Efficacy comparison of rescue therapies between TDF monotherapy and TDF-ETV combination therapy in CHB patients who failed to be rescued with ETV

Abstract

Abstract: Objective To compare the clinical efficacy and safety between tenofovir disoproxil fumarate (TDF) monotherapy and TDF-entecavir (ETV) therapy for ETV-refractory chronic hepatitis B (CHB) patients with prior lamivudine (LAM) treatment.Methods Eighty LAM-treated CHB patients with failure of ETV rescue therapy were randomly divided into monotherapy group and combination group. The monotherapy group received TDF (300mg/d) alone for 48 weeks, while the combination group was treated with TDF (300mg/d) plus ETV (0.5mg/d). Assessment of serum hepatitis B virus (HBV) DNA, hepatitis B e antigen (HBeAg), alanine aminotransferase (ALT) and adverse events at week 0, 12, 24 and 48 were performed to analyze therapy efficacy and adverse effects in both groups, respectively. Results After 48-week follow up, the virological response (VR) rate, biochemical response (BR) rate, virologic breakthrough (VB) rate, HBeAg seroconversion rate were 85.0% (34/40), 76.2% (16/21), 0% and 13.1% (3/23) in monotherapy group and 87.5% (35/40), 77.3% (17/22), 0% and 16.0% (4/25) in combination group, respectively (P＞0.05). There were no significant differences in all the monitoring indicators between the two groups. Both groups showed well tolerance with no serious adverse events. Conclusion The TDF monotherapy could be an effective and safe therapeutic strategy for LAM-treated CHB patients who failed to be rescued with ETV therapy.

Key words: Chronic hepatitis B, Entecavir, Suboptimal response, Rescue treatment, Tenofovir disoproxil fumarate

LI Zhong-bin, SHAO Qing, LI Fan, LI Bing, CHEN song-hai, WANG Chun-yan, CHEN Guo-feng. Efficacy comparison of rescue therapies between TDF monotherapy and TDF-ETV combination therapy in CHB patients who failed to be rescued with ETV[J]. Chinese Hepatolgy, 2016, 21(3): 165-167.

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