Long-term
Response to Lamivudine (Epivir-HBV) in Children with Chronic Hepatitis B
While a majority adults infected with hepatitis B virus
(HBV) spontaneously clear the virus, most children develop chronic infection. Nevertheless,
there has been little study of hepatitis B treatment in pediatric patients. While
lamivudine (3TC; Epivir-HBV)
has been shown to be safe and effective, the optimal duration of treatment and
long-term outcomes in children are unknown.
As
reported in the January 2008 Journal of
Viral Hepatitis, members of the International Pediatric Lamivudine
Investigator Group examined the safety of lamivudine
and the durability of clinical response in 151 children with chronic hepatitis
B in 9 countries who received treatment for up to 3 years.
Initially,
the patients were enrolled in a large prospective trial in which they were randomized
to receive either lamivudine or placebo for the first
year. In a subsequent extension study, those who remained hepatitis B “e” antigen
(HBeAg) positive received lamivudine for up to 2 years, while those who were HBeAg negative were observed for an additional 2 years. The
present study followed the children off treatment for 2 more years.
The
participants were divided into 2 groups for analysis:
•
Those
who achieved virological response, defined as HBeAg negative and undetectable HBV DNA at the end of the
extension study at 3 years.
•
Those
who did not.
Results
•
Among
children who experienced virological response by the
end of the extension study, the long-term durability of HBeAg
seroconversion was 82% for those who received lamivudine for 52 weeks.
•
The
sustained HBeAg seroconversion
rate was greater than 90% for those who received lamivudine
for at least 2 years (compared with
75% for those who experienced seroconversion after taking
placebo).
•
Among
the children who did not achieve virological response
by the end of the extension study, an additional 11% did so by the end of the
present observation period.
•
In
this group, all had received lamivudine in initial trial
and none had received further treatment during the study.
•
8
children lost hepatitis B surface antigen (HBsAg) during
the study, all of whom had received lamivudine at some
point during the earlier trials.
•
Evaluation
of safety data revealed no serious adverse events related to lamivudine.
•
2%
of the children experienced clinically benign alanine
aminotransferase (ALT) flares (>10 times normal).
•
Treatment
had no observable effect on body weight or height.
Conclusion
In
conclusion, the authors wrote, “Favorable outcomes
from lamivudine treatment of chronic hepatitis B in
children are maintained for at least several years after
completion of treatment.”
“Up
to 3 years of lamivudine treatment is safe in children,”
they added.
1/18/08
Reference
MM
Jonas, NR Little, SD Gardner, and others. Long-term lamivudine
treatment of children with chronic hepatitis B: durability of therapeutic responses
and safety. Journal of Viral Hepatitis
15(1): 20-27. January 2008.
Hepatitis
B Main Section 
Hepatitis
B FDA-approved Treatments
