|
|
 | |||||||||||||||||||||||||||||||
 | |||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||
Background and Methods Chronic hepatitis D is a severe and rapidly progressive liver disease for which no therapy has been proved effective. To evaluate the efficacy of treatment with interferon, we studied 42 patients with chronic hepatitis D who were randomly assigned to receive either 9 million or 3 million units of recombinant interferon alfa-2a (three times a week for 48 weeks) or no treatment.
Results By the end of the treatment period, serum alanine aminotransferase values had become normal in 10 of 14 patients receiving 9 million units (71 percent), as compared with 4 of 14 treated with 3 million units (29 percent, P = 0.029) and 1 of 13 untreated controls (8 percent, P = 0.001). Seven patients treated with the higher dose of interferon (50 percent) had a complete response (normal levels of alanine aminotransferase and no detectable serum hepatitis delta virus [HDV] RNA), as compared with three of those who received the lower dose (21 percent, P = 0.118), and none of the controls (P = 0.004). Treatment with 9 million units of interferon was associated with a marked improvement in the histologic findings (reduced periportal necrosis and portal and lobular inflammation), whereas in the untreated controls there was considerable histologic deterioration. In 5 of the 10 patients treated with 9 million units of interferon whose alanine aminotransferase values became normal, the biochemical responses persisted for up to 4 years (mean, 39 months), but the effects of treatment on viral replication were not sustained. In contrast, none of those who received 3 million units and none of the untreated controls had a sustained biochemical or virologic response.
Conclusions In about half the patients with chronic hepatitis D treated with high doses of interferon alfa-2a (9 million units three times a week for 48 weeks), the serum alanine aminotransferase level becomes normal, HDV RNA becomes undetectable in serum, and there is histologic improvement. However, a relapse is common after treatment has been stopped.
Source Information
From the Istituto di Medicina Interna, University of Cagliari, Cagliari, Italy (P.F., A.M., A.C., M.E.L., A.B.); the Department of Pathology, University of Leuven, Leuven, Belgium (V.D., P.V.E., Y.G.); the Istituto di Medicina Interna, University of Catania, Catania, Italy (L.C.); Clinical Research, Roche S.p.A., Milan, Italy (S.S., D.C.); and Clinical Research, Hoffman-LaRoche, Ltd., Basel, Switzerland (J.-C.R.). Presented in part at the annual meeting of the American Association for the Study of Liver Diseases, Chicago, November 3-6, 1990.The following investigators also participated in this study: Anna Maria Giulia Farci, M.D., Giovanna Peddis, Ph.D., Giuseppina Orgiana, Ph.D., Anna Paola Mazzoleni, Ph.D., and Aldo Casti, M.D., Istituto di Medicina Interna, and Gavino Faa, M.D., Istituto di Anatomia Patologica, University of Cagliari, Cagliari, Italy; Caterina Trischitta, M.D., Istituto di Medicina Interna, University of Catania, Catania, Italy; and Monique Chaneac, Ph.D., Clinical Research, Hoffmann-LaRoche, Ltd., Basel, Switzerland.
Address reprint requests to Dr. Farci at the Hepatitis Viruses Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bldg. 7, Rm. 200, 9000 Rockville Pike, Bethesda, MD 20892.
This article has been cited by other articles:
HOME | SUBSCRIBE | SEARCH | CURRENT ISSUE | PAST ISSUES | COLLECTIONS | PRIVACY | TERMS OF USE | HELP | beta.nejm.org Comments and questions? Please contact us. The New England Journal of Medicine is owned, published, and copyrighted © 2009 Massachusetts Medical Society. All rights reserved. |
Previous
