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 journalArticle

5 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 languageEnglish
Pages (from-to)410-414
Number of pages5
JournalJournal of Gastroenterology
Volume46
Issue number3
DOIs
Publication statusPublished - 2011 Mar 1

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Hepatitis B Surface Antigens
Hepatitis B Antigens
Alanine Transaminase
Hepatitis B virus
Therapeutics
DNA
Clevudine
Circular DNA
Hepatitis B
Hepatocytes
Cohort Studies

Keywords

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

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy. / Lee, Hyo Suk; Yoo, Byung Chul; Lee, Kwan Sik; Kim, Ju Hyun; Um, Soon-Ho; Ryu, Soo Hyung; Lee, Young Suk; Kim, Young Soo; Yoo, Kwon; Han, Joon Yeol; Hwang, Jae Seok; Kim, Tae Hun; Yang, Jin Mo; Lee, Heon Ju; Chon, Chae Yoon; Cho, Mong; Han, Byung Hoon; Hwang, Seong Gyu; Byun, Kwan Soo; Chung, Young Hwa; Cho, Se Hyun; Koh, Kwang Cheol; Kim, Byung Ik; Kim, Haak Cheoul; Paik, Seung Woon; Lee, Myung Seok; Yoo, Hee Won; Han, Cheol Ju.

In: Journal of Gastroenterology, Vol. 46, No. 3, 01.03.2011, p. 410-414.

Research output: Contribution to journalArticle

Lee, HS, Yoo, BC, Lee, KS, Kim, JH, Um, S-H, 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
Lee, Hyo Suk ; Yoo, Byung Chul ; Lee, Kwan Sik ; Kim, Ju Hyun ; Um, Soon-Ho ; Ryu, Soo Hyung ; Lee, Young Suk ; Kim, Young Soo ; Yoo, Kwon ; Han, Joon Yeol ; Hwang, Jae Seok ; Kim, Tae Hun ; Yang, Jin Mo ; Lee, Heon Ju ; Chon, Chae Yoon ; Cho, Mong ; Han, Byung Hoon ; Hwang, Seong Gyu ; Byun, Kwan Soo ; Chung, Young Hwa ; Cho, Se Hyun ; Koh, Kwang Cheol ; Kim, Byung Ik ; Kim, Haak Cheoul ; Paik, Seung Woon ; Lee, Myung Seok ; Yoo, Hee Won ; Han, Cheol Ju. / Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy. In: Journal of Gastroenterology. 2011 ; Vol. 46, No. 3. pp. 410-414.
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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

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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.

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KW - ccc-DNA

KW - HBeAg seroconversion

KW - HBsAg loss

KW - HBV DNA

KW - Hepatitis B virus

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