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1. Updated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents

Author

Wolf, Joshua, Abzug, Mark J, Anosike, Brenda I, Vora, Surabhi B, Waghmare, Alpana, Sue, Paul K, Olivero, Rosemary M, Oliveira, Carlos R, James, Scott H, Morton, Theodore H, Maron, Gabriela M, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Bio, Laura L, Willis, Zachary I, Lloyd, Elizabeth C, Hersh, Adam L, Huskins, Charles W, Soma, Vijaya L, Ratner, Adam J, Hayes, Molly, Downes, Kevin, Chiotos, Kathleen, Grapentine, Steven P, Wattier, Rachel L, Lamb, Gabriella S, Zachariah, Philip, and Nakamura, Mari M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Biodefense, Pneumonia & Influenza, Pediatric Research Initiative, Lung, Pediatric, Vaccine Related, Pneumonia, Prevention, Patient Safety, Biotechnology, Emerging Infectious Diseases, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Antibodies, Viral, Child, Drug Combinations, Humans, Practice Guidelines as Topic, SARS-CoV-2, COVID-19 Drug Treatment, bamlanivimab and etesevimab, COVID-19, pediatric, REGEN-COV, sotrovimab, Medical microbiology, Paediatrics
Abstract

BackgroundStarting in November 2020, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for multiple novel virus-neutralizing monoclonal antibody therapies, including bamlanivimab monotherapy (now revoked), bamlanivimab and etesivimab, casirivimab and imdevimab (REGEN-COV), and sotrovimab, for treatment or postexposure prophylaxis of Coronavirus disease 2019 (COVID-19) in adolescents (≥12 years of age) and adults with certain high-risk conditions. Previous guidance is now updated based on new evidence and clinical experience.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacotherapy, and pediatric critical care medicine from 18 geographically diverse US institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on a review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild, though more severe disease is occasionally observed. Evidence supporting risk stratification is incomplete. Randomized controlled trials have demonstrated the benefit of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-specific monoclonal antibody therapies in adults, but data on safety and efficacy in children or adolescents are limited. Potential harms associated with infusion reactions or anaphylaxis are reportedly low in adults.ConclusionsBased on evidence available as of August 31, 2021, the panel suggests a risk-based approach to administration of SARS-CoV-2 monoclonal antibody therapy. Therapy is suggested for the treatment of mild to moderate COVID-19 in adolescents (≥12 years of age) at the highest risk of progression to hospitalization or severe disease. Therapeutic decision-making about those at moderate risk of severe disease should be individualized. Use as postexposure prophylaxis could be considered for those at the highest risk who have a high-risk exposure but are not yet diagnosed with COVID-19. Clinicians and health systems should ensure safe and timely implementation of these therapeutics that does not exacerbate existing healthcare disparities.

Published
2022

2. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents

Author

Wolf, Joshua, Abzug, Mark J, Wattier, Rachel L, Sue, Paul K, Vora, Surabhi B, Zachariah, Philip, Dulek, Daniel E, Waghmare, Alpana, Olivero, Rosemary, Downes, Kevin J, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Aldrich, Margaret L, MacBrayne, Christine E, Soma, Vijaya L, Grapentine, Steven P, Oliveira, Carlos R, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, Bio, Laura L, Morton, Theodore H, Hankins, Jane S, Marόn-Alfaro, Gabriella M, Timberlake, Kathryn, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Goldman, David L, Groves, Helen E, Huskins, W Charles, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Lloyd, Elizabeth E, Hersh, Adam L, Thorell, Emily A, Ratner, Adam J, Chiotos, Kathleen, and Nakamura, Mari M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Pediatric Research Initiative, Infectious Diseases, Hematology, Biotechnology, Health Services, Patient Safety, Clinical Research, Pediatric, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antiviral Agents, COVID-19, Child, Drug Approval, Female, Humans, Male, Pandemics, Pneumonia, Viral, SARS-CoV-2, United States, United States Food and Drug Administration, COVID-19 Drug Treatment, bamlanivimab, casirivimab, imdevimab, pediatric, Medical microbiology, Paediatrics
Abstract

BackgroundIn November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.ConclusionsBased on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

Published
2021

3. Multicenter interim guidance on use of antivirals for children with COVID-19/SARS-CoV-2

Author

Chiotos, Kathleen, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Abzug, Mark J, MacBrayne, Christine E, Soma, Vijaya L, Dulek, Daniel E, Vora, Surabhi B, Waghmare, Alpana, Wolf, Joshua, Olivero, Rosemary, Grapentine, Steven, Wattier, Rachel L, Bio, Laura, Cross, Shane J, Dillman, Nicholas O, Downes, Kevin J, Oliveira, Carlos R, Timberlake, Kathryn, Young, Jennifer, Orscheln, Rachel C, Tamma, Pranita D, Schwenk, Hayden T, Zachariah, Philip, Aldrich, Margaret L, Goldman, David L, Groves, Helen E, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Hersh, Adam L, Thorell, Emily A, Denison, Mark R, Ratner, Adam J, Newland, Jason G, and Nakamura, Mari M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lung, Emerging Infectious Diseases, Infectious Diseases, Clinical Research, Pediatric, Good Health and Well Being, Adenosine Monophosphate, Alanine, Antiviral Agents, COVID-19, Child, Evidence-Based Medicine, Humans, Immunocompromised Host, Risk Factors, Severity of Illness Index, Systemic Inflammatory Response Syndrome, COVID-19 Drug Treatment, antiviral, pediatric, SARS-CoV-2, Medical microbiology, Paediatrics
Abstract

BackgroundAlthough coronavirus disease 2019 (COVID-19) is a mild infection in most children, a small proportion develop severe or critical illness. Data describing agents with potential antiviral activity continue to expand such that updated guidance is needed regarding use of these agents in children.MethodsA panel of pediatric infectious diseases physicians and pharmacists from 20 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of the best available evidence and expert opinion.ResultsGiven the typically mild course of COVID-19 in children, supportive care alone is suggested for most cases. For children with severe illness, defined as a supplemental oxygen requirement without need for noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), remdesivir is suggested, preferably as part of a clinical trial if available. Remdesivir should also be considered for critically ill children requiring invasive or noninvasive mechanical ventilation or ECMO. A duration of 5 days is appropriate for most patients. The panel recommends against the use of hydroxychloroquine or lopinavir-ritonavir (or other protease inhibitors) for COVID-19 in children.ConclusionsAntiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For children with severe or critical disease, this guidance offers an approach for decision-making regarding use of remdesivir.

Published
2021

4. Multicenter initial guidance on use of antivirals for children with COVID-19/SARS-CoV-2

Author

Chiotos, Kathleen, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Abzug, Mark J, MacBrayne, Christine E, Soma, Vijaya L, Dulek, Daniel E, Vora, Surabhi B, Waghmare, Alpana, Wolf, Joshua, Olivero, Rosemary, Grapentine, Steven, Wattier, Rachel L, Bio, Laura, Cross, Shane J, Dillman, Nicholas O, Downes, Kevin J, Timberlake, Kathryn, Young, Jennifer, Orscheln, Rachel C, Tamma, Pranita D, Schwenk, Hayden T, Zachariah, Philip, Aldrich, Margaret, Goldman, David L, Groves, Helen E, Lamb, Gabriella S, Tribble, Alison C, Hersh, Adam L, Thorell, Emily A, Denison, Mark R, Ratner, Adam J, Newland, Jason G, and Nakamura, Mari M

Subjects
Clinical Research, Emerging Infectious Diseases, Patient Safety, Pediatric, Infectious Diseases, Lung, Good Health and Well Being, Antiviral Agents, Child, Humans, Risk Assessment, Severity of Illness Index, COVID-19 Drug Treatment, antiviral, COVID-19, guidance, pediatric, SARS-CoV-2
Abstract

BackgroundAlthough coronavirus disease 2019 (COVID-19) is mild in nearly all children, a small proportion of pediatric patients develop severe or critical illness. Guidance is therefore needed regarding use of agents with potential activity against severe acute respiratory syndrome coronavirus 2 in pediatrics.MethodsA panel of pediatric infectious diseases physicians and pharmacists from 18 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of best available evidence and expert opinion.ResultsGiven the typically mild course of pediatric COVID-19, supportive care alone is suggested for the overwhelming majority of cases. The panel suggests a decision-making framework for antiviral therapy that weighs risks and benefits based on disease severity as indicated by respiratory support needs, with consideration on a case-by-case basis of potential pediatric risk factors for disease progression. If an antiviral is used, the panel suggests remdesivir as the preferred agent. Hydroxychloroquine could be considered for patients who are not candidates for remdesivir or when remdesivir is not available. Antivirals should preferably be used as part of a clinical trial if available.ConclusionsAntiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For those rare cases of severe or critical disease, this guidance offers an approach for decision-making regarding antivirals, informed by available data. As evidence continues to evolve rapidly, the need for updates to the guidance is anticipated.

Published
2020

6. Nonpolio Enteroviruses

Author

Messacar, Kevin, primary, Vogt, Matthew R., additional, Asturias, Edwin J., additional, and Abzug, Mark J., additional

Published
2023
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8. Contributors

Author

Abzug, Mark J., primary, Acharya, Priyamvada, additional, Acosta, Anna M., additional, Ahmed, S. Sohail, additional, Amanna, Ian J., additional, Anderson, Annaliesa S., additional, Asturias, Edwin J., additional, Bachmann, Martin F., additional, Bahl, Sunil, additional, Bailey, Justin R., additional, Baker, Carol J., additional, Balfour, Henry H., additional, Baric, Ralph S., additional, Barnett, Elizabeth D., additional, Barrett, Alan D.T., additional, Belser, Jessica A., additional, Berzofsky, Jay A., additional, Bethony, Jeffrey M., additional, Brewer-Jensen, Paul D., additional, Bubak, Andrew N., additional, Burns, Cara C., additional, Caplan, Arthur L., additional, Cavaleri, Marco, additional, Chandran, Aruna, additional, Cherian, Thomas, additional, Clemens, John D., additional, Cochino, Emil, additional, Cohet, Catherine, additional, Cohn, Amanda, additional, Cortese, Margaret M., additional, Crowcroft, Natasha S., additional, Curtis, Nigel, additional, Damron, F. Heath, additional, Danchin, Margie, additional, Debbink, Kari, additional, Desai, Sachin N., additional, Davis, Emily H., additional, Decker, Michael D., additional, Denison, Mark R., additional, DeStefano, Frank, additional, Douglas, R. Gordon, additional, Dreher-Lesnick, Sheila M., additional, Eberhardt, Christiane S., additional, Edmunds, W. John, additional, Edwards, Caitlin E., additional, Edwards, Kathryn M., additional, Eggers, Rudolf, additional, Ellis, Ronald, additional, Erdman, Dean D., additional, Ertl, Hildegund C.J., additional, Estivariz, Concepcion F., additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fisher, Allison M., additional, Fitzwater, Sean Patrick, additional, Freedman, Mark S., additional, Friede, Martin, additional, Friedlander, Arthur M., additional, Frumento, Nicole, additional, Fry, Alicia M., additional, Garçon, Nathalie, additional, Geris, Jennifer M., additional, Gershon, Anne A., additional, Gervier, Regis, additional, Gessner, Bradford D., additional, Gilbert, Peter B., additional, Gomez, Phillip Louis, additional, Ginsberg, Ann M., additional, Grabenstein, John D., additional, Graham, Rachel L., additional, Graham, Barney S., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Greenberg, David P., additional, Grohskopf, Lisa A., additional, Gruber, Marion F., additional, Guerena, Fernando B., additional, Havelange, Nicolas, additional, Halstead, Scott B., additional, Hanekom, Willem A., additional, Harrison, Lee H., additional, Hawn, Thomas R., additional, Haynes, Barton F., additional, Healy, C. Mary, additional, Hills, Susan L., additional, Hirabayashi, Kuniko, additional, Holmgren, Jan, additional, Hombach, Joachim M., additional, Hotez, Peter Jay, additional, Howe, Barbara J., additional, Hunegnaw, Ruth, additional, Izopet, Jacques, additional, Jamieson, Denise J., additional, Jansen, Kathrin, additional, Jarrahian, Courtney, additional, Johansen, Kari, additional, Kahn, Geoffrey D., additional, Karron, Ruth A., additional, Katz, Jacqueline M., additional, Kennedy, Richard B., additional, Broojerdi, Alireza Khadem, additional, Khetsuriani, Nino, additional, Khudyakov, Yury, additional, Klugman, Keith P., additional, Kocher, Jacob F., additional, Kollaritsch, Herwig, additional, Kotloff, Karen L., additional, Kozarsky, Phyllis E., additional, Kreimer, Aimée R., additional, Kroger, Andrew T., additional, Kwong, Peter D., additional, Lal, Manjari, additional, Levin, Myron J., additional, Levine, Myron M., additional, Lindesmith, Lisa C., additional, Lindstrand, Ann, additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Lundgren, Anna, additional, Lydon, Patrick, additional, Macklin, Grace R., additional, Maeng, Hoyoung M., additional, Mahalingam, Ravi, additional, Malley, Richard, additional, Mallory, Michael L., additional, Marfin, Anthony A., additional, Markowitz, Lauri E., additional, Marshall, CDR Valerie, additional, McCollum, Andrea, additional, Meyer, Sarah, additional, McNamara, Lucy A., additional, Menning, Lisa, additional, Messacar, Kevin, additional, Miller, Mark A., additional, Milutinovic, Pavle, additional, Modlin, John F., additional, Monath, Thomas P., additional, Morabito, Kaitlyn M., additional, Moss, William J., additional, Mulholland, Kim, additional, Mura, Manuela, additional, Musher, Daniel M., additional, Nagel, Maria A., additional, Nair, G. Balakrish, additional, Nelson, Noele P., additional, Netea, Mihai G., additional, Neuzil, Kathleen Maletic, additional, Niemeyer, Christy S., additional, Nohynek, Hanna, additional, Norheim, Gunnstein, additional, Nussbaum, Lauren, additional, O’Brien, Katherine L., additional, O’Leary, Sean, additional, Ockenhouse, Christian, additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Olkhanud, Purevdorj B., additional, Omer, Saad B., additional, Orenstein, Walter A., additional, Oyston, Petra C.F., additional, Parashar, Umesh D., additional, Patel, Manish M., additional, Payne, Daniel C., additional, Pebody, Richard, additional, Pecetta, Simone, additional, Perlman, Stanley, additional, Pierson, Benjamin, additional, Pierson, Theodore C., additional, Pittet, Laure F., additional, Pittman, Phillip R., additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Poland, Gregory A., additional, Pollard, Sir Andrew John, additional, Poovorawan, Yong, additional, Proctor, Richard A., additional, Qadri, Firdausi, additional, Rao, Agam, additional, Rappuoli, Rino, additional, Reef, Susan E., additional, Rogalewicz, Joseph A., additional, Robinson, James Michael, additional, Roesel, Sigrun, additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutter, Paul, additional, Samant, Vijay B., additional, Sambhara, Suryaprakash, additional, Samies, Nicole L., additional, Santosham, Mathuram, additional, Saunders, Kevin O., additional, Schiller, John T., additional, Schleiss, Mark R., additional, Schuerman, Lode, additional, Schwab, Jennifer, additional, Schwartz, Jason L., additional, Scobie, Heather M., additional, Scott, J. Anthony, additional, Shapiro, Eugene D., additional, Shenoy, Erica S., additional, Shimabukuro, Tom T., additional, Shouval, Daniel, additional, Siegrist, Claire-Anne, additional, Sitrin, Robert D., additional, Skinner, Nicole E., additional, Slifka, Mark K., additional, Sodha, Samir V., additional, Soeters, Heidi M., additional, Solomon, Tom, additional, Speiser, Daniel E., additional, Staples, J. Erin, additional, Steffen, Robert, additional, Stephens, David S., additional, Strebel, Peter M., additional, Subbarao, Kanta, additional, Sullivan, Nancy J., additional, Takashima, Yoshihiro, additional, Tate, Jacqueline E., additional, Tayman, Alice, additional, Telford, Sam R., additional, Thombley, Melisa, additional, Thomsen, Isaac, additional, Tohme, Rania A., additional, Trabold, Malin, additional, El-Turabi, Aadil, additional, Vaughn, David W., additional, Verardi, Raffaello, additional, Vicari, Andrea S., additional, Vidor, Emmanuel J., additional, Villafana, Tonya, additional, Vogt, Matthew R., additional, Walker, Mark J., additional, Walsh, Nick M., additional, Wanlapakorn, Nasamon, additional, Ward, John W., additional, Wassilak, Steven G.F., additional, Watts, Lisa A., additional, Weber, David J., additional, Weiner, David B., additional, Weng, Mark K., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitley, Richard J., additional, Whitney, Cynthia G., additional, Wiehe, Kevin, additional, Williamson, E. Diane, additional, Wormser, Gary P., additional, Xia, Ningshao, additional, Yildirim, Inci, additional, Zehrung, Darin, additional, and Zweigart, Mark R., additional

Published
2023
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9. Safety, tolerability, and efficacy of fluoxetine as an antiviral for acute flaccid myelitis.

Author

Messacar, Kevin, Sillau, Stefan, Hopkins, Sarah E, Otten, Catherine, Wilson-Murphy, Molly, Wong, Brian, Santoro, Jonathan D, Treister, Andrew, Bains, Harlori K, Torres, Alcy, Zabrocki, Luke, Glanternik, Julia R, Hurst, Amanda L, Martin, Jan A, Schreiner, Teri, Makhani, Naila, DeBiasi, Roberta L, Kruer, Michael C, Tremoulet, Adriana H, Van Haren, Keith, Desai, Jay, Benson, Leslie A, Gorman, Mark P, Abzug, Mark J, Tyler, Kenneth L, and Dominguez, Samuel R

Subjects
Humans, Central Nervous System Viral Diseases, Myelitis, Neuromuscular Diseases, Fluoxetine, Antiviral Agents, Treatment Outcome, Retrospective Studies, Child, Child, Preschool, Female, Male, Neurosciences, Brain Disorders, Patient Safety, Clinical Research, Clinical Sciences, Cognitive Sciences, Neurology & Neurosurgery
Abstract

ObjectiveTo determine the safety, tolerability, and efficacy of fluoxetine for proven or presumptive enterovirus (EV) D68-associated acute flaccid myelitis (AFM).MethodsA multicenter cohort study of US patients with AFM in 2015-2016 compared serious adverse events (SAEs), adverse effects, and outcomes between fluoxetine-treated patients and untreated controls. Fluoxetine was administered at the discretion of treating providers with data gathered retrospectively. The primary outcome was change in summative limb strength score (SLSS; sum of Medical Research Council strength in all 4 limbs, ranging from 20 [normal strength] to 0 [complete quadriparesis]) between initial examination and latest follow-up, with increased SLSS reflecting improvement and decreased SLSS reflecting worsened strength.ResultsFifty-six patients with AFM from 12 centers met study criteria. Among 30 patients exposed to fluoxetine, no SAEs were reported and adverse effect rates were similar to unexposed patients (47% vs 65%, p = 0.16). The 28 patients treated with >1 dose of fluoxetine were more likely to have EV-D68 identified (57.1% vs 14.3%, p < 0.001). Their SLSS was similar at initial examination (mean SLSS 12.9 vs 14.3, p = 0.31) but lower at nadir (mean SLSS 9.25 vs 12.82, p = 0.02) and latest follow-up (mean SLSS 12.5 vs 16.4, p = 0.005) compared with the 28 patients receiving 1 (n = 2) or no (n = 26) doses. In propensity-adjusted analysis, SLSS from initial examination to latest follow-up decreased by 0.2 (95% confidence interval [CI] -1.8 to +1.4) in fluoxetine-treated patients and increased by 2.5 (95% CI +0.7 to +4.4) in untreated patients (p = 0.015).ConclusionFluoxetine was well-tolerated. Fluoxetine was preferentially given to patients with AFM with EV-D68 identified and more severe paralysis at nadir, who ultimately had poorer long-term outcomes.Classification of evidenceThis study provides Class IV evidence that for patients with EV-D68-associated AFM, fluoxetine is well-tolerated and not associated with improved neurologic outcomes.

Published
2019

11. Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia

Author

Melvin, Ann J, Montepiedra, Grace, Aaron, Lisa, Meyer, William A, Spiegel, Hans M, Borkowsky, William, Abzug, Mark J, Best, Brookie M, Crain, Marilyn J, Borum, Peggy R, Graham, Bobbie, Anthony, Patricia, Shin, Katherine, and Siberry, George K

Subjects
Paediatrics, Biomedical and Clinical Sciences, Atherosclerosis, Prevention, Clinical Research, Pediatric, HIV/AIDS, Infectious Diseases, Cardiovascular, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Anti-HIV Agents, Atorvastatin, C-Reactive Protein, Child, Female, HIV Infections, Humans, Hyperlipidemias, Male, Young Adult, HIV, children, atorvastatin, P1063 Study Team, Paediatrics and Reproductive Medicine, Public Health and Health Services, Pediatrics, Clinical sciences
Abstract

BackgroundHuman immunodeficiency virus (HIV)-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population.MethodsHIV-infected youth 10 to

Published
2017

12. Clinical characteristics of enterovirus A71 neurological disease during an outbreak in children in Colorado, USA, in 2018: an observational cohort study

Author

Messacar, Kevin, Spence-Davizon, Emily, Osborne, Christina, Press, Craig, Schreiner, Teri L, Martin, Jan, Messer, Ricka, Maloney, John, Burakoff, Alexis, Barnes, Meghan, Rogers, Shannon, Lopez, Adriana S, Routh, Janell, Gerber, Susan I, Oberste, M Steven, Nix, W Allan, Abzug, Mark J, Tyler, Kenneth L, Herlihy, Rachel, and Dominguez, Samuel R

Published
2020
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13. Guidance for prevention and management of COVID-19 in children and adolescents: A consensus statement from the Pediatric Infectious Diseases Society Pediatric COVID-19 Therapies Taskforce

Author

Willis, Zachary I, primary, Oliveira, Carlos R, additional, Abzug, Mark J, additional, Anosike, Brenda I, additional, Ardura, Monica I, additional, Bio, Laura L, additional, Boguniewicz, Juri, additional, Chiotos, Kathleen, additional, Downes, Kevin, additional, Grapentine, Steven P, additional, Hersh, Adam L, additional, Heston, Sarah M, additional, Hijano, Diego R, additional, Huskins, W Charles, additional, James, Scott H, additional, Jones, Sarah, additional, Lockowitz, Christine R, additional, Lloyd, Elizabeth C, additional, MacBrayne, Christine, additional, Maron, Gabriela M, additional, Hayes McDonough, Molly, additional, Miller, Christine M, additional, Morton, Theodore H, additional, Olivero, Rosemary M, additional, Orscheln, Rachel C, additional, Schwenk, Hayden T, additional, Singh, Prachi, additional, Soma, Vijaya L, additional, Sue, Paul K, additional, Vora, Surabhi B, additional, Nakamura, Mari M, additional, and Wolf, Joshua, additional

Published
2024
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14. A Prospective, International Cohort Study of Invasive Mold Infections in Children

Author

Wattier, Rachel L, Dvorak, Christopher C, Hoffman, Jill A, Brozovich, Ava A, Bin-Hussain, Ibrahim, Groll, Andreas H, Castagnola, Elio, Knapp, Katherine M, Zaoutis, Theoklis E, Gustafsson, Britt, Sung, Lillian, Berman, David, Halasa, Natasha B, Abzug, Mark J, Velegraki, Aristea, Sharma, Tanvi S, Fisher, Brian T, and Steinbach, William J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Pediatric, Infectious Diseases, Clinical Research, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Antifungal Agents, Aspergillosis, Child, Child, Preschool, Female, Fungi, Humans, Male, Mycoses, Prospective Studies, Risk Factors, Treatment Outcome, antifungal, aspergillosis, mucormycosis, outcome, treatment, Medical microbiology, Paediatrics
Abstract

BackgroundInvasive mold infections (IMIs) are a leading cause of mortality in immunocompromised children, yet there has never been an international epidemiologic investigation of pediatric IMIs.MethodsThis international, prospective cohort study was performed to characterize the epidemiology, antifungal therapy, and outcomes of pediatric IMIs. Children (≤18 years) with proven or probable IMIs were enrolled between August 2007 and May 2011 at 22 sites. Risk factors, underlying diagnoses, and treatments were recorded. Outcomes were assessed at 12 weeks after diagnosis using European Organization for Research and Treatment of Cancer/Mycoses Study Group response criteria.ResultsOne hundred thirty-one pediatric patients with IMIs were enrolled; the most common IMI was invasive aspergillosis ([IA] 75%). Children with IA and those with other types of IMIs had similar underlying risk factors, except that children with IMIs caused by non-Aspergillus species were more likely to have received mold-active antifungal agents preceding diagnosis. The most commonly used antifungal classes after diagnosis were triazoles (82%) and polyenes (63%). Combination therapy was used in 53% of patients. Use of combination therapy was associated with an increased risk of adverse events (risk ratio, 1.98; 95% confidence interval, 1.06-3.68; P = .031), although there was no detectable difference in outcome.ConclusionsAlthough risk factors for IMIs are similar across specific subtypes, preceding antifungal therapy may be an important modifier. Combination antifungal therapy requires further study to determine its true risks and benefits.

Published
2015

15. Incidence of switching to second-line antiretroviral therapy and associated factors in children with HIV: an international cohort collaboration

Author

Collins, Intira J, Wools-Kaloustian, Kara, Goodall, Ruth, Smith, Colette, Abrams, Elaine J, Ben-Farhat, Jihane, Balkan, Suna, Davies, Mary-Ann, Edmonds, Andrew, Leroy, Valériane, Nuwagaba-Biribonwoha, Harriet, Patel, Kunjal, Paul, Mary E, Pinto, Jorge, Rojo Conejo, Pablo, Sohn, Annette, Van Dyke, Russell, Vreeman, Rachel, Maxwell, Nicky, Timmerman, Venessa, Duff, Charlotte, Judd, Ali, Seage III, George, Williams, Paige, Gibb, Diana M, Bekker, Linda-Gail, Mofenson, Lynne, Vicari, Marissa, Essajee, Shaffiq, Mohapi, Edith Q, Kazembe, Peter N, Hlatshwayo, Makhosazana, Lumumba, Mwita, Kekitiinwa-Rukyalekere, Adeodata, Wanless, Sebastian, Matshaba, Mogomotsi S., Goetghebuer, Tessa, Thorne, Claire, Warszawski, Josiane, Galli, Luisa, Geelen, Sybil, Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaia, Liubov, Noguera-Julian, Antoni, Naver, Lars, Rudin, Christoph, Jourdain, Gonzague, Volokha, Alla, Rouzier, Vanessa, Succi, Regina, Chokephaibulkit, Kulkanya, Kariminia, Azar, Yotebieng, Marcel, Lelo, Patricia, Lyamuya, Rita, Marete, Irene, Oyaro, Patrick, Boulle, Andrew, Malisita, Kennedy, Fatti, Geoffrey, Haas, Andreas D, Desmonde, Sophie, Dicko, Fatoumata, Abzug, Mark J, Levin, Myron, Oleske, James, Chernoff, Miriam, Traite, Shirley, Purswani, Murli, Teasdale, Chloe, and Chadwick, Ellen

Published
2019
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18. Adjunctive Diagnostic Studies Completed Following Detection of Candidemia in Children: Secondary Analysis of Observed Practice From a Multicenter Cohort Study Conducted by the Pediatric Fungal Network

Author

Wattier, Rachel L, primary, Bucayu, Robert F T, additional, Boge, Craig L K, additional, Ross, Rachael K, additional, Yildirim, Inci, additional, Zaoutis, Theoklis E, additional, Palazzi, Debra L, additional, Vora, Surabhi B, additional, Castagnola, Elio, additional, Avilés-Robles, Martha, additional, Danziger-Isakov, Lara, additional, Tribble, Alison C, additional, Sharma, Tanvi S, additional, Arrieta, Antonio C, additional, Maron, Gabriela, additional, Berman, David M, additional, Yin, Dwight E, additional, Sung, Lillian, additional, Green, Michael, additional, Roilides, Emmanuel, additional, Belani, Kiran, additional, Romero, José, additional, Soler-Palacin, Pere, additional, López-Medina, Eduardo, additional, Nolt, Dawn, additional, Bin Hussain, Ibrahim Zaid, additional, Muller, William J, additional, Hauger, Sarmistha B, additional, Halasa, Natasha, additional, Dulek, Daniel, additional, Pong, Alice, additional, Gonzalez, Blanca E, additional, Abzug, Mark J, additional, Carlesse, Fabianne, additional, Huppler, Anna R, additional, Rajan, Sujatha, additional, Aftandilian, Catherine, additional, Ardura, Monica I, additional, Chakrabarti, Arunaloke, additional, Hanisch, Benjamin, additional, Salvatore, Christine M, additional, Klingspor, Lena, additional, Knackstedt, Elizabeth D, additional, Lutsar, Irja, additional, Santolaya, Maria E, additional, Shuster, Sydney, additional, Johnson, Sarah K, additional, Steinbach, William J, additional, and Fisher, Brian T, additional

Published
2023
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20. Safety, tolerability, and efficacy of fluoxetine as an antiviral for acute flaccid myelitis

Author

Messacar, Kevin, Sillau, Stefan, Hopkins, Sarah E., Otten, Catherine, Wilson-Murphy, Molly, Wong, Brian, Santoro, Jonathan D., Treister, Andrew, Bains, Harlori K., Torres, Alcy, Zabrocki, Luke, Glanternik, Julia R., Hurst, Amanda L., Martin, Jan A., Schreiner, Teri, Makhani, Naila, DeBiasi, Roberta L., Kruer, Michael C., Tremoulet, Adriana H., Van Haren, Keith, Desai, Jay, Benson, Leslie A., Gorman, Mark P., Abzug, Mark J., Tyler, Kenneth L., and Dominguez, Samuel R.

Published
2018
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23. Contributors

Author

Abzug, Mark J., primary, Adderson, Elisabeth E., additional, Agwu, Allison L., additional, Alby, Kevin, additional, Aldrovandi, Grace M., additional, Allen, Upton D., additional, Alvarez-Hernández, Gerardo, additional, Ampofo, Krow, additional, Anderson, Evan J., additional, Anderson, Margot, additional, Antonara, Stella, additional, Ardura, Monica I., additional, Arguin, Paul M., additional, Arnold, John C., additional, Aronson, Naomi E., additional, Arvin, Ann M., additional, Ashkenazi, Shai, additional, Asturias, Edwin J., additional, Badalyan, Vahe, additional, Baker, Carol J., additional, Balakrishnan, Karthik, additional, Barros, Brittany S., additional, Barson, William J., additional, Bausch, Daniel G., additional, Bechtel, Kirsten, additional, Benjamin, Daniel K., additional, Berman, David M., additional, Blanco, David A., additional, Bloch, Karen C., additional, Blythe, Margaret J., additional, Bocchini, Joseph A., additional, Bowen, Anna, additional, Bowie, William R., additional, Boyce, Thomas G., additional, Bradley, John S., additional, Brady, Michael T., additional, Bratcher, Denise F., additional, Braverman, Paula K., additional, Bresee, Joseph, additional, Brook, Itzhak, additional, Brown, Kevin E., additional, Bryant, Kristina, additional, Buescher, E. Stephen, additional, Burns, Jane L., additional, Byington, Carrie L., additional, Camacho-Gonzalez, Andres F., additional, Cantey, Paul, additional, Carter, Bryan D., additional, Caserta, Mary T., additional, Castagnini, Luis A., additional, Cerini, Chiara, additional, Chadwick, Ellen Gould, additional, Chiang, Silvia S., additional, Christenson, John C., additional, Coffin, Susan E., additional, Collier, Melissa G., additional, Collins, Jennifer P., additional, Conklin, Laurie S., additional, Connelly, Beverly L., additional, Contopoulos-Ioannidis, Despina, additional, Conway, James H., additional, Cortese, Margaret M., additional, Cox, Elaine G., additional, Creech, C. Buddy, additional, Crews, Jonathan D., additional, Cunningham, Dennis J., additional, Curtis, Nigel, additional, Dailey, Natalie J.M., additional, Danziger-Isakov, Lara A., additional, Darville, Toni, additional, Dasch, Gregory A., additional, Daskalaki, Irini, additional, Daum, Robert S., additional, Davenport, Michael, additional, Davies, H. Dele, additional, Dawood, Fatimah S., additional, Day, J. Christopher, additional, de la Morena, Maite, additional, Demmler-Harrison, Gail J., additional, DeMuri, Gregory P., additional, Despommier, Dickson D., additional, Diefenbach, Karen A., additional, Edwards, Kathryn M., additional, Edwards, Morven S., additional, Eichenfield, Lawrence F., additional, Elston, Dirk M., additional, Emerson, Beth, additional, Ephros, Moshe, additional, Erdem, Guliz, additional, Eremeeva, Marina E., additional, Ericson, Jessica E., additional, Esposito, Douglas H., additional, Farley, Monica M., additional, Feingold, Anat R., additional, Feja, Kristina N., additional, Finn, Adam, additional, Fischer, Marc, additional, Flynn, Patricia M., additional, Fox, LeAnne M., additional, Frank, Michael M., additional, Fredrick, Douglas R., additional, Frenck, Robert W., additional, Friedlander, Sheila Fallon, additional, Gans, Hayley A., additional, Gauthier, Gregory M., additional, Gerber, Jeffrey S., additional, Gigliotti, Francis, additional, Gilger, Mark A., additional, Glaser, Carol A., additional, Goddard, Amanda F., additional, Gold, Benjamin D., additional, Gould, Jane M., additional, Green, Michael, additional, Greenberg, David, additional, Greywal, Tanya, additional, Griffin, Daniel, additional, Griffin, Patricia M., additional, Grom, Alexei A., additional, Gutierrez, Kathleen, additional, Gutman, Julie, additional, Guzman-Cottrill, Judith A., additional, Hall, Aron J., additional, Han, Jin-Young, additional, Harper, Marvin B., additional, Harris, Julie R., additional, Harrison, Christopher J., additional, Haslam, David B., additional, Hawkes, Sarah J., additional, Hendley, J. Owen, additional, Henry, Marion C.W., additional, Hilinski, Joseph A., additional, Hills, Susan L., additional, Holmberg, Scott D., additional, Holtzman, Deborah, additional, Hong, David K., additional, Hotez, Peter J., additional, Hsu, Katherine K., additional, Hunstad, David A., additional, Hwang, Loris Y., additional, Jackson, Mary Anne, additional, Jacobs, Richard F., additional, Jhaveri, Ravi, additional, Jirků-Pomajbíková, Kateřina, additional, Jones, Jeffrey L., additional, Karki, Mahima, additional, Karlowicz, M. Gary, additional, Katz, Ben Z., additional, Kaur, Ishminder, additional, Kersh, Gilbert J., additional, Keystone, Jay S., additional, Khan, Muhammad Ali, additional, Kimberlin, David W., additional, Kleiman, Martin B., additional, Klein, Bruce S., additional, Klontz, Karl, additional, Knust, Barbara, additional, Koh, Andrew Y., additional, Korgenski, E. Kent, additional, Krogstad, Paul, additional, Kutty, Preeta Krishnan, additional, Lauren, Christine T., additional, Lawrence, Hillary S., additional, Leber, Amy, additional, Lee, Grace M., additional, Leibovitz, Eugene, additional, Leshem, Eyal, additional, Levasseur, Stéphanie, additional, Lewis, David B., additional, Livingston, Robyn A., additional, Llata, Eloisa, additional, Long, Sarah S., additional, Lopman, Ben A., additional, Lucero, Yalda C., additional, Luján-Zilbermann, Jorge, additional, Luzuriaga, Katherine, additional, MacDonald, Noni E., additional, Maldonado, Yvonne A., additional, Manaloor, John, additional, Mani, Chitra S., additional, Manthiram, Kalpana, additional, Marshall, Gary S., additional, Martin, Stacey W., additional, Matanock, Almea, additional, Matiz, Catalina, additional, Mawle, Alison C., additional, Mazzulli, Tony, additional, McGann, Kathleen A., additional, McIntosh, Kenneth, additional, McNamara, Lucy A., additional, Meir, Michal, additional, Meislich, Debrah, additional, Meissner, H. Cody, additional, Meites, Elissa, additional, Mejías, Asunción, additional, Mertsola, Jussi, additional, Messacar, Kevin, additional, Mhaissen, Mohammed Nael, additional, Michaels, Marian G., additional, Miller, Melissa B., additional, Mintz, Eric D., additional, Modlin, John F., additional, Mohan, Parvathi, additional, Montgomery, Susan P., additional, Montoya, José G., additional, Moro, Pedro L., additional, Moscicki, Anna-Barbara, additional, Moss, R. Lawrence, additional, Myers, Angela L., additional, Nadel, Simon, additional, Neely, Michael N., additional, Neil, Karen P., additional, Nelson, Joanna, additional, Nelson, Noele P., additional, Nicholson, William L., additional, Nizet, Victor, additional, Nopper, Amy Jo, additional, Ochoa, Theresa J., additional, Orenstein, Walter A., additional, O'Ryan, Miguel, additional, Paddock, Christopher D., additional, Pall, Harpreet, additional, Panuganti, Suresh Kumar, additional, Pappas, Diane E., additional, Pass, Robert F., additional, Patterson, Thomas F., additional, Patton, Monica E., additional, Pelton, Stephen I., additional, Petersen, Brett W., additional, Pickering, Larry K., additional, Pinninti, Swetha, additional, Planet, Paul J., additional, Pollard, Andrew J., additional, Posfay-Barbe, Klara M., additional, Poulsen, Casper S., additional, Poutanen, Susan M., additional, Powers, Ann M., additional, Prober, Charles G., additional, Ramilo, Octavio, additional, Rangel, Shawn J., additional, Rao, Suchitra, additional, Rawstron, Sarah A., additional, Read, Jennifer S., additional, Reed, Michael D., additional, Relich, Ryan F., additional, Reller, Megan E., additional, Rellosa, Neil, additional, Rempe, Katherine A., additional, Reyes, Melissa A., additional, Rice-Townsend, Samuel E., additional, Richards, Frank O., additional, Romero, José R., additional, Rosen, David A., additional, Rostad, Christina A., additional, Rours, G. Ingrid J.G., additional, Routh, Janell A., additional, Rowley, Anne H., additional, Rubin, Lorry G., additional, Ryan, Edward T., additional, Saiman, Lisa, additional, Sammons, Julia S., additional, Sass, Laura, additional, Sauberan, Jason B., additional, Schillie, Sarah, additional, Schulert, Grant S., additional, Schuster, Jennifer E., additional, Schwartz, Kevin L., additional, Sederdahl, Bethany K., additional, Serpa, Jose A., additional, Shah, Kara N., additional, Shah, Samir S., additional, Shane, Andi L., additional, Shapiro, Eugene D., additional, Shaw, Jana, additional, Shetty, Avinash K., additional, Dairiki, Linda M., additional, Siberry, George Kelly, additional, Siegel, Jane D., additional, Siegel, Robert David, additional, Simonsen, Kari A., additional, Singh, Nalini, additional, Singh, Upinder, additional, Smith, P. Brian, additional, Snyder, John D., additional, Song, Eunkyung, additional, Sorrell, Jennifer L., additional, Souder, Emily, additional, St. Geme, Joseph W., additional, Staat, Mary Allen, additional, Staples, J. Erin, additional, Starke, Jeffrey R., additional, Steinbach, William J., additional, Stensvold, Christen R., additional, Stoner, Bradley P., additional, Strikas, Raymond A., additional, Strober, Jonathan B., additional, Sue, Paul K., additional, Sutton, Deanna A., additional, Swanson, Douglas, additional, Tate, Jacqueline E., additional, Tebruegge, Marc, additional, Teshale, Eyasu H., additional, Thompson, Amelia B., additional, Thompson, George R., additional, Thompson-Stone, Robert, additional, Thomson, Richard B., additional, Thorell, Emily A., additional, Tobin, Nicole H., additional, Toltzis, Philip, additional, Treat, James, additional, Troy, Stephanie B., additional, Van, Russell B., additional, Vaz, Louise Elaine, additional, Vodzak, Jennifer, additional, Wald, Ellen R., additional, Wallihan, Rebecca, additional, Wangu, Zoon, additional, Washam, Matthew, additional, Watson, Joshua R., additional, Wattier, Rachel L., additional, Weinberg, Geoffrey A., additional, White, A. Clinton, additional, Wiesenfeld, Harold C., additional, Williams, John V., additional, Willoughby, Rodney E., additional, Wingerter, Sarah L., additional, Wittler, Robert R., additional, Wong, Karen K., additional, Workowski, Kimberly A., additional, Wright, Terry W., additional, Yagupsky, Pablo, additional, Yen, Catherine, additional, Yi, Jumi, additional, Yoder, Jonathan S., additional, Young, Edward J., additional, Zaenglein, Andrea L., additional, and Zimmerman, Kanecia, additional

Published
2018
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27. Outcomes of second‐line antiretroviral therapy among children living with HIV: a global cohort analysis

Author

Patel, Kunjal, Smith, Colette, Collins, Intira Jeannie, Goodall, Ruth, Abrams, Elaine J., Sohn, Annette H., Mohamed, Thahira J., Van Dyke, Russell B., Rojo, Pablo, Wools?Kaloustian, Kara, Pinto, Jorge, Edmonds, Andrew, Marete, Irene, Paul, Mary, Nuwaqaba?Biribonwoha, Harriet, Leroy, Valériane, Davies, Mary?Ann, Vreeman, Rachel, Maxwell, Nicky, Timmerman, Venessa, Duff, Charlotte, Mofenson, Lynne, Bekker, Linda?Gail, Vicari, Marissa, Essajee, Shaffiq, Penazzato, Martina, Slogrove, Amy, Williams, Paige, Crichton, Siobhan, Seage, George, Thahane, Lineo, Kazembe, Peter N., Lukhele, Bhekumusa, Mwita, Lumumba, Kekitiinwa?Rukyalekere, Adeodata, Wanless, Sebastian, Matshaba, Mogomotsi S., Goetghebuer, Tessa, Thorne, Claire, Warszawski, Josiane, Galli, Luisa, Geelen, Sybil, Gibb, Diana M., Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaia, Liubov, Noguera?Julian, Antoni, Naver, Lars, Rudin, Christoph, Jourdain, Gonzague, Judd, Ali, Volokha, Alla, Rouzier, Vanessa, Succi, Regina, Kariminia, Azar, Yotebieng, Marcel, Lelo, Patricia, Lyamuya, Rita, Oyaro, Patrick, Boulle, Andrew, Malisita, Kennedy, Fatti, Geoffrey, Haas, Andreas D., Desmonde, Sophie, Dicko, Fatoumata, Abzug, Mark J., Purswani, Murli, Van Dyke, Russell, Chadwick, Ellen, Abrams, Elaine, Teasdale, Chloe, and Nuwagaba, Harriet

Subjects
HIV infection in children -- Statistics -- Drug therapy -- Patient outcomes, Highly active antiretroviral therapy -- Patient outcomes -- Statistics, Pediatric research, Health
Abstract

: Introduction: Limited data describe outcomes on second‐line antiretroviral therapy (ART) among children globally. Our objective was to contribute data on outcomes among children living with HIV after initiation of second‐line ART in the context of routine care within a large global cohort collaboration. Methods: Patient‐level data from 1993 through 2015 from 11 paediatric HIV cohorts were pooled. Characteristics at switch and through two years of follow‐up were summarized for children who switched to second‐line ART after starting a standard first‐line regimen in North America, Latin America, Europe, Asia, Southern Africa (South Africa & Botswana) and the rest of sub‐Saharan Africa (SSA). Cumulative incidences of mortality and loss to follow‐up (LTFU) were estimated using a competing risks framework. Results: Of the 85,389 children on first‐line ART, 3,555 (4%) switched to second‐line after a median of 2.8 years on ART (IQR: 1.6, 4.7); 69% were from Southern Africa or SSA and 86% of second‐line regimens were protease inhibitor‐based. At switch, median age was 8.4 years and 50% had a prior AIDS diagnosis. Median follow‐up after switch to second‐line ranged from 1.8 years in SSA to 5.3 years in North America. Median CD4 counts at switch to second‐line ranged from 235 cells/mm[sup.3] in SSA to 828 cells/mm[sup.3] in North America. Improvements in CD4 counts were observed over two years of follow‐up, particularly in regions with lower CD4 counts at second‐line switch. Improvements in weight‐for‐age z‐scores were not observed during follow‐up. Cumulative incidence of LTFU at two years was Conclusions: Children switched to second‐line ART experience CD4 count increases as well as low to moderate rates of LTFU and mortality within two years after switch. Severe immune deficiency at time of switch in some settings suggests need for improved recognition and management of treatment failure in children., Introduction In 2018, there were an estimated 1.7 million children living with HIV globally and 160,000 new paediatric infections [1]. With the recommendation for immediate antiretroviral therapy (ART) [2], substantial [...]

Published
2020
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31. Growth and CD4 patterns of adolescents living with perinatally acquired HIV worldwide, a CIPHER cohort collaboration analysis

Author

Jesson, Julie, Crichton, Siobhan, Quartagno, Matteo, Yotebieng, Marcel, Abrams, Elaine J., Chokephaibulkit, Kulkanya, Le Coeur, Sophie, Aké-Assi, Marie-Hélène, Patel, Kunjal, Pinto, Jorge, Paul, Mary, Vreeman, Rachel, Davies, Mary-Ann, Ben-Farhat, Jihane, Van Dyke, Russell, Judd, Ali, Mofenson, Lynne, Vicari, Marissa, Seage, George, Bekker, Linda-Gail, Essajee, Shaffiq, Gibb, Diana, Penazzato, Martina, Collins, Intira Jeannie, Wools-Kaloustian, Kara, Slogrove, Amy, Powis, Kate, Williams, Paige, Matshaba, Mogomotsi, Thahane, Lineo, Nyasulu, Phoebe, Lukhele, Bhekumusa, Mwita, Lumumba, Kekitiinwa-Rukyalekere, Adeodata, Wanless, Sebastian, Goetghebuer, Tessa, Thorne, Claire, Warszawski, Josiane, Galli, Luisa, van Rossum, Annemarie M.C, Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaya, Lyuba, Navarro, Marisa, Frick, Antoinette, Naver, Lars, Kahlert, Christian, Volokha, Alla, Chappell, Elizabeth, Pape, Jean William, Rouzier, Vanessa, Marcelin, Adias, Succi, Regina, Sohn, Annette H., Kariminia, Azar, Edmonds, Andrew, Lelo, Patricia, Lyamuya, Rita, Ogalo, Edith Apondi, Odhiambo, Francesca Akoth, Haas, Andreas D., Bolton, Carolyn, Muhairwe, Josephine, Tweya, Hannock, Sylla, Mariam, D'Almeida, Marceline, Renner, Lorna, Abzug, Mark J., Oleske, James, Purswani, Murli, Teasdale, Chloe, Nuwagaba-Biribonwoha, Harriet, Goodall, Ruth, Leroy, Valériane, Universitat Autònoma de Barcelona, Jesson, Julie, Crichton, Siobhan, Quartagno, Matteo, Yotebieng, Marcel, Abrams, Elaine J., Chokephaibulkit, Kulkanya, Le Coeur, Sophie, Aké-Assi, Marie-Hélène, Patel, Kunjal, Pinto, Jorge, Paul, Mary, Vreeman, Rachel, Davies, Mary-Ann, Ben-Farhat, Jihane, Van Dyke, Russell, Judd, Ali, Mofenson, Lynne, Vicari, Marissa, Seage, George, Bekker, Linda-Gail, Essajee, Shaffiq, Gibb, Diana, Penazzato, Martina, Collins, Intira Jeannie, Wools-Kaloustian, Kara, Slogrove, Amy, Powis, Kate, Williams, Paige, Matshaba, Mogomotsi, Thahane, Lineo, Nyasulu, Phoebe, Lukhele, Bhekumusa, Mwita, Lumumba, Kekitiinwa-Rukyalekere, Adeodata, Wanless, Sebastian, Goetghebuer, Tessa, Thorne, Claire, Warszawski, Josiane, Galli, Luisa, van Rossum, Annemarie M.C, Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaya, Lyuba, Navarro, Marisa, Frick, Antoinette, Naver, Lars, Kahlert, Christian, Volokha, Alla, Chappell, Elizabeth, Pape, Jean William, Rouzier, Vanessa, Marcelin, Adias, Succi, Regina, Sohn, Annette H., Kariminia, Azar, Edmonds, Andrew, Lelo, Patricia, Lyamuya, Rita, Ogalo, Edith Apondi, Odhiambo, Francesca Akoth, Haas, Andreas D., Bolton, Carolyn, Muhairwe, Josephine, Tweya, Hannock, Sylla, Mariam, D'Almeida, Marceline, Renner, Lorna, Abzug, Mark J., Oleske, James, Purswani, Murli, Teasdale, Chloe, Nuwagaba-Biribonwoha, Harriet, Goodall, Ruth, Leroy, Valériane, and Universitat Autònoma de Barcelona

Abstract

Adolescents living with HIV are subject to multiple co-morbidities, including growth retardation and immunodeficiency. We describe growth and CD4 evolution during adolescence using data from the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) global project. Data were collected between 1994 and 2015 from 11 CIPHER networks worldwide. Adolescents with perinatally acquired HIV infection (APH) who initiated antiretroviral therapy (ART) before age 10 years, with at least one height or CD4 count measurement while aged 10-17 years, were included. Growth was measured using height-for-age Z-scores (HAZ, stunting if <-2 SD, WHO growth charts). Linear mixed-effects models were used to study the evolution of each outcome between ages 10 and 17. For growth, sex-specific models with fractional polynomials were used to model non-linear relationships for age at ART initiation, HAZ at age 10 and time, defined as current age from 10 to 17 years of age. A total of 20,939 and 19,557 APH were included for the growth and CD4 analyses, respectively. Half were females, two-thirds lived in East and Southern Africa, and median age at ART initiation ranged from <3 years in North America and Europe to >7 years in sub-Saharan African regions. At age 10, stunting ranged from 6% in North America and Europe to 39% in the Asia-Pacific; 19% overall had CD4 counts <500 cells/mm 3. Across adolescence, higher HAZ was observed in females and among those in high-income countries. APH with stunting at age 10 and those with late ART initiation (after age 5) had the largest HAZ gains during adolescence, but these gains were insufficient to catch-up with non-stunted, early ART-treated adolescents. From age 10 to 16 years, mean CD4 counts declined from 768 to 607 cells/mm 3. This decline was observed across all regions, in males and females. Growth patterns during adolescence differed substantially by sex and region, while CD4 patterns were similar, with an observed CD4 decline th

Published
2022

34. Sinusitis

Author

Chan, Kenny H., primary, Abzug, Mark J., additional, and Liu, Andrew H., additional

Published
2016
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35. List of Contributors

Author

Abzug, Mark J., primary, Akdis, Cezmi A., additional, Allen, Katrina, additional, Bacharier, Leonard B., additional, Ballow, Mark, additional, Bartholow, Ashton, additional, Becker, Allan, additional, Behrens, Edward M., additional, Bender, Bruce G., additional, Berin, M. Cecilia, additional, Bielory, Brett P., additional, Bielory, Leonard, additional, Bock, S. Allan, additional, Boguniewicz, Mark, additional, Bonilla, Francisco A., additional, Burks, A. Wesley, additional, Bush, Andrew, additional, Chan, Kenny H., additional, Chehade, Mirna, additional, Chiriac, Anca M., additional, Cicutto, Lisa, additional, Collins, Samuel A., additional, Covar, Ronina A., additional, Davis, Benjamin P., additional, Dedeoglu, Fatma, additional, Demoly, Pascal, additional, Eggleston, Peyton A., additional, Eisenberg, Robert, additional, Fleisher, Thomas A., additional, Fonacier, Luz, additional, Gentile, Deborah A., additional, Gern, James E., additional, Groetch, Marion, additional, Halken, Susanne, additional, Hamilton, Robert G., additional, Hollams, Elysia M., additional, Holland, Steven M., additional, Holloway, John W., additional, Holt, Patrick G., additional, Høst, Arne, additional, Jackson, Daniel J., additional, Jones, Stacie M., additional, Kattan, Meyer, additional, Kelly, Brian T., additional, Kelly, Kevin J., additional, Kim, Susan, additional, Kohn, Donald B., additional, Lederman, Howard M., additional, Lehman, Heather K., additional, Lemanske, Robert F., additional, Leung, Donald Y.M., additional, Liacouras, Chris A., additional, Liu, Andrew H., additional, Lockett, Gabrielle A., additional, Markowitz, Jonathan E., additional, Martinez, Fernando D., additional, Matsui, Elizabeth C., additional, Mazer, Bruce D., additional, Milgrom, Henry, additional, Muir, Amanda B., additional, Nelson, Harold S., additional, Nichols, David P., additional, Notarangelo, Luigi D., additional, Novak, Natalija, additional, Nowak-Węgrzyn, Anna, additional, Oettgen, Hans C., additional, Olin, J. Tod, additional, Oliveira, Joao Bosco, additional, Oude Elberink, Hanneke (Joanne) N.G., additional, Palomares, Oscar, additional, Phipatanakul, Wanda, additional, Pleskovic, Nicole, additional, Prescott, Susan, additional, Rosenzweig, Sergio D., additional, Rothenberg, Marc E., additional, Sampson, Hugh A., additional, Sheehan, William J., additional, Sicherer, Scott H., additional, Simons, F. Estelle R., additional, Skoner, David P., additional, Spahn, Joseph D., additional, Strunk, Robert C., additional, Sullivan, Kathleen E., additional, Sundel, Robert P., additional, Szefler, Stanley J., additional, Torgerson, Troy R., additional, von Mutius, Erika, additional, Wagner, Rudolph S., additional, Wang, Julie, additional, Weber, Richard W., additional, Wood, Robert A., additional, and Zuraw, Bruce L., additional

Published
2016
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37. A Randomized, Double-Blind, Placebo-Controlled Trial of Pleconaril for the Treatment of Neonates With Enterovirus Sepsis

Author

Abzug, Mark J., Michaels, Marian G., Wald, Ellen, Jacobs, Richard F., Romero, José R., Sánchez, Pablo J., Wilson, Gregory, Krogstad, Paul, Storch, Gregory A., Lawrence, Robert, Shelton, Mark, Palmer, April, Robinson, Joan, Dennehy, Penelope, Sood, Sunil K., Cloud, Gretchen, Jester, Penelope, Acosta, Edward P., Whitley, Richard, Kimberlin, David, Rotbart, Harley, Modlin, John, Kinney, Janet, Bradley, John, Weiner, Leonard, McKinlay, Mark, Grose, Charles, Cohen, Jeffrey, Van Raden, Mark, Fisher, Gerald, Jankelevich, Shirley, Blount, Sharon, Austin, Linda, Ritchey, Dunia, Edwards, Kathryn, Halasa, Natasha, Esterl, Elizabeth, Goodman, Sharolene, Smitely, Leslie, Winborn, Anna, Perry, Dewan, Zeray, Fiker, and Johnson, Shanda

Published
2016
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38. The epidemiology of adolescents living with perinatally acquired HIV: A cross-region global cohort analysis

Author

Slogrove, Amy L., Schomaker, Michael, Davies, Mary-Ann, Williams, Paige, Balkan, Suna, Ben-Farhat, Jihane, Calles, Nancy, Chokephaibulkit, Kulkanya, Duff, Charlotte, Eboua, Tanoh François, Kekitiinwa-Rukyalekere, Adeodata, Maxwell, Nicola, Pinto, Jorge, Seage, George, Teasdale, Chloe A., Wanless, Sebastian, Warszawski, Josiane, Wools-Kaloustian, Kara, Yotebieng, Marcel, Timmerman, Venessa, Collins, Intira J., Goodall, Ruth, Smith, Colette, Patel, Kunjal, Paul, Mary, Gibb, Diana, Vreeman, Rachel, Abrams, Elaine J., Hazra, Rohan, Van Dyke, Russell, Bekker, Linda-Gail, Mofenson, Lynne, Vicari, Marissa, Essajee, Shaffiq, Penazzato, Martina, Anabwani, Gabriel, Q. Mohapi, Edith, N. Kazembe, Peter, Hlatshwayo, Makhosazana, Lumumba, Mwita, Goetghebuer, Tessa, Thorne, Claire, Galli, Luisa, van Rossum, Annemarie, Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaia, Liubov, Rojo, Pablo, Fortuny, Claudia, Naver, Lars, Rudin, Christoph, Le Coeur, Sophie, Volokha, Alla, Rouzier, Vanessa, Succi, Regina, Sohn, Annette, Kariminia, Azar, Edmonds, Andrew, Lelo, Patricia, Ayaya, Samuel, Ongwen, Patricia, Jefferys, Laura F., Phiri, Sam, Mubiana-Mbewe, Mwangelwa, Sawry, Shobna, Renner, Lorna, Sylla, Mariam, Abzug, Mark J., Levin, Myron, Oleske, James, Chernoff, Miriam, Traite, Shirley, Purswani, Murli, Chadwick, Ellen G., Judd, Ali, and Leroy, Valériane

Subjects
Pediatric HIV infections -- Care and treatment -- Patient outcomes -- Statistics, Medical research, Adolescent medicine -- Research, Epidemiology -- Research, Biological sciences
Abstract

Background Globally, the population of adolescents living with perinatally acquired HIV (APHs) continues to expand. In this study, we pooled data from observational pediatric HIV cohorts and cohort networks, allowing comparisons of adolescents with perinatally acquired HIV in 'real-life' settings across multiple regions. We describe the geographic and temporal characteristics and mortality outcomes of APHs across multiple regions, including South America and the Caribbean, North America, Europe, sub-Saharan Africa, and South and Southeast Asia. Methods and findings Through the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER), individual retrospective longitudinal data from 12 cohort networks were pooled. All children infected with HIV who entered care before age 10 years, were not known to have horizontally acquired HIV, and were followed up beyond age 10 years were included in this analysis conducted from May 2016 to January 2017. Our primary analysis describes patient and treatment characteristics of APHs at key time points, including first HIV-associated clinic visit, antiretroviral therapy (ART) start, age 10 years, and last visit, and compares these characteristics by geographic region, country income group (CIG), and birth period. Our secondary analysis describes mortality, transfer out, and lost to follow-up (LTFU) as outcomes at age 15 years, using competing risk analysis. Among the 38,187 APHs included, 51% were female, 79% were from sub-Saharan Africa and 65% lived in low-income countries. APHs from 51 countries were included (Europe: 14 countries and 3,054 APHs; North America: 1 country and 1,032 APHs; South America and the Caribbean: 4 countries and 903 APHs; South and Southeast Asia: 7 countries and 2,902 APHs; sub-Saharan Africa, 25 countries and 30,296 APHs). Observation started as early as 1982 in Europe and 1996 in sub-Saharan Africa, and continued until at least 2014 in all regions. The median (interquartile range [IQR]) duration of adolescent follow-up was 3.1 (1.5-5.2) years for the total cohort and 6.4 (3.6-8.0) years in Europe, 3.7 (2.0-5.4) years in North America, 2.5 (1.2-4.4) years in South and Southeast Asia, 5.0 (2.7-7.5) years in South America and the Caribbean, and 2.1 (0.9-3.8) years in sub-Saharan Africa. Median (IQR) age at first visit differed substantially by region, ranging from 0.7 (0.3-2.1) years in North America to 7.1 (5.3-8.6) years in sub-Saharan Africa. The median age at ART start varied from 0.9 (0.4-2.6) years in North America to 7.9 (6.0-9.3) years in sub-Saharan Africa. The cumulative incidence estimates (95% confidence interval [CI]) at age 15 years for mortality, transfers out, and LTFU for all APHs were 2.6% (2.4%-2.8%), 15.6% (15.1%-16.0%), and 11.3% (10.9%-11.8%), respectively. Mortality was lowest in Europe (0.8% [0.5%-1.1%]) and highest in South America and the Caribbean (4.4% [3.1%-6.1%]). However, LTFU was lowest in South America and the Caribbean (4.8% [3.4%-6.7%]) and highest in sub-Saharan Africa (13.2% [12.6%-13.7%]). Study limitations include the high LTFU rate in sub-Saharan Africa, which could have affected the comparison of mortality across regions; inclusion of data only for APHs receiving ART from some countries; and unavailability of data from high-burden countries such as Nigeria. Conclusion To our knowledge, our study represents the largest multiregional epidemiological analysis of APHs. Despite probable under-ascertained mortality, mortality in APHs remains substantially higher in sub-Saharan Africa, South and Southeast Asia, and South America and the Caribbean than in Europe. Collaborations such as CIPHER enable us to monitor current global temporal trends in outcomes over time to inform appropriate policy responses., Author(s): The Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Global Cohort Collaboration, Amy L. Slogrove 1, Michael Schomaker 1, Mary-Ann Davies 1, Paige Williams 2, Suna Balkan 3, [...]

Published
2018
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42. Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease

Author

Kimberlin, David W., Jester, Penelope M., Sánchez, Pablo J., Ahmed, Amina, Arav-Boger, Ravit, Michaels, Marian G., Ashouri, Negar, Englund, Janet A., Estrada, Benjamin, Jacobs, Richard F., Romero, José R., Sood, Sunil K., Whitworth, Suzanne M., Abzug, Mark J., Caserta, Mary T., Fowler, Sandra, Lujan-Zilbermann, Jorge, Storch, Gregory A., DeBiasi, Roberta L., Han, Jin-Young, Palmer, April, Weiner, Leonard B., Bocchini, Joseph A., Dennehy, Penelope H., Finn, Adam, Griffiths, Paul D., Luck, Suzanne, Gutierrez, Kathleen, Halasa, Natasha, Homans, James, Shane, Andi L., Sharland, Michael, Simonsen, Kari, Vanchiere, John A., Woods, Charles R., Sabo, Diane L., Aban, Inmaculada, Kuo, Huichien, James, Scott H., Prichard, Mark N., Griffin, Jill, Giles, Dusty, Acosta, Edward P., and Whitley, Richard J.

Published
2015
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43. Comparative Effectiveness of Echinocandins vs Triazoles or Amphotericin B Formulations as Initial Directed Therapy for Invasive Candidiasis in Children and Adolescents

Author

Fisher, Brian T, primary, Zaoutis, Theoklis E, additional, Xiao, Rui, additional, Wattier, Rachel L, additional, Castagnola, Elio, additional, Pana, Zoi Dorothea, additional, Fullenkamp, Allison, additional, Boge, Craig L K, additional, Ross, Rachael K, additional, Yildirim, Inci, additional, Palazzi, Debra L, additional, Danziger-Isakov, Lara, additional, Vora, Surabhi B, additional, Arrieta, Antonio, additional, Yin, Dwight E, additional, Avilés-Robles, Martha, additional, Sharma, Tanvi, additional, Tribble, Alison C, additional, Maron, Gabriela, additional, Berman, David, additional, Green, Michael, additional, Sung, Lillian, additional, Romero, José, additional, Hauger, Sarmistha B, additional, Roilides, Emmanuel, additional, Belani, Kiran, additional, Nolt, Dawn, additional, Soler-Palacin, Pere, additional, López-Medina, Eduardo, additional, Muller, William J, additional, Halasa, Natasha, additional, Dulek, Daniel, additional, Hussain, Ibrahim Zaid Bin, additional, Pong, Alice, additional, Hoffman, Jill, additional, Rajan, Sujatha, additional, Gonzalez, Blanca E, additional, Hanisch, Benjamin, additional, Aftandilian, Catherine, additional, Carlesse, Fabianne, additional, Abzug, Mark J, additional, Huppler, Anna R, additional, Salvatore, Christine M, additional, Ardura, Monica I, additional, Chakrabarti, Arunaloke, additional, Santolaya, Maria E, additional, Localio, A Russell, additional, and Steinbach, William J, additional

Published
2021
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44. Multicenter Interim Guidance on Use of Antivirals for Children With Coronavirus Disease 2019/Severe Acute Respiratory Syndrome Coronavirus 2

Author

Chiotos, Kathleen, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Abzug, Mark J, MacBrayne, Christine E, Soma, Vijaya L, Dulek, Daniel E, Vora, Surabhi B, Waghmare, Alpana, Wolf, Joshua, Olivero, Rosemary, Grapentine, Steven, Wattier, Rachel L, Bio, Laura, Cross, Shane J, Dillman, Nicholas O, Downes, Kevin J, Oliveira, Carlos R, Timberlake, Kathryn, Young, Jennifer, Orscheln, Rachel C, Tamma, Pranita D, Schwenk, Hayden T, Zachariah, Philip, Aldrich, Margaret L, Goldman, David L, Groves, Helen E, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Hersh, Adam L, Thorell, Emily A, Denison, Mark R, Ratner, Adam J, Newland, Jason G, and Nakamura, Mari M

Subjects
Pediatric, Alanine, Evidence-Based Medicine, SARS-CoV-2, COVID-19, Antiviral Agents, Severity of Illness Index, antiviral, Adenosine Monophosphate, Systemic Inflammatory Response Syndrome, COVID-19 Drug Treatment, Immunocompromised Host, Infectious Diseases, Emerging Infectious Diseases, Good Health and Well Being, Risk Factors, Clinical Research, Humans, Child, Lung
Abstract

BackgroundAlthough coronavirus disease 2019 (COVID-19) is a mild infection in most children, a small proportion develop severe or critical illness. Data describing agents with potential antiviral activity continue to expand such that updated guidance is needed regarding use of these agents in children.MethodsA panel of pediatric infectious diseases physicians and pharmacists from 20 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of the best available evidence and expert opinion.ResultsGiven the typically mild course of COVID-19 in children, supportive care alone is suggested for most cases. For children with severe illness, defined as a supplemental oxygen requirement without need for noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), remdesivir is suggested, preferably as part of a clinical trial if available. Remdesivir should also be considered for critically ill children requiring invasive or noninvasive mechanical ventilation or ECMO. A duration of 5 days is appropriate for most patients. The panel recommends against the use of hydroxychloroquine or lopinavir-ritonavir (or other protease inhibitors) for COVID-19 in children.ConclusionsAntiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For children with severe or critical disease, this guidance offers an approach for decision-making regarding use of remdesivir.

Published
2021

45. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents.

Author

Wolf, Joshua, Wolf, Joshua, Abzug, Mark J, Wattier, Rachel L, Sue, Paul K, Vora, Surabhi B, Zachariah, Philip, Dulek, Daniel E, Waghmare, Alpana, Olivero, Rosemary, Downes, Kevin J, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Aldrich, Margaret L, MacBrayne, Christine E, Soma, Vijaya L, Grapentine, Steven P, Oliveira, Carlos R, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, Bio, Laura L, Morton, Theodore H, Hankins, Jane S, Maron, Gabriela M, Timberlake, Kathryn, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Goldman, David L, Groves, Helen E, Huskins, W Charles, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Lloyd, Elizabeth C, Hersh, Adam L, Thorell, Emily A, Ratner, Adam J, Chiotos, Kathleen, Nakamura, Mari M, Wolf, Joshua, Wolf, Joshua, Abzug, Mark J, Wattier, Rachel L, Sue, Paul K, Vora, Surabhi B, Zachariah, Philip, Dulek, Daniel E, Waghmare, Alpana, Olivero, Rosemary, Downes, Kevin J, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Aldrich, Margaret L, MacBrayne, Christine E, Soma, Vijaya L, Grapentine, Steven P, Oliveira, Carlos R, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, Bio, Laura L, Morton, Theodore H, Hankins, Jane S, Maron, Gabriela M, Timberlake, Kathryn, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Goldman, David L, Groves, Helen E, Huskins, W Charles, Rajapakse, Nipunie S, Lamb, Gabriella S, Tribble, Alison C, Lloyd, Elizabeth C, Hersh, Adam L, Thorell, Emily A, Ratner, Adam J, Chiotos, Kathleen, and Nakamura, Mari M

Abstract

BackgroundIn November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.ConclusionsBased on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

Published
2021

48. Multicenter Initial Guidance on Use of Antivirals for Children With Coronavirus Disease 2019/Severe Acute Respiratory Syndrome Coronavirus 2

Author

Chiotos, Kathleen, Hayes, Molly, Kimberlin, David W, Jones, Sarah B, James, Scott H, Pinninti, Swetha G, Yarbrough, April, Abzug, Mark J, MacBrayne, Christine E, Soma, Vijaya L, Dulek, Daniel E, Vora, Surabhi B, Waghmare, Alpana, Wolf, Joshua, Olivero, Rosemary, Grapentine, Steven, Wattier, Rachel L, Bio, Laura, Cross, Shane J, Dillman, Nicholas O, Downes, Kevin J, Timberlake, Kathryn, Young, Jennifer, Orscheln, Rachel C, Tamma, Pranita D, Schwenk, Hayden T, Zachariah, Philip, Aldrich, Margaret, Goldman, David L, Groves, Helen E, Lamb, Gabriella S, Tribble, Alison C, Hersh, Adam L, Thorell, Emily A, Denison, Mark R, Ratner, Adam J, Newland, Jason G, and Nakamura, Mari M

Subjects
Pediatric, SARS-CoV-2, COVID-19, Antiviral Agents, Severity of Illness Index, Risk Assessment, antiviral, COVID-19 Drug Treatment, Emerging Infectious Diseases, Infectious Diseases, Good Health and Well Being, Clinical Research, Humans, Patient Safety, Child, Lung, guidance
Abstract

BackgroundAlthough coronavirus disease 2019 (COVID-19) is mild in nearly all children, a small proportion of pediatric patients develop severe or critical illness. Guidance is therefore needed regarding use of agents with potential activity against severe acute respiratory syndrome coronavirus 2 in pediatrics.MethodsA panel of pediatric infectious diseases physicians and pharmacists from 18 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of best available evidence and expert opinion.ResultsGiven the typically mild course of pediatric COVID-19, supportive care alone is suggested for the overwhelming majority of cases. The panel suggests a decision-making framework for antiviral therapy that weighs risks and benefits based on disease severity as indicated by respiratory support needs, with consideration on a case-by-case basis of potential pediatric risk factors for disease progression. If an antiviral is used, the panel suggests remdesivir as the preferred agent. Hydroxychloroquine could be considered for patients who are not candidates for remdesivir or when remdesivir is not available. Antivirals should preferably be used as part of a clinical trial if available.ConclusionsAntiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For those rare cases of severe or critical disease, this guidance offers an approach for decision-making regarding antivirals, informed by available data. As evidence continues to evolve rapidly, the need for updates to the guidance is anticipated.

Published
2020

50. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents

Author

Wolf, Joshua, primary, Abzug, Mark J, additional, Wattier, Rachel L, additional, Sue, Paul K, additional, Vora, Surabhi B, additional, Zachariah, Philip, additional, Dulek, Daniel E, additional, Waghmare, Alpana, additional, Olivero, Rosemary, additional, Downes, Kevin J, additional, James, Scott H, additional, Pinninti, Swetha G, additional, Yarbrough, April, additional, Aldrich, Margaret L, additional, MacBrayne, Christine E, additional, Soma, Vijaya L, additional, Grapentine, Steven P, additional, Oliveira, Carlos R, additional, Hayes, Molly, additional, Kimberlin, David W, additional, Jones, Sarah B, additional, Bio, Laura L, additional, Morton, Theodore H, additional, Hankins, Jane S, additional, Maron, Gabriela M, additional, Timberlake, Kathryn, additional, Young, Jennifer L, additional, Orscheln, Rachel C, additional, Schwenk, Hayden T, additional, Goldman, David L, additional, Groves, Helen E, additional, Huskins, W Charles, additional, Rajapakse, Nipunie S, additional, Lamb, Gabriella S, additional, Tribble, Alison C, additional, Lloyd, Elizabeth C, additional, Hersh, Adam L, additional, Thorell, Emily A, additional, Ratner, Adam J, additional, Chiotos, Kathleen, additional, and Nakamura, Mari M, additional

Published
2021
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