Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine |
| |
Authors: | Rifaat Safadi Qing Xie Yagang Chen You‐Kuan Yin Lai Wei Seong Gyu Hwang Eli Zuckerman Ji‐Dong Jia Patricia Lopez |
| |
Institution: | 1. Hadassah Medical Center, Jerusalem, Israel;2. Holy Family Hospital, Nazareth, Israel;3. Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China;4. The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China;5. Huashan Hospital, Shanghai, China;6. People's Hospital, Peking University, Beijing, China;7. CHA Bundang Medical Center, CHA University, Gyeonggi‐Do, Korea;8. Liver Unit in Carmel Medical Center, Haifa, Israel;9. Beijing Friendship Hospital, Capital Medical University, Beijing, China;10. Novartis Pharma AG, Basel, Switzerland |
| |
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. |
| |
Keywords: | chronic hepatitis B HBV DNA lamivudine nucleoside analogue telbivudine switch |
|
|