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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 
 LIVER INTERNATIONAL, Vol.42(11) : 2408-2417, 2022-11 
Journal Title
Issue Date
Adenine / adverse effects ; Alanine / adverse effects ; Antiviral Agents / adverse effects ; Guanine / analogs & derivatives ; Hepatitis B* / drug therapy ; Hepatitis B, Chronic* / drug therapy ; Humans ; Kidney ; Longitudinal Studies ; Maleates / therapeutic use ; Organophosphonates ; Renal Insufficiency, Chronic* ; Retrospective Studies ; Tenofovir / adverse effects ; Tenofovir / analogs & derivatives ; Treatment Outcome
antiviral therapy ; besifovir dipivoxil maleate ; hepatitis B virus ; kidney function ; tenofovir alafenamide
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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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Beom Seok(김범석) ORCID logo https://orcid.org/0000-0002-5732-2583
Kim, Seung Up(김승업) ORCID logo https://orcid.org/0000-0002-9658-8050
Kim, Hyung Woo(김형우) ORCID logo https://orcid.org/0000-0002-6305-452X
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Jung Il(이정일) ORCID logo https://orcid.org/0000-0002-0142-1398
Lee, Hyun Woong(이현웅) ORCID logo https://orcid.org/0000-0002-6958-3035
Jung, Chan-Young(정찬영) ORCID logo https://orcid.org/0000-0002-2893-9576
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