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[The efficacy and safety of telbivudine in korean patients with chronic hepatitis B].
- Source :
-
The Korean journal of hepatology [Korean J Hepatol] 2007 Dec; Vol. 13 (4), pp. 503-12. - Publication Year :
- 2007
-
Abstract
- Background and Aims: Telbivudine is an L-nucleoside analogue with potent antiviral activity against hepatitis B virus (HBV). Clinical trials have shown that telbivudine is more potent than lamivudine for suppressing virus.<br />Methods: A total 101 Korean patients among 1,367 patients who participated in the phase III GLOBE trial were randomized in this study. All 101 HBeAg positive or HBeAg negative patients were assigned to treatment with 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy endpoint (the "therapeutic response") was defined as suppression of the serum HBV DNA to less than 5 log10 copies/mL coupled with either normalization of the serum alanine aminotransferase level or loss of HBeAg. The secondary endpoints included the histologic response, serum HBV DNA reduction, serum alanine aminotransferase normalization and HBeAg loss for the HBeAg positive patients. This analysis includes the data collected at 52 weeks of treatment.<br />Results: Fifty four of 101 patients were assigned to telbivudine treatment and 47 patients were assigned to lamivudine treatment. At week 52, significantly more patients who were treated with telbivudine than those treated with lamivudine had a therapeutic response (83% vs 62%, respectively, P=0.017), their mean serum HBV DNA levels were more reduced (6.6 vs 5.6 log10 copies/mL, respectively, P=0.027), and they more often achieved PCR-undetectable levels of serum HBV DNA (74% vs 34%, P<0.0001). No virologic resistance to telbivudine was detected (0% vs 18%, respectively, P=0.001). Telbivudine was well tolerated and it had a safety profile comparable to lamivudine.<br />Conclusions: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine.
- Subjects :
- Adolescent
Adult
Alanine Transaminase analysis
Antiviral Agents administration & dosage
Antiviral Agents adverse effects
Drug Resistance, Viral
Female
Hepatitis B e Antigens analysis
Hepatitis B virus drug effects
Hepatitis B virus genetics
Hepatitis B virus isolation & purification
Hepatitis B, Chronic virology
Humans
Korea
Lamivudine administration & dosage
Lamivudine adverse effects
Lamivudine therapeutic use
Male
Middle Aged
Nucleosides administration & dosage
Nucleosides adverse effects
Pyrimidinones administration & dosage
Pyrimidinones adverse effects
Telbivudine
Thymidine analogs & derivatives
Treatment Outcome
Antiviral Agents therapeutic use
Hepatitis B, Chronic drug therapy
Nucleosides therapeutic use
Pyrimidinones therapeutic use
Subjects
Details
- Language :
- Korean
- ISSN :
- 1738-222X
- Volume :
- 13
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- The Korean journal of hepatology
- Publication Type :
- Academic Journal
- Accession number :
- 18159148
- Full Text :
- https://doi.org/10.3350/kjhep.2007.13.4.503