In this pilot study, 12 patients with
chronic delta hepatitis were studied. The diagnosis was based on the presence of
antibodies to the
hepatitis delta antigen in the serum and hepatitis delta virus
RNA and
hepatitis delta antigen in the serum and liver. All patients were also positive for
hepatitis B surface antigen. The
infection was presumed to have been transmitted by
intravenous drug abuse in six of the patients,
blood transfusion in one and by sexual contact in four (two had
antibodies to human immunodeficiency virus in their serum, but did not show signs of
acquired immunodeficiency syndrome). In one further patient, the source of
infection was unknown.
Interferon alfa-2b (INTRON A, Schering-Plough Corporation) was initiated at 5 million units per day subcutaneously for at least 4 months, being reduced by half if side effects occurred. Serum
alanine aminotransferase levels, hepatitis delta virus
RNA and
hepatitis delta antigen were measured at monthly intervals for up to 12 months in some patients.
Interferon therapy resulted in decreased serum levels of these three markers. On cessation of
therapy, most patients experienced a relapse over 6 months, but
alanine amino
transferase levels could be normalized once more by restarting
interferon therapy. In conclusion,
interferon decreased hepatic
inflammation by the inhibition of hepatitis delta virus replication, although relapse occurred when
interferon was stopped and long-term
therapy is required to achieve permanent control of the disease. Care will be required when treating patients with advanced or decompensated
liver disease.