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

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

doi:10.1007/BF01316787

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

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

Gastroenterology and Hepatology

Research output: Contribution to journal › Article › peer-review

40 Scopus citations

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.

Original language	English (US)
Pages (from-to)	601-607
Number of pages	7
Journal	Digestive diseases and sciences
Volume	38
Issue number	4
DOIs	https://doi.org/10.1007/BF01316787
State	Published - Apr 1 1993

Keywords

HCV RNA
anti-HCV IgM
anti-interferon antibodies
hepatitis C
non-A, non-B hepatitis
polymerase chain reaction
recombinant alpha-2a-interferon

ASJC Scopus subject areas

Physiology
Gastroenterology

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10.1007/BF01316787

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Douglas, D. D., Rakela, J., Lin, H. J., Hollinger, F. B., Taswell, H. F., Czaja, A. J., Gross, J. B., Anderson, M. L., Parent, K., Fleming, C. R., Cangemi, J. R., O'Brien, P. C., & Powis, P. E. (1993). 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. Digestive diseases and sciences, 38(4), 601-607. https://doi.org/10.1007/BF01316787

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. / Douglas, David D.; Rakela, Jorge; Lin, Hsiang Ju et al.

In: Digestive diseases and sciences, Vol. 38, No. 4, 01.04.1993, p. 601-607.

Research output: Contribution to journal › Article › peer-review

Douglas, DD, Rakela, J, Lin, HJ, Hollinger, FB, Taswell, HF, Czaja, AJ, Gross, JB, Anderson, ML, Parent, K, Fleming, CR, Cangemi, JR, O'Brien, PC & Powis, PE 1993, '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', Digestive diseases and sciences, vol. 38, no. 4, pp. 601-607. https://doi.org/10.1007/BF01316787

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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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AU - Douglas, David D.

AU - Rakela, Jorge

AU - Lin, Hsiang Ju

AU - Hollinger, F. Blaine

AU - Taswell, Howard F.

AU - Czaja, Albert J.

AU - Gross, John B.

AU - Anderson, Monte L.

AU - Parent, Kevin

AU - Fleming, C. Richard

AU - Cangemi, John R.

AU - O'Brien, Peter C.

AU - Powis, Pauline E.

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N2 - 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.

AB - 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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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

Abstract

Keywords

ASJC Scopus subject areas

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