1. Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon-[alpha]2b: A Randomized Trial
- Author
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Carlos E. Brandao-Mello, Donald M. Jensen, B. Freilich, Antonio Olveira Martin, Patrick Marcellin, Antonio Craxì, James Thommes, G. Teuber, Diethelm Messinger, Adrian M. Di Bisceglie, K. Rajender Reddy, Andreas Tietz, Pietro Andreone, Jensen, DM, Marcellin, P, Freilich, B, Andreone, P, Di Bisceglie, A, Brandão-Mello, CE, Reddy, KR, Craxi, A, Martin, AO, Teuber, G, Messinger, D, Thommes, JA, Tietz, A, Jensen DM, Marcellin P, Freilich B, Andreone P, Di Bisceglie A, Brandão-Mello CE, Reddy KR, Craxi A, Martin AO, Teuber G, Messinger D, Thommes JA, and Tietz A.
- Subjects
Male ,medicine.medical_specialty ,Hepatitis C virus ,Alpha interferon ,Hepacivirus ,Interferon alpha-2 ,medicine.disease_cause ,Antiviral Agents ,Gastroenterology ,Drug Administration Schedule ,Polyethylene Glycols ,law.invention ,chemistry.chemical_compound ,Double-Blind Method ,Randomized controlled trial ,law ,Pegylated interferon ,Internal medicine ,Ribavirin ,Internal Medicine ,retreatment non responder hepatitis C ,Humans ,Medicine ,Treatment Failure ,Not evaluated ,business.industry ,Interferon-alpha ,virus diseases ,General Medicine ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,Recombinant Proteins ,digestive system diseases ,Surgery ,chemistry ,Retreatment ,RNA, Viral ,Drug Therapy, Combination ,Female ,business ,Viral load ,medicine.drug - Abstract
BACKGROUND Many patients with chronic hepatitis C have not responded to therapy with pegylated interferon plus ribavirin. OBJECTIVE To evaluate use of peginterferon-alpha2a plus ribavirin to re-treat nonresponders to peginterferon-alpha2b plus ribavirin. DESIGN Randomized, parallel-group trial conducted between September 2003 and February 2007. Patients and researchers were not blinded to intervention assignment. Random assignment was centralized, computer-generated, and stratified by geographic region, hepatitis C virus (HCV) genotype, and histologic diagnosis. SETTING 106 international centers. PATIENTS 950 nonresponders to 12 or more weeks of therapy with peginterferon-alpha2b plus ribavirin. INTERVENTION Peginterferon-alpha2a, 360 microg/wk, for 12 weeks, then 180 microg/wk to complete 72 weeks (group A) or 48 weeks (group B), or peginterferon-alpha2a, 180 microg/wk for 72 weeks (group C) or 48 weeks (group D). All patients received ribavirin, 1000 or 1200 mg/d. MEASUREMENTS Sustained virologic response (SVR), defined as undetectable (
- Published
- 2009