A Randomized Study of the Effects of Adenine Arabinoside 5′–Monophosphate (Short or Long Courses) and Lymphoblastoid Interferon on Hepatitis B Virus Replication

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Abstract
A previous randomized controlled study has shown a 30% rate of HBe antigen/antibody serocon–version within 1 year of a month course of adenine arabinoside–5′–monophosphate; no seroconversion occurred in the control group. In this study of patients derived from the same population, 45 hepatitis B virus carriers with chronic liver disease were randomized to receive either a short (4–week) course of adenine arabinoside–5′–monophosphate, a long (7 to 8–week) course of adenine arabinoside–5′–monophosphate or a 12–week course of lymphoblastoid interferon. Long–lasting suppression of hepatitis B virus replication with disappearance of serum hepatitis B virus DNA and clearance of HBeAg occurred within 12 months of treatment in four patients who received the short course of adenine arabinoside–5′–monophosphate and in five who received interferon. Of the nine responders, four also lost HBsAg. A response to antiviral therapy was accompanied by clinical and biochemical evidence of improvement in liver disease. None of the patients who received a long course of adenine arabinoside–5′–monophosphate responded. Peripheral neuropathy and myalgia were the most serious adverse effect affecting three recipients of the short course of adenine arabinoside–5′–monophosphate and eight recipients of the long course. Thrice weekly administration of interferon was well–tolerated. Further studies to identify the characteristics of the “responder patients” and large–scale controlled trials of antiviral therapy in these subgroups are indicated.

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