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Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine
Author(s) -
Safadi Rifaat,
Xie Qing,
Chen Yagang,
Yin YouKuan,
Wei Lai,
Hwang Seong Gyu,
Zuckerman Eli,
Jia JiDong,
Lopez Patricia
Publication year - 2011
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/j.1478-3231.2010.02360.x
Subject(s) - lamivudine , telbivudine , medicine , chronic hepatitis , virology , hepatitis b , gastroenterology , virus
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 log 10 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 log 10 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.