Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine

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http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2010.02360.x/abstract

Efficacy of switching to telbivudine in chronic hepatitis B patients treated

previously with lamivudine

Rifaat Safadi1,2, Qing Xie3, Yagang Chen4, You-Kuan Yin5, Lai Wei6, Seong Gyu

Hwang7, Eli Zuckerman8, Ji-Dong Jia9, 10

Article first published online: 29 OCT 2010

DOI: 10.1111/j.1478-3231.2010.02360.x

© 2010 Wiley & Sons A/S

Issue

Liver International

Volume 31, Issue 5, pages 667–675, May 2011

Abstract

Background: Telbivudine showed greater antiviral suppression than lamivudine in

phase II and III clinical trials.

Aims: The present phase IIIb, randomized, double-blind, multicentre global trial

assessed the antiviral efficacy and safety of telbivudine switch in chronic

hepatitis B (CHB) patients who exhibited persistent viraemia under lamivudine

therapy.

Methods: HBeAg-positive and HBeAg-negative adult patients (N=246) with

persistent viraemia [hepatitis B virus (HBV) DNA>3 log10 copies/ml] under

lamivudine treatment for 12–52 weeks were randomized (1:1) to continue

lamivudine 100 mg/day or switch to telbivudine 600 mg/day for 1 year. Primary

endpoint was the reduction in serum HBV DNA levels from baseline at Week 24.

Results: The mean reduction in serum HBV DNA levels from baseline with

telbivudine was significantly higher than lamivudine at Week 24 (−1.9 ± 0.18

vs. −0.9 ± 0.27 log10 copies/ml; P<0.001) and maintained through 1 year. The

rate of treatment failure was significantly lower (P<0.001) for patients who

switched to telbivudine (5%) compared with those who continued lamivudine (20%)

after 52 weeks of treatment. In the telbivudine group, treatment failure

occurred in only five patients with >24 weeks of prior lamivudine treatment, all

associated with pre-existent lamivudine-resistant mutations. Genotypic

resistance rates were higher in patients continuing lamivudine compared with

those who switched to telbivudine with <24 weeks of lamivudine exposure. Both

treatments were well tolerated with similar safety profiles.

Conclusions: Early (≤24 weeks) switch to telbivudine improves virological

outcomes in CHB patients with persistent viral replication under lamivudine

treatment.