Current therapeutic approaches in childhood chronic hepatitis B infection: a multicenter study.

Department of Pediatrics, Dicle University Medical Faculty, Diyarbakir, Turkey.
Journal of Gastroenterology and Hepatology (Impact Factor: 3.63). 02/2004; 19(2):127-33. DOI: 10.1111/j.1440-1746.2004.03209.x
Source: PubMed

ABSTRACT The aim of the present study was to compare the therapeutic efficacy of three different regimens in childhood chronic hepatitis B (CHB) infection.
A total of 182 children with CHB infection were prospectively allocated to three random groups. Sixty-two patients in the first group received high-dose interferon (IFN)-alpha 2b (10 MU/m2) thrice/weekly alone for 6 months. In the second (n = 60) and third groups (n = 60), IFN-alpha was used for 6 months (5 MU/m2) thrice/weekly in combination with lamivudine (LAM) (4 mg/kg, maximum 100 mg/day) for 12 months. Lamivudine was started simultaneously with IFN in the second group, while it was started 2 months prior to IFN injections in the third group.
The initial mean alanine aminotransferase (ALT) values for the first, second and third groups were 109 +/- 93 IU/L, 101 +/- 64 IU/L and 92 +/- 42 IU/L, respectively (P > 0.05). At the end of the therapy, ALT values decreased to 82 +/- 111 IU/L, 38 +/- 41 IU/L and 29 +/- 16 IU/L in groups 1, 2 and 3, respectively. The mean ALT value of the first group was significantly different to the second and third groups (P = 0.046 and P = 0.002, respectively) at the end of the therapy and these differences were found to be sustained after 18 months. However, results in the second and third groups were similar (P > 0.05). There were no significant differences in HBeAg clearance and anti-HBe seroconversion at the initial stage, 12 months and 18 months between the three groups (P > 0.05). Hepatitis B virus (HBV) DNA clearance in the first group was different from the second and third groups, while the second and third groups had similar HBV DNA clearance ratios at 12 and 18 months. No significant difference was found in the complete response (normalization of ALT, clearance of HBV DNA and seroconversion of anti HBe) ratios of all groups (at 12 months: 28.8, 45.5, 35.8% and at 18 months 33.3, 49 and 34% in groups 1, 2 and 3, respectively, P > 0.05).
Although the ALT normalization and HBV DNA clearance ratios of IFN plus LAM combination groups were better than the high-dose IFN-alpha monotherapy group, no significant difference was found in the complete response ratios of all three groups.

  • [Show abstract] [Hide abstract]
    ABSTRACT: Background Effective management of children with chronic hepatitis B is still an unresolved issue. Aim To assess the outcome of different therapeutic regimens among children with HBeAg-positive chronic hepatitis B. Methods Electronic database searches identified clinical trials that completed specific periods of treatment and follow-up. Sustained response rates were defined by the loss of HBV DNA and HBeAg, and by the normalization of liver enzymes. The loss of HBsAg and seroconversion to anti-HBs were also listed. Results Our searches found 20 eligible articles (1112 enrolled patients, 2–18 years old). Interferon-alpha therapy showed significantly higher sustained response rate and loss of HBsAg than no therapy (Odd's ratio 3.0, 95% confidence interval 1.6–5.4; and 2.3, 1.1–11.3, respectively). The sustained response rate was not significantly different between interferon and interferon plus lamivudine, or plus prednisone, or plus hepatitis B vaccine; this rate was significantly higher for interferon compared with combined interferon plus levamisole or vitamin E. Conclusion Interferon-alpha is still the most effective treatment option for children with HBeAg-positive chronic hepatitis B. Randomized trials are warranted for further comparing interferon to newer antiviral agents in terms of efficacy, safety, emergence of mutant variants, and cost/benefit ratio.
    Digestive and Liver Disease 09/2014; 46(12). DOI:10.1016/j.dld.2014.08.032 · 2.89 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To identify the predictive factors of long-term therapeutic response or resistance to lamivudine treatment in children and adolescents with chronic hepatitis B. Eighty one children and adolescents with chronic hepatitis B were included, who received lamivudine treatment for at least 6 months. Their condition was monitored for at least 12 months (12-88 months) thereafter. Twenty one (25.9%) were preschool children (age≤6). For patients who had developed HBeAg seroconversion or breakthrough, univariate and multivariate analyses were used to identify the effects of age, gender, pretreatment alanine aminotransferase (ALT) and hepatitis B virus DNA levels. HBeAg seroconversion occurred in 49 (60.5%) of the 81 patients after the initiation of the lamivudine therapy. In 65 patients whom were monitored for over 24 months, the seroconversion rate was significantly higher in younger patients (p=0.040), especially in those patients of preschool age (age≤6, p=0.031). The seroconversion rate was significantly higher in higher pretreatment ALT (p=0.003). The breakthrough occurred in 21 (25.9%) of the 81. The breakthrough rate was lower in younger aged patients (age≤6), and with higher pretreatment ALT levels, but no significant difference. Younger age is a good predictor of HBeAg seroconversion in children with long-term lamivudine treatment as well as high pretreatment ALT levels.
    06/2013; 16(2):80-8. DOI:10.5223/pghn.2013.16.2.80
  • [Show abstract] [Hide abstract]
    ABSTRACT: Interferon (IFN) alpha has been the first line therapy of chronic hepatitis B in children, but HBeAg seroconversion occurred in 26% of treated children compared to 11% of controls in multinational randomized controlled study. Recently, lamivudine was shown to be a potent inhibitor of Hepatitis B virus (HBV) reproduction both in HBeAg positive and in HBeAg negative (the pre-core mutant form) chronic hepatitis in randomized studies worldwide. Lamivudine therapy led to considerable improvement in the seroconversion rate of HBeAg in children with chronic hepatitis B, though long-term therapy resulted in the expansion of lamivudine-resistant mutant viruses. Combination therapy with lamivudine plus alpha-IFN does not seem to improve HBe Ag seroconversion. Above all, the most effective way to prevent hepatitis B is universal HBV vaccination.
    Korean Journal of Pediatrics 01/2007; 50(9). DOI:10.3345/kjp.2007.50.9.823