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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
Author(s) -
Tassopoulos N. C.,
Ketikoglou I.,
Tsantoulas D.,
Raptopoulou M.,
Hatzis G.,
Vafiadis I.,
Sidiropoulos L.,
Kanatakis S.,
Anagnostopoulos G.,
Sypsa V.,
Hatzakis A.
Publication year - 2003
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1046/j.1365-2893.2003.00439.x
Subject(s) - ribavirin , medicine , discontinuation , gastroenterology , adverse effect , alpha interferon , randomized controlled trial , chronic hepatitis , hepatitis c , interferon , immunology , virus
Summary. 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.