Similar risk of kidney function decline between tenofovir alafenamide and besifovir dipivoxil maleate in chronic hepatitis B

Chan Young Jung; Hyung Woo Kim; Jung Il Lee; Hyun Woong Lee; Sang Hoon Ahn; Seung Up Kim; Beom Seok Kim

doi:10.1111/liv.15388

Similar risk of kidney function decline between tenofovir alafenamide and besifovir dipivoxil maleate in chronic hepatitis B

Chan Young Jung, Hyung Woo Kim, Jung Il Lee, Hyun Woong Lee, Sang Hoon Ahn, Seung Up Kim, Beom Seok Kim

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Background and Aims: Although tenofovir alafenamide (TAF) and besifovir dipivoxil maleate (BSV) are potent antiviral agents in the treatment of chronic hepatitis B (CHB) infection, their renal safety profiles have not been previously compared. This study compared the risk of kidney function decline among patients with treatment-naïve CHB treated with TAF or BSV. Methods: This multicenter, retrospective, longitudinal cohort study included 556 patients with treatment-naïve CHB treated with TAF (n = 366) or BSV (n = 190) between November 2017 and August 2021. The primary outcome was chronic kidney disease (CKD) progression, defined as an increase in CKD stage by at least one stage for at least three consecutive months. Results: 1:1 Propensity score matching yielded 154 patients in each treatment group. The mean estimated glomerular filtration rate (eGFR) was 100.4 vs. 100.3 ml/min/1.73 m² in the TAF and BSV groups respectively. A total of 25 patients developed a progression in CKD stage ≥1, of which 13 and 12 patients were from the TAF and BSV treated groups respectively (3.1 vs. 3.3 per 1000 person-years; p =.751). The unadjusted hazard ratio for risk of progression in CKD stage ≥1 of the BSV group (vs. the TAF group) was 1.13 (95% confidence interval, 0.50–2.58; p =.758). This association persisted even after adjusting for potential confounders. Virological, serological and biochemical responses were also similar between the two treatment groups (all p >.05). Conclusions: TAF and BSV showed a similar risk of kidney function decline in patients with treatment-naïve CHB. Further prospective randomized studies are warranted for validation.

Original language	English
Pages (from-to)	2408-2417
Number of pages	10
Journal	Liver International
Volume	42
Issue number	11
DOIs	https://doi.org/10.1111/liv.15388
Publication status	Published - 2022 Nov

Bibliographical note

Funding Information:
Seung Up Kim has served as an advisory committee member Gilead Sciences, Bayer, Eisai and Novo Nordisk. He is a speaker for Gilead Sciences, GSK, Bayer, Eisai, AbbVie, EchoSens, MSD, Eisai, Otsuka and Bristol‐Myers Squibb. He has also received a research grant from Abbive and Bristol‐Myers Squibb. The other authors declare that they have no competing interests.

Funding Information:
This study was supported by the Technology Innovation Program (20013712) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

Publisher Copyright:
© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

All Science Journal Classification (ASJC) codes

Hepatology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1111/liv.15388

Cite this

@article{7c1442feaf47497ab9609177654aee0e,

title = "Similar risk of kidney function decline between tenofovir alafenamide and besifovir dipivoxil maleate in chronic hepatitis B",

abstract = "Background and Aims: Although tenofovir alafenamide (TAF) and besifovir dipivoxil maleate (BSV) are potent antiviral agents in the treatment of chronic hepatitis B (CHB) infection, their renal safety profiles have not been previously compared. This study compared the risk of kidney function decline among patients with treatment-na{\"i}ve CHB treated with TAF or BSV. Methods: This multicenter, retrospective, longitudinal cohort study included 556 patients with treatment-na{\"i}ve CHB treated with TAF (n = 366) or BSV (n = 190) between November 2017 and August 2021. The primary outcome was chronic kidney disease (CKD) progression, defined as an increase in CKD stage by at least one stage for at least three consecutive months. Results: 1:1 Propensity score matching yielded 154 patients in each treatment group. The mean estimated glomerular filtration rate (eGFR) was 100.4 vs. 100.3 ml/min/1.73 m2 in the TAF and BSV groups respectively. A total of 25 patients developed a progression in CKD stage ≥1, of which 13 and 12 patients were from the TAF and BSV treated groups respectively (3.1 vs. 3.3 per 1000 person-years; p =.751). The unadjusted hazard ratio for risk of progression in CKD stage ≥1 of the BSV group (vs. the TAF group) was 1.13 (95% confidence interval, 0.50–2.58; p =.758). This association persisted even after adjusting for potential confounders. Virological, serological and biochemical responses were also similar between the two treatment groups (all p >.05). Conclusions: TAF and BSV showed a similar risk of kidney function decline in patients with treatment-na{\"i}ve CHB. Further prospective randomized studies are warranted for validation.",

author = "Jung, {Chan Young} and Kim, {Hyung Woo} and Lee, {Jung Il} and Lee, {Hyun Woong} and Ahn, {Sang Hoon} and Kim, {Seung Up} and Kim, {Beom Seok}",

note = "Funding Information: Seung Up Kim has served as an advisory committee member Gilead Sciences, Bayer, Eisai and Novo Nordisk. He is a speaker for Gilead Sciences, GSK, Bayer, Eisai, AbbVie, EchoSens, MSD, Eisai, Otsuka and Bristol‐Myers Squibb. He has also received a research grant from Abbive and Bristol‐Myers Squibb. The other authors declare that they have no competing interests. Funding Information: This study was supported by the Technology Innovation Program (20013712) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. Publisher Copyright: {\textcopyright} 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.",

year = "2022",

month = nov,

doi = "10.1111/liv.15388",

language = "English",

volume = "42",

pages = "2408--2417",

journal = "Liver International",

issn = "1478-3223",

publisher = "Wiley-Blackwell",

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TY - JOUR

T1 - Similar risk of kidney function decline between tenofovir alafenamide and besifovir dipivoxil maleate in chronic hepatitis B

AU - Jung, Chan Young

AU - Kim, Hyung Woo

AU - Lee, Jung Il

AU - Lee, Hyun Woong

AU - Ahn, Sang Hoon

AU - Kim, Seung Up

AU - Kim, Beom Seok

N1 - Funding Information: Seung Up Kim has served as an advisory committee member Gilead Sciences, Bayer, Eisai and Novo Nordisk. He is a speaker for Gilead Sciences, GSK, Bayer, Eisai, AbbVie, EchoSens, MSD, Eisai, Otsuka and Bristol‐Myers Squibb. He has also received a research grant from Abbive and Bristol‐Myers Squibb. The other authors declare that they have no competing interests. Funding Information: This study was supported by the Technology Innovation Program (20013712) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. Publisher Copyright: © 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2022/11

Y1 - 2022/11

N2 - Background and Aims: Although tenofovir alafenamide (TAF) and besifovir dipivoxil maleate (BSV) are potent antiviral agents in the treatment of chronic hepatitis B (CHB) infection, their renal safety profiles have not been previously compared. This study compared the risk of kidney function decline among patients with treatment-naïve CHB treated with TAF or BSV. Methods: This multicenter, retrospective, longitudinal cohort study included 556 patients with treatment-naïve CHB treated with TAF (n = 366) or BSV (n = 190) between November 2017 and August 2021. The primary outcome was chronic kidney disease (CKD) progression, defined as an increase in CKD stage by at least one stage for at least three consecutive months. Results: 1:1 Propensity score matching yielded 154 patients in each treatment group. The mean estimated glomerular filtration rate (eGFR) was 100.4 vs. 100.3 ml/min/1.73 m2 in the TAF and BSV groups respectively. A total of 25 patients developed a progression in CKD stage ≥1, of which 13 and 12 patients were from the TAF and BSV treated groups respectively (3.1 vs. 3.3 per 1000 person-years; p =.751). The unadjusted hazard ratio for risk of progression in CKD stage ≥1 of the BSV group (vs. the TAF group) was 1.13 (95% confidence interval, 0.50–2.58; p =.758). This association persisted even after adjusting for potential confounders. Virological, serological and biochemical responses were also similar between the two treatment groups (all p >.05). Conclusions: TAF and BSV showed a similar risk of kidney function decline in patients with treatment-naïve CHB. Further prospective randomized studies are warranted for validation.

AB - Background and Aims: Although tenofovir alafenamide (TAF) and besifovir dipivoxil maleate (BSV) are potent antiviral agents in the treatment of chronic hepatitis B (CHB) infection, their renal safety profiles have not been previously compared. This study compared the risk of kidney function decline among patients with treatment-naïve CHB treated with TAF or BSV. Methods: This multicenter, retrospective, longitudinal cohort study included 556 patients with treatment-naïve CHB treated with TAF (n = 366) or BSV (n = 190) between November 2017 and August 2021. The primary outcome was chronic kidney disease (CKD) progression, defined as an increase in CKD stage by at least one stage for at least three consecutive months. Results: 1:1 Propensity score matching yielded 154 patients in each treatment group. The mean estimated glomerular filtration rate (eGFR) was 100.4 vs. 100.3 ml/min/1.73 m2 in the TAF and BSV groups respectively. A total of 25 patients developed a progression in CKD stage ≥1, of which 13 and 12 patients were from the TAF and BSV treated groups respectively (3.1 vs. 3.3 per 1000 person-years; p =.751). The unadjusted hazard ratio for risk of progression in CKD stage ≥1 of the BSV group (vs. the TAF group) was 1.13 (95% confidence interval, 0.50–2.58; p =.758). This association persisted even after adjusting for potential confounders. Virological, serological and biochemical responses were also similar between the two treatment groups (all p >.05). Conclusions: TAF and BSV showed a similar risk of kidney function decline in patients with treatment-naïve CHB. Further prospective randomized studies are warranted for validation.

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