HIV and Hepatitis.com Coverage of the
42nd EASL Conference
April 11 - 15, 2007, Barcelona, Spain
THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER

Liver Inflammation and Fibrosis Can Occur in Hepatitis B Patients with Normal ALT

Hepatitis B
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Current treatment guidelines recommend that patients with chronic hepatitis B should receive treatment if they have active liver disease, indicated by an alanine aminotransferase (ALT) level 2 or more times the upper limit of normal (x ULN). However, some patients with lower ALT levels may still develop extensive liver damage.

As reported at the 42nd Annual Meeting of the European Association for the Study of the Liver this month in Barcelona, Spain, researchers assessed the distribution of Knodell necroinflammatory scores and Ishak fibrosis scores in chronic hepatitis B patients within 3 baseline ALT categories:

  • < 2 x ULN;

  • 2-5 x ULN;

  • 5 x ULN.

The study included 1253 treatment-naive chronic hepatitis B patients from 2 Phase III trials of entecavir, 1 of which included HBeAg positive subjects (ETV-022; n = 652) and the other HBeAg negative patients (ETV-027; n = 601). At baseline, the mean HBV DNA levels were 9.6 log10 in ETV-022 and 7.6 log10 in ETV-027.

Results

  • Percentages of HBeAg positive and negative patients with necroinflammatory (NI) scores of 7 or higher and Ishak fibrosis (IF) scores of 4 or higher are shown in the table below.
  • Among patients with ALT levels below 2 x ULN, 68% of HBeAg positive patients and 75% of HBeAg negative subjects had significant necroinflammation.

  • 11% of HBeAg positive patients and 17% of HBeAg negative subjects had advanced liver fibrosis.

Conclusion

“Over two-thirds of nucleoside-naive chronic hepatitis B patients with elevated [HBV] viral load demonstrate clinically significant (NI >/= 7) necroinflammation, despite ALT values < 2 x ULN,” the researchers concluded. “Consistent with the natural history of chronic hepatitis B in this population, fewer patients demonstrate advanced fibrosis or cirrhosis than elevated necroinflammatory scores, but advanced fibrosis is common even when ALT is < 2 x ULN.”

They added that, “Patients with elevated [HBV] viral load frequently demonstrate clinically relevant changes in histopathology which merit treatment even when ALT values are not elevated > 2 x ULN.”

University of California, San Francisco, CA; Mayo Clinic Medical Center, Rochester, MN; Erasmus MC University Medical Center, Rotterdam, Netherlands; National University of Singapore, Singapore; Academic Department of Medicine, Hippokration General Hospital, Athens, Greece; University of Padova, Italy; Queen Mary Hospital, Pok Fu Lam, Hong Kong, China; Armed Forces Institute of Pathology, Washington, DC; Bristol-Myers Squibb Company, Wallingford, CT and Princeton, NJ.

04/27/07

Reference
N Terrault, R Kim, S Schalm, and others. Presence of biopsy-proven histologic damage (necroinflammation and fibrosis) is common even when ALT is less than 2 x ULN in patients with chronic hepatitis B (CHB). 42 Annual Meeting of the European Association for the Study of the Liver. Barcelona, Spain. April 11-15, 2007.

 





























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