Monitoring Adherence and Renal Safety of Nucleos(t)ide Analogs for Patients With Chronic Hepatitis B

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.

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.

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.

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.