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Chronic hepatitis C patients with a post‐treatment virological relapse re‐treated with an induction dose of 18 MU interferon‐ α in combination with ribavirin and amantadine: a two‐arm randomized pilot study
Author(s) -
Weegink C. J.,
Sentjens R. E.,
Beld M. G.,
Dijkgraaf M. G. W.,
Reesink H. W.
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.1365-2893.2003.00421.x
Subject(s) - amantadine , ribavirin , medicine , interferon , randomized controlled trial , virology , chronic hepatitis , gastroenterology , pharmacology , virus
Summary. Thirty‐seven chronic hepatitis C patients with virological relapse (VR) after previous interferon‐ α (IFN) or IFN/ribavirin (Riba) therapy, were re‐treated. Patients were randomized for either IFN/Riba and amantadine (Ama) including a 2‐week initial high IFN induction course (18 MU IFN daily) (group A) or the same 2‐week IFN induction course combined with Riba/Ama, followed by Riba/Ama without IFN (group B). Treatment duration for both groups was 24 weeks with a 24‐week follow‐up thereafter. The inclusion in group B was prematurely stopped because all patients ( n = 10) relapsed within 2 weeks after stopping IFN. Therefore, all subsequent patients were included in group A ( n = 27). In group A, 44% achieved a sustained virological response (SVR) and 29% of the patients with an end‐of‐treatment virological response had a VR again. Of all pretreatment characteristics, only genotype non‐1 patients had a significantly higher chance of achieving SVR ( P < 0.001). Of the characteristics during treatment only a negative hepatitis C virus (HCV)‐RNA test result in transcription‐mediated amplification (TMA) at week 6 had a high predictive value for SVR, 80% in all patients and 92% in genotype non‐1 patients. In conclusion, hepatitis C patients with a VR to previous antiviral treatment can be succesfully re‐treated with IFN induction combined with Riba/Ama for only 6 months, when they have genotype non‐1 and a negative HCV‐RNA test result in TMA 6 weeks after the start of therapy. Riba/Ama combination therapy without IFN does not prevent VR after 2 weeks high IFN induction.