Interferon-alpha2b induction treatment with or without ribavirin in chronic hepatitis C: a multicenter, randomized, controlled trial.

Abstract

We aimed to compare the efficacy of interferon-alpha2b (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.

• Authors: Hakan Senturk, Galip Ersoz, Resat Ozaras, Sabahattin Kaymakoglu, Hakan Bozkaya, Meral Akdogan, Ali Mert, Mithat Bozdayi, Fehmi Tabak, Necati Yenice, Gulsen Ozbay
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 48 Issue 6 Pg. 1124-9 (Jun 2003) ISSN: 0163-2116 [Print] United States
• PMID: 12822874 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Ribavirin

Topics

• Antiviral Agents (administration & dosage, therapeutic use)
• Drug Therapy, Combination
• Female
• Hepatitis C, Chronic (drug therapy)
• Humans
• Interferon alpha-2
• Interferon-alpha (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Recombinant Proteins
• Ribavirin (administration & dosage, therapeutic use)