Virological response to entecavir is associated with a better clinical outcome in chronic hepatitis B patients with cirrhosis

Gut, 04/13/2012

Virological response (VR) to Entecavir (ETV) is associated with a lower probability of disease progression in patients with cirrhosis, even after correction for possible baseline confounders. When using a threshold of 2000IU/ml, the association between viral replication and disease progression was reduced, suggesting that complete viral suppression is essential for nucleoside/nucleotide analogue treatment, especially in patients with cirrhosis.

Methods

  • In a multicentre cohort study, 372 ETV-treated patients were investigated.
  • Clinical events were defined as development of hepatocellular carcinoma (HCC), hepatic decompensation or death.
  • Virological response (VR) was defined as HBV DNA <80 IU/ml.

Results

  • Patients were classified as having chronic hepatitis B without cirrhosis (n=274), compensated cirrhosis (n=89) and decompensated cirrhosis (n=9).
  • The probability of VR was not influenced by severity of liver disease (p=0.62).
  • During a median follow-up of 20 months (IQR 11–32), the probability of developing clinical events was higher for patients with cirrhosis (HR 15.41 (95% CI 3.42 to 69.54), p<0.001).
  • VR was associated with a lower probability of disease progression (HR 0.29 (95% CI 0.08 to 1.00), p=0.05) which remained after correction for established risk factors such as age.
  • The benefit of VR was only significant in patients with cirrhosis (HR 0.22 (95% CI 0.05 to 0.99), p=0.04) and remained after excluding decompensated patients (HR 0.15 (95% CI 0.03 to 0.81), p=0.03).
  • A higher HBV DNA threshold of 2000 IU/ml was not associated with the probability of disease progression (HR 0.20 (95% CI 0.03 to 1.10), p=0.10).
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