Citation:
Tassopoulos NC, Ketikoglou I, Tsantoulas D, Raptopoulou M, Hatzis G, Vafiadis I, Sidiropoulos L, Kanatakis S, Anagnostopoulos G, Sypsa V, et al. A randomized trial to assess the efficacy of interferon-alpha daily in combination with ribavirin in the treatment of naive patients with chronic hepatitis C. J Viral HepatJ Viral HepatJ Viral Hepat. 2003;10:383-9.
Abstract:
A randomized trial was conducted to assess the efficacy of interferon-alpha (IFN) daily in combination with ribavirin in 301 naive 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 naive patients with CHC.Notes:
Tassopoulos, N CKetikoglou, ITsantoulas, DRaptopoulou, MHatzis, GVafiadis, ISidiropoulos, LKanatakis, SAnagnostopoulos, GSypsa, VHatzakis, AengClinical TrialRandomized Controlled TrialResearch Support, Non-U.S. Gov'tEngland2003/09/13 05:00J Viral Hepat. 2003 Sep;10(5):383-9. doi: 10.1046/j.1365-2893.2003.00439.x.
