Comparison of the Efficacy of Tenofovir Versus Tenofovir plus Entecavir in the Treatment of Chronic Hepatitis B in Patients With Poor Efficacy of Entecavir: A Systematic Review and Meta-analysis

Abstract

Purpose: This study aimed to compare the efficacy between tenofovir disoproxil fumarate (TDF) and TDF plus entecavir (ETV) combination therapy in patients with chronic hepatitis B (CHB) with a poor response to ETV.

Methods: We searched the China National Knowledge Infrastructure (CNKI), PubMed, EMBASE, and SCOPE libraries for articles using the keywords chronic hepatitis B virus or CHB or HBV, entecavir or ETV, and tenofovir or TDF.

Findings: Five studies (from CNKI and PubMed) with a total of 408 patients met the inclusion criteria: 212 patients in the TDF group and 196 patients in the TDF plus ETV group. The rates of viral suppression between the 2 groups were comparable at weeks 24 and 48 of treatment (P = 0.546 vs P = 0.818). In addition, the subanalysis revealed that no significant differences were observed in the rates of viral suppression between the 2 groups at week 24 (subgroup 1 [partial response to ETV]: P = 0.822; subgroup 2 [resistance to ETV]: P = 0.294) and week 48 (subgroup 1: P = 0.797; subgroup 2: P = 0.545). No significant differences were found in alanine aminotransferase normalization, hepatitis B e antigen loss, hepatitis B e antigen seroconversion, virologic breakthrough, and tolerability between the 2 groups at weeks 24 and 48. Therefore, the results suggest that TDF monotherapy should be chosen for patients with CHB with a poor response to ETV for reasons of economy and convenience.

Implications: We conclude that TDF monotherapy is comparable to TDF-ETV combination therapy for patients with a poor response to ETV; thus, TDF monotherapy may be a better choice for these patients. However, because of the limited citations in this meta-analysis, complete and systematic evidence is needed to evaluate the differences in efficacy and tolerability between TDF and TDF-ETV. Larger and longer randomized clinical trials and further studies should be conducted to verify the results.

Keywords: chronic hepatitis B; entecavir; entecavir resistance; partial response; tenofovir; tenofovir plus entecavir.