title: A pilot study of 2',3'-dideoxyinosine for the treatment of chronic hepatitis B.
abstract: The nucleoside analog 2',3'-dideoxyinosine, currently being used to treat patients infected with the human immunodeficiency virus, has been shown to inhibit viral replication in certain cell culture systems of hepatitis B virus and the duck model of chronic hepatitis B infection. We studied the effect of dideoxyinosine on viral replication in patients with chronic hepatitis B. In the initial dose-finding phase, patients received sequential 2-wk courses of dideoxyinosine in escalating doses of 3, 6 and 9 mg/kg/day. In the second, long-term treatment phase, patients received dideoxyinosine at a dose of 9 mg/kg/day for 12 wk. Dideoxyinosine was given orally in three divided doses. The effects of dideoxyinosine on hepatitis B were assessed by serial measurements of ALT, hepatitis B virus DNA and DNA polymerase activity in serum. Six patients completed the dose-finding phase, and five patients continued into the long-term treatment phase. No significant differences were seen in serum aminotransferases, hepatitis B virus DNA levels or DNA polymerase activity at any time during treatment when compared with pretreatment levels. All patients remained positive for HBeAg during treatment and during 6 mo of follow-up. Thus at the doses tested, dideoxyinosine had no appreciable effect on viral replication in patients with chronic hepatitis B.
authors.affiliation: Liver Diseases Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892.
authors.forename: M W
authors.initials: MW
authors.lastname: Fried
authors.forename: J C
authors.initials: JC
authors.lastname: Korenman
authors.forename: A M
authors.initials: AM
authors.lastname: Di Bisceglie
authors.forename: Y
authors.initials: Y
authors.lastname: Park
authors.forename: J G
authors.initials: JG
authors.lastname: Waggoner
authors.forename: H
authors.initials: H
authors.lastname: Mitsuya
authors.forename: N R
authors.initials: NR
authors.lastname: Hartman
authors.forename: R
authors.initials: R
authors.lastname: Yarchoan
authors.forename: S
authors.initials: S
authors.lastname: Broder
authors.forename: J H
authors.initials: JH
authors.lastname: Hoofnagle
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004279:DNA, Viral / Q000097:blood; D004259:DNA-Directed DNA Polymerase / Q000097:blood; D016049:Didanosine / Q000627:therapeutic use*; D006509:Hepatitis B / Q000097:blood / Q000188:drug therapy* / Q000235:genetics; D006515:Hepatitis B virus / Q000235:genetics; D006801:Humans; D008297:Male; D010865:Pilot Projects
chemical_list: D004279:DNA, Viral; D004259:DNA-Directed DNA Polymerase; D016049:Didanosine