{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T00:08:51Z","timestamp":1773792531118,"version":"3.50.1"},"reference-count":14,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2012,1,16]],"date-time":"2012-01-16T00:00:00Z","timestamp":1326672000000},"content-version":"vor","delay-in-days":2632,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2004,11]]},"abstract":"<jats:p><jats:bold>Study Objective<\/jats:bold>. To investigate the adverse drug reactions (ADRs) from peginterferon alfa\u20102b plus ribavirin in patients infected with the hepatitis C virus (HCV).<\/jats:p><jats:p><jats:bold>Design<\/jats:bold>. Prospective, observational, pharmacovigilance study.<\/jats:p><jats:p><jats:bold>Setting<\/jats:bold>. Gastroenterology department of a French university hospital.<\/jats:p><jats:p><jats:bold>Patients<\/jats:bold>. A cohort of consecutive outpatients who were treated with peginterferon alfa\u20102b plus ribavirin for viral hepatitis.<\/jats:p><jats:p><jats:bold>Intervention<\/jats:bold>. During the 1\u2010year 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.<\/jats:p><jats:p><jats:bold>Measurements and Main Results<\/jats:bold>. A total of 87 patients were treated for HCV. Among these, peginterferon alfa\u20102b plus ribavirin therapy was started in 51 patients; one patient was lost to follow\u2010up 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\u20102b 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\u20102b 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\u2010site reactions, lower frequency of depression or insomnia, and higher frequency of endocrine ADRs or blurred vision were detected.<\/jats:p><jats:p><jats:bold>Conclusion<\/jats:bold>. 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.<\/jats:p>","DOI":"10.1592\/phco.24.16.1546.50947","type":"journal-article","created":{"date-parts":[[2004,10,25]],"date-time":"2004-10-25T08:12:34Z","timestamp":1098691954000},"page":"1546-1553","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Follow\u2010up of Adverse Drug Reactions from Peginterferon alfa\u20102b\u2014Ribavirin Therapy"],"prefix":"10.1002","volume":"24","author":[{"given":"Haleh","family":"Bagheri","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atoussa","family":"Fouladi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karl","family":"Barange","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maryse","family":"Lapeyre\u2010Mestre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Louis","family":"Payen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean Louis","family":"Montastruc","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Pierre","family":"Vinel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,16]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020047"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06102-5"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199410020-00003"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200012073432301"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2001.26371"},{"key":"e_1_2_1_7_2","doi-asserted-by":"crossref","first-page":"S237","DOI":"10.1002\/hep.1840360730","article-title":"Side effects of therapy of hepatitis C and their management","volume":"36","author":"Fried MW","year":"2002","journal-title":"Hepatology"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.1800600817"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02799-9"},{"key":"e_1_2_1_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.1840200104"},{"key":"e_1_2_1_11_2","first-page":"B50","article-title":"Chronic hepatitis C: what to do if the first treatment failed?","volume":"26","author":"Asselah T.","year":"2002","journal-title":"Gastroenterol Clin Biol"},{"key":"e_1_2_1_12_2","first-page":"B180","article-title":"Management of patients with hepatitis C virus infection: virological tests","volume":"26","author":"Pawlotsky JM","year":"2002","journal-title":"Gastroenterol Clin Biol"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.1.74"},{"key":"e_1_2_1_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/00126334-200204010-00003"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v8.i4.577"}],"container-title":["Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1592%2Fphco.24.16.1546.50947","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1592\/phco.24.16.1546.50947","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T13:42:12Z","timestamp":1761054132000},"score":1,"resource":{"primary":{"URL":"https:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/10.1592\/phco.24.16.1546.50947"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2004,11]]},"references-count":14,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2004,11]]}},"alternative-id":["10.1592\/phco.24.16.1546.50947"],"URL":"https:\/\/doi.org\/10.1592\/phco.24.16.1546.50947","archive":["Portico"],"relation":{},"ISSN":["0277-0008","1875-9114"],"issn-type":[{"value":"0277-0008","type":"print"},{"value":"1875-9114","type":"electronic"}],"subject":[],"published":{"date-parts":[[2004,11]]},"assertion":[{"value":"2012-01-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}