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.

• Authors: 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
• Journal: Journal of gastroenterology (J Gastroenterol) Vol. 46 Issue 3 Pg. 410-4 (Mar 2011) ISSN: 1435-5922 [Electronic] Japan
• PMID: 21181212 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Arabinofuranosyluracil
• Alanine Transaminase
• clevudine

Topics

• Alanine Transaminase (blood)
• Antiviral Agents (therapeutic use)
• Arabinofuranosyluracil (analogs & derivatives, therapeutic use)
• DNA, Viral (blood)
• Follow-Up Studies
• Hepatitis B (blood, drug therapy, immunology, virology)
• Hepatitis B Surface Antigens (blood)
• Hepatitis B e Antigens (blood, immunology)
• Hepatitis B virus (immunology)
• Humans
• Viral Load