Combination of baseline parameters and on-treatment hepatitis B virus DNA levels to start and continue patients with lamivudine therapy

Abstract

Background

This study aimed to identify the baseline hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) levels and on-treatment HBV DNA levels for favourable outcome in patients receiving 5-year lamivudine.

Methods

Virological, serological and biochemical parameters were assessed in 74 hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients at year 5 of therapy.

Results

Patients with baseline HBV DNA levels <9 log₁₀ copies/ml and ALT≥2x the upper limit of normal (ULN) had a significantly higher chance of HBV DNA suppression to <4 log₁₀ copies/ml (76.5%) and HBeAg seroconversion (82.4%), and a lower chance of YMDD mutations (35.3%) compared with patients with HBV DNA<9 log₁₀ copies/ml and ALT<2xULN and patients with HBV DNA≥9 log₁₀ copies/ml (all P<0.05). All patients with these two baseline parameters plus week 4 HBV DNA<4 log₁₀ copies/ml achieved HBV DNA<35 copies/ml, HBeAg seroconversion and ALT normalization without YMDD mutations at year 5. When these two baseline parameters were combined with week 24 HBV DNA<3 log₁₀ copies/ml, 60%, 80% and 90% of patients had HBV DNA<35 copies/ml, <3 log₁₀ copies/ml and <4 log₁₀ copies/ml, respectively at year 5. Overall, 90% of patients had HBeAg seroconversion and only 10% had YMDD mutations.

Conclusions

For HBeAg-positive patients with baseline HBV DNA<9 log₁₀ copies/ml and ALT≥2xULN, lamivudine could be initiated. For those with HBV DNA<4 log₁₀ copies/ml at week 4 or <3 log₁₀ copies/ml at week 24, continuation of lamivudine treatment would be more likely to result in a good long-term response.