Comparison of the Safety Profiles of Pegylated Interferon α-2a and α-2b Administered in Combination with Ribavirin for Chronic Hepatitis C Infection: A Real-World Retrospective Cohort Study

作者: Kazuki Ide , Izumi Sato , Takumi Imai , Philip Hawke , Hiroshi Yamada

DOI: 10.1248/BPB.B16-00617

关键词:

摘要: This study compares the safety profiles of pegylated interferon (PEG-IFN) α-2a and α-2b administered in combination with ribavirin, based on variable time to withdrawal from treatment due adverse events. We conducted a real-world retrospective cohort using Japanese database. Based eligibility criteria, individuals chronic hepatitis C virus (HCV) infection were identified database covering period December 2009 August 2015. The primary outcome measure was defined as difference events between patients receiving PEG-IFN combined ribavirin those ribavirin. analyzed multivariate Cox proportional hazards regression model. A frailty model also applied consider regional (prefectural) variation. After evaluation, 11058 included analysis. 3774 treated α-2a, 6764 α-2b, 11.84 12.30% respectively withdrawing showed no significant two groups (hazard ratio (HR), 95%CI; 0.918, 0.817 1.031; p=0.1475). results consistent even when variation other confounding variables adjusted In conclusion, there may be Applying method used here future studies novel regimens provide important information for HCV clinical practice.

参考文章(19)
Naohiko Masaki, , Yoko Yamagiwa, Takuro Shimbo, Kazumoto Murata, Masaaki Korenaga, Tatsuya Kanto, Masashi Mizokami, Regional disparities in interferon therapy for chronic hepatitis C in Japan: a nationwide retrospective cohort study. BMC Public Health. ,vol. 15, pp. 566- 566 ,(2015) , 10.1186/S12889-015-1891-2
PATRICIA M. GRAMBSCH, TERRY M. THERNEAU, Proportional hazards tests and diagnostics based on weighted residuals Biometrika. ,vol. 81, pp. 515- 526 ,(1994) , 10.1093/BIOMET/81.3.515
Tatsuya Minami, Takahiro Kishikawa, Masaya Sato, Ryosuke Tateishi, Haruhiko Yoshida, Kazuhiko Koike, Meta-analysis: mortality and serious adverse events of peginterferon plus ribavirin therapy for chronic hepatitis C Journal of Gastroenterology. ,vol. 48, pp. 254- 268 ,(2013) , 10.1007/S00535-012-0631-Y
Shiho Miyase, Katsuki Haraoka, Yoshihiro Ouchida, Yuko Morishita, Shigetoshi Fujiyama, Randomized trial of peginterferon α-2a plus ribavirin versus peginterferon α-2b plus ribavirin for chronic hepatitis C in Japanese patients Journal of Gastroenterology. ,vol. 47, pp. 1014- 1021 ,(2012) , 10.1007/S00535-012-0560-9
Claire M. A. Wintrebert, Hein Putter, Aeilko H. Zwinderman, J.C. van Houwelingen, Centre-effect on Survival after Bone Marrow Transplantation: Application of Time-dependent Frailty Models Biometrical Journal. ,vol. 46, pp. 512- 525 ,(2004) , 10.1002/BIMJ.200310051
Yohei Kawasaki, Takuro Shimbo, Naohiko Masaki, Izumi Sato, Comparison of peginterferon alfa-2a and alfa-2b for treatment of patients with chronic hepatitis C:a retrospective study using the Japanese Interferon Database Drug Design Development and Therapy. ,vol. 9, pp. 283- 290 ,(2014) , 10.2147/DDDT.S72245
John G. McHutchison, Eric J. Lawitz, Mitchell L. Shiffman, Andrew J. Muir, Greg W. Galler, Jonathan McCone, Lisa M. Nyberg, William M. Lee, Reem H. Ghalib, Eugene R. Schiff, Joseph S. Galati, Bruce R. Bacon, Mitchell N. Davis, Pabak Mukhopadhyay, Kenneth Koury, Stephanie Noviello, Lisa D. Pedicone, Clifford A. Brass, Janice K. Albrecht, Mark S. Sulkowski, Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. The New England Journal of Medicine. ,vol. 361, pp. 580- 593 ,(2009) , 10.1056/NEJMOA0808010
Regino P. González-Peralta, Deirdre A. Kelly, Barbara Haber, Jean Molleston, Karen F. Murray, Maureen M. Jonas, Mark Shelton, Giorgina Mieli-Vergani, Yoav Lurie, Steven Martin, Thomas Lang, Andrew Baczkowski, Michael Geffner, Samir Gupta, Mark Laughlin, , Interferon alfa‐2b in combination with ribavirin for the treatment of chronic hepatitis C in children: Efficacy, safety, and pharmacokinetics Hepatology. ,vol. 42, pp. 1010- 1018 ,(2005) , 10.1002/HEP.20884
Vincenza Calvaruso, Marta Mazza, Piero L Almasio, Pegylated-interferon-α(2a) in clinical practice: how to manage patients suffering from side effects. Expert Opinion on Drug Safety. ,vol. 10, pp. 429- 435 ,(2011) , 10.1517/14740338.2011.559161