Document Detail

Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function.
MedLine Citation:
PMID:  19937695     Owner:  NLM     Status:  MEDLINE    
Entecavir is a potent nucleoside inhibitor of the hepatitis B virus (HBV) polymerase with a high antiviral efficacy and a high genetic barrier to viral resistance. After approval in 2006, knowledge on the side effect profile in patients with advanced liver disease and impaired liver function is still limited. Here, we report on 16 patients with liver cirrhosis and chronic hepatitis B who were treated with entecavir. Five of these patients developed lactic acidosis during entecavir treatment. All patients who developed lactic acidosis had highly impaired liver function (Model for End-Stage Liver Disease [MELD] score >or= 20). Lactic acidosis (lactate 26-200 mg/dL, pH 7.02-7.40, base excess -5 mmol/L to -18 mmol/L) occurred between 4 and 240 days after treatment initiation with entecavir. Lactic acidosis was lethal in one patient but resolved in the other cases after termination/interruption of entecavir treatment. No increased lactate serum concentrations were observed during treatment with entecavir in the other 11 patients with chronic hepatitis B and liver cirrhosis who all had MELD scores below 18. The MELD score correlated with the development of lactic acidosis (P < 0.005) as well as its single parameters bilirubin, international normalized ratio, and creatinine. In contrast, Child-Pugh Score did not correlate with the development of lactic acidosis. Our data indicate that entecavir should be applied cautiously in patients with impaired liver function.
Christian M Lange; J?rg Bojunga; Wolf Peter Hofmann; Katrin Wunder; Ulrike Mihm; Stefan Zeuzem; Christoph Sarrazin
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Hepatology (Baltimore, Md.)     Volume:  50     ISSN:  1527-3350     ISO Abbreviation:  Hepatology     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-11-27     Completed Date:  2009-12-15     Revised Date:  2010-06-02    
Medline Journal Info:
Nlm Unique ID:  8302946     Medline TA:  Hepatology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2001-6     Citation Subset:  IM    
Klinikum der J. W. Goethe-Universit?t Frankfurt am Main, Medizinische Klinik 1, Frankfurt am Main, Germany.
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MeSH Terms
Acidosis, Lactic / chemically induced*
Aged, 80 and over
Antiviral Agents / adverse effects*
Guanine / adverse effects,  analogs & derivatives*
Hepatitis B, Chronic / drug therapy*,  physiopathology,  virology
Liver Failure / physiopathology*
Middle Aged
Reg. No./Substance:
0/Antiviral Agents; 0/entecavir; 73-40-5/Guanine
Comment In:
Hepatology. 2010 Jun;51(6):2235   [PMID:  20229521 ]

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