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A randomized controlled clinical trial of recombinant interferon α‐2b in the treatment of acute post‐transfusion hepatitis C: A preliminary report
Author(s) -
HWANG SJ.,
LEE SD.,
LEE YH. W.,
WU JC.,
CHAN CY.,
HUANG YS.,
WANG YJ.,
LO KJ.
Publication year - 1993
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.1993.tb01691.x
Subject(s) - medicine , seroconversion , gastroenterology , hepatitis c virus , alanine transaminase , interferon , blood transfusion , interferon alfa , immunology , hepatitis c , antibody , alpha interferon , virus
Twenty patients with acute post‐transfusion hepatitis C were prospectively followed after blood transfusion. All had seroconversion of serum antibody to hepatitis C virus (anti‐HCV) or hepatitis C virus (HCV) RNA. They were randomly allocated to two groups. Ten patients received a subcutaneous injection of recombinant interferon (IFN) α‐2b, 3 million units (MU) thrice weekly for 3 months; this was generally 8 weeks after the first post‐transfusional elevation of serum alanine transaminase (ALT). Ten patients without specific treatment were selected as a control group. During the 3 month period, nine (90%, 95% CI = 54–99%) patients in the IFN‐treated group normalized serum ALT level, while only three (30%, 95% CI = 8–65%) in the control group normalized the serum ALT spontaneously ( P < 0.01). Two (25%) of eight patients who initially showed a complete response to IFN‐treatment had serum ALT elevated again. After a 6 month follow‐up, five (63%, 95% CI = 26–90%) of eight patients in the IFN‐treated group and four (44%, 95% CI = 15–77%) of nine patients in the control group normalized serum ALT ( P = 0.40). Among the nine patients who normalized serum ALT during IFN treatment, eight had undetectable serum HCV RNA and one showed a decreased level. Two patients had detectable serum HCV RNA accompanied by elevated serum ALT again after completion of the IFN treatment. After 6 months follow‐up four (50%, 95% CI = 17–83%) of eight patients lost their serum HCV RNA in the IFN‐treated group and two (22%, 95% CI = 4–60%) of nine patients spontaneously lost their HCV RNA in the control group ( P = 0.25). All patients tolerated the IFN treatment well but had minor side effects such as fever, rigor, malaise, leukopenia, myalgia, headache and hair loss. In conclusion, recombinant IFN α‐2b injections in patients with acute post‐transfusion hepatitis C can successfully suppress the viral RNA and lead to normalization of serum ALT. Whether this regimen can prevent the development of chronicity needs further evaluation.