Acute Dane Particle Suppression with Recombinant Leukocyte A Interferon in Chronic Hepatitis B Virus Infection

The clinical, virologic, biochemical, and immunologic effects of a biosynthetic human leukocyte interferon, recombinant leukocyte A interferon (rIFN-A or HuIFN-a2) are reported in nine patients with chronic hepatitis B virus infection and circulating Dane particle-associated polymerase activity. Eight-day courses of rIFN-A were given starting at a dose of 3 x 106 units per day and reaching 68 x 106 units per day in two patients. Major toxic side effects included fever, fatigue, gastrointestinal symptoms, myalgias, and headache. Most courses of rIFN-A were associated with a reduction in Dane particle-associated polymerase activity, but in no case was this change permanent. There were also changes in lymphocyte subpopulations at the higher dosage levels of rIFN-A. Because of the reproducible, statistically significant effect on viral replication, further study with this and other biosynthetic interferon species is warranted. Chronic infection with hepatitis B virus (HBV) is an infrequent sequel to acute HBV infection. There is currently no clinically acceptable, proven therapy for this condition. Our group has observed that antiviral treatment of chronic HBV infection may produce one of three different responses. Therapy may be associated with (1) a transient decrease in viral markers during the period of drug administration, (2) long-term eradication of circulating Dane particles and hepatitis B e antigen (HBeAg) seroconversion, or (3) the complete disappearance of hepatitis B surface antigen (HBsAg) as well as