Adenine arabinoside monophosphate (vidarabine phosphate) in combination with human leukocyte interferon in the treatment of chronic hepatitis B. a randomized, double-blinded, placebo-controlled trial

Garcia, G.; Smith, C.I.; Weissberg, J.I.; Eisenberg, M.; Bissett, J.; Nair, P.V.; Mastre, B.; Rosno, S.; Roskamp, D.; Waterman, K.

Annals of Internal Medicine 107(3): 278-285

1987


ISSN/ISBN: 0003-4819
PMID: 2441633
DOI: 10.7326/0003-4819-107-2-278
Accession: 039185548

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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.