Comparative Efficacy and Renal Safety of Entecavir and Tenofovir Disoproxil Fumarate in the Treatment of Chronic Hepatitis B: A Retrospective Cohort Study From Vietnam.
Thong Duy Vo, Han Ngoc Gia Nguyen, Sang The Phan
Abstract
Open AccessTenofovir disoproxil fumarate (TDF) and entecavir (ETV) are first-line antiviral agents for chronic hepatitis B (CHB), yet comparative real-world data in Southeast Asian populations remain limited. This retrospective cohort study aimed to compare the efficacy, biochemical response, antifibrotic effect, and renal safety of TDF versus ETV in treatment-naïve Vietnamese patients with CHB over a 48-week period. A total of 348 patients (TDF: 181; ETV: 167) were included and evaluated at baseline, Weeks 12, 24, and 48. Both groups demonstrated comparable virologic suppression at Week 48 (TDF: 58.0%, ETV: 52.1%, p > 0.05). TDF achieved significantly higher ALT normalization at Week 24 (72.9% vs. 59.9%, p = 0.01) and Week 48 (84.0% vs. 69.5%, p = 0.001). In contrast, ETV led to faster AST normalization and greater early reductions in APRI and FIB-4 at Week 12. Renal function mildly declined in the TDF group (mean eGFR change: -3.84 ± 11.98, p < 0.001) but improved in the ETV group (+3.02 ± 12.34, p = 0.002). Both treatments were well tolerated with no virologic breakthrough or serious adverse events. In conclusion, both TDF and ETV offer effective antiviral therapy for Vietnamese CHB patients. TDF may be preferable in patients with active hepatic inflammation, whereas ETV may benefit those with baseline renal concerns or early fibrotic progression. These findings support a tailored approach to HBV management based on individual patient profiles.