Lieberman J, Baruch A, Fisher S, Salgo M, Soo W; International Conference on AIDS.
Int Conf AIDS. 1993 Jun 6-11; 9: 487 (abstract no. PO-B26-2114).
Hoffmann-LaRoche Inc., Nutley, NJ.
An expanded access program and several clinical trials have provided a large body of information concerning the safety of zalcitabine (ddC, HIVID) when given alone or in combination with zidovudine (ZDV). Comparative analyses were performed and will be presented relative to the incidence and severity of adverse events for ddC and ZDV as single agents, and the combination of ddC and ZDV. In these studies ddC showed acceptable tolerability in patients who cannot tolerate or have failed ZDV therapy. In addition, combination use of ddC with ZDV was demonstrated to be tolerable without an increase in the major dose limiting toxicities above those associated with each drug alone. The major adverse effects of ZDV on the gastrointestinal system and on hematological function (e.g. nausea, anemia) are different from toxicities associated with ddC. Peripheral neuropathy (PN) is the major adverse effect associated with ddC. In a comparative study moderate and severe, possibly or probably related PN has occurred in 23.1% of patients (n = 320) receiving ddC (.75 mg q8h) and in 6.0% of patients (n = 318) receiving ZDV (200 mg q4h). The true incidence of PN in combination ddC + ZDV is not currently known due to the small number of patients evaluated. Additional data from ACTG trial 155, including more than 400 patients on combination ddC + ZDV therapy, is expected shortly and will be presented. To date, evidence indicates that the severity of PN observed in patients receiving ddC + ZDV combination is comparable to ddC alone. ddC should be used with caution in patients with impairment of renal function, preexisting PN, or history of pancreatitis, since these patients may be at higher risk for developing toxicities caused by this drug.
Publication Types:
Keywords:
- Combined Modality Therapy
- Electric Stimulation Therapy
- Humans
- Incidence
- Peripheral Nervous System Diseases
- Safety
- Zalcitabine
- Zidovudine
Other ID:
UI: 102205102
From Meeting Abstracts