Zidovudine and ddC for advanced HIV infection - dideoxycytidine - Tips from Other Journals

Date: May, 1992

Meng and associates evaluated the safety and the immunologic and antiviral effects of combination therapy with zidovudine and dideoxycytidine (ddC) in patients with advanced human immunodeficiency virus (HIV) infection.

The study included 56 patients with HIV type 1 infection and CD4 counts below 200 cells per mm3 (200 X 106 per L). Patients were randomly assigned to one of six dosing regimens of zidovudine plus ddc. Pharmacokinetics, toxicity, CD4 counts, p24 antigenemia and clinical end points were assessed. Median follow-up was 40.6 weeks (range: 0.3 to 70 weeks).

Neither drug appeared to affect the pharmacokinetics of the other. Serious hematologic toxicity occurred in 17. 9 percent of patients and did not differ among regimens. Severe sensory peripheral neuropathy occurred in two patients. One patient died.

The mean maximal increase in CD4 counts exceeded 109 cells per mm3 (109 x 106 per L), and 69 percent of patients receiving combinations 'containing 300 or 600 mg of zidovudine daily had an increase in CD4 counts of 50 cells per mm3 (50 X 106 per L). Regimens containing 600 mg of zidovudine daily were more likely to produce increases in CD4 counts than the two lower dose regimens. CD4 counts declined more rapidly and p24 antigenemia was less rapidly suppressed in patients receiving the lowest dose of zidovudine (100 mg daily). The addition of ddC to this regimen resulted in slower declines in CD4 counts.

The authors conclude that combination therapy with zidovudine and ddC was well tolerated by the patients in this study.

Combination therapy with ddC and higher doses of zidovudine produced greater and more persistent effects in patients with advanced HIV infection, compared with the other study regimens and with the results of previous trials of zidovudine therapy alone. (Annals of Internal Medicine, January 1, 1992, vol. 116, p. 13.)

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