1. Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response
- Author
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Maria, Buti, Yoav, Lurie, Natalia G, Zakharova, Natalia P, Blokhina, Andrzej, Horban, Gerlinde, Teuber, Christoph, Sarrazin, Ligita, Balciuniene, Saya V, Feinman, Rab, Faruqi, Lisa D, Pedicone, Rafael, Esteban, S, Ryder, Department of Medicine, Clinicum, Hospital General, and Vall d'Hebron University Hospital [Barcelona]
- Subjects
Male ,Time Factors ,Medizin ,Hepacivirus ,medicine.disease_cause ,Gastroenterology ,law.invention ,Polyethylene Glycols ,MESH: Recombinant Proteins ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,INFECTION ,Medicine ,MESH: Hepacivirus ,MESH: Treatment Outcome ,MESH: Aged ,MESH: Middle Aged ,Hepatitis C ,Middle Aged ,Viral Load ,PLUS RIBAVIRIN ,Recombinant Proteins ,3. Good health ,MESH: Hepatitis C, Chronic ,Treatment Outcome ,030220 oncology & carcinogenesis ,MESH: RNA, Viral ,Peginterferon alfa-2b ,RNA, Viral ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,Female ,MESH: Interferon-alpha ,MESH: Viral Load ,Viral load ,medicine.drug ,MESH: Antiviral Agents ,Adult ,medicine.medical_specialty ,Adolescent ,Hepatitis C virus ,Interferon alpha-2 ,Antiviral Agents ,Drug Administration Schedule ,03 medical and health sciences ,MESH: Ribavirin ,Internal medicine ,Ribavirin ,Humans ,Aged ,MESH: Adolescent ,MESH: Humans ,Hepatology ,business.industry ,Body Weight ,MESH: Time Factors ,Interferon-alpha ,MESH: Adult ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Hepatitis C, Chronic ,medicine.disease ,MESH: Male ,Surgery ,Discontinuation ,MESH: Drug Therapy, Combination ,COMBINATION THERAPY ,chemistry ,MESH: Polyethylene Glycols ,3121 General medicine, internal medicine and other clinical medicine ,business ,TREATMENT DURATION ,MESH: Female - Abstract
International audience; UNLABELLED: The benefit of extending treatment duration with peginterferon (PEG-IFN) and ribavirin (RBV) from 48 weeks to 72 weeks for patients with chronic hepatitis C genotype 1 infection has not been well established. In this prospective, international, open-label, randomized, multicenter study, 1,428 treatment-naïve patients from 133 centers were treated with PEG-IFN alfa-2b (1.5 μg/kg/week) plus RBV (800-1,400 mg/day). Patients with detectable hepatitis C virus (HCV) RNA and a ≥2-log(10) drop in HCV RNA levels at week 12 (slow responders) were randomized 1:1 to receive 48 weeks (n = 86) or 72 weeks (n = 73) of treatment. Sustained virologic response (SVR) rates were 43% in slow responders treated for 48 weeks and 48% in slow responders treated for 72 weeks (P = 0.644). Relapse rates were similar in slow responders treated for 48 or 72 weeks (47% versus 33%, P = 0.169). The safety profile was similar in both treatment arms; serious adverse events leading to discontinuation of treatment were observed in 3.5% of slow responders treated for 48 weeks and 8.2% of those treated for 72 weeks. Among slow responders with a
- Published
- 2010