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      Impacto de la disminución de la carga viral en el tratamiento de la hepatitis B en pacientes pediátricos

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          Abstract

          El objetivo de este trabajo es comprobar la eficacia del tratamiento para Hepatitis B con Lamivudina como monoterapia durante 6 meses y posteriormente combinado con Interferon convencional o Pegilado durante 6 meses más, y comparar si hay diferencias entre los dos esquemas de tratamiento. Materiales y métodos: se incluyeron 15 pacientes con Hepatitis B crónica. 8/15 recibieron lamivudina + interferon convencional y 7/15 recibieron lamivudina + interferon pegilado. Se realizó ADNHBV a los 6 meses de tratamiento (antes de empezar tratamiento con interferon) y 6 meses posterior a terminarlo. Resultados: 15 pacientes en edades entre 2 y 15 años fueron incluidos. No fue estadísticamente significativo al comparar las edades y el sexo entre los grupos. Las aminotransferasas pretratamiento y postratmiento variaron significativamente. No hubo veriación significativa en la negativización del ADNVHB durante y posterior al tratamiento, en los 2 grupos. 12/15 negativizaron ADNVHB y AgHBe; 3/12 presentan AgHbs positivo. Conclusión: la disminución de la carga viral con lamivudina mejora la respuesta al tratamiento coninterferon en pacientes pediátricos.

          Translated abstract

          The objective of this study is to determine the effectiveness of treatment for Hepatitis B with Lamivudine as monotherapy for 6 months followed with conventional or pegylated interferon therapy for another 6 months, and compare whether there are differences between the two treatment modalities. Materials and methods: 15 patients with chronic Hepatitis B were included. 8 / 15 received conventional interferon and lamivudine and 7 / 15 received lamivudine + pegylated interferon. ADNHBV was performed at 6 months of treatment (before starting treatment with interferon) and 6 months after completion. Results: 15 patients with ages between 2 and 15 years were included. There was not statistically significanse when comparing the age and gender between the groups. Aminotransferases pretreatment and postreatment varied significantly. There was no significant variation between both groups in regard to ADNVHB negativization during and after treatment. 12/15 had ADNVHB and eAgHB negativization; 3 / 12 were HBsAg positive. Conclusion: the decrease in viral load with lamivudine improves the response to treatment with interferon in pediatric patients.

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          Clinical trial of lamivudine in children with chronic hepatitis B.

          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. 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. 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. 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.
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            Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial.

            BACKGROUND, AIM, AND METHODS: Alpha interferon is the generally approved therapy for HBe antigen positive patients with chronic hepatitis B, but its efficacy is limited. Lamivudine is a new oral nucleoside analogue which potently inhibits hepatitis B virus (HBV) DNA replication. To investigate the possibility of an additive effect of interferon-lamivudine combination therapy compared with interferon or lamivudine monotherapy, we conducted a randomised controlled trial in 230 predominantly Caucasian patients with hepatitis B e antigen (HBeAg) and HBV DNA positive chronic hepatitis B. Previously untreated patients were randomised to receive: combination therapy of lamivudine 100 mg daily with alpha interferon 10 million units three times weekly for 16 weeks after pretreatment with lamivudine for eight weeks (n=75); alpha interferon 10 million units three times weekly for 16 weeks (n=69); or lamivudine 100 mg daily for 52 weeks (n=82). The primary efficacy end point was the HBeAg seroconversion rate at week 52 (loss of HBeAg, development of antibodies to HBeAg and undetectable HBV DNA). The HBeAg seroconversion rate at week 52 was 29% for the combination therapy, 19% for interferon monotherapy, and 18% for lamivudine monotherapy (p=0.12 and p=0.10, respectively, for comparison of the combination therapy with interferon or lamivudine monotherapy). The HBeAg seroconversion rates at week 52 for the combination therapy and lamivudine monotherapy were significantly different in the per protocol analysis (36% (20/56) v 19% (13/70), respectively; p=0.02). The effect of combining lamivudine and interferon appeared to be most useful in patients with moderately elevated alanine aminotransferase levels at baseline. Adverse events with the combination therapy were similar to interferon monotherapy; patients receiving lamivudine monotherapy had significantly fewer adverse events. HBeAg seroconversion rates at one year were similar for lamivudine monotherapy (52 weeks) and standard alpha interferon therapy (16 weeks). The combination of lamivudine and interferon appeared to increase the HBeAg seroconversion rate, particularly in patients with moderately elevated baseline aminotransferase levels. The potential benefit of combining lamivudine and interferon should be investigated further in studies with different regimens of combination therapy.
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              Interferon alfa therapy for chronic hepatitis B in children: a multinational randomized controlled trial.

              Treatment of chronic hepatitis B with interferon alfa is not approved in children. The aim of this study was to evaluate the safety and efficacy of interferon alfa (IFN-alpha) in children with chronic hepatitis B and increased transaminase levels.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Journal
                gen
                Gen
                Gen
                Sociedad Venezolana de Gastroentereología (Caracas )
                0016-3503
                December 2008
                : 62
                : 4
                : 278-281
                Affiliations
                [1 ] Hospital de Niños J. M. de los Ríos Venezuela
                Article
                S0016-35032008000400003
                8973fe5d-283d-407e-af5d-96ae6d3220ef

                http://creativecommons.org/licenses/by/4.0/

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                SciELO Venezuela

                Self URI (journal page): http://www.scielo.org.ve/scielo.php?script=sci_serial&pid=0016-3503&lng=en

                Hepatitis B in children,interferon,lamivudine,treatment,Hepatitis B en niños,Interferon,Lamivudina,tratamiento

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