Adenine Arabinoside Monophosphate (Vidarabine Phosphate) in Combination with Human Leukocyte Interferon in the Treatment of Chronic Hepatitis B

Authors:
  • GGGabriel Garcia
    Gabriel Garcia
  • CSColeman I. Smith
    Coleman I. Smith
  • JWJed I. Weissberg
    Jed I. Weissberg
  • MEMark Eisenberg
    Mark Eisenberg
  • JBJack Bissett
    Jack Bissett
  • PNPrem V. Nair
    Prem V. Nair
  • BMBarbara Mastre
    Barbara Mastre
  • SRSue Rosno
    Sue Rosno
  • DRDebbie Roskamp
    Debbie Roskamp
  • KWKaren Waterman
    Karen Waterman
  • RPRichard B. Pollard
    Richard B. Pollard
  • MTMyron J. Tong
    Myron J. Tong
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Abstract
To determine the efficacy of adenine arabinoside monophosphate (Ara-AMP vidarabine phosphate) with or without human leukocyte interferon in chronic hepatitis B. Randomized, double-blinded, placebo-controlled trial with 6-month treatment and an 18-month follow-up. Referral-based liver-disease clinics at three university medical centers. Twenty-five patients with chronic active hepatitis or cirrhosis and 39 with chronic persistent hepatitis. Thirteen patients received intramuscular Ara-AMP, 2.5 mg/kg body weight, twice daily, alternated monthly for 6 months with subcutaneous human leukocyte interferon, 5 million units, twice daily. Painful paresthesia of the legs necessitated dosage reduction and early discontinuation of enrollment. Twenty-four patients received intramuscular Ara-AMP, 2.5 mg/kg, twice daily, alternated monthly for 6 months with a matching placebo given subcutaneously twice daily. Twenty-seven patients received placebo by intramuscular and subcutaneous injections twice daily for 6 months. Of the 64 patients, 95% had symptomatic and virologic data available and 64% had biopsies at 12 months; at 24 months, 77% had data available and 56% had repeat biopsies. The highest dropout rate was seen in the group receiving Ara-AMP. The group receiving the placebo was less symptomatic (Karnofsky score of 96% compared with 91% in the group receiving Ara-AMP/placebo and 92% in the group receiving Ara-AMP/human leukocyte interferon, p = 0.02) at 12 but not at 24 months. Loss of DNA polymerase, the hepatitis B e antigen, and the serum hepatitis B virus DNA was similar in all three groups. Histologically, erosion of the limiting plate and lobular activity favored Ara-AMP at 12 but not at 24 months and these differences did not result in differences in the histologic diagnosis. These results do not support the use of Ara-AMP and human leukocyte interferon in chronic persistent or chronic active hepatitis B.

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