Prospective trial of recombinant leucocyte interferon in chronic hepatitis B: a long-term follow-up study.
Twenty-one adult patients with chronic hepatitis B and active viral replication as indicated by positivity for hepatitis B e antigen and hepatitis B virus DNA, with increased DNA polymerase levels for more than 6 months, were entered into a prospective trial of low-dose recombinant human alpha-interferon therapy. All patients were treated with 5 million units of recombinant interferon alfa-2b given subcutaneously every other day for 12 weeks. During treatment, 18 patients (86%) showed a significant reduction of DNA polymerase levels (p less than or equal to 0.001), which reached normal values in ten (48%). After 10 months' mean follow up, seven patients (33%) were hepatitis B e antigen negative and five (24%) subsequently became positive for antibodies to e antigen. By 27 months, nine patients (43%) were both hepatitis B e antigen negative and e antibody positive. Only one patient became permanently negative for hepatitis B surface antigen. One patient relapsed during the second year of follow up. Side effects necessitated withdrawal of therapy in two patients: one due to worsening thrombocytopenia after two doses of interferon (data omitted from the study results) and one due to a local reaction at the injection sites. Our data indicate that small doses of recombinant interferon alfa-2b given during a 12-week period induce a significant reduction in viral replication and approximately triple the spontaneous seroconversion rate observed in patients with chronic hepatitis B.
Coppens
J P
JP
Department of Gastroenterology, St-Luc University Hospital, Brussels, Belgium.
Cornu
C
C
Lens
E
E
Lamy
M
M
Geubel
A P
AP
D000410:Alanine Transaminase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D002908:Chronic Disease; D004259:DNA-Directed DNA Polymerase / Q000097:blood; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000097:blood / Q000628:therapy*; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000502:physiology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008111:Liver Function Tests; D011446:Prospective Studies; D011994:Recombinant Proteins; D014779:Virus Replication
D015415:Biomarkers; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase; D004259:DNA-Directed DNA Polymerase