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Decrease in Serum Hepatitis C Viral RNA during Alpha-Interferon Therapy for Chronic Hepatitis C
- Michiko Shindo, MD, PhD;
- Adrian M. Di Bisceglie, MD;
- Ling Cheung, BA;
- J. Wai-Kuo Shih, PhD;
- Karen Cristiano, PhD;
- Stephen M. Feinstone, MD; and
- Jay H. Hoofnagle, MD
Abstract
▪ Objective: To assess the effect of alpha-interferon therapy on hepatitis C viral RNA in serum of patients with chronic hepatitis C.
▪ Design: Retrospective testing for hepatitis C viral (HCV) RNA and antibody to the hepatitis C virus (anti-HCV) of stored serum samples from a randomized, double-blind, placebo-controlled trial of alphainterferon therapy.
▪ Setting: Warren Grant Magnuson Clinical Center of the National Institutes of Health, a tertiary referral center.
▪ Patients: Forty-one patients with chronic non-A, non-B hepatitis were entered in this trial.
▪ Interventions: Twenty-one patients were treated with alpha-interferon, and 20 patients were treated with placebo for 6 months. Seventeen placebo recipients were then treated with alpha-interferon for up to 1 year.
▪ Methods: Samples were tested for anti-HCV by enzyme-linked immunosorbent assay. Hepatitis C viral RNA was detected in serum using the polymerase chain reaction. Titers of both antibody and RNA were determined by serial end-point dilution.
▪ Main Results: At entry into the trial, 37 (90%) of 41 patients had anti-HCV and 39 (95%) had HCV RNA in serum. Anti-HCV titers decreased slightly with treatment. Serum levels of HCV RNA decreased in all patients who responded to alpha-interferon therapy with improvements in serum aminotransferases; in 17 of 21 responders (81%; 95% Cl, 58% to 95%) HCV RNA became undetectable. In contrast, in only 2 of 16 (12%; Cl, 2% to 38%) patients who did not respond to treatment did HCV RNA become undetectable. In 19 patients treated during the preliminary 6-month period with placebo, HCV RNA remained detectable. Finally, in the 11 patients who relapsed when treatment was stopped, HCV RNA reappeared in the serum, but in 4 of 7 patients with a sustained improvement in serum aminotransferases, HCV RNA remained undetectable.
▪ Conclusions: These results indicate that the clinical and serum biochemical response to alpha-interferon in chronic hepatitis C is associated with a loss of detectable HCV genome from serum.
Article and Author Information
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From the National Institutes of Health, Bethesda, Maryland; and the Food and Drug Administration, Rockville, Maryland. For current author addresses, see end of text.
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Requests for Reprints: Michiko Shindo, MD, PhD, Liver Diseases Section, Building 10, Room 4D52, National Institutes of Health, Bethesda, MD 20892.
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Current Author Addresses: Drs. Shindo, Di Bisceglie, and Hoofnagle: Liver Diseases Section, Building 10, Room 4D52, National Institutes of Health, Bethesda, MD 20892.
Ms. Cheung and Dr. Shih: Department of Transfusion Transmitted Virus Research, Building 10, Room ID46, National Institutes of Health, Bethesda, MD 20892.
Drs. Cristiano and Feinstone: Center for Biologic Evaluation and Research, Hepatitis Research Laboratory, Food and Drug Administration, Rockville, MD 20895.
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