Abstract
INTRODUCTION: Entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are first-line nucleos(t)ide analogs (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 patients with CHB who initiated ETV, TDF, or TAF between 2012 and 2022. Levels of serum alanine aminotransferase, total bilirubin, albumin, serum creatinine, hepatitis B virus DNA, and abdominal sonograms were assessed every 6 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. Alanine aminotransferase was monitored in >90% across all groups; other tests (bilirubin, albumin, creatinine, hepatitis B virus DNA, sonogram) were performed in only 20%-80%. After multivariable adjustment, TDF (HR 1.41; 95% confidence interval 0.95-2.08) and TAF (HR 0.91; 95% confidence interval 0.52-2.18) showed no significant difference in renal dysfunction risk vs 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. DISCUSSION: In this real-world cohort, adherence to recommended monitoring for patients with CHB on NAs was suboptimal. ETV, TDF, and TAF demonstrated comparable renal safety profiles over 3 years.