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A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B "e" Antigen-Positive Chronic Hepatitis B  期刊论文  

  • 编号:
    a5e76cd6-5b57-4bf0-8836-4179191374de
  • 作者:
    Xie, Qing#*[1]Zhou, Huijuan[1];Bai, Xuefan[2];Wu, Shuhuan[3];Chen, JianJie(陈建杰)[4]Sheng, Jifang[5];Xie, Yao[6];Chen, Chengwei[7];Chan, Henry LikYuen[8];Zhao, Mianzhi[9];
  • 语种:
    英文
  • 期刊:
    CLINICAL INFECTIOUS DISEASES ISSN:1058-4838 2014 年 59 卷 12 期 (1714 - 1723) ; DEC 15
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  • 关键词:
  • 摘要:

    Background. Treatment with pegylated interferon (peg-IFN) alfa-2a (40KD) results in hepatitis B "e" antigen (HBeAg) seroconversion 6 months after treatment in up to 36% of HBeAg-positive chronic hepatitis B patients. This study explored the efficacy of a novel combination of peg-IFN alfa-2a and entecavir (ETV), a potent nucleoside analogue.
    Methods. In total, 218 treatment-naive Chinese HBeAg-positive patients were randomized to peg-IFN alfa-2a (180 mu g/week) for 48 weeks, either as monotherapy (n = 72), or with 24 weeks of ETV (0.5 mg/daily) added at week 13 (ETV add-on, n = 73), or pretreatment with a 24-week course of ETV, starting peg-IFN alfa-2a at week 21 (ETV pretreatment, n = 73). The primary endpoint was reduction in quantitative HBeAg from baseline to 24 weeks posttreatment.
    Results. Significant reductions in HBeAg from baseline were achieved in all treatment groups 24 weeks post-treatment; reductions were comparable across treatment arms (shown as log(10) Paul Ehrlich international units [PEIU]/mL): monotherapy: -1.4 (SD, 1.8); ETV add-on: -1.6 (SD, 1.8); ETV pretreatment: -1.3 (SD, 1.7). Rates of HBeAg seroconversion were similar across treatment groups posttreatment (monotherapy: 22 [31%]; ETV add-on: 18 [25%]; ETV pretreatment: 19 [26%]). Significantly greater reductions of hepatitis B virus DNA were achieved with ETV add-on while on treatment, but were not sustained posttreatment. Safety profiles were comparable between treatment groups; adverse events were experienced by 62 (86%) monotherapy, 65 (89%) ETV add-on, and 58 (81%) ETV pretreatment patients.
    Conclusions. Neither ETV add-on nor ETV pretreatment demonstrated superiority compared with 48 weeks of peg-IFN alfa-2a monotherapy. The optimal treatment strategy using nucleos(t) ide analogues and peg-IFN alfa-2a remains to be determined.

  • 推荐引用方式
    GB/T 7714:
    Xie Qing,Zhou Huijuan,Bai Xuefan, et al. A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B "e" Antigen-Positive Chronic Hepatitis B [J].CLINICAL INFECTIOUS DISEASES,2014,59(12):1714-1723.
  • APA:
    Xie Qing,Zhou Huijuan,Bai Xuefan,Wu Shuhuan,&Zhao Mianzhi.(2014).A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B "e" Antigen-Positive Chronic Hepatitis B .CLINICAL INFECTIOUS DISEASES,59(12):1714-1723.
  • MLA:
    Xie Qing, et al. "A Randomized, Open-Label Clinical Study of Combined Pegylated Interferon Alfa-2a (40KD) and Entecavir Treatment for Hepatitis B "e" Antigen-Positive Chronic Hepatitis B" .CLINICAL INFECTIOUS DISEASES 59,12(2014):1714-1723.
  • 入库时间:
    1/6/2020 5:54:58 PM
  • 更新时间:
    1/6/2020 5:54:58 PM
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