title: Long-term versus short-term treatment with recombinant interferon alfa-2a in patients with chronic hepatitis B: a prospective, randomized treatment trial.
abstract: We conducted a prospective, randomized trial to study the efficacy and tolerance of long-term versus short-term treatment with recombinant interferon alfa-2a in patients with chronic hepatitis B. Ten patients were randomly assigned to a 6-month interferon regimen, and 10 patients were assigned to a 3-week interferon trial. Eleven patients (five assigned to long-term treatment and six to short-term treatment) did not complete interferon therapy: eight had either severe thrombocytopenia or neutropenia; one had pronounced fatigue in relationship to administration of interferon; one had spontaneous bacterial peritonitis and sepsis and died; and one had a massive fatal variceal hemorrhage during interferon therapy. Most of the serious hematologic complications occurred in patients with cirrhosis and hypersplenism. In one patient, seroconversion to hepatitis B virus DNA negativity occurred before the onset of treatment. Four of the five patients able to complete the 6-month interferon regimen and only one of four patients able to complete the 3-week trial had seroconversion to hepatitis B virus DNA negativity. Thus, we conclude that the therapeutic response was better among patients who were able to complete a 6-month interferon trial. In patients with cirrhosis and hypersplenism, development of either severe thrombocytopenia or leukopenia associated with interferon therapy precluded completion of treatment.
authors.affiliation: Division of Gastroenterology, Mayo Clinic, Rochester, MN 55905.
authors.forename: J
authors.initials: J
authors.lastname: Rakela
authors.forename: J R
authors.initials: JR
authors.lastname: Wood
authors.forename: A J
authors.initials: AJ
authors.lastname: Czaja
authors.forename: P C
authors.initials: PC
authors.lastname: O'Brien
authors.forename: H F
authors.initials: HF
authors.lastname: Taswell
authors.forename: B A
authors.initials: BA
authors.lastname: Bowyer
authors.forename: S M
authors.initials: SM
authors.lastname: Lange
authors.forename: M L
authors.initials: ML
authors.lastname: Anderson
authors.forename: K
authors.initials: K
authors.lastname: Parent
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000628:therapy*; D006515:Hepatitis B virus / Q000235:genetics; D006521:Hepatitis, Chronic / Q000276:immunology / Q000628:therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000209:etiology; D011446:Prospective Studies; D011994:Recombinant Proteins; D013921:Thrombocytopenia / Q000209:etiology; D013997:Time Factors
chemical_list: D004279:DNA, Viral; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins