An international group of researchers evaluated the efficacy and tolerability of lamivudine as a treatment for chronic hepatitis B virus (HBV) infection in children.
A total of 288 children with chronic hepatitis B were included in the study.
They were randomly assigned in a 2:1 ratio to receive either oral lamivudine (3 mg per kg of body weight; maximum, 100 mg, n = 191) or placebo (n = 97), once daily for 52 weeks.
The primary end point was virologic response at week 52 of treatment. This was defined by the absence of serum hepatitis B e antigen and serum HBV DNA.
The rate of virologic response at week 52 was higher among children who received lamivudine than among those who received placebo (23% vs 13%).
|Virologic response at 1 year:|
| New England Journal of Medicine |
The team found that lamivudine therapy was well tolerated.
It was also associated with higher rates of seroconversion from hepatitis B e antigen to hepatitis B e antibody, normalization of alanine aminotransferase levels, and suppression of HBV DNA.
Dr Maureen M. Jonas, of the Children's Hospital, Boston, Massachusetts, USA, concluded on behalf of her colleagues, "In children with chronic hepatitis B, a year of treatment with lamivudine was associated with a significantly higher rate of virologic response than was placebo."