Monitoring adherence and renal safety of nucleos(t)ide analogues for patients with chronic hepatitis B

Introduction: Entecavir (ETV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are first-line nucleos(t)ide analogues (NA) for chronic hepatitis B (CHB). Real-world monitoring of patients on these agents and their comparative renal safety remain poorly characterized. We evaluated guideline-adherent monitoring practices and compared renal dysfunction risk across ETV, TDF and TAF. Methods: We retrospectively analyzed CHB patients who initiated ETV, TDF or TAF between 2012 and 2022. Levels of serum alanine aminotransferase (ALT), total bilirubin, albumin, serum creatinine, hepatitis B virus (HBV) DNA, and abdominal sonograms were assessed every six months during the 36 months of NA treatment. Incidence rates and adjusted hazard ratios (HRs) for renal dysfunction were estimated by Cox regression. Results: Of the 2,155 enrolled patients, 65.8% received ETV, 23.1% received TDF, and 11.1% underwent TAF. ALT was monitored in > 90% across all groups; other tests (bilirubin, albumin, creatinine, HBV DNA, sonogram) were performed in only 20–80%. After multivariable adjustment, TDF (HR 1.41; 95% CI 0.95–2.08) and TAF (HR 0.91; 95% CI 0.52–2.18) showed no significant difference in renal dysfunction risk versus ETV. Independent predictors of increased renal risk included older age, higher Charlson comorbidity index, fibrosis-4 score and diuretic use, whereas elevated serum albumin levels were associated with a lower risk. Conclusions: In this real-world cohort, adherence to recommended monitoring for CHB patients on NAs was suboptimal. ETV, TDF and TAF demonstrated comparable renal safety profiles over 3 years.