Effect of tenofovir on renal function in patients with chronic hepatitis B

Abstract

Tenofovir disoproxil fumarate (TDF) is widely used to treat patients with hepatitis B virus (HBV) infection. We investigated the effect of TDF on renal insufficiency in patients with chronic hepatitis B (CHB).A consecutive cohort analysis was applied to CHB patients taking prescribed TDF from January 2012 to May 2016 at Soonchunhyang University Seoul Hospital. Alterations over time in corrected calcium, phosphate, creatinine, and estimated glomerular filtration rate (eGFR) were analyzed using the generalized estimating equation method. The percentage increase in creatinine from baseline to the maximum creatinine level (delta creatinine) was compared according to the underlying disease using the Mann–Whitney U test. Cox proportional hazard regression model was used to determine risk factors associated with renal insufficiency.The baseline creatinine, eGFR, corrected calcium, and phosphate levels were 0.72 ± 0.01 mg/dL (mean ± SD), 106.37 ± 1.06 mL/min/1.73 m2, 8.82 ± 0.04 mg/dL, and 3.42 ± 0.05 mg/dL, respectively. The creatinine level had increased significantly at 12, 24, 48, 72, and 96 weeks, while the eGFR level had decreased significantly at these 5 time points. Multivariate analysis confirmed that age ≥60 years and the baseline bilirubin level were independently associated with the risk of renal insufficiency. Delta creatinine was significantly higher in patients with diabetes mellitus (DM) than in patients without DM.Renal function was decreased from baseline in CHB patients receiving TDF therapy, which indicates that the renal function of patients undergoing treatment with TDF should be monitored regularly. Old age, DM, and serum bilirubin were risk factors for the development of renal insufficiency in CHB patients receiving TDF therapy.

An observational study on long‐term renal outcome in patients with chronic hepatitis B treated with tenofovir disoproxil fumarate

“…In this study, hypertension or DM were not meaningful predictors for renal insufficiency. Although hypertension and DM are well‐known risk factors for CKD, several studies reported that they were not significant predictors for renal insufficiency after TDF use, similar to our results. In addition, current EASL guideline does not recommend change from TDF to other drugs in patients with well‐controlled hypertension or DM .…”

“…SCr was increased, and eGFR was decreased during five years of TDF treatment. Increase of SCr was statistically significant during the first year after TDF treatment, while eGFR was significantly decreased during the first 2 years after TDF treatment.This result suggested that renal function showed a decreasing trend during five years after TDF treatment, but statistically, it was significantly reduced only during the first 2 years after TDF treatment.This finding is similar to recent Korean study with follow-up period of 2 years, showing that SCr was elevated, and eGFR was decreased during 2 years of TDF treatment 21. In that study, eGFR decline was statistically significant comparing baseline to the first year, but at year 2 compared to year 1, eGFR decline was not statistically significant.…”

“…Although the follow‐up duration is short, based on these results, in the real world, TDF was widely used even in patients with decreased renal function until the development of tenofovir alafenamide fumarate (TAF). However, several recent studies suggested that TDF can reduce eGFR in patients with CHB, but long‐term real world data are still lacking.…”

“…However, the long‐term safety on renal function of TDF users for CHB is still unclear because of relatively recent approval of TDF use for CHB treatment in 2008 . Several previous studies reported that the effect of TDF on renal function is minimal, while other recent studies suggested that renal function was reduced after TDF use . Real world data of long‐term TDF use in Asia have been lacking .…”

“…17 Several previous studies reported that the effect of TDF on renal function is minimal, 5,17,18 while other recent studies suggested that renal function was reduced after TDF use. [19][20][21] Real world data of long-term TDF use in Asia have been lacking. 4 Especially in Korea, studies concerning five-year renal outcome on TDF have been lacking because of the late approval of TDF for CHB treatment in 2012.…”