ACYCLOVIR PROPHYLAXIS AND FEVER DURING REMISSION-INDUCTION THERAPY OFPATIENTS WITH ACUTE MYELOID-LEUKEMIA - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Purpose: A randomized, double-blind, placebo-controlled was performed to estimate the preventive effect of the antiherpetic drug acyclovir o n fever, incidence of bacteremia, use of antibiotics, and presentation of infections in patients with acute myeloid leukemia (AML). Patients and Methods: Ninety herpes simplex virus (HSV)-seropositive patients aged 18 to 84 years were included. Forty-five patients received acyclo vir (800 mg by mouth daily) and 45 placebo. The patients were examined daily for 28 days from the initiation of remission-induction chemothe rapy. Results: Fever developed in all patients in both groups. Acyclov ir prophylaxis postponed the development of an oral temperature greate r than or equal to 38.0 degrees C by 3 days (95% confidence interval [ CI], 1 to 4 days; P = .03) and the initiation of antibacterial treatme nt by 3 days (95% CI, 1 to 5 days; P = .008). The duration of fever, u se of antibacterial treatment, incidence of bacteremia, and need for s ystemic antifungal therapy were not affected by acyclovir prophylaxis. At fever development, acyclovir prophylaxis affected the incidence an d localization pattern of oral ulcers. Thus, in the acyclovir group, t he number of nonfungal oral infections was reduced (relative risk, 0.4 5 [95% CI, 0.24 to 0.85]) and mainly located on the soft palate (relat ive risk, 2.49 [95% CI, 1.19, to 5.22]), Conclusion: Acyclovir prophyl axis has an impact on fever development, but not on the duration of fe ver or the need for antibiotics. It does not reduce the incidence of b acteremia, but the presentation of acute oral infections is changed. ( C) 1997 by American Society of Clinical Oncology.