Follow-up of adverse drug reactions from peginterferon alfa-2b-ribavirin therapy

被引:23
作者
Bagheri, H
Fouladi, A
Barange, K
Lapeyre-Mestre, M
Payen, JL
Montastruc, JL
Vinel, JP
机构
[1] Fac Med Toulouse, Serv Pharmacol Clin, Ctr Midi Pyrenees Pharmacovigilance Pharmacoepide, F-31073 Toulouse, France
[2] Hop Toulouse, Serv Hepatogastroenterol, Federat Digest Purpan, Toulouse, France
来源
PHARMACOTHERAPY | 2004年 / 24卷 / 11期
关键词
pharmacovigilance; peginterferon alfa-2b; hepatitis C; adverse drug reactions;
D O I
10.1592/phco.24.16.1546.50947
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Study Objective. To investigate the adverse drug reactions (ADRs) from peginterferon alfa-2b plus ribavirin in patients infected with the hepatitis C virus (HCV). Design. Prospective, observational, pharmacovigilance study. Setting. Gastroenterology department of a French university hospital. Patients. A cohort of consecutive outpatients who were treated with peginterferon alfa-2b plus ribavirin for viral hepatitis. Intervention. During the 1-year period of HCV therapy visits, a medical staff member trained in pharmacovigilance interviewed the patients about all ADRs and their use of other drugs. The ADRs assessed as serious were confirmed from regular review of the medical records. Measurements and Main Results. A total of 87 patients were treated for HCV Among these, peginterferon alfa-2b plus ribavirin therapy was started in 51 patients; one patient was lost to follow-up after 1 month. The ADRs were assessed as serious in 10 patients (20%): suicide (one patient), hospitalization (three patients), and definitive discontinuation of peginterferon alfa-2b plus ribavirin (six patients). The ADRs contributed to or were the main reason for withdrawing HCV drugs in 8 patients (16%). Dosage reductions of ribavirin and/or peginterferon alfa-2b were required in 10 patients (20%) and seemed less frequent than that needed in clinical trials. Compared with results of clinical trials, a similar frequency of hair loss, higher frequency of injection-site reactions, lower frequency of depression or insomnia, and higher frequency of endocrine ADRs or blurred vision were detected. Conclusion. Results suggest some differences in the frequencies of ADRs compared with data from clinical trials. A longer period of monitoring is warranted to improve knowledge about ADRs of pegylated interferon. A medical staff member trained in pharmacovigilance is useful to collect quantitative and qualitative data about ADRs.
引用
收藏
页码:1546 / 1553
页数:8
相关论文
共 14 条
[1]  
Asselah T, 2002, GASTROEN CLIN BIOL, V26, pB50
[2]  
BEDOSSA P, 1994, HEPATOLOGY, V20, P15
[3]   Adverse drug reactions: definitions, diagnosis, and management [J].
Edwards, IR ;
Aronson, JK .
LANCET, 2000, 356 (9237) :1255-1259
[4]   Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. [J].
Fried, MW ;
Shiffman, ML ;
Reddy, KR ;
Smith, C ;
Marinos, G ;
Goncales, FL ;
Haussinger, D ;
Diago, M ;
Carosi, G ;
Dhumeaux, D ;
Craxi, A ;
Lin, A ;
Hoffman, J ;
Yu, J .
NEW ENGLAND JOURNAL OF MEDICINE, 2002, 347 (13) :975-982
[5]   Side effects of therapy of hepatitis C and their management [J].
Fried, MW .
HEPATOLOGY, 2002, 36 (05) :S237-S244
[6]   A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C [J].
Lindsay, KL ;
Trepo, C ;
Heintges, T ;
Shiffman, ML ;
Gordon, SC ;
Hoefs, JC ;
Schiff, ER ;
Goodman, ZD ;
Laughlin, M ;
Yao, RJ ;
Albrecht, JK .
HEPATOLOGY, 2001, 34 (02) :395-403
[7]   Hepatitis C and HIV co-infection: a review [J].
Maier, I ;
Wu, GY .
WORLD JOURNAL OF GASTROENTEROLOGY, 2002, 8 (04) :577-579
[8]   Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial [J].
Manns, MP ;
McHutchison, JG ;
Gordon, SC ;
Rustgi, VK ;
Shiffman, M ;
Reindollar, R ;
Goodman, ZD ;
Koury, K ;
Ling, MH ;
Albrecht, JK .
LANCET, 2001, 358 (9286) :958-965
[9]  
Palmon R, 2002, J ACQ IMMUN DEF SYND, V29, P340, DOI 10.1097/00126334-200204010-00003
[10]  
Pawlotsky JM, 2002, GASTROEN CLIN BIOL, V26, pB180