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Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study
Although hepatitis B surface antigen (HBsAg) removal is considered the goal of chronic hepatitis B treatment, it can rarely be achieved with nucleos(t)ide analogues (NAs). It has been reported that tenofovir disoproxil fumarate (TDF) is superior in reducing HBsAg compared with entecavir (ETV) in tre...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
D.A. Spandidos
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7739848/ https://www.ncbi.nlm.nih.gov/pubmed/33335726 http://dx.doi.org/10.3892/br.2020.1396 |
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author | Inoue, Jun Akahane, Takehiro Kobayashi, Tomoo Obara, Noriyuki Umetsu, Teruyuki Kakazu, Eiji Ninomiya, Masashi Iwata, Tomoaki Sano, Akitoshi Tsuruoka, Mio Sato, Kosuke Masamune, Atsushi |
author_facet | Inoue, Jun Akahane, Takehiro Kobayashi, Tomoo Obara, Noriyuki Umetsu, Teruyuki Kakazu, Eiji Ninomiya, Masashi Iwata, Tomoaki Sano, Akitoshi Tsuruoka, Mio Sato, Kosuke Masamune, Atsushi |
author_sort | Inoue, Jun |
collection | PubMed |
description | Although hepatitis B surface antigen (HBsAg) removal is considered the goal of chronic hepatitis B treatment, it can rarely be achieved with nucleos(t)ide analogues (NAs). It has been reported that tenofovir disoproxil fumarate (TDF) is superior in reducing HBsAg compared with entecavir (ETV) in treatment-naïve patients; however, the effect of TDF in patients who have received NAs is still unclear. The aim of the present study was to evaluate the efficacy of switching from ETV to TDF in patients who were already receiving ETV. A pilot randomized controlled study for 2 years in patients who had been treated with ETV for >1 year and did not exhibit drug resistance was performed (Clinical trial registration: UMIN000021948, UMIN-CTR, May 1, 2016). A total of 20 patients were enrolled and 19 patients were randomized into 2 groups, a TDF-switching group (n=12) or an ETV-continuing group (n=7). The mean change in HBsAg levels after 2 years was greater in the TDF group compared with the ETV group, but the difference was not significant (-0.25 vs. -0.06 log IU/ml). In the TDF group, hepatitis B e antigen (HBeAg)-positive patients at baseline showed significantly greater changes in HBsAg (-0.63 vs. -0.03 log IU/ml; P=0.030). In contrast, no difference between HBeAg-positive and HBeAg-negative patients was observed in the ETV group. No significant differences of estimated glomerular filtration rate and inorganic phosphorus changes were observed among the TDF and ETV groups. In conclusion, a significant HBsAg decrease was not achieved after switching from ETV to TDF in the overall analysis, but HBeAg-positive patients showed a larger HBsAg decrease after switching treatment. |
format | Online Article Text |
id | pubmed-7739848 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | D.A. Spandidos |
record_format | MEDLINE/PubMed |
spelling | pubmed-77398482020-12-16 Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study Inoue, Jun Akahane, Takehiro Kobayashi, Tomoo Obara, Noriyuki Umetsu, Teruyuki Kakazu, Eiji Ninomiya, Masashi Iwata, Tomoaki Sano, Akitoshi Tsuruoka, Mio Sato, Kosuke Masamune, Atsushi Biomed Rep Articles Although hepatitis B surface antigen (HBsAg) removal is considered the goal of chronic hepatitis B treatment, it can rarely be achieved with nucleos(t)ide analogues (NAs). It has been reported that tenofovir disoproxil fumarate (TDF) is superior in reducing HBsAg compared with entecavir (ETV) in treatment-naïve patients; however, the effect of TDF in patients who have received NAs is still unclear. The aim of the present study was to evaluate the efficacy of switching from ETV to TDF in patients who were already receiving ETV. A pilot randomized controlled study for 2 years in patients who had been treated with ETV for >1 year and did not exhibit drug resistance was performed (Clinical trial registration: UMIN000021948, UMIN-CTR, May 1, 2016). A total of 20 patients were enrolled and 19 patients were randomized into 2 groups, a TDF-switching group (n=12) or an ETV-continuing group (n=7). The mean change in HBsAg levels after 2 years was greater in the TDF group compared with the ETV group, but the difference was not significant (-0.25 vs. -0.06 log IU/ml). In the TDF group, hepatitis B e antigen (HBeAg)-positive patients at baseline showed significantly greater changes in HBsAg (-0.63 vs. -0.03 log IU/ml; P=0.030). In contrast, no difference between HBeAg-positive and HBeAg-negative patients was observed in the ETV group. No significant differences of estimated glomerular filtration rate and inorganic phosphorus changes were observed among the TDF and ETV groups. In conclusion, a significant HBsAg decrease was not achieved after switching from ETV to TDF in the overall analysis, but HBeAg-positive patients showed a larger HBsAg decrease after switching treatment. D.A. Spandidos 2021-02 2020-12-01 /pmc/articles/PMC7739848/ /pubmed/33335726 http://dx.doi.org/10.3892/br.2020.1396 Text en Copyright: © Inoue et al. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
spellingShingle | Articles Inoue, Jun Akahane, Takehiro Kobayashi, Tomoo Obara, Noriyuki Umetsu, Teruyuki Kakazu, Eiji Ninomiya, Masashi Iwata, Tomoaki Sano, Akitoshi Tsuruoka, Mio Sato, Kosuke Masamune, Atsushi Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study |
title | Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study |
title_full | Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study |
title_fullStr | Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study |
title_full_unstemmed | Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study |
title_short | Switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis B patients: A pilot randomized controlled study |
title_sort | switching to tenofovir disoproxil fumarate in entecavir-treated chronic hepatitis b patients: a pilot randomized controlled study |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7739848/ https://www.ncbi.nlm.nih.gov/pubmed/33335726 http://dx.doi.org/10.3892/br.2020.1396 |
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