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.
RCT Entities:
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.
Authors: Robert P Perrillo; Hie-Won Hann; Eugene Schiff; David Mutimer; Bernard Willems; Nancy Leung; William M Lee; Susan Dixon; Mary Woessner; Carol L Brosgart; Lynn D Condreay; Stephen D Gardner Journal: Hepatol Int Date: 2011-01-05 Impact factor: 6.047
Authors: Markus Peck-Radosavljevic; Johann Deutsch; Peter Ferenci; Ivo Graziadei; Harald Hofer; Heidemarie Holzmann; Wolf-Dietrich Huber; Herman Laferl; Andreas Maieron; Rudolf Stauber; Wolfgang Vogel Journal: Wien Klin Wochenschr Date: 2010-05-04 Impact factor: 1.704
Authors: Morris Sherman; Vincent Bain; Jean-Pierre Villeneuve; Robert P Myers; Curtis Cooper; Steven Martin; Catherine Lowe Journal: Can J Infect Dis Med Microbiol Date: 2004-11 Impact factor: 2.471