Aerosolized ribavirin in the treatment of patients with respiratory syncytial virus disease.

Thirty children 1 to 33 months of age were enrolled in a study of aerosolized ribavirin therapy for respiratory syncytial virus lower respiratory tract illness. Twenty patients received ribavirin and 10 received placebo. There were no significant differences between the groups in chronologic or gestational age or in days of illness prior to admission. Among patients with pneumonia 17% of 6 placebo patients vs. 64% of 11 ribavirin patients had radiographic evidence that multiple lung lobes were affected (P = 0.06). Placebo patients received 42.5 to 94.7 hours (mean, 58.6) of aerosol therapy, whereas ribavirin patients received 36.3 to 95.6 hours (mean, 55.7). Seventy-seven percent of all study patients were discharged within 5 days of starting treatment. Severity of illness was evaluated daily using a scale of 0 (normal) to 4+ (most severe). Ribavirin patients initially had a mean severity score 0.5 higher than placebo patients. By Day 2, their rate of improvement was significantly greater than that of placebo patients (P = 0.001). By Day 5, 36% of ribavirin patients with rales showed improvement, whereas rales persisted in 100% of placebo patients. The rate of improvement of oxygen saturation from first to last day of treatment was statistically significant only for ribavirin patients (P = 0.02). On Day 3, 65% of ribavirin patients (13) vs. 50% (5) placebo patients shed 10(-0.5) 50% tissue culture infective dose virus per 0.2 ml of nasal wash. No side effects or toxicity were associated with aerosol therapy. A short course of ribavirin treatment (approximately 3 days) proved safe and beneficial.