Changes in renal function and indicators in chronic hepatitis B patients undergoing antiviral therapy for 48 weeks: A prospective cohort study in China

Abstract Background There is limited research comparing the renal safety of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) when used with pegylated interferon (pegIFN) in patients with chronic hepatitis B (CHB). Here, renal function changes in CHB patients were compared between treated with pegyIFN combined with ETV or TDF. Methods 713 patients with the combination therapy of pegIFN with ETV or TDF were included in a matched analysis comparing outcomes between cured (HBsAg < 0.05IU/mL) and uncured patients, while 104 patients received pegIFN alone as a control group for comparison with the pegIFN-ETV and pegIFN-TDF treatment groups. The primary outcome was the change in renal function. Patients were categorized into stage 1 or stage 2 based on baseline estimated glomerular filtration rate (eGFR) < 90 ml/min/m². Results In total, 125 CHB patients were matched 1:1 in both the cured and the uncured group. Renal function in the stage 1 and stage 2 groups showed a decreasing trend at 48 weeks after an initial increase. After PSM matching, the study included patients in the pegIFN-ETV or pegIFN-TDF group (n = 208, respectively), and 104 patients in the pegIFN-alone group. No significant difference in the impact of the three drug regimens on renal function at 48 weeks was found ( P = 0.955). A logistic regression model using age and baseline eGFR predicted the AUC of eGFR status at 48 weeks to be 0.851 (95% CI , 0.807, 0.895). Conclusions After 48 weeks of combined treatment in patients with CHB, neither pegIFN-TDF nor pegIFN-ETV led to an increase in renal injury.