Interferon-alpha(2b) induction treatment with or without ribavirin in chronic hepatitis C - A multicenter, randomized, controlled trial


Senturk H., Ersoz G., Ozaras R. , Kaymakoglu S., Bozkaya H., Akdogan M. A. , ...Daha Fazla

DIGESTIVE DISEASES AND SCIENCES, cilt.48, ss.1124-1129, 2003 (SCI İndekslerine Giren Dergi) identifier identifier identifier

  • Cilt numarası: 48 Konu: 6
  • Basım Tarihi: 2003
  • Doi Numarası: 10.1023/a:1023725014751
  • Dergi Adı: DIGESTIVE DISEASES AND SCIENCES
  • Sayfa Sayıları: ss.1124-1129

Özet

We aimed to compare the efficacy of interferon-alpha(2b) (IFN) induction treatment in combination with ribavirin to IFN induction alone in chronic hepatitis C. In total, 125 patients (66 male, 59 female, mean age: 48 +/- 9, range: 21-70) were enrolled and randomized into two arms.In the first, patients received 5 MU/day of IFN for 4 weeks followed by 3 MU/day for the next 4 weeks. Treatment was continued with 3 MU three times a week IFN for an additional 40 weeks. Ribavirin was administered 1000-1200 mg/day according to the body weight for the entire 48-week period. In the second arm, patients received placebo in addition to IFN. Fifty-nine patients were placed in the ribavirin arm and 66 in placebo arm. All patients were genotype 1. At week 48, 24/66 (36%) from the placebo and 31/59 (52%) from the ribavirin group responded (P > 0.05). However, during the 24-week untreated follow-up period, 13/24 (54%) from the placebo, and 8/31 (26%) from the ribavirin group relapsed (P = 0.002.), resulting in a sustained virologic response (SVR) rate of 17% in the placebo and 39% in the ribavirin group (P = 0.005.) In conclusion, IFN induction treatment in combination with ribavirin is superior to IFN induction treatment alone in genotype 1 patients, and the SVR rate of 39% is encouraging.