RSV-IVIG Prophylaxis

Abstract & Commentary

Source: The PREVENT Study Group. Reduction of respiratory syncytial virus hospitalization among infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. Pediatrics 1997;99:93-99.

Respiratory syncytial virus (rsv) is an important respiratory pathogen among young children. Infection with this virus causes lower respiratory tract disease and, each winter, more than 90,000 pediatric hospitalizations and 4500 deaths. RSV-associated morbidity and mortality are increased in children with bronchopulmonary dysplasia (BPD), prematurity, congenital heart disease, and immunodeficiency. Researchers have developed intravenous immune globulin (IVIG) preparations enriched for neutralizing antibody to RSV, and a recent study reports on the safety and efficacy of RSV-IVIG prophylaxis for the prevention of RSV illness.

The "PREVENT" trial was a randomized, double-blind, placebo-controlled clinical trial conducted at 54 U.S. medical centers. Children judged to be at risk for severe RSV disease were enrolled. The study population included children less than 6 months of age with a history of prematurity (35 weeks gestation or less), or less than 24 months old with a history of BPD and a requirement for supplemental oxygen within the last six months. The study period was the 1994-1995 RSV season. Children were randomized to receive monthly infusions of either RSV-IVIG or placebo.

Five hundred ten children were enrolled; the two study groups were well-balanced for demographics, RSV risk factors, and birth characteristics. The incidence of RSV hospitalization was reduced by 41% in children receiving RSV-IVIG prophylaxis. Even among those children hospitalized with RSV-related illness, the children in the RSV-IVIG group had a significant reduction in the number of days in hospital, with increased oxygen requirement, and with moderate or severe lower respiratory tract illness. RSV-IVIG was safe and well-tolerated, with a safety profile similar to other IVIG preparations.

COMMENT BY LEONARD FRIEDLAND, MD

This study demonstrates that monthly infusions of RSV-IVIG during the RSV season for children at risk for severe RSV disease is safe and effective in preventing serious disease as well as hospitalizations. Don’t be surprised if during the 1997-1998 RSV season you begin to see children presenting to the ED with bronchiolitis whose parents give a history that their child has been receiving monthly RSV-IVIG treatments. It certainly would be nice to see RSV infection in at-risk children reduced to just routine bronchiolitis. Active immunization against RSV is also being investigated and I hope to report on its status in a future issue.