https://scholars.lib.ntu.edu.tw/handle/123456789/582024
標題: | Revisiting the Stopping Rule for Hepatitis C Genotype 1 Patients Treated with Peginterferon Plus Ribavirin | 作者: | Yu M.-L. CHEN-HUA LIU Huang C.-F. TAI-CHUNG TSENG Huang J.-F. Dai C.-Y. Lin Z.-Y. Chen S.-C. Wang L.-Y. Juo S.-H.H. Chuang W.-L. JIA-HORNG KAO |
公開日期: | 2012 | 卷: | 7 | 期: | 12 | 起(迄)頁: | e52048 | 來源出版物: | PLoS ONE | 摘要: | Background: The current stopping rule for peginterferon/ribavirin therapy in hepatitis C virus genotype-1 (HCV-1) patients is based on an early virological response (EVR, defined as >2 log10 viral reduction at treatment week 12). We aimed to explore rapid stopping rules at week 4. Methods: We randomly allocated 528 HCV-1 patients into training and validation sets (at a 1:2 ratio). The interleukin-28B rs8099917 genotypes and on-treatment virological responses were evaluated to determine the negative predictive value (NPV) for achieving a sustained virological response (SVR, defined as undetectable HCV RNA 24 weeks after end-of-treatment). The study was approved by the ethics committees of the participating hospitals. All of the patients gave written informed consent before enrollment. Results: A poor week 4 response (W4R), defined as a HCV RNA reduction of <1 log10 IU/mL at week 4 or a week 4 HCV RNA>10,000 IU/mL with interleukin-28B non-TT genotype, had the highest NPV (95%). In the complete sample, poor W4R could identify 43.4% (59/136) of the non-responders, with an NPV of 95% and a false negative rate of only 0.8% (3/396). The multivariate analysis revealed that a poor W4R was the most important negative predictor (odds ratio/95% confidence intervals: 49.01/13.70-175.37), followed by the lack of an EVR. In addition to HCV RNA<1 log10 IU/mL reduction, using the criteria of HCV RNA>10,000 IU/mL/non-TT genotype helped identifying an additional one-third of non-SVR patients at W4.Using the strategy of sequential rapid stopping rule strategy could identify 53.7% (73/136) of the non-responders (43.4% at week 4 and an addition 11.3% at week 12), as compared to 40.4% for the classical week-12 early stopping rule. Conclusions: Sequential rapid stopping rules using on-treatment virological responses and interleukin-28B genotype can rapidly identify additional peginterferon/ribavirin non-responders. ? 2012 Yu et al. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84871355062&doi=10.1371%2fjournal.pone.0052048&partnerID=40&md5=3764c569ce8b011c911c3ce0fd97a66b https://scholars.lib.ntu.edu.tw/handle/123456789/582024 |
ISSN: | 1932-6203 | DOI: | 10.1371/journal.pone.0052048 | SDG/關鍵字: | interleukin 28B; peginterferon alpha2a; peginterferon alpha2b; ribavirin; virus RNA; adult; age distribution; article; body weight; controlled study; drug response; drug treatment failure; drug withdrawal; early virological response; end of treatment virological response; false negative result; female; gender; genotype; hepatitis C; homozygote; human; major clinical study; male; poor week 4 response; predictive value; rapid virological response; stopping rule; sustained virological response; treatment duration; validation process; virus load; Adult; Female; Genotype; Hepacivirus; Hepatitis C; Humans; Interferon-alpha; Interleukins; Male; Middle Aged; Polyethylene Glycols; Recombinant Proteins; Ribavirin; Time Factors; Treatment Outcome; Viral Load; Hepatitis C virus; Hepatitis C virus genotype 1; Nucleopolyhedrovirus |
顯示於: | 臨床醫學研究所 |
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