The efficacy and safety of telbivudine in korean patients with chronic hepatitis B

Young Myoung Moon, Seong Gyu Hwang, Boo Sung Kim, Kyu Sung Rim, Mong Cho, Dong Joon Kim, Joon Yeol Han, Young Seok Kim, Ho Soon Choi, SangHoon Ahn

Research output: Contribution to journalArticle

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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. 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. 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. CONCLUSIONS: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine.

Original languageEnglish
Pages (from-to)503-512
Number of pages10
JournalThe Korean journal of hepatology
Volume13
Issue number4
DOIs
Publication statusPublished - 2007 Jan 1

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Chronic Hepatitis B
Lamivudine
Hepatitis B e Antigens
Safety
Hepatitis B virus
Serum
DNA
Alanine Transaminase
Therapeutics
telbivudine
Nucleosides
Antiviral Agents
Clinical Trials
Viruses
Polymerase Chain Reaction

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Moon, Young Myoung ; Hwang, Seong Gyu ; Kim, Boo Sung ; Rim, Kyu Sung ; Cho, Mong ; Kim, Dong Joon ; Han, Joon Yeol ; Kim, Young Seok ; Choi, Ho Soon ; Ahn, SangHoon. / The efficacy and safety of telbivudine in korean patients with chronic hepatitis B. In: The Korean journal of hepatology. 2007 ; Vol. 13, No. 4. pp. 503-512.
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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. 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. 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. CONCLUSIONS: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine.",
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Moon, YM, Hwang, SG, Kim, BS, Rim, KS, Cho, M, Kim, DJ, Han, JY, Kim, YS, Choi, HS & Ahn, S 2007, 'The efficacy and safety of telbivudine in korean patients with chronic hepatitis B', The Korean journal of hepatology, vol. 13, no. 4, pp. 503-512. https://doi.org/10.3350/kjhep.2007.13.4.503

The efficacy and safety of telbivudine in korean patients with chronic hepatitis B. / Moon, Young Myoung; Hwang, Seong Gyu; Kim, Boo Sung; Rim, Kyu Sung; Cho, Mong; Kim, Dong Joon; Han, Joon Yeol; Kim, Young Seok; Choi, Ho Soon; Ahn, SangHoon.

In: The Korean journal of hepatology, Vol. 13, No. 4, 01.01.2007, p. 503-512.

Research output: Contribution to journalArticle

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T1 - The efficacy and safety of telbivudine in korean patients with chronic hepatitis B

AU - Moon, Young Myoung

AU - Hwang, Seong Gyu

AU - Kim, Boo Sung

AU - Rim, Kyu Sung

AU - Cho, Mong

AU - Kim, Dong Joon

AU - Han, Joon Yeol

AU - Kim, Young Seok

AU - Choi, Ho Soon

AU - Ahn, SangHoon

PY - 2007/1/1

Y1 - 2007/1/1

N2 - 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. 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. 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. CONCLUSIONS: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine.

AB - 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. 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. 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. CONCLUSIONS: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine.

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