Virologic and biochemical responses to clevudine in patients with chronic HBV infection- associated cirrhosis: data at week 48

[Guest guest]

Virologic and biochemical responses to clevudine in patients with chronic HBV

infection- associated cirrhosis: data at week 48

J. H. Kim, H. J. Yim, E. S. Jung, Y. K. Jung, J. H. Kim, Y. S. Seo, J. E. Yeon,

H. S. Lee, S. H. Um, K. S. Byun

Article first published online: 28 MAR 2010

DOI: 10.1111/j.1365-2893.2010.01304.x

© 2010 Blackwell Publishing Ltd

Issue

Journal of Viral Hepatitis

Volume 18, Issue 4, pages 287–293, April 2011

Summary.  Clevudine shows high rates of virologic and biochemical responses in

patients with chronic hepatitis B. However, the efficacy and safety of clevudine

in patients with cirrhosis are unknown. The aims of this study were to evaluate

the safety and to assess the virologic and the biochemical responses to

clevudine in patients with cirrhosis with chronic hepatitis B virus (HBV)

infection. We reviewed data from treatment-naïve patients with chronic

hepatitis B with and without cirrhosis who started clevudine between April 2007

and March 2008 (n = 52, hepatitis B without cirrhosis n = 21 and chronic

hepatitis B with cirrhosis n = 31) at Korea University Ansan/Guro Hospital. All

of the patients were treated for more than 48 weeks. The mean age was older in

the patients with cirrhosis. Baseline HBV DNA levels were 6.9 and 7.78 log

copies/mL (P = 0.042), and alanine aminotransferase (ALT) levels were 104.9 and

147.4 IU/L (P = 0.204), for those with and without cirrhosis, respectively.

Virologic response (HBV DNA <1000 copies/mL) (87.1%vs 71.4%, P = 0.24) and

biochemical response (83.9%vs 80.9%, P = 0.99) at week 48 were not significantly

different between the two groups. Early virologic response at week 12 was even

higher in the patients with cirrhosis (61.3%vs 28.6%, P = 0.026). Neither ALT

flare nor newly onset hepatic decompensation was found in the patients with

cirrhosis, whereas ALT flare was transiently observed in 14.3% of the chronic

hepatitis group. In conclusion, although clevudine may produce a transient

elevation of ALT during the early treatment period, such findings were not

observed in patients with cirrhosis and the virologic and biochemical responses

of the groups were comparable.

[Guest guest]

Virologic and biochemical responses to clevudine in patients with chronic HBV

infection- associated cirrhosis: data at week 48

J. H. Kim, H. J. Yim, E. S. Jung, Y. K. Jung, J. H. Kim, Y. S. Seo, J. E. Yeon,

H. S. Lee, S. H. Um, K. S. Byun

Article first published online: 28 MAR 2010

DOI: 10.1111/j.1365-2893.2010.01304.x

© 2010 Blackwell Publishing Ltd

Issue

Journal of Viral Hepatitis

Volume 18, Issue 4, pages 287–293, April 2011

Summary.  Clevudine shows high rates of virologic and biochemical responses in

patients with chronic hepatitis B. However, the efficacy and safety of clevudine

in patients with cirrhosis are unknown. The aims of this study were to evaluate

the safety and to assess the virologic and the biochemical responses to

clevudine in patients with cirrhosis with chronic hepatitis B virus (HBV)

infection. We reviewed data from treatment-naïve patients with chronic

hepatitis B with and without cirrhosis who started clevudine between April 2007

and March 2008 (n = 52, hepatitis B without cirrhosis n = 21 and chronic

hepatitis B with cirrhosis n = 31) at Korea University Ansan/Guro Hospital. All

of the patients were treated for more than 48 weeks. The mean age was older in

the patients with cirrhosis. Baseline HBV DNA levels were 6.9 and 7.78 log

copies/mL (P = 0.042), and alanine aminotransferase (ALT) levels were 104.9 and

147.4 IU/L (P = 0.204), for those with and without cirrhosis, respectively.

Virologic response (HBV DNA <1000 copies/mL) (87.1%vs 71.4%, P = 0.24) and

biochemical response (83.9%vs 80.9%, P = 0.99) at week 48 were not significantly

different between the two groups. Early virologic response at week 12 was even

higher in the patients with cirrhosis (61.3%vs 28.6%, P = 0.026). Neither ALT

flare nor newly onset hepatic decompensation was found in the patients with

cirrhosis, whereas ALT flare was transiently observed in 14.3% of the chronic

hepatitis group. In conclusion, although clevudine may produce a transient

elevation of ALT during the early treatment period, such findings were not

observed in patients with cirrhosis and the virologic and biochemical responses

of the groups were comparable.