Ribavirin for respiratory syncytial virus infection of the lower respiratory tract in infants and young children
Abstract
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 methods
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 2006, issue 3) which contains the Acute Respiratory Infections Group's specialized register; 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 Unpublished data were requested from trial authors when necessary.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.
Plain language summary
Ribavirin may be an effective treatment for respiratory syncytial virus (RSV) but more research is needed
Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infection in infants. Ribavirin is an expensive antiviral drug that has been used to treat RSV infections. It is the only drug currently available, but there are ongoing concerns about its effectiveness and high cost. This review of trials found that ribavirin may reduce the need for mechanical ventilatory support and the number of days in hospital, and may be associated with a decrease in the long‐term incidence of recurrent wheezing following RSV induced lower respiratory tract infection. These results are based on a small number of studies and therefore may not represent a reliable estimate of the drug's effects. We found no adverse effects attributable to the use of ribavirin for RSV bronchiolitis. Additional research is needed to clarify the effect of ribavirin on feasible and clinically important outcome measures such as duration of mechanical ventilatory support, in large prospective trials that incorporate strict patient management protocols.
