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.
Safadi R et al. - Early (≤24 weeks) switch to telbivudine improves
virological outcomes in chronic hepatitis B(CHB) patients with persistent
viral replication under lamivudine treatment.
Methods • HBeAg-positive and HBeAg-negative adult patients (N=246) with
persistent viraemia 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 hepatitis B virus(HBV) DNA
levels from baseline at Week 24.
Results • Mean reduction in serum HBV DNA levels from baseline with
telbivudine was significantly higher than lamivudine at Week 24 and
maintained through 1 year.
• Rate of treatment failure was significantly lower for patients who
switched to telbivudine (5%) compared with those who continued lamivudine
(20%) after 52 weeks of treatment.
• In 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.
Safadi R等。 - 早期(≤24周)开关替比夫定改善
在慢性乙型肝炎(CHB)患者的病毒学成果与持久性
在拉米夫定治疗病毒复制。