Drug regimen adherence key in keeping babies virus-free, study suggests

November 08, 2001

COLUMBUS, Ohio - The best available defense against serious lower respiratory infections in infants is a drug that can cost the consumer more than $2,000 a treatment.

That cost may prove problematic for some parents, said Diane Langkamp, co-author of a study that looked at the factors affecting compliance with the drug palivizumab (brand name Synagis). Langkamp did the study while an assistant professor of pediatrics at Ohio State University.

Palivizumab reduces an infant's risk of developing respiratory syncytial virus (RSV). RSV causes minor upper respiratory illnesses - such as colds - in older children and adults. But it can cause serious lower respiratory illnesses - such as pneumonia or bronchiolitis - in babies born prematurely or those with chronic lung disease.

Also, palivizumab must be given monthly during the RSV season, which starts in November in Ohio and usually lasts five months. Therefore, a season's treatment could cost more than $10,000. RSV is spread through person-to-person contact. "Palivizumab is a very effective preventive measure," said Langkamp, now director of the neonatal follow-up program at Children's Hospital Medical Center of Akron. "The drug is reserved for children two years of age and younger, and then only for those babies whose lungs aren't fully developed or have other complications.

"But compliance is a major concern, because the drug is so expensive. And a parent's perception of the protection palivizumab offers her child against RSV is the biggest indicator of that compliance."

The research appears in the current issue of the American Journal of Perinatology. Langkamp co-authored the study with Sally Hlavin, a nurse clinician in the neonatal follow-up clinic at Columbus Children's Hospital.

The researchers mailed surveys to 385 families of children eligible to receive palivizumab during the 1998-1999 RSV season. The drug received FDA approval in early 1998 for use in children who are younger than two and at high risk for developing lower respiratory illnesses.

The families of 211 children responded to the survey. Parents were asked questions such as how severe they perceived their child's illness to be; beliefs about the benefits of preventing RSV; and the use of health care services during the RSV season.

The overall compliance rate with all recommended doses of palivizumab was 78 percent. Parents who believed that the drug would protect their child against RSV were more likely to adhere to the monthly dosing schedule. Children whose families had difficulty with transportation to the doctor's office were less likely to receive all of the doses.

While most of the parents said cost wasn't a factor in deciding whether or not their child received the drug, 25 percent of the families surveyed did express concern about the cost or time spent negotiating with their health insurance company.

Among palivizumab recipients, 36 children (17 percent) were hospitalized with a lower respiratory tract infection during the RSV season. Eleven of these children had not complied with all doses of palivizumab. In other words, 12.9 percent of those who did not comply were hospitalized with a lower respiratory tract illness, compared to 8.3 percent of the compliant children.

Palivizumab is given by injection. It gives an antibody to the child, whose system hasn't yet had time to develop its own defense against RSV. Nearly all children younger than two years old contract RSV at least once. But the infants with lung problems are the most at risk for developing serious complications.

"It is important that once a child starts the palivizumab regimen, he or she continue throughout the RSV season," Langkamp said.

According to MedImmune, Inc., the maker of Synagis, hospitalizations due to RSV infection average 125,000 annually in the United States. In some communities, 50 to 80 percent of bronchiolitis hospitalizations from November to early April are due to RSV disease.

The research was supported by a grant from MedImmune, Inc.
-end-
Contact: Diane Langkamp, 330-543-8261; Dlangkamp@chmca.org Written by Holly Wagner, 614-292-8310;
Wagner.235@osu.edu

Ohio State University

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