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  • Clinical trial of lamivudine in children with chronic hepatitis B.
    Publication . Jonas, M.M.; Mizerski, J.; Badia, I.B.; Areias, J.A.; Schwarz, K.B.; Little, N.R.; Greensmith, M.J.; Gardner, S.D.; Bell, M.S.; Sokal, E.M.; International Pediatric Lamivudine Investigator Group.
    N Engl J Med. 2002 May 30;346(22):1706-13. Clinical trial of lamivudine in children with chronic hepatitis B. Jonas MM, Mizerski J, Badia IB, Areias JA, Schwarz KB, Little NR, Greensmith MJ, Gardner SD, Bell MS, Sokal EM; International Pediatric Lamivudine Investigator Group. of Gastroenterology, Children's Hospital, Boston, MA 02115, USA. Erratum in: N Engl J Med 2002 Sep 19;347(12):955. Kelley, Deirdre [corrected to Kelly, Deirdre]. Comment in: J Hepatol. 2003 May;38(5):698-9. N Engl J Med. 2002 May 30;346(22):1682-3. 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. PMID: 12037150 [PubMed - indexed for MEDLINE]
    2002-05Journal article Open access Show more