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

[Guest guest]

http://www.ingentaconnect.com/content/mksg/liv/2011/00000031/00000005/art00010

Liver International, Volume 31, Number 5

Efficacy of switching to telbivudine in chronic hepatitis B patients treated

previously with lamivudine

Authors: Safadi, Rifaat; Xie, Qing1; Chen, Yagang2; Yin, You-Kuan3; Wei, Lai4;

Hwang, Seong Gyu5; Zuckerman, Eli6; Jia, Ji-Dong7; , 8

Source: Liver International, Volume 31, Number 5, May 2011 , pp. 667-675(9)

Publisher: Wiley-Blackwell

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.

Document Type: Research article

DOI: 10.1111/j.1478-3231.2010.02360.x

Affiliations:1: Department of Infectious Diseases, Ruijin Hospital, Shanghai

Jiaotong University School of Medicine, Shanghai, China 2: The First Affiliated

Hospital, School of Medicine, Zhejiang University, Hangzhou, China 3: Huashan

Hospital, Shanghai, China 4: People's Hospital, Peking University, Beijing,

China 5: CHA Bundang Medical Center, CHA University, Gyeonggi-Do, Korea 6: Liver

Unit in Carmel Medical Center, Haifa, Israel 7: Beijing Friendship Hospital,

Capital Medical University, Beijing, China 8: Novartis Pharma AG, Basel,

Switzerland

Publication date: 2011-05-01