Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

Hyo Suk Lee; Byung Chul Yoo; Kwan Sik Lee; Ju Hyun Kim; Soon Ho Um; Soo Hyung Ryu; Young Suk Lee; Young Soo Kim; Kwon Yoo; Joon Yeol Han; Jae Seok Hwang; Tae Hun Kim; Jin Mo Yang; Heon Ju Lee; Chae Yoon Chon; Mong Cho; Byung Hoon Han; Seong Gyu Hwang; Kwan Soo Byun; Young Hwa Chung; Se Hyun Cho; Kwang Cheol Koh; Byung Ik Kim; Haak Cheoul Kim; Seung Woon Paik; Myung Seok Lee; Hee Won Yoo; Cheol Ju Han

doi:10.1007/s00535-010-0354-x

Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

Hyo Suk Lee, Byung Chul Yoo, Kwan Sik Lee, Ju Hyun Kim, Soon Ho Um, Soo Hyung Ryu, Young Suk Lee, Young Soo Kim, Kwon Yoo, Joon Yeol Han, Jae Seok Hwang, Tae Hun Kim, Jin Mo Yang, Heon Ju Lee, Chae Yoon Chon, Mong Cho, Byung Hoon Han, Seong Gyu Hwang, Kwan Soo Byun, Young Hwa ChungSe Hyun Cho, Kwang Cheol Koh, Byung Ik Kim, Haak Cheoul Kim, Seung Woon Paik, Myung Seok Lee, Hee Won Yoo, Cheol Ju Han

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

Abstract

Background: This study was conducted to evaluate the durability of clevudine-induced viral response after the withdrawal of treatment. Methods: Patients who showed a complete response [alanine aminotransferase (ALT) normalization and hepatitis B virus (HBV) DNA <4,700 copies/mL for hepatitis B envelope antigen (HBeAg)-negative patients; ALT normalization, HBV DNA <4,700 copies/mL, and HBeAg seroconversion for HBeAg-positive patients] in the previous clevudine phase III trials were followed for an additional 96 weeks without any treatment for hepatitis B. Results: Of the 63 patients in the study cohort, 73% and 35% of the patients had HBV DNA <141,500 and <4,700 copies/mL, respectively, and 75% of the patients had normal ALT at the end of follow-up. HBeAg seroconversion was maintained in 81% of the patients and hepatitis B surface antigen (HBsAg) loss occurred in 3 patients. Continued HBsAg titer decrease (-0.5 log IU/mL) was observed in the sustained viral responders, suggesting the reduction of covalently closed circular DNA in hepatocytes. Conclusions: The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.

Original language	English
Pages (from-to)	410-414
Number of pages	5
Journal	Journal of Gastroenterology
Volume	46
Issue number	3
DOIs	https://doi.org/10.1007/s00535-010-0354-x
Publication status	Published - 2011 Mar
Externally published	Yes

Bibliographical note

Funding Information:
This study was sponsored by Bukwang Pharmaceutical Co. Ltd and in part by the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (Grant No. 02-PJ2-PG4-PT01-0034).

Keywords

HBV DNA
HBeAg seroconversion
HBsAg loss
Hepatitis B virus
ccc-DNA

ASJC Scopus subject areas

Gastroenterology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s00535-010-0354-x

Cite this

Lee, H. S., Yoo, B. C., Lee, K. S., Kim, J. H., Um, S. H., Ryu, S. H., Lee, Y. S., Kim, Y. S., Yoo, K., Han, J. Y., Hwang, J. S., Kim, T. H., Yang, J. M., Lee, H. J., Chon, C. Y., Cho, M., Han, B. H., Hwang, S. G., Byun, K. S., ... Han, C. J. (2011). Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy. Journal of Gastroenterology, 46(3), 410-414. https://doi.org/10.1007/s00535-010-0354-x

Lee, HS, Yoo, BC, Lee, KS, Kim, JH, Um, SH, Ryu, SH, Lee, YS, Kim, YS, Yoo, K, Han, JY, Hwang, JS, Kim, TH, Yang, JM, Lee, HJ, Chon, CY, Cho, M, Han, BH, Hwang, SG, Byun, KS, Chung, YH, Cho, SH, Koh, KC, Kim, BI, Kim, HC, Paik, SW, Lee, MS, Yoo, HW & Han, CJ 2011, 'Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy', Journal of Gastroenterology, vol. 46, no. 3, pp. 410-414. https://doi.org/10.1007/s00535-010-0354-x

@article{d23de36da71b4e5bb077e27cb825be71,

title = "Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy",

abstract = "Background: This study was conducted to evaluate the durability of clevudine-induced viral response after the withdrawal of treatment. Methods: Patients who showed a complete response [alanine aminotransferase (ALT) normalization and hepatitis B virus (HBV) DNA <4,700 copies/mL for hepatitis B envelope antigen (HBeAg)-negative patients; ALT normalization, HBV DNA <4,700 copies/mL, and HBeAg seroconversion for HBeAg-positive patients] in the previous clevudine phase III trials were followed for an additional 96 weeks without any treatment for hepatitis B. Results: Of the 63 patients in the study cohort, 73% and 35% of the patients had HBV DNA <141,500 and <4,700 copies/mL, respectively, and 75% of the patients had normal ALT at the end of follow-up. HBeAg seroconversion was maintained in 81% of the patients and hepatitis B surface antigen (HBsAg) loss occurred in 3 patients. Continued HBsAg titer decrease (-0.5 log IU/mL) was observed in the sustained viral responders, suggesting the reduction of covalently closed circular DNA in hepatocytes. Conclusions: The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.",

keywords = "HBV DNA, HBeAg seroconversion, HBsAg loss, Hepatitis B virus, ccc-DNA",

author = "Lee, {Hyo Suk} and Yoo, {Byung Chul} and Lee, {Kwan Sik} and Kim, {Ju Hyun} and Um, {Soon Ho} and Ryu, {Soo Hyung} and Lee, {Young Suk} and Kim, {Young Soo} and Kwon Yoo and Han, {Joon Yeol} and Hwang, {Jae Seok} and Kim, {Tae Hun} and Yang, {Jin Mo} and Lee, {Heon Ju} and Chon, {Chae Yoon} and Mong Cho and Han, {Byung Hoon} and Hwang, {Seong Gyu} and Byun, {Kwan Soo} and Chung, {Young Hwa} and Cho, {Se Hyun} and Koh, {Kwang Cheol} and Kim, {Byung Ik} and Kim, {Haak Cheoul} and Paik, {Seung Woon} and Lee, {Myung Seok} and Yoo, {Hee Won} and Han, {Cheol Ju}",

note = "Funding Information: This study was sponsored by Bukwang Pharmaceutical Co. Ltd and in part by the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (Grant No. 02-PJ2-PG4-PT01-0034).",

year = "2011",

month = mar,

doi = "10.1007/s00535-010-0354-x",

language = "English",

volume = "46",

pages = "410--414",

journal = "Journal of Gastroenterology",

issn = "0944-1174",

publisher = "Springer",

number = "3",

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T1 - Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

AU - Lee, Hyo Suk

AU - Yoo, Byung Chul

AU - Lee, Kwan Sik

AU - Kim, Ju Hyun

AU - Um, Soon Ho

AU - Ryu, Soo Hyung

AU - Lee, Young Suk

AU - Kim, Young Soo

AU - Yoo, Kwon

AU - Han, Joon Yeol

AU - Hwang, Jae Seok

AU - Kim, Tae Hun

AU - Yang, Jin Mo

AU - Lee, Heon Ju

AU - Chon, Chae Yoon

AU - Cho, Mong

AU - Han, Byung Hoon

AU - Hwang, Seong Gyu

AU - Byun, Kwan Soo

AU - Chung, Young Hwa

AU - Cho, Se Hyun

AU - Koh, Kwang Cheol

AU - Kim, Byung Ik

AU - Kim, Haak Cheoul

AU - Paik, Seung Woon

AU - Lee, Myung Seok

AU - Yoo, Hee Won

AU - Han, Cheol Ju

N1 - Funding Information: This study was sponsored by Bukwang Pharmaceutical Co. Ltd and in part by the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (Grant No. 02-PJ2-PG4-PT01-0034).

PY - 2011/3

Y1 - 2011/3

N2 - Background: This study was conducted to evaluate the durability of clevudine-induced viral response after the withdrawal of treatment. Methods: Patients who showed a complete response [alanine aminotransferase (ALT) normalization and hepatitis B virus (HBV) DNA <4,700 copies/mL for hepatitis B envelope antigen (HBeAg)-negative patients; ALT normalization, HBV DNA <4,700 copies/mL, and HBeAg seroconversion for HBeAg-positive patients] in the previous clevudine phase III trials were followed for an additional 96 weeks without any treatment for hepatitis B. Results: Of the 63 patients in the study cohort, 73% and 35% of the patients had HBV DNA <141,500 and <4,700 copies/mL, respectively, and 75% of the patients had normal ALT at the end of follow-up. HBeAg seroconversion was maintained in 81% of the patients and hepatitis B surface antigen (HBsAg) loss occurred in 3 patients. Continued HBsAg titer decrease (-0.5 log IU/mL) was observed in the sustained viral responders, suggesting the reduction of covalently closed circular DNA in hepatocytes. Conclusions: The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.

AB - Background: This study was conducted to evaluate the durability of clevudine-induced viral response after the withdrawal of treatment. Methods: Patients who showed a complete response [alanine aminotransferase (ALT) normalization and hepatitis B virus (HBV) DNA <4,700 copies/mL for hepatitis B envelope antigen (HBeAg)-negative patients; ALT normalization, HBV DNA <4,700 copies/mL, and HBeAg seroconversion for HBeAg-positive patients] in the previous clevudine phase III trials were followed for an additional 96 weeks without any treatment for hepatitis B. Results: Of the 63 patients in the study cohort, 73% and 35% of the patients had HBV DNA <141,500 and <4,700 copies/mL, respectively, and 75% of the patients had normal ALT at the end of follow-up. HBeAg seroconversion was maintained in 81% of the patients and hepatitis B surface antigen (HBsAg) loss occurred in 3 patients. Continued HBsAg titer decrease (-0.5 log IU/mL) was observed in the sustained viral responders, suggesting the reduction of covalently closed circular DNA in hepatocytes. Conclusions: The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.

KW - HBV DNA

KW - HBeAg seroconversion

KW - HBsAg loss

KW - Hepatitis B virus

KW - ccc-DNA

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AN - SCOPUS:79954420265

SN - 0944-1174

VL - 46

SP - 410

EP - 414

JO - Journal of Gastroenterology

JF - Journal of Gastroenterology

IS - 3

ER -

Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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