Concetta Marsico1, Immaculada Aban2, Huichien Kuo2, Scott H James3, Pablo J Sanchez4, Amina Ahmed5, Ravit Arav-Boger6, Marian G Michaels7, Negar Ashouri8, Janet A Englund9, Benjamin Estrada10, Richard F Jacobs11, José R Romero11, Sunil K Sood12, Suzanne Whitworth13, Penelope M Jester3, Richard J Whitley3, David W Kimberlin3. 1. Neonatology Unit, Department of Medical and Surgical Sciences, University of Bologna, Italy. 2. Department of Biostatistics, Division of Infectious Diseases, University of Alabama at Birmingham. 3. Department of Pediatrics, Division of Infectious Diseases, University of Alabama at Birmingham. 4. Department of Pediatrics, Divisions of Pediatric Infectious Diseases and Neonatology, Nationwide Children's Hospital - Ohio State University College of Medicine, Columbus. 5. Department of Pediatrics, Carolinas Medical Center, Charlotte, North Carolina. 6. Medical College of Wisconsin, Milwaukee. 7. Department of Pediatrics, Children's Hospital of Pittsburgh of UPMC, Pennsylvania. 8. Infectious Diseases, CHOC Children's Hospital, Orange, California. 9. University of Washington/Seattle Children's Hospital. 10. University of South Alabama, Mobile. 11. University of Arkansas, Little Rock. 12. Steven and Alexandra Cohen Children's Medical Center, New Hyde Park, New York. 13. Cook Children's Medical Center, Fort Worth, Texas.
Abstract
BACKGROUND: Viral loads (VLs) frequently are followed during treatment of symptomatic congenital cytomegalovirus disease, but their predictive value is unclear. METHODS: Post hoc analysis of 2 antiviral studies was performed. Seventy-three subjects were treated for 6 weeks and 47 subjects were treated for 6 months. Whole blood VL was determined by real-time polymerase chain reaction before and during therapy. RESULTS: Higher baseline VL was associated with central nervous system involvement (3.82 log, range 1-5.65 vs 3.32 log, range 1-5.36; P = .001), thrombocytopenia (3.68 log, range 1-5.65 vs 3.43 log, range 1-5.36; P = .03), and transaminitis at presentation (3.73 log, range 1-5.60 vs 3.39 log, range 1-5.65; P = .009), but with overlap in the amount of virus detected between groups. In subjects treated for 6 months, lower VL at presentation correlated with better hearing outcomes at 12 months, but VL breakpoints predictive of hearing loss were not identified. Sustained viral suppression during 6 months of therapy correlated with better hearing outcomes at 6, 12, and 24 months (P = .01, P = .0007, P = .04), but a majority without viral suppression still had improved hearing. CONCLUSIONS: In infants with symptomatic congenital cytomegalovirus disease, higher whole blood VL before initiation of antiviral therapy has no clinically meaningful predictive value for long-term outcomes.
BACKGROUND: Viral loads (VLs) frequently are followed during treatment of symptomatic congenital cytomegalovirus disease, but their predictive value is unclear. METHODS: Post hoc analysis of 2 antiviral studies was performed. Seventy-three subjects were treated for 6 weeks and 47 subjects were treated for 6 months. Whole blood VL was determined by real-time polymerase chain reaction before and during therapy. RESULTS: Higher baseline VL was associated with central nervous system involvement (3.82 log, range 1-5.65 vs 3.32 log, range 1-5.36; P = .001), thrombocytopenia (3.68 log, range 1-5.65 vs 3.43 log, range 1-5.36; P = .03), and transaminitis at presentation (3.73 log, range 1-5.60 vs 3.39 log, range 1-5.65; P = .009), but with overlap in the amount of virus detected between groups. In subjects treated for 6 months, lower VL at presentation correlated with better hearing outcomes at 12 months, but VL breakpoints predictive of hearing loss were not identified. Sustained viral suppression during 6 months of therapy correlated with better hearing outcomes at 6, 12, and 24 months (P = .01, P = .0007, P = .04), but a majority without viral suppression still had improved hearing. CONCLUSIONS: In infants with symptomatic congenital cytomegalovirus disease, higher whole blood VL before initiation of antiviral therapy has no clinically meaningful predictive value for long-term outcomes.
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