Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness.

Abstract

BACKGROUND:

This study was conducted to determine whether treatment with motavizumab, an anti-respiratory syncytial virus (RSV) monoclonal antibody, would decrease viral load and improve clinical outcomes in previously healthy term infants hospitalized with RSV lower respiratory tract infection.

METHODS:

Infants hospitalized with lower respiratory tract infection and a positive RSV test performed locally were randomized to receive 1 intravenous dose of motavizumab (30 or 100 mg/kg) or placebo. Nasal wash samples were tested by real-time reverse transcriptase polymerase chain reaction at a central laboratory to determine viral load. Clinical data were collected during RSV hospitalization and at 12-month follow up.

RESULTS:

Of 118 infants, 112 were confirmed RSV positive by real-time reverse transcriptase polymerase chain reaction. In each study group, median (range) RSV load (log10 copies/mL) decreased at a similar rate from baseline to study day 7 [motavizumab 30 mg/kg: 8.35 (2.5-9.5) to 5.03 (2.5-6.8); motavizumab 100 mg/kg: 8.22 (5.5-9.7) to 4.25 (2.5-8.0); placebo: 8.02 (6.7-9.8) to 5.17 (2.5-7.3)]. Median (range) duration of hospitalization was 3.05 (0.8-16.0), 2.99 (1.0-25.0) and 2.88 (0.8-11.7) days for the motavizumab 30 mg/kg, motavizumab 100 mg/kg and placebo groups, respectively. Six (8%) motavizumab and 0 placebo recipients were admitted to the intensive care unit and 4 required mechanical ventilation. The incidence of wheezing episodes during the 12-month follow up was comparable for all 3 groups.

CONCLUSIONS:

Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection. No differences were observed for duration of hospitalization, severity of illness measures or wheezing episodes during 12-month follow up in children treated with motavizumab or placebo.

• Authors: Octavio Ramilo, Rosanna Lagos, Xavier Sáez-Llorens, JoAnn Suzich, C Kathy Wang, Kathryn M Jensen, Brian S Harris, Genevieve A Losonsky, M Pamela Griffin, Motavizumab Study Group
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 33 Issue 7 Pg. 703-9 (Jul 2014) ISSN: 1532-0987 [Electronic] United States
• PMID: 24356256 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antiviral Agents
• Placebos
• motavizumab

Topics

• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antiviral Agents (therapeutic use)
• Female
• Humans
• Infant
• Infant, Newborn
• Length of Stay
• Longitudinal Studies
• Male
• Nasal Cavity (virology)
• Placebos (therapeutic use)
• Real-Time Polymerase Chain Reaction
• Respiratory Syncytial Virus Infections (drug therapy, pathology, virology)
• Respiratory Syncytial Virus, Human (isolation & purification)
• Reverse Transcriptase Polymerase Chain Reaction
• Severity of Illness Index
• Treatment Outcome
• Viral Load