https://scholars.lib.ntu.edu.tw/handle/123456789/581814
標題: | Peginterferon alfa-2a (40 kD) stopping rules in chronic hepatitis B: A systematic review and meta-analysis of individual participant data | 作者: | Pavlovic V. Yang L. Chan H.L.-Y. Hou J. Janssen H.L. JIA-HORNG KAO Lampertico P. Peng C.-Y. Piratvisuth T. Thompson A.J. Wedemeyer H. Wei L. Wat C. |
公開日期: | 2019 | 出版社: | International Medical Press Ltd | 卷: | 24 | 期: | 2 | 起(迄)頁: | 133-140 | 來源出版物: | Antiviral Therapy | 摘要: | Background: Peginterferon alfa-2a (PEG-IFN) treatment stopping rules in chronic hepatitis B (CHB) are clinically desirable. Previous studies exploring this topic contained important limitations resulting in inconsistent recommendations within the current treatment guidelines. We undertook a systematic review and individual patient data meta-analysis to identify the most appropriate PEG-IFN treatment stopping rules. Methods: Roche’s internal database, PubMed and conference abstracts were searched for studies that enrolled >50 treatment-naive patients with CHB who received PEG-IFN treatment for 48 weeks. Stopping rules were identified using receiver-operating characteristic curve analyses and pre-specified biomarker cutoff target performance characteristics (sensitivity >95%, specificity >10%, negative predictive value >90%). Robustness of proposed stopping rules was assessed using internal/external validation analyses. Results: Eight study datasets were included in the meta-analysis (n=1,423; 765 hepatitis B e antigen [HBeAg]-positive, 658 HBeAg-negative patients). In general, performance of hepatitis B surface antigen (HBsAg) and HBV DNA cutoffs at weeks 12 and 24 was similar, and common biomarker cutoffs that met target performance criteria were identified across multiple patient subgroups. For HBeAg-positive genotype B/C and HBeAg-negative genotype D patients the proposed stopping rule is HBsAg >20,000 IU/ml at week 12. Alternatively, HBV DNA level cutoffs of >8 log10 and >6.5 log10 IU/ml, respectively, can be used instead. The proposed stopping rules accurately identify up to 26% of non-responders. Conclusions: The meta-analysis demonstrates that early PEG-IFN discontinuation should be considered in HBeAg-positive genotype B/C and HBeAg-negative genotype D patients at week 12 of treatment based on HBsAg or HBV DNA levels. ?2019 International Medical Press |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85065857249&doi=10.3851%2fIMP3304&partnerID=40&md5=16bf8c883e5ef265db03b229b4de3705 https://scholars.lib.ntu.edu.tw/handle/123456789/581814 |
ISSN: | 1359-6535 | DOI: | 10.3851/IMP3304 | SDG/關鍵字: | alanine aminotransferase; biological marker; hepatitis B surface antigen; hepatitis B(e) antigen; peginterferon alpha2a; peginterferon alpha2b; virus DNA; alpha interferon; antivirus agent; biological marker; hepatitis B surface antigen; macrogol; peginterferon alpha2a; recombinant protein; virus DNA; alanine aminotransferase blood level; Article; chronic hepatitis B; drug efficacy; Hepatitis B virus genotype A; Hepatitis B virus genotype B; Hepatitis B virus genotype C; Hepatitis B virus genotype D; human; meta analysis; predictive value; prevalence; priority journal; receiver operating characteristic; sensitivity and specificity; systematic review; treatment duration; treatment response; treatment withdrawal; validation process; blood; chronic hepatitis B; female; genotype; Hepatitis B virus; immunology; male; treatment outcome; virology; virus load; Antiviral Agents; Biomarkers; DNA, Viral; Female; Genotype; Hepatitis B Surface Antigens; Hepatitis B virus; Hepatitis B, Chronic; Humans; Interferon-alpha; Male; Polyethylene Glycols; Recombinant Proteins; Treatment Outcome; Viral Load |
顯示於: | 臨床醫學研究所 |
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