Anti-viral effect in chronic hepatitis B patients with normal or mildly elevated alanine aminotransferase.

BACKGROUND & AIMS: Normal/mildly elevated ALT (<2×ULN) CHB patients are potentially at risk of progression to cirrhosis and/or hepatocellular carcinoma (HCC). We aimed to assess the outcomes of anti-viral therapy for normal/mild elevation of ALT CHB patients. CHB patients (n=432) were liver biopsied was determined.

METHODS: It was determined that the outcomes of anti-viral therapy in CHB patients with normal/mild elevation of ALT, in response to nucleoside/nucleotide analogues (NAs) (n=190) and pegylated interferon (PEG-IFN) (n=30) treatment for up to 72 weeks. Non-antiviral treated patients were used as control (n=40).

RESULTS: There was about 50% of the CHB patients showed hepatic inflammatory necrosis ≥ G2 and/or fibrosis ≥ S2, and were >30-years. The rate of undetectable HBV DNA in NAs and PEG-IFN groups was ∼50%, ∼80% or ∼90% at week 24, 48 or 72, respectively. HBeAg clearance rate was lower in NAs treated than that in PEG-IFN group at week 48 (6% vs 20%, P<0.05). ALT normalization rate was increased by 1.18-fold at week 72. HBsAg decline in HBeAg+ patients treated with NAs or PEG-IFN was 0.418 or 1.217 log IU/mL (P<0.0001) at week 48; whereas HBsAg decline was 0.176 or 0.816 log IU/mL (P<0.001) in HBeAg- patients. HBsAg at baseline and week 24 were strong predictors of "low HBsAg at week 48".

CONCLUSION: Long term antiviral therapy inhibits HBV replication effectively in ALT<2×ULN CHB patients. PEG-IFN therapy is recommended for HBeAg+ patients with baseline HBsAg<4.37 log IU/ml and HBeAg- patients with baseline HBsAg<2.66 log IU/ml to achieve "low HBsAg at week 48".