Objective: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) have been accepted as the standard treatment drugs for hepatitis B virus (HBV) reactivation. We aim to compare the efficacy and safety of TDF and ETV initial treatment of chronic hepatitis B (CHB) patients.
Methods: We retrospectively analyzed the efficacy and safety of TDF treatment on 33 CHB patients and of ETV treatment on 65 CHB patients by comparing the HBV DNA levels, HBV DNA undetectable rate, HBV DNA negative conversion multi-factor analysis, alanine amino transferase (ALT) normalization rate, and the adverse event incidence at weeks 4, 12, 24, 36, 48, 72 before and after treatment in each group.
Results: The HBV DNA levels in the ETV group were significantly lower than that in the TDF group at week 4 (95.05 ± 39.49 versus 103.3 ± 80.25 U/L, P = 0.005). The differences in HBV DNA levels at the other times between these two treatment groups were not statistically significant. No significant differences were observed with HBV DNA undetectable rate and ALT normalization rate between the two groups (P = 0.114, 0.656, respectively). HBV DNA negativity multi-factor analysis showed that the differences in TDF and ETV treatment were not statistically significant (P = 0.116). Therefore, the proportion of Creatine Kinase (CK) levels that were 2 times over the upper limit of normal (2ULN) showed no significant differences in any time points between the two groups (P > 0.05).
Conclusion: TDF and ETV treatment both exhibited rapid inhibiting effects on HBV DNA replication in the early phase of naïve CHB patients in Mainland China.
Keywords: ETV; TDF; chronic hepatitis B; treatment.