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

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http://www.ingentaconnect.com/content/bsc/jvh/2011/00000018/00000004/art00028

Virologic and biochemical responses to clevudine in patients with chronic HBV

infection- associated cirrhosis: data at week 48

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

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

Source: Journal of Viral Hepatitis, Volume 18, Number 4, April 2011 , pp.

287-293(7)

Publisher: Wiley-Blackwell

Abstract:

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.

Document Type: Research article

DOI: 10.1111/j.1365-2893.2010.01304.x

Publication date: 2011-04-01

[Guest guest]

http://www.ingentaconnect.com/content/bsc/jvh/2011/00000018/00000004/art00028

Virologic and biochemical responses to clevudine in patients with chronic HBV

infection- associated cirrhosis: data at week 48

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

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

Source: Journal of Viral Hepatitis, Volume 18, Number 4, April 2011 , pp.

287-293(7)

Publisher: Wiley-Blackwell

Abstract:

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.

Document Type: Research article

DOI: 10.1111/j.1365-2893.2010.01304.x

Publication date: 2011-04-01