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Previous Volume 346:1706-1713 May 30, 2002 Number 22 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Lok, A. S.F. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article PubMed Citation

ABSTRACT

Background Lamivudine therapy is effective for chronic hepatitis B infection in adults. We evaluated the efficacy and tolerability of lamivudine as a treatment for chronic infection with hepatitis B virus (HBV) in children.

Methods Children with chronic hepatitis B were randomly assigned in a 2:1 ratio to receive either oral lamivudine (3 mg per kilogram of body weight; maximum, 100 mg) or placebo once daily for 52 weeks. The primary end point was virologic response (defined by the absence of serum hepatitis B e antigen and serum HBV DNA) at week 52 of treatment.

Results Of the 403 children screened, 191 were randomly assigned to receive lamivudine and 97 to receive placebo. The rate of virologic response at week 52 was higher among children who received lamivudine than among those who received placebo (23 percent vs. 13 percent, P=0.04). Lamivudine therapy was well tolerated and 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.

Conclusions In children with chronic hepatitis B, 52 weeks of treatment with lamivudine was associated with a significantly higher rate of virologic response than was placebo.

Source Information

From Children's Hospital, Boston (M.M.J.); Diana Princess of Wales Hospital, Birmingham, United Kingdom (D.A.K.); John Paul II Hospital, Krakow, Poland (J.M.); Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina (I.B.B.); Hospital Geral de Santo Antonio, Porto, Portugal (J.A.A.); Johns Hopkins University, Baltimore (K.B.S.); GlaxoSmithKline, Research Triangle Park, N.C. (N.R.L., S.D.G., M.S.B.); GlaxoSmithKline, Greenford, United Kingdom (M.J.G.); and Cliniques Universitaires St. Luc, Brussels, Belgium (E.M.S.).

Address reprint requests to Dr. Jonas at the Division of Gastroenterology, Children's Hospital, 300 Longwood Ave., Boston, MA 02115.

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