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Randomized controlled trial of recombinant alpha-2a-interferon for chronic hepatitis C

Comparison of alanine aminotransferase normalization versus loss of HCV RNA and anti-HCV IgM

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Abstract

We enrolled 32 patients with chronic hepatitis C into a randomized, controlled trial to evaluate the efficacy of recombinant alpha-2a-interferon treatment. Sixteen patients were randomized to receive 1.5 million units of recombinant alpha-2a-interferon subcutaneously, thrice weekly, for six months while the remaining 16 patients were randomized to a control group that received no treatment. The mean serum alanine aminotransferase (ALT) level during the six-month study period, expressed as a percentage of the prestudy baseline value, was 82% for the control group compared to 56% for the treatment group (P=0.014). One fourth of the treatment group normalized their serum ALT level compared to only 6% of the controls (P=0.05). During posttherapy follow-up, 86% of responders clinically relapsed. Loss of anti-HCV IgM and HCV RNA occurred exclusively in interferon-treated responders. Anti-interferon antibodies developed in 32% of all treated patients. Forty percent of nonresponders developed anti-interferon antibodies compared to only 14% of responders (P=NS). We conclude that recombinant alpha-2a-interferon is clinically effective in patients with chronic hepatitis C. However, most responders in this trial of low-dose interferon relapsed upon cessation of treatment.

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Authors and Affiliations

  1. Baylor College of Medicine, 77030, Houston, Texas

    David D. Douglas MD,  Jorge Rakela MD, Hsiang Ju Lin DSc, F. Blaine Hollinger MD, Howard F. Taswell MD, Albert J. Czaja MD, John B. Gross MD, Monte L. Anderson MD, Kevin Parent MD, C. Richard Fleming MD, John R. Cangemi MD, Peter C. O'Brien PhD & Pauline E. Powis RN

  2. Mayo Clinic, 85259, Scottsdale, Arizona

    David D. Douglas MD,  Jorge Rakela MD, Hsiang Ju Lin DSc, F. Blaine Hollinger MD, Howard F. Taswell MD, Albert J. Czaja MD, John B. Gross MD, Monte L. Anderson MD, Kevin Parent MD, C. Richard Fleming MD, John R. Cangemi MD, Peter C. O'Brien PhD & Pauline E. Powis RN

  3. Mayo Clinic, 32224, Jacksonville, Florida

    David D. Douglas MD,  Jorge Rakela MD, Hsiang Ju Lin DSc, F. Blaine Hollinger MD, Howard F. Taswell MD, Albert J. Czaja MD, John B. Gross MD, Monte L. Anderson MD, Kevin Parent MD, C. Richard Fleming MD, John R. Cangemi MD, Peter C. O'Brien PhD & Pauline E. Powis RN

  4. Mayo Clinic, 200 First Street SW, 55905, Rochester, Minnesota

    David D. Douglas MD,  Jorge Rakela MD, Hsiang Ju Lin DSc, F. Blaine Hollinger MD, Howard F. Taswell MD, Albert J. Czaja MD, John B. Gross MD, Monte L. Anderson MD, Kevin Parent MD, C. Richard Fleming MD, John R. Cangemi MD, Peter C. O'Brien PhD & Pauline E. Powis RN

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  1. David D. Douglas MD
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  2. Jorge Rakela MD
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Douglas, D.D., Rakela, J., Lin, H.J. et al. Randomized controlled trial of recombinant alpha-2a-interferon for chronic hepatitis C. Digest Dis Sci 38, 601–607 (1993). https://doi.org/10.1007/BF01316787

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  • DOI: https://doi.org/10.1007/BF01316787

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