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

[Guest guest]

http://www.springerlink.com/content/m5m68831888p2848/

Journal of Gastroenterology

DOI: 10.1007/s00535-010-0354-xOnline Firstâ„¢

Rapid Communication

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 and Joon-Yeol Han, et al.

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.

[Guest guest]

http://www.springerlink.com/content/m5m68831888p2848/

Journal of Gastroenterology

DOI: 10.1007/s00535-010-0354-xOnline Firstâ„¢

Rapid Communication

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 and Joon-Yeol Han, et al.

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.