to TDF in terms of 
      efficacy. Safety was assessed based on adverse events (AEs), laboratory tests, 
      bone mineral density, and renal function abnormalities. RESULTS: Overall, 189 
      subjects were randomized in a 2:1 ratio, and 117 and 66 subjects in the TD and 
      TDF groups, respectively, completed the study. In the per-protocol set, the 
      HBV-DNA suppression rate at week 48 was 99.1% and 100% in the TD and TDF groups, 
      respectively. The lower limit of the 97.5% one-sided confidence interval for the 
      intergroup difference in HBV-DNA suppression rate was -2.8%, which was greater 
      than the prespecified margin of non-inferiority. The changes in creatinine 
      clearance from baseline to week 48 was significantly less in the TD group and in 
      the TDF group; -0.8 +/- 9.8 versus -2.4 +/- 12.8 mL/min, respectively (P=0.017). 
      CONCLUSION: TD was non-inferior to TDF for maintaining viral suppression in CHB 
      patients, showing the less decline of renal function.
CI  - (c) 2022 Yim et al.
FAU - Yim, Hyung Joon
AU  - Yim HJ
AUID- ORCID: 0000-0002-6036-2754
AD  - Department of Internal Medicine, Korea University Ansan Hospital, Korea 
      University College of Medicine, Seoul, Korea.
FAU - Kim, Ji Hoon
AU  - Kim JH
AUID- ORCID: 0000-0003-3924-0434
AD  - Department of Internal Medicine, Korea University Guro Hospital, Korea University 
      College of Medicine, Seoul, Korea.
FAU - Cho, Yong Kyun
AU  - Cho YK
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, 
      Korea.
FAU - Kweon, Young Oh
AU  - Kweon YO
AD  - Department of Internal Medicine, Kyungpook National University, School of 
      Medicine, Daegu, Korea.
FAU - Cho, Hyun Chin
AU  - Cho HC
AD  - Department of Internal Medicine, Gyeongsang National University Hospital, 
      Gyeongsang National University School of Medicine, Jinju, Korea.
FAU - Hwang, Jae Seok
AU  - Hwang JS
AD  - Department of Internal Medicine, Keimyung University School of Medicine, Daegu, 
      Korea.
FAU - Lee, Changhyeong
AU  - Lee C
AUID- ORCID: 0000-0001-5726-8890
AD  - Department of Internal Medicine, Daegu Catholic University School of Medicine, 
      Daegu, Korea.
FAU - Koh, Moon Soo
AU  - Koh MS
AD  - Department of Internal Medicine, Dongguk University Ilsan Hospital, College of 
      Medicine, Dongguk University, Goyang, Korea.
FAU - Baek, Yang-Hyun
AU  - Baek YH
AD  - Department of Gastroenterology, DongA University College of Medicine, Busan, 
      Korea.
FAU - Park, Young-Min
AU  - Park YM
AD  - Department of Internal Medicine, Bundang Jesaeng General Hospital, Seongnam, 
      Korea and Hepatology Center, Bundang Jesaeng General Hospital, Seongnam, Korea.
FAU - Lee, Jeong-Hoon
AU  - Lee JH
AUID- ORCID: 0000-0002-0315-2080
AD  - Department of Internal Medicine and Liver Research Institute, Seoul National 
      University College of Medicine, Seoul, Korea.
FAU - Kim, Seung Up
AU  - Kim SU
AUID- ORCID: 0000-0002-9658-8050
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea, and Yonsei Liver Center, Severance Hospital, Seoul, Korea.
FAU - Kang, Min-Kyu
AU  - Kang MK
AUID- ORCID: 0000-0002-1435-3312
AD  - Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, 
      Korea.
FAU - Park, Neung Hwa
AU  - Park NH
AD  - Department of Internal Medicine, Ulsan University Hospital, University of Ulsan 
      College of Medicine, Ulsan, Korea.
FAU - Lee, June Sung
AU  - Lee JS
AUID- ORCID: 0000-0002-1803-9398
AD  - Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of 
      Medicine, Goyang, Korea.
FAU - Chon, Young Eun
AU  - Chon YE
AD  - Department of Internal Medicine, CHA Bundang Medical Center, CHA University, 
      Seongnam, Korea.
FAU - Cheon, Gab Jin
AU  - Cheon GJ
AD  - Department of Medicine, GangNeung Asan Hospital, Ulsan University College of 
      Medicine, Gangwon-do, Korea.
FAU - Chae, Hee Bok
AU  - Chae HB
AD  - Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, 
      Korea.
FAU - Sohn, Joo Hyun
AU  - Sohn JH
AD  - Department of Internal Medicine, Hanyang University College of Medicine, Seoul, 
      Korea, and Hanyang University Guri Hospital, Guri, Korea.
FAU - Lim, Young-Suk
AU  - Lim YS
AD  - Department of Gastroenterology, Liver Center, Asan Medical Center, University of 
      Ulsan College of Medicine, Seoul, Korea.
LA  - eng
PT  - Case Reports
PT  - Clinical Trial
PT  - Randomized Controlled Trial
DEP - 20220923
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Antiviral Agents)
RN  - 0 (DNA, Viral)
RN  - 0 (Fumarates)
RN  - 0 (Hepatitis B e Antigens)
RN  - 0 (Tablets)
RN  - 99YXE507IL (Tenofovir)
RN  - AYI8EX34EU (Creatinine)
RN  - JAC85A2161 (Adenine)
SB  - IM
MH  - Adenine/adverse effects
MH  - Antiviral Agents/adverse effects
MH  - Creatinine
MH  - DNA, Viral
MH  - Fumarates/therapeutic use
MH  - Hepatitis B e Antigens
MH  - Hepatitis B virus
MH  - *Hepatitis B, Chronic/drug therapy
MH  - Humans
MH  - Tablets/therapeutic use
MH  - Tenofovir/adverse effects
MH  - Treatment Outcome
MH  - Viral Load
PMC - PMC9514787
OTO - NOTNLM
OT  - antiviral agents
OT  - bone density
OT  - viral DNA
OT  - viral suppression
COIS- Y-S.L. and the authors received research funds from Daewoong Pharmaceuticals Co., 
      Ltd. The authors have indicated that they have no other conflicts of interest 
      regarding the content of this article.
EDAT- 2022/10/01 06:00
MHDA- 2022/10/04 06:00
PMCR- 2022/09/23
CRDT- 2022/09/30 02:46
PHST- 2022/06/16 00:00 [received]
PHST- 2022/09/16 00:00 [accepted]
PHST- 2022/09/30 02:46 [entrez]
PHST- 2022/10/01 06:00 [pubmed]
PHST- 2022/10/04 06:00 [medline]
PHST- 2022/09/23 00:00 [pmc-release]
AID - 376821 [pii]
AID - 10.2147/DDDT.S376821 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2022 Sep 23;16:3263-3274. doi: 10.2147/DDDT.S376821. 
      eCollection 2022.