Currently, there are no conclusive results on the efficacy of Tenofovir disoproxil fumarate (TDF) monotherapy in chronic hepatitis B (CHB) patients with lamivudine-resistant (LAM-R).

The aim of this study was to compare the efficacy between TDF and TDF-based combination therapy against LAM-R HBV in CHB patients.

Randomized and non-randomized control trials directly comparing TDF and TDF-based therapy for treatment of LAM-R CHB patients, were searched in Pubmed, Medline, EMBASE, database up to June 15, 2015. The data were analyzed with Review Manager (v.5.3).

Five articles (683 patients in total) met entry criteria. The overall efficacy of tenofovir-based combination therapy was not significantly better with regard to the rates of virological response (85.5% vs. 81.5%; RR=0.95, 95%CI=0.88–1.03, P=0.25), ALT normalization (61.9% vs.72.0%; RR=1.18, 95%CI=0.96–1.44, P=0.11) and HBeAg loss (17.0% vs. 18.1%; RR=1.40, 95%CI=0.78–2.49, P=0.26) compared with TDF monotherapy through 48-week treatment. Additionally, subgroup analysis showed that no significant difference was determined as TDF group compared to TDF-based group at 48weeks, in terms of rates of HBV DNA undetectability, ALT normalization and HBeAg loss in the treatment of LAM-R patients with prior failure of LAM monotherapy. Moreover, the rates of HBV DNA suppression between groups were similar through 24 or 48weeks of treatment in LAM-R patients with prior failure of LAM/ADV therapy.

TDF monotherapy is as effective as TDF-based combination therapy in maintaining viral suppression in LAM-R patients with prior failure of LAM or LAM/ADV therapy.