https://scholars.lib.ntu.edu.tw/handle/123456789/536943
標題: | Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B | 作者: | Jonas M.M. MEI-HWEI CHANG Sokal E. Schwarz K.B. Kelly D. Kim K.M. Ling S.C. Rosenthal P. Oraseanu D. Reynolds L. Thiry A. Ackerman P. |
公開日期: | 2016 | 出版社: | John Wiley and Sons Inc. | 卷: | 63 | 期: | 2 | 起(迄)頁: | 377-387 | 來源出版物: | Hepatology | 摘要: | This ongoing, randomized phase III study assesses the safety and efficacy of entecavir versus placebo in nucleos(t)ide-na?ve 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 randomized (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-randomized 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. ? 2016 by the American Association for the Study of Liver Diseases. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84956665697&doi=10.1002%2fhep.28015&partnerID=40&md5=891932d60ed837c797c13ca049363aba https://scholars.lib.ntu.edu.tw/handle/123456789/536943 |
ISSN: | 0270-9139 | DOI: | 10.1002/hep.28015 | SDG/關鍵字: | alanine aminotransferase; entecavir; hepatitis B(e) antigen; placebo; virus DNA; antivirus agent; entecavir; guanine; hepatitis B(e) antigen; antiviral resistance; Article; child; chronic hepatitis B; controlled study; coughing; double blind procedure; drug efficacy; female; fever; headache; Hepatitis B virus; human; major clinical study; male; phase 3 clinical trial; preschool child; priority journal; randomized controlled trial; rhinopharyngitis; school child; seroconversion; upper respiratory tract infection; adolescent; analogs and derivatives; blood; clinical trial; Hepatitis B, Chronic; multicenter study; virology; Adolescent; Antiviral Agents; Child; Child, Preschool; Double-Blind Method; Female; Guanine; Hepatitis B e Antigens; Hepatitis B, Chronic; Humans; Male |
顯示於: | 醫學系 |
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