Journal article

ALT flares during nucleotide analogue therapy are associated with HBsAg loss in genotype A HBeAg-positive chronic hepatitis B

Darren Wong, Margaret Littlejohn, Rosalind Edwards, Kathy Jackson, Peter Revill, Anuj Gaggar, Kathryn Kitrinos, Mani Subramanian, Patrick Marcellin, Maria Buti-Ferret, Harry Janssen, Ed Gane, Stephen Locarnini, Alexander Thompson



BACKGROUND: Alanine aminotransferase (ALT) flares during NA therapy are uncommon but occur. Evaluation of ALT flares during nucleos(t)ide analogue (NA) therapy is important as new immunomodulatory therapies for hepatitis B virus (HBV) are developed. We evaluated the association between ALT flares and HBsAg loss during long-term therapy for genotype A CHB. METHODS: This analysis included genotype A subjects from a phase III study of tenofovir vs adefovir in HBeAg-positive HBV. ALT flare was defined as (i) a rise in ALT >2x ULN from normal ALT levels; or (ii) a rise in ALT >2x baseline ALT level. HBsAg response at week 384 was recorded as one of HBsAg loss vs HBsAg decline (≥1 log10  IU/mL dec..

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