Renal safety and biochemical changes for two years of tenofovir alafenamide after switching from long-term other nucleotide analogues treatment in patients with chronic hepatitis B
Tetsuya Hosaka 1 , Fumitaka Suzuki 1 , Masahiro Kobayashi 1 , Shunichirou Fujiyama 1 , Yusuke Kawamura 1 , Hitomi Sezaki 1 , Norio Akuta 1 , Yoshiyuki Suzuki 1 , Satoshi Saitoh 1 , Yasuji Arase 1 , Kenji Ikeda 1 , Mariko Kobayashi 2 , Hiromitsu Kumada 1
Affiliations
Affiliations
1
Department of Hepatology and.
2
Research Institute for Hepatology, Toranomon Hospital, Tokyo, Japan.
PMID: 34687121 DOI: 10.1111/hepr.13726
Abstract
Background: Long-term use of nucleotide analogues such as adefovir (ADV) or tenofovir disoproxil fumarate (TDF) may cause renal impairment. Tenofovir alafenamide (TAF) has lesser systemic exposure than TDF. To examine longitudinal changes in renal function and biochemical parameters for two years after switching from long-term ADV and TDF to TAF and to explore factors associated with improved renal function after TAF in chronic hepatitis B (CHB) patients.
Methods: The prospective observational cohort study included 306 CHB patients who underwent switching from long-term TDF or ADV to TAF. The primary outcome was the changes in estimated glomerular filtration rate (eGFR) after TAF.
Results: Among 306 patients, 190 (65.3%) and 106 (34.7%) had chronic kidney disease (CKD) stages 1-2 and 3a-4 at baseline. In patients with CKD stage 3a-4, the mean eGFR significantly increased until week 12 and plateaued from week 12 to year 2 (Adjusted slope using linear mixed effect models: +9.01 ml/min/1.73 m2 /year until week 12; P < 0.001). In contrast, the mean eGFR plateaued from baseline to year 2 in the CKD stage 1-2 subgroup. Multivariate logistic regression showed that baseline CKD stage ≥ 3a, steeper decline in eGFR 1-year before TAF, and shorter duration of any nucleotide analogue use were significantly associated with ≥ 10% improvement in eGFR in year 1.
Conclusions: Switching from TDF or ADV to TAF resulted in favourable renal safety for 2 years. In CKD stage 3a-4 subgroup, eGFR after TAF was recovered in the first 12 weeks and subsequently stabilised. This article is protected by copyright. All rights reserved.