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Clinical trial: interferon alpha‐2b continuous long‐term therapy vs. repeated 24‐week cycles for re‐treating chronic hepatitis C
Author(s) -
MCHUTCHISON J. G.,
PATEL K.,
SCHIFF E. R.,
GITLIN N.,
MUR R. E.,
EVERSON G. T.,
CARITHERS R. L.,
DAVIS G. L.,
MARCELLIN P.,
SHIFFMAN M. L.,
HARVEY J.,
ALBRECHT J. K.
Publication year - 2008
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2007.03590.x
Subject(s) - medicine , ribavirin , gastroenterology , alpha interferon , hepatitis c virus , pegylated interferon , interferon alfa , hepatitis c , interferon , randomized controlled trial , fibrosis , combination therapy , immunology , virus
Summary Background Treatment options are limited for patients with hepatitis C virus who do not experience sustained viral eradication with pegylated interferon and ribavirin therapy. Aim To compare, in an open‐label, randomized study, long‐term continuous interferon alpha‐2b treatment with repeated 24‐week courses in patients with chronic hepatitis C virus that relapsed after prior interferon monotherapy. Methods A total of 499 patients received 24 weeks of interferon alpha‐2b, 3 MIU administered 3 TIW. Responders (normal alanine aminotransferase and negative hepatitis C virus ‐RNA, n = 244) were then randomized to continuous interferon therapy (1, 2 or 3 MIU TIW depending on response) or cyclical therapy (3 MIU TIW for 24 weeks per relapse). Mean Knodell inflammation (I + II + III) and necrosis (IV) scores at baseline vs. year 2 were compared. Results Patients receiving continuous low‐dose therapy vs. cycled therapy had larger reductions in inflammation (−3.9 vs. −3.1) and fibrosis (−0.49 vs. −0.24). Among both groups, the mean change was −3.4 for inflammation and −0.36 for fibrosis. Overall, 73% (95% CI: 67–79) of patients experienced reduced inflammation and 28% (95% CI: 22–34) had reduced fibrosis. Conclusions Our results suggest hepatitis C virus patients experiencing viral suppression during long‐term maintenance therapy with interferon demonstrate histological improvement. Further prospective trials testing this hypothesis are in progress.