Comparison Between Tenofovir and Entecavir Treatment in Real-World Clinical Practice

Abstract

Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are effective as two first-line anti-viral therapies for chronic hepatitis B (CHB); however, data are limited on directly comparing these two antivirals. This study aimed to compare the effectiveness and safety of TDF and ETV initial treatment of CHB patients. From October 2008 to December 2013, 257 consecutive treatment-naive CHB patients receiving TDF (n = 79) or ETV (n = 178) at Taipei Veterans General Hospital were enrolled. The baseline characteristics were comparable between the two groups. Kaplan-Meier curve estimated probability of complete HBV DNA suppression was 56.5% vs 75.9% at 6 months (P = .003), 81.7% vs 89.9% at 12 months (P = .098) and 93.3% vs 96.2% at 24 months (P = .565) in ETV and TDF group, respectively. Multivariate Cox regression indicated that treatment with TDF compared to ETV was a significant predictor of HBV DNA suppression (HR = 1.33; 95% CI 1.01-1.76; P = .045). In addition, HBAg positive (HR = 0.70; 95% CI 0.52-0.96; P = .025) and higher baseline HBV DNA level (HR = 0.84; 95% CI 0.76-0.92; P < .001) were significant negative predictors for viral suppression. The ALT normalization rate between these two treatment groups were not statistically significant (P = .114). Estimated glomerular filtration rate (eGFR) calculated by MDRD formula significantly decreased in both group at 24 months (-6.4027 in ETV vs -16.0556 in TDF, P = .006). Multivariate analysis indicated that TDF and baseline eGFR were independent factors associated with change of eGFR at 24 months. However, a small amount of patients progressed into moderate renal dysfunction during 24 months (0.7% vs 5.6%, P = .058). TDF was significantly more effective in achieving complete viral suppression, whereas it was also more significant in reduction of eGFR than ETV group.