Randomised trial of interferon α2b plus ribavirin for 48 weeks or for 24 weeks versus interferon α2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus

• Published in: The Lancet (British edition) 1998-10, Vol.352 (9138), p.1426-1432
• Main Authors: Poynard, Thierry, Marcellin, Patrick, Lee, Samuel S, Niederau, Christian, Minuk, Gerald S, Ideo, Gaetano, Bain, Vincent, Heathcote, Jenny, Zeuzem, Stefan, Trepo, Christian, Albrecht, Janice
• Format: Article
• Language: English
• Subjects: Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; Human viral diseases; Infectious diseases; Medical sciences; Pharmacology. Drug treatments; Viral diseases; Viral hepatitis
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(98)07124-4

Only 15–20% of patients with chronic hepatitis C achieve a sustained virological response with interferon therapy. The aim of this study was to compare the efficacy and safety of interferon α2b in combination with oral ribavirin with interferon alone, for treatment of chronic infection with hepatitis C virus (HCV). 832 patients aged 18 years or more with chronic HCV who had not been treated with interferon or ribavirin, were enrolled and randomly allocated one of three regimens: 3 mega units (MU) interferon α2b three times a week plus 1000–1200 mg ribavirin per day for 48 weeks; 3 MU interferon α2b three times a week plus 1000–1200 mg ribavirin per day for 24 weeks; or 3 MU interferon α2b three times a week and placebo for 48 weeks. All patients were assessed for safety, tolerance, and efficacy at the end of weeks 1, 2, 4, 6, and 8, and every 4 weeks during treatment. After treatment was completed patients were followed up on weeks 4, 8, 12, and 24. The primary endpoint was loss of detectable HCV-RNA (serum HCV-RNA