Tolerability of combined ganciclovir and didanosine for the treatment of cytomegalovirus disease associated with AIDS.
Ganciclovir is one of only two drugs licensed by the U.S. Food and Drug Administration for the treatment of opportunistic cytomegalovirus (CMV) disease. The combination of ganciclovir and zidovudine has been reported to be poorly tolerated because of dose-limiting hematologic toxicity; thus we retrospectively examined the tolerability of combination therapy with ganciclovir and didanosine in 32 patients with AIDS. These patients were receiving ganciclovir for CMV disease in addition to didanosine in the Videx U.S. Expanded Access Program. During the period of combined therapy, dose-limiting hematologic toxicity (absolute neutrophil count, < 500 cells/microL) developed in only 9.4% of patients and severe anemia (hemoglobin level, < 8.0 g/dL) in only 12.5%. Rates of dose-limiting intolerance to didanosine were similar to those previously reported in the Expanded Access Program. Overall, 15 of 32 patients in the current study tolerated therapeutic doses of didanosine in combination with ganciclovir; in contrast, only 5 of 29 patients tolerated zidovudine (600 mg/d) in combination with ganciclovir in the largest trial of therapy with this combination whose results have been published to date (P = .02, Fisher's exact test). Since recent data suggest that the administration of some form of antiretroviral therapy prolongs survival in patients with CMV retinitis, coadministration of didanosine with ganciclovir should be considered for such patients who do not tolerate other regimens with activity against both retroviruses and CMV.
Jacobson
M A
MA
Department of Medicine, University of California, San Francisco.
Owen
W
W
Campbell
J
J
Brosgart
C
C
Abrams
D I
DI
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D003586:Cytomegalovirus Infections / Q000188:drug therapy* / Q000209:etiology; D016049:Didanosine / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D012189:Retrospective Studies
D016049:Didanosine; D015774:Ganciclovir