Renal safety and biochemical changes for 2 years after switching to tenofovir alafenamide from long‐term other nucleotide analog treatment in patients with chronic hepatitis B

Abstract

Background: Long-term use of nucleotide analogs such as adefovir (ADV) or tenofovir disoproxil fumarate (TDF) may cause renal impairment. Tenofovir alafenamide (TAF) has less systemic exposure than TDF did. The aims were to examine longitudinal changes in renal function and biochemical parameters for 2 years after switching from long-term ADV and TDF to TAF, and to explore factors associated with improved renal function after TAF in patients with chronic hepatitis B. Methods:The prospective observational cohort study included 306 patients with chronic hepatitis B 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 stages 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 m 2 /year until week 12; p < 0.001). In contrast, the mean eGFR plateaued from baseline to year 2 in the CKD stages 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 analog use was significantly associated with ≥10% improvement in eGFR in year 1. Conclusions:Switching from TDF or ADV to TAF resulted in favorable renal safety for 2 years. In CKD stage 3a-4 subgroup, eGFR after TAF was recovered in the first 12 weeks and subsequently stabilized.

Effects of entecavir and tenofovir alafenamide fumarate treatment on renal function in Japanese elderly patients with chronic hepatitis B

“…15 Renal function has been reported to improve after switching from TDF to TAF. [16][17][18] The European Association for the Study of the Liver Clinical Practice Guidelines recommend ETV or TAF over TDF if high-risk conditions exist, such as age >60 years, bone disease, or renal alteration, as evidenced by an eGFR of <60 mL/min/ m 2 , albuminuria, hypophosphatemia, and hemodialysis. 4 Total HBsAg clearance is not achievable in most CHB patients so to avoid relapse after discontinuation, lifelong NA treatment is necessary.…”

“…Treatment of CHB with TAF results in fewer renal adverse events than treatment with TDF, while both drugs have a comparable antiviral efficacy 15 . Renal function has been reported to improve after switching from TDF to TAF 16–18 . The European Association for the Study of the Liver Clinical Practice Guidelines recommend ETV or TAF over TDF if high‐risk conditions exist, such as age >60 years, bone disease, or renal alteration, as evidenced by an eGFR of <60 mL/min/m 2 , albuminuria, hypophosphatemia, and hemodialysis 4 …”