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A double‐blind controlled trial of recombinant interferon‐α2b in haemodialysis patients with chronic hepatitis C virus infection and abnormal aminotransferase levels
Author(s) -
Fernández J. L.,
Rendo P.,
Pino N.,
Viola L.
Publication year - 1997
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 - 10.1111/j.1365-2893.1997.tb00213.x
Subject(s) - medicine , gastroenterology , placebo , hepatitis c virus , interferon , recombinant dna , alanine aminotransferase , chronic hepatitis , immunology , virus , pathology , biology , biochemistry , alternative medicine , gene
SUMMARY. The efficacy and safety of recombinant interferon‐α2b (rIFN‐α2b) was evaluated in a double‐blind controlled trial comprising 23 haemodialysis patients with antibodies to hepatitis C virus (anti‐HCV), detectable serum HCV RNA by polymerase chain reaction and chronic alanine aminotransferase elevation. The patients were randomly assigned to receive rIFN‐α2b at a dose of 1.5 MU (increasing to 3 MU if no response was observed) (Group I: n = 14) or identical placebo (Group II: n = 9), for 6 months. A biochemical response (normal alanine aminotransferase) was observed in 10 patients (71.4%) from Group I and in one patient (11.1%) from Group II ( P < 0.01) at the end of therapy, and in four patients from Group I (28.6%) and in none from Group II (NS) 12 months after therapy. Virological response (HCV RNA negative) was observed in four patients (28.6%) from Group I and in none from Group II (NS) at the end of therapy, and in two patients (14.2%) from Group I and in none from Group LT (NS) 12 months after therapy. Interferon doses were 1.5 MU in 12 patients and 3 MU in two patients. Therapy interruption owing to severe side‐effects was necessary in three patients (21.4%) from Group I and in two patients (22.2%) from Group II. Although long‐term statistical differences were not observed, these results suggest that rIFN‐α2b at a low dose is a reasonable and well tolerated therapeutic approach for haemodialysis patients with chronic hepatitis C.