The ultra-short virological dynamics in response to entecavir or lamivudine during chronic hepatitis B with spontaneous severe acute exacerbation.

BACKGROUND: Nucleoside/nucleotide analogue (NA) therapy could be life-saving in chronic hepatitis B (CHB) with spontaneous severe acute exacerbation (SAE). We aimed to investigate the ultra-short virological responses to NA.

METHODS: We conducted a randomized controlled trial in which CHB patients with spontaneous SAE were randomized to receive lamivudine (LVD) or entecavir (ETV) between July 2012 and April 2016 (ClinicalTrials.gov: NCT01627223). The serum HBV viral loads on day 1 (baseline), 3, 5, 8, 15, 22, 29, 85 and 180 after initiating NA therapy were checked and analysed.

RESULTS: In total, 17 patients (7 in LVD and 10 in ETV group) were recruited, and 3 patients (17.7%) died or received liver transplantation due to hepatic failure. The median (IQR) HBV DNA decline on days 3, 5, 8, 15, 22, 29, 85 and 180 were 1.38 (1.09-1.50), 2.36 (1.89-2.58), 3.19 (2.21-3.51), 3.76 (2.54-4.40), 3.43 (2.44-4.75), 4.00 (3.01-5.04), 5.00 (3.61-6.21) and 6.50 (4.12-7.20) log IU/ml, respectively. The baseline characteristics were basically similar between the two groups, and the dynamic changes in HBV DNA were not significantly different between the two groups. Further analysis of the patients with high HBV viral load (>6 log IU/ml) revealed that a similar baseline HBV DNA level in the two groups (LVD versus ETV: median 8.0 [7.5-8.8] versus 7.7 [6.6-8.4] log IU/ml; P=0.45), and the dynamic changes of HBV DNA were very similar.

CONCLUSIONS: CHB with spontaneous SAE responded similarly to treatment using either LVD or ETV, with both drugs inducing a rapid decline of HBV viral load.