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Palivizumab not effective treatment for RSV bronchiolitis
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IV palivizumab, a monoclonal antibody to respiratory syncytial virus, or RSV, did not appear to help or harm infants with RSV-positive bronchiolitis, according to findings from a double-blind, randomized trial.
Khalid Alansari, MD, FRCPC, FAAP (PEM), director of pediatric emergency centers at Hamad Medical Corporation in Qatar, told Infectious Diseases in Children that infants aged younger than 3 months are prone to longer hospital stays and more complications when diagnosed with RSV bronchiolitis. He said palivizumab therapy for RSV acute infection was well-tolerated and decreased viral load in tracheal secretions in previous small studies.
“We wanted to test this in a large, randomized study because RSV bronchiolitis is such a significant problem worldwide, straining hospitals and sometimes costing lives,” he said.
Alansari and colleagues enrolled children aged 3 months and younger who presented to a pediatric ED with RSV-positive bronchiolitis and were admitted for inpatient care. During the trial, infants were randomly assigned to receive 15 mg/kg of palivizumab or placebo. The primary efficacy outcome was the need for inpatient readmission 3 weeks after discharge.
Of the 417 infants treated, 210 received palivizumab. Fewer infants receiving palivizumab (11.1%) required readmission compared with those receiving placebo (9.3%), but this finding was not statistically significant (difference = 1.8%; 95% CI, –4.4 to 7.7%). The geometric mean time to discharge was similar among infants who received palivizumab (29.5 hours) and those who received placebo (30.2 hours; ratio = 0.98; 95% CI, 0.81-1.2).
The researchers did not observe any safety issues during the trial.
Even if palivizumab was available as a treatment for RSV, Alansari said the cost of drug would be an “enormous barrier” unless an organization such as WHO or UNICEF could provide it cheaply to infants in resource-poor countries.
“We found that palivizumab was not effective across the board but did appear to be a possibly effective treatment in the very sickest infants with RSV bronchiolitis,” he said. “We are now testing that in those children in a randomized trial.” – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.
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