***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND & AIMS The treatment of chronic hepatitis B infection ( CHB ) in children is still an area of great uncertainty . Vitamin E is an immunostimulating/antioxidant compound proven to be safe and effective for the treatment of adult CHB . The aim of this phase 2 controlled study was to evaluate the safety and efficacy of vitamin E for the treatment of paediatric HBeAg-positive CHB . METHODS Forty-six children were r and omized in a 1:1 ratio to receive vitamin E at a dose of 15 mg/kg/day ( in galenic preparation ) or no treatment for 12 months and were monitored for the subsequent 12 months . Clinical , biochemical , haematological and serovirological evaluations were carried out every 3 months . RESULTS No significant side effects were associated with the vitamin E treatment . At the end of the study , anti-HBe seroconversion was obtained in 7 of 23 ( 30.4 % ) of vitamin E-treated versus 1 of 23 ( 4.3 % ) of the control patients ( P = 0.05 ) , while a virological response ( ≥2 log decrease in HBV-DNA from baseline ) was observed in 9 of 23 ( 39.1 % ) vs. 2 of 23 ( 8.7 % ) respectively ( P = 0.035 ) . CONCLUSIONS Vitamin E administration for the treatment of paediatric CHB at the tested dosage has no significant side effects and may induce anti-HBe seroconversion  . Vitamin E could represent a tool for the treatment of paediatric CHB One year of lamivudine treatment results in increased hepatitis B e antigen ( HBeAg ) seroconversion and serum hepatitis B virus ( HBV ) DNA negativity in children with chronic hepatitis B and high serum alanine aminotransferase concentrations . Two hundred seventy-six children who participated in a 1-year r and omized , placebo-controlled study of lamivudine  were enrolled in a 24-month , open-label extension . Patients were stratified into two groups based on HBeAg status at week 48 of the previous study : 213 HBeAg-positive children were entered into a treatment arm , and 63 HBeAg-negative children were entered into an observation arm to evaluate durability of HBeAg loss . In the treatment arm , 28 of 133 ( 21 % ) children previously treated with lamivudine and 23 of 77 ( 30 % ) children who previously received placebo achieved the primary end point : virological response ( VR ) ( HBeAg loss and HBV DNA negativity ) at month 24 . The incidence of YMDD ( tyrosine , methionine , aspartate , aspartate ) mutations at month 24 was 64 % ( 66/103 ) in the children previously treated with lamivudine and 49 % ( 34/70 ) in those previously treated with placebo . The incidence of VR at month 24 was 5 % ( 5/100 ) for patients with YMDD mutant HBV and 54 % ( 39/72 ) for patients without . The durability of response in the observation arm was 89 % ( 48/54 ) at month 24 . In conclusion , further clinical response was seen over the 24-month open-label study period in children who had not initially achieved a VR after 12 months of lamivudine treatment . However , the incidence of YMMD mutations increased over time and result ed in lower response rates . VR was maintained in most patients who had initially responded to lamivudine in the first 12 months UNLABELLED This ongoing , r and omized phase III study assesses the safety and efficacy of entecavir versus placebo in nucleos(t)ide-naïve children ( 2 to < 18 years ) with hepatitis B envelope antigen (HBeAg)-positive chronic hepatitis B ( CHB ) . Blinded treatment was administered for a minimum of 48 weeks . After week 48 , patients with HBeAg seroconversion continued blinded treatment ; those without switched to open-label entecavir . The primary endpoint was HBeAg seroconversion and HBV DNA < 50 IU/mL at week 48 . A total of 180 patients were r and omized ( 2:1 ) and treated . Baseline median age was 12 years , with approximately 50 % of children ages > 12 to < 18 , and 25 % each ages ≥2 to ≤6 and > 6 to ≤12  . Rates for the primary endpoint at week 48 were significantly higher with entecavir than placebo ( 24.2 % [ 29 of 120 ] vs. 3.3 % [ 2 of 60 ] ; P = 0.0008 ) . Furthermore , higher response rates were observed with entecavir compared with placebo for the key week 48 secondary endpoints : HBV DNA < 50 IU/mL ( 49.2 % [ 59 of 120 ] vs. 3.3 % [ 2 of 60 ] ; P < 0.0001 ) ; alanine aminotransferase normalization ( 67.5 % [ 81 of 120 ] vs. 23.3 % [ 14 of 60 ] ; P < 0.0001 ) ; and HBeAg seroconversion ( 24.2 % [ 29 of 120 ] vs. 10.0 % [ 6 of 60 ] ; P = 0.0210 ) . Among entecavir-r and omized patients , there was an increase in all efficacy endpoints between weeks 48 and 96 , including an increase from 49 % to 64 % in virological suppression . The cumulative probability of emergent entecavir resistance through years 1 and 2 of entecavir was 0.6 % and 2.6 % , respectively . Entecavir was well tolerated with no observed differences in adverse events or changes in growth  compared with placebo . CONCLUSION In childhood CHB , entecavir demonstrated superior antiviral efficacy to placebo with a favorable safety profile . These results support the use of entecavir as a therapeutic option in children and adolescents with CHB AIM To evaluate the safety and efficacy of Vitamin E in children with chronic hepatitis B. METHODS We r and omly assigned patients with chronic hepatitis B , positive for hepatitis B e antigen ( HBeAg ) , to receive either Vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner . The primary end point was HBeAg seroconversion , defined as the loss of HBeAg , undetectable levels of serum hepatitis B virus DNA , and the appearance of antibodies against HBeAg 12 mo after therapy . RESULTS At baseline visit , 49 patients had normal and 43 had increased serum aminotransferase levels . Twenty-nine patients did not respond to previous treatment with interferon-alpha or lamivudine . Seventy-six children completed the study ; 16 were non-compliant ( n = 7 ) , lost to follow-up ( n = 7 ) , or started another antiviral treatment ( n = 3 ) . Intention-to-treat analysis showed HBeAg seroconversion in 16 children ( 23.2 % ) treated with Vitamin E and two ( 8.7 % ) in the placebo group ( P = 0.13 ) . Vitamin E was well tolerated . CONCLUSION There is only a tendency that Vitamin E may promote HBeAg seroconversion . Therefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis BACKGROUND & AIMS 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 . METHODS Children were given either IFN-alpha2b ( 6 megaunits/m2 thrice weekly for 24 weeks ) or no treatment . Clearance of markers of viral replication was evaluated 24 weeks after therapy and after 48 weeks of observation in controls . RESULTS Of 149 children enrolled , 144 were evaluable ( 70 treated and 74 controls ) .  Serum hepatitis B e antigen and viral DNA became negative in 26 % of treated children and 11 % of controls ( P < 0.05 ) . Serum aminotransferase levels normalized and liver histology improved among responders . Hepatitis B surface antigen became undetectable in 10 % of treated patients and 1 % of controls . Female gender and interferon treatment were the only significant predictors of response . Ethnic origin , baseline aminotransferase level , initial DNA levels , and histology did not correlate with response . Most adverse reactions were mild or moderate , and dose was reduced in 24 % of children . CONCLUSIONS In children with chronic hepatitis B , INF-alpha promotes loss of viral replication markers and surface antigen and improves aminotransferases and histology BACKGROUND & AIMS Little is known about the benefit of antiviral therapy for hepatitis B e antigen (HBeAg)-positive patients with high viral load and normal levels of alanine aminotransferase . We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B. METHODS In a double-blind study , nucleos(t)ide-naïve patients with high levels of hepatitis B virus ( HBV ) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were r and omly assigned to groups given either oral tenofovir disoproxil fumarate ( TDF , 300 mg ) and placebo ( n = 64 ) or a combination of TDF ( 300 mg ) and emtricitabine ( 200 mg , n = 62 ) for 192 weeks . The primary end point was proportion of patients with serum levels of HBV DNA < 69 IU/mL at week 192 . RESULTS The study population ( mean age was 33 years ; 89 % were Asian ) was predominantly infected with HBV genotypes B and C ( 93 % ) , 99 % were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL. At week 192 , 55 % of patients ( 35 of 64 ) in the TDF+placebo group and 76 % of patients ( 47 of 62 ) in the TDF+emtricitabine group had levels of HBV DNA < 69 IU/mL ( P = .016 ) . No patients were found to have viral resistance to therapy . HBeAg seroconversion occurred in 3 patients ( 5 % ) , all in the TDF+placebo group ; no patient had loss of hepatitis B surface antigen . In multivariate analysis , female sex ( odds ratio = 7.05 ; P = .002 ) and TDF+emtricitabine treatment ( odds ratio = 3.9 ; P = .01 ) were associated with a favorable response . Both regimens were well tolerated . CONCLUSIONS In HBeAg-positive patients with chronic HBV infection , high viral loads , normal levels of alanine aminotransferase , and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone , although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low BACKGROUND AND AIMS Interferon-alpha treatment has been the treatment of choice for chronic hepatitis with unpredictable results . Recently , Lamivudine has been licensed for use against HBV infection with good results . Unfortunately , recurrence of viremia after lamivudine withdrawal is common and prolonged treatment can induce the emergence of resistant mutant strains . It has been shown that vitamin E can increase the host immune response , and this may provide protection against infectious diseases . METHODS We evaluated vitamin E supplementation as therapy for chronic hepatitis B in a pilot study including 32 patients . Patients were r and omly allocated to receive vitamin E at the dose of 300 mg twice daily for 3 months ( 15 patients ) or no treatment ( 17 patients ) . They were seen monthly during the first 3 months and thereafter quarterly for additional 12 months . RESULTS The two groups were comparable at enrollment . At the end of the study period , alanine aminotransferase ( ALT ) normalization was observed in 7 ( 47 % ) patients in vitamin E group and only in 1 ( 6 % ) of the controls ( P=0.011 ) ; HBV-DNA negativization was observed in 8 ( 53 % ) patients in the vitamin E group as compared to 3 ( 18 % ) in the control group , respectively ( P=0.039 ) . A complete response ( normal ALT and negative HBV-DNA ) was obtained in 7 ( 47 % ) patients taking vitamin E and in none of the controls ( P=0.0019 ) . CONCLUSION Vitamin E supplementation might be effective in the treatment of chronic hepatitis UNLABELLED Hepatitis B e antigen (HBeAg)-negative hepatitis is a clinical indicator of poor outcome for chronic hepatitis B viral ( HBV ) infection . This long-term prospect i ve cohort study aim ed to eluci date the predictors of developing HBeAg-negative hepatitis in chronic HBV-infected subjects followed from childhood to adulthood . We followed 434 HBeAg- 
    Output:
    
Although our meta- analysis has several limits , including the very small number of available studies and enrolled children with HBeAg positivity-related hepatitis , it suggests that vitamin E use may enhance the probability to induce HBeAg seroconversion in these patients .