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Randomized clinical trial comparing high versus standard dose of ribavirin plus peginterferon alfa-2a in hepatitis C genotype 3 and high viral load. Dargen-3 study.
- Source :
-
Gastroenterologia y hepatologia [Gastroenterol Hepatol] 2014 Jan; Vol. 37 (1), pp. 1-8. Date of Electronic Publication: 2013 Dec 17. - Publication Year :
- 2014
-
Abstract
- Introduction: Less than half of patients with chronic hepatitis C genotype 3 (G3) and high viral load (HVL) without a rapid virological response (RVR) achieve a sustained virological response (SVR) when treated with peginterferon plus ribavirin (RBV).<br />Objectives: To assess the impact of high doses of RBV on SVR in patients with G3 and HVL.<br />Methods: Ninety-seven patients were randomized to receive peginterferon α-2a+RBV 800 mg/day (A; n=42) or peginterferon α-2a+RBV 1600 mg/day+epoetin β 400 IU/kg/week SC (B; n=55). Patients allocated to group B who achieved RVR continued on RBV (800mg/day) for a further 20 weeks (B1; n=42) while non-RVR patients received a higher dose of RBV (1600 mg/day)+epoetin β (B2; n=13).<br />Results: RVR was observed in 64.3% of patients in A and in 76.4% in B (p=0.259). Intention-to-treat (ITT) analysis showed SVR rates of 64.3% (A) and 61.8% (B), with a reduction of -2.5% (-21.8% to 16.9%) (p=0.835). The SVR rate was 61.9% in arm B1 and 61.5% in arm B2. No serious adverse events were reported, and the rate of moderate adverse events was < 5%.<br />Conclusions: G3 patients with high viral load without RVR did not obtain a benefit from a higher dose of RBV. Higher doses of RBV plus epoetin β were safe and well tolerated (Clin Trials Gov NCT00830609).<br /> (Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antiviral Agents therapeutic use
Dose-Response Relationship, Drug
Drug Therapy, Combination
Erythropoietin administration & dosage
Erythropoietin therapeutic use
Female
Genotype
Hepacivirus classification
Hepacivirus genetics
Hepacivirus isolation & purification
Hepatitis C, Chronic blood
Hepatitis C, Chronic virology
Humans
Interferon-alpha therapeutic use
Male
Middle Aged
Polyethylene Glycols therapeutic use
Recombinant Proteins administration & dosage
Recombinant Proteins therapeutic use
Ribavirin therapeutic use
Treatment Outcome
Viral Load
Viremia blood
Viremia drug therapy
Viremia virology
Antiviral Agents administration & dosage
Hepatitis C, Chronic drug therapy
Interferon-alpha administration & dosage
Polyethylene Glycols administration & dosage
Ribavirin administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 0210-5705
- Volume :
- 37
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Gastroenterologia y hepatologia
- Publication Type :
- Academic Journal
- Accession number :
- 24360571
- Full Text :
- https://doi.org/10.1016/j.gastrohep.2013.10.005