title: A controlled trial of 6 months thrice weekly lymphoblastoid interferon versus no therapy in chronic hepatitis B virus infection. A preliminary analysis of the first 32 patients.
abstract: A controlled trial of lymphoblastoid interferon versus no therapy in patients positive for HBsAg, HBeAg and DNA polymerase activity with separate randomisation for sexual preference and histology is underway. Thirty two patients have been followed for a minimum period of 6 months of whom 15 have been randomised to receive interferon thrice weekly for 6 months after a 5-day induction phase. Five treated patients developed an hepatitis-like illness during the 3rd month of therapy concurrent with an abrupt and complete loss of DNA polymerase activity from serum. In 3 this was permanent and anti-HBe subsequently developed; 2 of these have also lost HBsAg. In the other 2 patients inhibition of viral replication was transient. In 5 further treated patients DNA polymerase activity was completely inhibited throughout treatment only to return as soon as interferon was withdrawn. In this group serum aminotransferase became normal during treatment. In the remaining 5 treated patients, inhibition of DNA polymerase activity was never complete and serum aminotransferases were unaffected. All the control patients remain seropositive for HBsAg, HBeAg and DNA polymerase activity. The low seroconversion rate in treated patients and the absence of seroconversion in the control group are probably a reflection of the exclusion of patients with marked elevation of serum aminotransferases. The occurrence of an hepatitis-like illness in the 3rd month of therapy in a third of the patients and the loss of HBsAg in 2 of 3 who eventually seroconverted are likely to be a consequence of therapy rather than spontaneous events.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.forename: G J
authors.initials: GJ
authors.lastname: Alexander
authors.forename: E A
authors.initials: EA
authors.lastname: Fagan
authors.forename: P
authors.initials: P
authors.lastname: Guarner
authors.forename: N
authors.initials: N
authors.lastname: Rolando
authors.forename: J
authors.initials: J
authors.lastname: Brahm
authors.forename: A L
authors.initials: AL
authors.lastname: Eddleston
authors.forename: R
authors.initials: R
authors.lastname: Williams
mesh_terms: D002986:Clinical Trials as Topic; D004259:DNA-Directed DNA Polymerase / Q000097:blood; D006509:Hepatitis B / Q000628:therapy*; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D006521:Hepatitis, Chronic / Q000628:therapy*; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011897:Random Allocation; D013997:Time Factors
chemical_list: D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D007370:Interferon Type I; D004259:DNA-Directed DNA Polymerase