A Randomized Comparative Study between the Effect of Tenofovir Alafenamide and Entecavir in Treatment naïve Chronic Hepatitis B Patients

Abstract

Background: Chronic hepatitis B (CHB) remains a major global health problem and is associated with significant morbidity and mortality due to liver cirrhosis and hepatocellular carcinoma. Potent nucleos(t)ide analogues such as tenofovir alafenamide (TAF) and entecavir (ETV) are recommended as first-line antiviral therapies. However, comparative data regarding their efficacy and safety in treatment-naïve CHB patients in Bangladesh remain limited.
Objective: To compare the efficacy and safety of TAF and ETV in treatment-naïve CHB patients.

Methods: This randomized comparative study was conducted at the Hepatitis Clinic of the Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from January 2024 to December 2024. A total of 44 treatment-naïve CHB patients were enrolled and randomly allocated into two groups: TAF group (n=22) and ETV group (n=22). Patients received TAF 25 mg once daily or ETV 0.5 mg once daily for 48 weeks. Clinical assessment and laboratory investigations including HBV DNA, alanine aminotransferase (ALT), hepatitis B surface antigen (HBsAg), anti-HBe, and serum creatinine were performed at baseline, 24 weeks, and 48 weeks. Data were analyzed using SPSS version 27.
Results: Both treatment groups showed significant reduction of HBV DNA levels from baseline to 24 weeks and 48 weeks. ALT levels also decreased progressively in both groups, indicating improvement in biochemical response. No statistically significant difference was observed between TAF and ETV groups regarding virological suppression, ALT normalization, or serological response. However, serum creatinine levels at one year were significantly higher in the ETV group compared with the TAF group (p=0.028).
Conclusion: Both TAF and ETV are effective antiviral therapies for treatment-naïve CHB patients, achieving significant virological suppression and biochemical improvement. TAF demonstrated a relatively favorable safety profile, particularly regarding renal function. Larger studies with longer follow-up are required to evaluate long-term outcomes.