Ribavirin for respiratory syncytial virus infection of the lower respiratory tract in infants and young children.

BACKGROUND: Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infection in infants and is responsible for 100,000 hospitalizations annually. Ribavirin is approved for treatment of these infections, but its use is controversial because of questions about its efficacy, concerns about occupational exposure, and its high cost.
OBJECTIVES: The objective of this review is to assess the efficacy of aerosolized ribavirin for infants and children with lower respiratory tract infection due to RSV. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2004), MEDLINE (January 1975 to January week 3, 2004) and EMBASE (January 1990 to December 2003). We scanned reference lists of articles and contacted experts in the field. SELECTION CRITERIA: Randomized trials comparing ribavirin with placebo in infants and children with RSV infection and lower respiratory tract infection. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. Unpublished data were requested from authors when necessary. MAIN
RESULTS: Twelve trials were included. All trials enrolled infants below the age of six months. In four trials with 158 patients, mortality with ribavirin was 5.8% compared with 9.7% with placebo (odds ratio (OR) 0.58; 95% confidence interval (CI) 0.18 to 1.85). In three trials with 116 patients the probability of respiratory deterioration with ribavirin was 7.1% compared with 18.3% with placebo (OR 0.37; 95% CI 0.12 to 1.18). In three studies with 104 ventilated patients, the weighted mean difference in days of hospitalization was 1.9 fewer days with ribavirin (95% CI -4.6 to +0.9) and the weighted mean difference in days of ventilation was 1.8 fewer days with ribavirin (95% CI -3.4 to -0.2). No statistically significant differences in long-term pulmonary function or in incidence of recurrent wheezing following RSV infection were associated with the use of ribavirin. REVIEWERS'
CONCLUSIONS: Trials of ribavirin for RSV lack sufficient power to provide reliable estimates of the effects. The cumulative results of three small trials show that ribavirin may reduce the duration of mechanical ventilation and may reduce days of hospitalization. In addition, use of ribavirin may be associated with a decrease in the long-term incidence of recurrent wheezing following RSV disease. A large randomized controlled trial of ribavirin for ventilated and other high-risk patients is indicated.