Comparison of efficacy and safety of entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide fumarate treatment in patients with high viral load of hepatitis B virus

Abstract

Nucleos(t)ide analogues (NAs) have demonstrated potent efficacy in suppressing viral replication in chronic hepatitis B (CHB). This 48-week study compared the efficacy and safety of NA treatment for CHB patients with high viral load (hepatitis B virus [HBV] deoxyribonucleic acid [DNA]>7 log10 IU/mL). This retrospective study included 180 nucleos(t)ide-naïve CHB patients with high viral load undergoing NA monotherapy, which were stratified into 3 groups: entecavir (ETV, n=82), tenofovir disoproxil fumarate (TDF, n=58), and tenofovir alafenamide fumarate (TAF, n=40). The primary endpoint was the proportion of patients achieving HBV DNA<20 IU/mL, with safety assessed by lipid profiles and renal function. The study infjects' mean baseline HBV DNA levels were 7.68, 7.73, and 7.75 log10 IU/mL in ETV, TDF, and TAF groups, respectively. At week 48, TDF had a higher viral suppression (HBV DNA<20 IU/mL) rate (67.74%) than TAF (37.50%) cohort (P=.004) and ETV (54.88%) was comparable to both (P>.05). Hepatitis B e antigen loss and seroconversion were comparable across all groups, with no hepatitis B surface antigen loss observed. Similar proportions of patients with high alanine aminotransferase levels at baseline achieved normalization by week 48 in all regimens. Low-density lipoprotein, total cholesterol, and triglyceride elevations were comparable across all groups. High-density lipoprotein reductions were 15.63%, 35.71%, and 17.86% in ETV, TDF, and TAF, respectively (P=.043), with TDF reducing high-density lipoprotein and total cholesterol more than ETV (P=.014 and P