Safety and tolerability of zalcitabine (ddC) in patients with AIDS or advanced AIDS-related complex in the European expanded access programme.
This international expanded access programme was initiated to provide zalcitabine (o 75 mg three times daily) to patients with AIDS or advanced ARC who had failed, were no longer able to tolerate or were ineligible to receive zidovudine (ZDV). Data are available from 517 patients. No unexpected adverse events occurred during the study with 13.2% of patients discontinuing treatment due to drug-related adverse events. Peripheral neuropathy (PN) was the most common adverse event reported. This was considered to be at least possibly related to zalcitabine in 12.2% of patients, with only 2.3% of patients withdrawing from the study due to zalcitabine-associated PN. Patients with a baseline diagnosis of AIDS and a CD4 count </= 50 cells/mm(3) were most likely to develop PN on zalcitabine. Fifty-seven patients (11%) died during the study, with death considered to be at least remotely related to therapy in only 2 cases (1 case each of pancreatitis and cerebral toxoplasmosis with possible sepsis/granulocytopenia).
Moyle
G
G
Chelsea & Westminster Hospital, London, UK.
Goll
A
A
Snape
S
S
Harris
R
R
Wilkes
C
C
Warburg
M
M
Salgo
M
M