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 many 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 performed an updated electronic search of the Cochrane Central Register of Controlled Trials (CENTRAL), the Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database (EED) (The Cochrane Library Issue 3, 2006); MEDLINE (Ovid) (2004 to September Week 3 2006); and EMBASE (WebSpirs) (2004 to June 2006).

Selection Criteria: Randomized trials comparing ribavirin with placebo in infants and children with lower respiratory tract infection attributable to RSV.

Data Collection And Analysis: Two review authors independently extracted data and assessed trial quality. Unpublished data were requested from trial authors when necessary.

Main Results: Twelve trials were included. All trials enrolled infants below the age of six months. In four trials with 158 participants, 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 participants 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 participants, the mean difference in days of hospitalization was 1.9 fewer days with ribavirin (95% CI -4.6 to +0.9) and the 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.

Authors' 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 participants is indicated.