1. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads
- Author
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Michael J. McKenna, Maribel Rodriguez–Torres, K. Rajender Reddy, Michael Rabbia, Stephen A. Harrison, James Thommes, Hugo Cheinquer, Natalia Geyvandova, Igor G. Bakulin, Giovanni Faria Silva, Carol Stanciu, Viacheslav Morozov, Mitchell L. Shiffman, and Djamal Abdurakhmanov
- Subjects
Adult ,Male ,medicine.medical_specialty ,Genotype ,Hepacivirus ,Hepatitis C virus ,Interferon alpha-2 ,medicine.disease_cause ,Gastroenterology ,Antiviral Agents ,Polyethylene Glycols ,Efficacy ,chemistry.chemical_compound ,Pegylated interferon ,Internal medicine ,Ribavirin ,Medicine ,Humans ,Obesity ,Hepatology ,biology ,Dose-Response Relationship, Drug ,business.industry ,Body Weight ,virus diseases ,Interferon-alpha ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,Viral Load ,biology.organism_classification ,medicine.disease ,Virology ,digestive system diseases ,Recombinant Proteins ,Fatty Liver ,Regimen ,chemistry ,Drug Therapy, Combination ,Female ,business ,Viral load ,medicine.drug - Abstract
Patients infected with hepatitis C virus (HCV) genotype 1, body weight ≥85 kg, and high baseline viral load respond poorly to standard doses of pegylated interferon (peginterferon) and ribavirin. We evaluated intensified therapy with peginterferon alfa-2a plus ribavirin.This double-blind randomized trial included HCV genotype 1-infected outpatients from hepatology clinics with body weight ≥85 kg and HCV RNA titer ≥400,000 IU/mL. Patients were randomized to 180 μg/wk peginterferon alfa-2a for 48 weeks plus 1200 mg/day ribavirin (standard of care) (group A, n = 191) or 1400/1600 mg/day ribavirin (group B, n = 189). Additional groups included 360 μg/wk peginterferon alfa-2a for 12 weeks then 180 μg/wk peginterferon alfa-2a for 36 weeks plus 1200 mg/day ribavirin (group C, n = 382) or 1400/1600 mg/day ribavirin (group D, n = 383). Follow-up lasted 24 weeks after treatment.Sustained virologic response rates (HCV RNA level15 IU/mL at end of follow-up) in groups A, B, C, and D were 38%, 43%, 44%, and 41%, respectively. There were no significant differences among the 4 groups or between pooled peginterferon alfa-2a regimens (A + B vs C + D: odds ratio [OR], 1.08; 95% confidence interval [CI], 0.83-1.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.79-1.28; P = .974).In patients infected with HCV genotype 1 who are difficult to treat (high viral load, body weight ≥85 kg), a 12-week induction regimen of peginterferon alfa-2a and/or higher-dose ribavirin is not more effective than the standard regimen.
- Published
- 2010