https://scholars.lib.ntu.edu.tw/handle/123456789/593098
標題: | Rapid prediction of treatment futility of boceprevir with peginterferon-ribavirin for Taiwanese treatment experienced hepatitis C virus genotype 1-infected patients | 作者: | Yang C.-C. Tsai W.-L. Su W.-W. Huang C.-F. Cheng P.-N. Lo C.-C. Tseng K.-C. Mo L.-R. Wang C.-H. SHIH-JER HSU Lai H.-C. Su C.-W. CHUN-JEN LIU Peng C.-Y. Yu M.-L. |
公開日期: | 2015 | 出版社: | Public Library of Science | 卷: | 10 | 期: | 9 | 起(迄)頁: | e0137852 | 來源出版物: | PLoS ONE | 摘要: | The efficacy and safety of the boceprevir (BOC)-containing triple therapy in Taiwanese treatment-experienced patients remains elusive. After 4 weeks of peginterferon/ribavirin lead-in therapy, patients with cirrhosis or previous null-response received triple therapy for 44 weeks; whereas others received 32 weeks of triple therapy followed by 12 weeks of peginterferon/ribavirin therapy. Patients with HCV RNA > 100 IU/mL at week 12 or with detectable HCV RNA at week 24 of treatment were viewed as futile. A total of 123 patients received treatment. The rates of sustained virological response (SVR) and relapse were 66.7% and 8.9%, respectively by using intention-to-treat analysis. Multivariate analysis revealed that factors associated with SVR included HCV-1b (odds ratio [OR]/ 95% confidence intervals [CI]: 19.23/1.76-525.15, P = 0.01), BOC adherence (7.69/1.55-48.78, P = 0.01), serum albumin (OR/CI:6.25/1.14-40.07, P = 0.03) levels and HCV RNA levels (OR/CI:0.34/0.12-0.79, P = 0.01). Twenty-six (21.1%) patients experienced severe adverse events (SAEs). Multivariate analysis revealed that APRI > 1.5 was the single factor associated with occurring SAEs (OR/CI: 3.77/ 0.97-14.98, P = 0.05). Merging the cut-off values of HCV RNA > 7 log IU/mL at baseline and HCV RNA > 6 log IU/mL at week 4 provided the earliest and best combing viral kinetics in predicting week 12/24 futility with the PPV of 100% and accuracy of 93.5%. HCV-1 treatment experienced Taiwanese patients treated with boceprevir-containing triple therapy in real world had comparable efficacy and safety profiles with those reported in clinical trials. Early viral kinetics before week 4 of treatment highly predicted futility at week 12 or 24 of treatment. ? 2015 Liu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84947418628&doi=10.1371%2fjournal.pone.0137852&partnerID=40&md5=6149bae1cf8e9721c1c764a6e71d744e https://scholars.lib.ntu.edu.tw/handle/123456789/593098 |
ISSN: | 1932-6203 | DOI: | 10.1371/journal.pone.0137852 | SDG/關鍵字: | boceprevir; peginterferon alpha2b; ribavirin; virus RNA; alpha interferon; antivirus agent; macrogol derivative; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alpha2b; proline; recombinant protein; ribavirin; adult; anemia; Article; combination chemotherapy; disease severity; drug efficacy; drug safety; drug withdrawal; dysgeusia; female; flu like syndrome; follow up; gastrointestinal symptom; hair loss; hepatitis; hepatitis C; Hepatitis C virus genotype 1; human; liver cirrhosis; major clinical study; male; mental disease; neutropenia; prediction; skin manifestation; Taiwanese; thrombocytopenia; treatment outcome; virus detection; aged; analogs and derivatives; blood; clinical trial; combination drug therapy; genetics; Hepacivirus; hepatitis C; Hepatitis C, Chronic; middle aged; multicenter study; pathogenicity; Taiwan; virology; Aged; Antiviral Agents; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; Humans; Interferon-alpha; Male; Medical Futility; Middle Aged; Polyethylene Glycols; Proline; Recombinant Proteins; Ribavirin; RNA, Viral; Taiwan; Treatment Outcome |
顯示於: | 臨床醫學研究所 |
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