Prevention of Respiratory Syncytial Virus Infections: Indications for the Use of Palivizumab and Update on the Use of RSV-IGIV

Abstract

The Food and Drug Administration recently approved the use of palivizumab (palē-vizhū-mäb), an intramuscularly administered monoclonal antibody preparation. Recommendations for its use are based on a large, randomized study demonstrating a 55% reduction in the risk of hospitalization attributable to respiratory syncytial virus (RSV) infections in high-risk pediatric patients. Infants and children with chronic lung disease (CLD), formerly designated bronchopulmonary dysplasia, as well as prematurely born infants without CLD experienced a reduced number of hospitalizations while receiving palivizumab compared with a placebo. Both palivizumab and respiratory syncytial virus immune globulin intravenous (RSV-IGIV) are available for protecting high-risk children against serious complications from RSV infections. Palivizumab is preferred for most high-risk children because of ease of administration (intramuscular), lack of interference with measles–mumps–rubella vaccine and varicella vaccine, and lack of complications associated with intravenous administration of human immune globulin products. RSV-IGIV, however, provides additional protection against other respiratory viral illnesses and may be preferred for selected high-risk children including those receiving replacement intravenous immune globulin because of underlying immune deficiency or human immuno-deficiency virus infection. For premature infants about to be discharged from hospitals during the RSV season, physicians could consider administering RSV-IGIV for the first month of prophylaxis. Most of the guidelines from the American Academy of Pediatrics for the selection of infants and children to receive RSV-prophylaxis remain unchanged. Palivizumab has been shown to provide benefit for infants who were 32 to 35 weeks of gestation at birth. RSV-IGIV is contraindicated and palivizumab is not recommended for children with cyanotic congenital heart disease. The number of patients with adverse events judged to be related to palivizumab was similar to that of the placebo group (11% vs 10%, respectively); discontinuation of injections for adverse events related to palivizumab was rare.

Factors predicting length of stay in bronchiolitis

“…Of those hospitalized, 507 (13%) required PICU. In a large multicenter study (38 ERs), 261 of 2722 (9.6%) study infants received escalated care (defined by HFNC, noninvasive ventilation and mechanical ventilation) [18]. The high percentage of hospitalization, and more specifically the significant need for PICU, reflects the high burden of bronchiolitis.…”

“…When analyzing co-morbidities, we found that prematurity and, more strikingly, cardiac anomalies were correlated with increased LOS. Since 1998, the American Academy of Pediatrics has recommended administration of Palivizumab for defined high-risk groups, mainly infants born prematurely and those with severe congenital heart disease (CHD) [18]. In 410 infants with positive viral cultures, bronchopulmonary dysplasia (OR 7.2), congenital heart disease (OR 4.7), prematurity (OR 2.6), and fever (OR 1.8) predicted severe clinical scores [28].…”

Characterization of potent RSV neutralizing antibodies isolated from human memory B cells and identification of diverse RSV/hMPV cross-neutralizing epitopes

“…36 MAbs recognizing other antigenic sites, including site Ø, I, II and V, only show mono-specific neutralizing activities and no cross-neutralizing mAb against these sites has been reported. 9,27,[31][32][33][34]38,39 In this study, we focused on characterization of a panel of nAbs isolated from adult human memory B cells with relatively high binding affinity to RSV F antigen and potent RSV neutralizing activities. We aimed to understand the antibody binding epitopes in relation to their binding specificities and neutralization potencies to different RSV and hMPV viruses.…”

Impact of Palivizumab on RSV Hospitalizations for Children with Hemodynamically Significant Congenital Heart Disease

“…Palivizumab (Synagis; Med-Immune, Gaithersburg, MD) is an anti-RSV, humanized murine, monoclonal antibody that aims to provide passive immunity for the recipient [12]. Palivizumab is administered by monthly injections during the RSV season to patients at risk for severe RSV infection [1]. When palivizumab was first studied in children with prematurity, it was shown to reduce RSV-associated hospitalizations by 55% [15].…”