Recommendations for the use of palivizumab as prophylaxis against respiratory syncytial virus in infants with congenital cardiac disease

Abstract

New data are emerging on the use of palivizumab as prophylaxis against infection with the respiratory syncytial virus in infants with congenital cardiac disease. Following a 4-year multicentre randomised trial, it was shown that prophylactic injections with palivizumab were effective and safe for such children. Prophylaxis consists of 5, monthly, intramuscular injections of palivizumab, at a dose of 15 mg/kg, given during the season for infection with the respiratory syncytial virus. Timing is at the discretion of the physician, depending on the onset of the season locally. It is suggested that, in the United Kingdom, this should be commenced in mid-September. To help clinicians to identify appropriate candidates for palivizumab, a working group of the British Paediatric Cardiac Association has developed recommendations.Infants, namely those under 1 year old, with congenital cardiac disease likely to benefit from prophylaxis include those with haemodynamically significant lesions, particularly increased pulmonary blood flow with or without cyanosis; pulmonary venous congestion, pulmonary hypertension or long-term pulmonary complications, residual haemodynamic abnormalities following medical or surgical intervention (patients who have undergone cardiopulmonary bypass should receive an injection as soon as they are medically stable), cardiomyopathy requiring treatment, and congenital cardiac disease likely to need hospital admission for medical or surgical intervention during the season of infection with the virus. Prophylaxis with palivizumab may also be indicated, at the discretion of the physician, in some children with complex cardiac disease over the age of 1 year. Children less likely to benefit from prophylaxis are those with haemodynamically insignificant disease, or those with lesions adequately corrected by medical or surgical intervention.

Nationwide survey of severe respiratory syncytial virus infection in children who do not meet indications for palivizumab in Japan

“…In the recommendations for the use of palivizumab as prophylaxis against RSV in infants with CHD, the Working Group of the British Paediatric Cardiac Association has included children with cardiomyopathy requiring treatment in the list of children likely to benefit from prophylaxis [20]. Although the number of patients with cardiomyopathy reported in the present survey was too small to examine effects on the outcome of severe RSV infection, this patient group should be carefully evaluated for the presence of congestive heart failure that requires prophylaxis in accordance with the CHD trial [6].…”

Prospective Population-based Study of RSV-related Intermediate Care and Intensive Care Unit Admissions in Switzerland over a 4-Year Period (2001–2005)

“…Unfortunately, the costs of these drugs are very high. Recently, various national expert committees have published recommendations for the use of palivizumab (Synagis Ò ) in high-risk patients [15][16][17][18][19][20][21][22][23][24][25]. While these experts agree that palivizumab is effective, their assessment of the cost-effectiveness of this intervention varies substantially.…”

Respiratory syncytial virus prevention in children with congenital heart disease: who and how?

“…Palivizumab (MEDI-493) is a humanized monoclonal antibody to F glycoprotein and has neutralizing and fusion inhibitory effect against RSV5). Studies proving the efficacy of RSV prevention through palivizumab in CHD patients have been developing, and multinational, randomized, double-blind trials have proved its safety and efficacy6). This study included patients who were 1 year old or younger, with hemodynamically significant CHD.…”

“…Since RSV-IVIG is no longer available, palivizumab is the only licensed product for prevention of RSV infection. Infants diagnosed as CHD are considered as high-risk group for severe lower respiratory infection due to RSV infection, therefore immunoprophylaxis is recommended using palivizumab2,6,7,13-16). Patients with hemodynamically significant cyanotic and acyanotic CHD should start administration of palivizumab before the RSV season starts.…”