title: A pilot, open-labelled, phase II study using oral ribavirin in the treatment of patients with chronic active hepatitis B.
abstract: BACKGROUND
  Ribavirin is a synthetic purine nucleoside with demonstrated antiviral activity against several DNA and RNA viruses.
  
  
  OBJECTIVE
  An open-labelled pilot study to evaluate the safety and effect of ribavirin in the treatment of patients with chronic active hepatitis B (CAH-B).
  
  
  METHODS
  24 CAH-B patients were treated with oral ribavirin 1200 mg daily in 3 divided doses for 4 weeks. Biochemical and virological parameters were monitored at regular interval during and after treatment.
  
  
  RESULTS
  The serum hepatitis B e antigen (HBeAg) and HBV DNA measured by dot-blot hybridization were positive in all patients before treatment. At the end of 4 weeks of therapy, the HBV DNA levels decreased in 15 (63%) patients and became undetectable in 1 (4%) of these individuals. The mean HBV DNA decreased from 288+/-78 pg/ml at baseline to 219+/-79 pg/ml at the end of the 4 weeks of treatment (p = 0.046). Eight weeks after cessation of treatment, HBV DNA was undetectable in 10 (42%) patients, and the mean HBV DNA was 46+/-23 pg/ml (p < 0.01 when compared to mean baseline value). Seven (29%) patients seroconverted from HBeAg positive to anti-HBe positive but no patients lost hepatitis B surface antigen (HBsAg) during the 8 weeks of follow-up. At the end of 4 weeks of ribavirin treatment, serum levels of alanine aminotransferase (ALT) decreased in all but 1 patient; only 1 patient normalized serum ALT at this time. The mean serum ALT decreased significantly from 416+/-72 IU/l at baseline to 179+/-35 IU/l at the end of 4 weeks of treatment (p = 0.001). Eight weeks after cessation of therapy, the mean serum ALT value was 151+/-32 IU/l (p < 0.001 when compared to mean baseline value) and 5 (21%) patients normalized serum ALT at this time. During ribavirin treatment, the main side effect was a decrease in the hemoglobin level which returned to the pretreatment level in each instance within 2 months after discontinuance of therapy.
  
  
  CONCLUSIONS
  Results of this pilot study indicated that oral ribavirin was well tolerated in CAH-B patients and resulted in lowering of serum ALT and HBV DNA values. A randomized controlled trial is needed to fully evaluate the beneficial effects of ribavirin in CAH-B patients.
authors.affiliation: Liver Center, Huntington Memorial Hospital, 744 Fairmount Avenue, Pasadena, CA. 91105, USA.
authors.forename: M J
authors.initials: MJ
authors.lastname: Tong
authors.forename: S J
authors.initials: SJ
authors.lastname: Hwang
authors.forename: M
authors.initials: M
authors.lastname: Lefkowitz
authors.forename: S D
authors.initials: SD
authors.lastname: Lee
authors.forename: R L
authors.initials: RL
authors.lastname: Co
authors.forename: K J
authors.initials: KJ
authors.lastname: Lo