INTERFERON VS ADENINE-ARABINOSIDE 5'-MONOPHOSPHATE IN PATIENTS WITH ANTI-HBE-POSITIVE CHRONIC HEPATITIS

Anti-HBe-positive patients with precore mutants may have severe, progr essive liver disease. Therapy with interferon has been effective, but relapses are frequent. To evaluate and compare two antiviral treatment s, lymphoblastoid interferon (ly-IFN) and adenine arabinoside 5'-monop hosphate (ARA-AMP), 20 patients with anti-HBe-positive chronic hepatit is (5 cirrhosis and 15 CAH) and viral replication (HBcAg in the liver and HBV DNA in serum) were treated. Patients were randomized into two groups: 11 patients received ARA-AMP, 5 mg/kg/day during 7 weeks, and 9 received human ly-IFN, 5,000,000 units, three times per week, during 4 months. Baseline clinical, biochemical and histological features we re not significantly different between the two groups. At the end of t herapy, 8 (89%) patients in the interferon group and 5 (45%) in the AR A-AMP group showed normal ALT levels and no HBV DNA in serum by a liqu id hybridization assay (P < 0.05). At 1 year of follow-up, a persisten t response was observed in 33% of ly-IFN patients and in 27% of ARA-AM P patients, a transient response in 56% and 18%, and nonresponse in 11 % and 55%, respectively. HBV DNA remained detectable by polymerase cha in reaction (PCR) in 19 of the 20 patients. Among the responders, an i mprovement in histological lesion and the disappearance of intrahepati c HBcAg were observed; in the nonresponders, histological lesion remai ned stable or worsened. In conclusion, the efficacy of interferon and ARA-AMP was similar in treating anti-HBe-positive chronic hepatitis. A lthough interferon treatment led to initial improvement in a larger nu mber of patients, there was a much higher rate of relapses with this d rug. (C) 1996 Wiley-Liss, Inc.