A year of lamivudine treatment results in increased Hepatitis B e antigen seroconversion
It also leads to serum Hepatitis B virus DNA negativity in children with chronic Hepatitis B and high serum alanine aminotransferase concentrations.
Dr Etienne Sokal and colleagues from Belgium conducted a 1-year randomized, placebo-controlled study of lamivudine in 276 children.
The patients were stratified into 2 groups based on Hepatitis B e antigen status at week 48 of the previous study.
The investigative team entered 213 Hepatitis B e antigen-positive children into a treatment arm.
A further 63 Hepatitis B e antigen-negative children were entered into an observation arm to evaluate durability of Hepatitis B e antigen loss.
The team's primary endpoint included virological response, or Hepatitis B e antigen loss and Hepatitis B virus DNA negativity, at month 24.
In the treatment arm, 21 % of children previously treated with lamivudine achieved the primary endpoint.
|21% previously treated achieved virological response vs 30% with placebo|
Of the children who previously received placebo, 30% achieved virological response.
The investigators assessed the incidence of YMDD - tyrosine, methionine, aspartate, aspartate - mutations at month 24.
In the children previously treated with lamivudine, the incidence of YMDD mutations at month 24 was 64% vs 49% in those treated with placebo.
The incidence of virological response at month 24 was 5% for patients with YMDD mutant Hepatitis B virus and 54% for patients without.
In addition, the investigators found that the durability of response in the observation arm was 89% at month 24.
Dr Sokal's team concluded, “Further clinical response was seen over the 24-month open-label study period in children who had not initially achieved a virological response after 12 months of lamivudine treatment.”
“However, the incidence of YMMD mutations increased over time and resulted in lower response rates.”
“Virological response was maintained in most patients who had initially responded to lamivudine in the first 12 months.”