A randomized trial to assess the efficacy of interferon-alpha daily in combination with ribavirin in the treatment of naïve patients with chronic hepatitis C

• Published in: Journal of viral hepatitis Vol. 10; no. 5; pp. 383 - 389
• Main Authors: Tassopoulos, N. C., Ketikoglou, I., Tsantoulas, D., Raptopoulou, M., Hatzis, G., Vafiadis, I., Sidiropoulos, L., Kanatakis, S., Anagnostopoulos, G., Sypsa, V., Hatzakis, A.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01-09-2003
• Subjects: Adolescent; Adult; Aged; Antiviral Agents - administration & dosage; Antiviral Agents - therapeutic use; chronic hepatitis C; daily interferon; Drug Therapy, Combination; Female; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; interferon α; Interferon-alpha - administration & dosage; Interferon-alpha - therapeutic use; Male; Middle Aged; randomized clinical trial; ribavirin; Ribavirin - administration & dosage; Ribavirin - therapeutic use; Time Factors; Treatment Outcome; Viral Load
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1046/j.1365-2893.2003.00439.x

A randomized trial was conducted to assess the efficacy of interferon‐alpha (IFN) daily in combination with ribavirin in 301 naïve patients with chronic hepatitis C (CHC). Patients were randomized to receive ribavirin 1.2 g daily (QD) for 48 weeks with either IFN 5 MU (thrice weekly) TIW for 8 weeks followed by IFN 3 MU TIW for 40 weeks (IFN TIW, n = 154) or IFN 5 MU QD for 8 weeks followed by IFN 3 MU QD for 16 weeks followed by IFN 3 MU TIW for 24 weeks (IFN QD, n = 147). Treatment discontinuation rates, because of adverse events, were similar in the two arms (14.9% in IFN TIW and 14.3% in IFN QD, P = 0.87). The proportion of patients with sustained virological response (SVR) was 27.9% for patients treated TIW and 38.8% for those treated QD (P = 0.046). According to logistic regression analysis, patients in the IFN QD arm had 1.7 times higher probability of achieving SVR, than those receiving IFN TIW (P = 0.038). Low baseline viral load (P = 0.017) and genotype non‐1 (P = 0.036) were associated with higher SVR rates. Combination of IFN/ribavirin for 48 weeks is more effective when IFN is administered daily for the first 24 weeks in naïve patients with CHC.