Neurotoxicity associated with adenine arabinoside monophosphate in the treatment of chronic hepatitis B virus infection.

Thirty-one patients with chronic HBV infection were randomized to receive a short or long course of ARA-AMP. Fifteen completed a 4 week course of treatment and 16 completed longer courses varying from 7 to 12 weeks. Eighteen patients did not experience any neurological side effects. Six patients had myalgia. This was not associated with any neurological deficit. Seven patients developed a sensory neuropathy with distressing pain and dysesthesiae in the feet and abnormalities in nerve conduction. The development of neurotoxicity was related to a long duration of treatment and a correspondingly higher total dose but there was no association with the severity of liver disease.

RCT Entities:   Population Interventions Outcomes