Anti-HBe-positive patients with precore mutants may have severe, progressive
liver disease.
Therapy with
interferon has been effective, but relapses are frequent. To evaluate and compare two
antiviral treatments,
lymphoblastoid interferon (ly-IFN) and
adenine arabinoside 5'-monophosphate (
ARA-AMP), 20 patients with anti-HBe-positive
chronic hepatitis (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 were not significantly different between the two groups. At the end of
therapy, 8 (89%) patients in the
interferon group and 5 (45%) in the
ARA-AMP group showed normal ALT levels and no HBV
DNA in serum by a liquid hybridization assay (P < 0.05). At 1 year of follow-up, a persistent response was observed in 33% of ly-IFN patients and in 27% of
ARA-AMP patients, a transient response in 56% and 18%, and nonresponse in 11% and 55%, respectively. HBV
DNA remained detectable by polymerase chain reaction (PCR) in 19 of the 20 patients. Among the responders, an improvement in histological lesion and the disappearance of intrahepatic
HBcAg were observed; in the nonresponders, histological lesion remained stable or worsened. In conclusion, the efficacy of
interferon and
ARA-AMP was similar in treating anti-HBe-positive
chronic hepatitis. Although
interferon treatment led to initial improvement in a larger number of patients, there was a much higher rate of relapses with this
drug.