Document Detail

Combination therapy for children with chronic hepatitis B virus infection.
MedLine Citation:
PMID:  12201869     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND AIM: To compare the therapeutic efficacy of two different interferon (INF)-alpha and lamivudine (LAM) combination therapy regimens in childhood chronic hepatitis B (CHB) infections. METHODS: Thirty-two children with CHB infection were prospectively evaluated in two random groups. In the first group, patients received INF-alpha 10 MU/m2 and LAM 4 mg/kg (max 100 mg) simultaneously for 6 months, and then LAM alone was continued for 6 months. In the second group, LAM was started alone for the first 2 months, then INF-alpha added to LAM for 6 months, after which INF-alpha was stopped, and LAM alone was continued for 4 months. The same doses of LAM and INF-alpha were used in both groups. RESULTS: In the first group, the mean values of alanine aminotransferase (ALT) were 125 +/- 100 IU/L and 28 +/- 8 IU/L at the beginning of the treatment and at the end of the 12 months, respectively (P < 0.05). At the end of 6 months of the follow-up period, the mean ALT value was 36 +/- 37 IU/L. In group 2, mean ALT values were 111 +/- 63 IU/L, 35 +/- 2 IU/L and 34 +/- 2 IU/L initially, at the end of 12 months and at the end of 6 months of follow up, respectively (P < 0.05). At the end of therapy, the ratios of hepatitis B early antigen (HBeAg) clearance and antibody to HBeAg (anti-HBe) seroconversion were 65% and 47% in group 1 and 60% and 40% in group 2, respectively (P > 0.05). After 6 months from completion of therapy, rates of seroconversion to anti-HBe were found to be 64% and 47% in group 1, and 53% and 46% in group 2, respectively (P > 0.05). Hepatitis B virus (HBV) DNA was detectable by polymerase chain reaction in only one patient in group 1 at the end of therapy and 6 months after termination of therapy. Clearance of HBV DNA in group 2 was observed in all but one patient at the end of the therapy. However, two patients relapsed within 6 months of cessation of therapy. Complete response occurred in 47% and 40% of patients at the end of the therapy in group 1 and 2, respectively (P > 0.05). These ratios were changed to 47% and 46%, respectively, 6 months after discontinuation of drugs (P > 0.05). CONCLUSIONS: Comparison of our two different combination regimens disclosed similar results in the normalization of ALT, clearance of HBeAg and HBV DNA and seroconversion to anti-HBe. However, the most beneficial combination of LAM and INF-alpha treatment modalities needs to be further investigated.
Bunyamin Dikici; Mehmet Bosnak; Vuslat Bosnak; Abdullah Dagli; Aydin Ece; Rasit Vural Yagci; Kenan Haspolat
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of gastroenterology and hepatology     Volume:  17     ISSN:  0815-9319     ISO Abbreviation:  J. Gastroenterol. Hepatol.     Publication Date:  2002 Oct 
Date Detail:
Created Date:  2002-08-30     Completed Date:  2002-12-11     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8607909     Medline TA:  J Gastroenterol Hepatol     Country:  Australia    
Other Details:
Languages:  eng     Pagination:  1087-91     Citation Subset:  IM    
Department of Pediatrics, Dicle University Medical School, Diyarbakir, Turkey.
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MeSH Terms
Alanine Transaminase / blood
Antiviral Agents / therapeutic use*
Child, Preschool
DNA, Viral / analysis
Drug Therapy, Combination
Hepatitis B Antibodies / blood
Hepatitis B e Antigens / blood
Hepatitis B, Chronic / blood,  drug therapy*
Interferon-alpha / therapeutic use*
Lamivudine / therapeutic use*
Prospective Studies
Reverse Transcriptase Inhibitors / therapeutic use*
Reg. No./Substance:
0/Antiviral Agents; 0/DNA, Viral; 0/Hepatitis B Antibodies; 0/Hepatitis B e Antigens; 0/Interferon-alpha; 0/Reverse Transcriptase Inhibitors; 134678-17-4/Lamivudine; EC Transaminase

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