Responding to Higher-Than-Expected Infant Mortality Rates from Respiratory Syncytial Virus (RSV): Improving Treatment and Reporting Strategies

References

• Srikantiah P, Vora P, Klugman KP. Assessing the full burden of respiratory syncytial virus in young infants in low- and middle-income countries: the importance of community mortality studies. Clin Infect Dis. 2021;73(Supplement_3):S177–9. doi:10.1093/cid/ciab486
   PubMedGoogle Scholar
• Shi T, McAllister DA, O’Brien KL, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017;390(10098):946–958.
   PubMed Web of Science ®Google Scholar
• Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022;399(10340):2047–2064.
   PubMed Web of Science ®Google Scholar
• Li Y, Johnson EK, Shi T, et al. National burden estimates of hospitalisations for acute lower respiratory infections due to respiratory syncytial virus in young children in 2019 among 58 countries: a modelling study. Lancet Respir Med. 2021;9(2):175–185.
   PubMed Web of Science ®Google Scholar
• Mazur NI, Terstappen J, Baral R, et al. Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape. Lancet Infect Dis. 2022;2022:1.
   Google Scholar
• Li X, Willem L, Antillon M, Bilcke J, Jit M, Beutels P. Health and economic burden of respiratory syncytial virus (RSV) disease and the cost-effectiveness of potential interventions against RSV among children under 5 years in 72 Gavi-eligible countries. BMC Med. 2020;18(1):82.
   PubMed Web of Science ®Google Scholar
• Zhang S, Akmar LZ, Bailey F, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: a Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Supplement_7):S680–7.
   PubMedGoogle Scholar
• Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010;375(9725):1545–1555.
   PubMed Web of Science ®Google Scholar
• Geoghegan S, Erviti A, Caballero MT, et al. Mortality due to respiratory syncytial virus. burden and risk factors. Am J Respir Crit Care Med. 2017;195(1):96–103.
   PubMed Web of Science ®Google Scholar
• Simões EAF, DeVincenzo JP, Boeckh M, et al. Challenges and opportunities in developing respiratory syncytial virus therapeutics. J Infect Dis. 2015;211(suppl_1):S1–20.
   PubMedGoogle Scholar
• WHO preferred product characteristics for respiratory syncytial virus (RSV) vaccines; 2022. Available from: https://www.who.int/publications-detail-redirect/WHO-IVB-17.11. Accessed January 16, 2023.
   Google Scholar
• Caballero MT, Satav A, Gill CJ, et al. Challenges of assessing community mortality due to respiratory viruses in children aged less than 5 years. Clin Infect Dis. 2021;73(Supplement_3):S248–54.
   PubMedGoogle Scholar
• Kovacs SD, Mullholland K, Bosch J, et al. Deconstructing the differences: a comparison of GBD 2010 and CHERG’s approach to estimating the mortality burden of diarrhea, pneumonia, and their etiologies. BMC Infect Dis. 2015;15(1):1.
   PubMedGoogle Scholar
• Mazur NI, Löwensteyn YN, Willemsen JE, et al. Global respiratory syncytial virus–related infant community deaths. Clin Infect Dis. 2021;73(Supplement_3):S229–37.
   PubMedGoogle Scholar
• Caballero MT, Bianchi AM, Nuño A, et al. Mortality associated with acute respiratory infections among children at home. J Infect Dis. 2019;219(3):358–364.
   PubMed Web of Science ®Google Scholar
• Caballero MT, Bianchi AM, Grigaites SD, et al. Community mortality due to respiratory syncytial virus in Argentina: population-based surveillance study. Clin Infect Dis. 2021;73(Supplement_3):S210–7.
   PubMedGoogle Scholar
• Blau DM, Baillie VL, Els T, et al. Deaths attributed to respiratory syncytial virus in young children in high–mortality rate settings: report from Child Health And Mortality Prevention Surveillance (CHAMPS). Clin Infect Dis. 2021;73(Supplement_3):S218–28.
   PubMedGoogle Scholar
• Gill CJ, Mwananyanda L, MacLeod WB, et al. Infant deaths from respiratory syncytial virus in Lusaka, Zambia from the ZPRIME study: a 3-year, systematic, post-mortem surveillance project. Lancet Glob Health. 2022;10(2):e269–77.
   PubMed Web of Science ®Google Scholar
• Simões EAF, Dani V, Potdar V, et al. mortality from respiratory syncytial virus in children under 2 years of age: a prospective community cohort study in Rural Maharashtra, India. Clin Infect Dis. 2021;73(Supplement_3):S193–202.
   PubMedGoogle Scholar
• Kazi AM, Aguolu OG, Mughis W, et al. Respiratory syncytial virus–associated mortality among young infants in Karachi, Pakistan: a prospective postmortem surveillance study. Clin Infect Dis. 2021;73(Supplement_3):S203–9.
   PubMedGoogle Scholar
• Zanone SM, Krause LK, Madhi SA, et al. Challenges in estimating RSV-associated mortality rates. Lancet Respir Med. 2016;4(5):345–347.
   PubMed Web of Science ®Google Scholar
• Butt SA, Maceira VP, McCallen ME, Stellrecht KA. Comparison of three commercial RT-PCR systems for the detection of respiratory viruses. J Clin Virol. 2014;61(3):406–410.
   PubMed Web of Science ®Google Scholar
• Menéndez C, Quintó L, Castillo P, et al. Limitations to current methods to estimate cause of death: a validation study of a verbal autopsy model. Gates Open Res. 2021;4:55.
   PubMedGoogle Scholar
• Gupta N, Bharti B, Singhi S, Kumar P, Thakur JS. Errors in filling WHO death certificate in children: lessons from 1251 death certificates. J Trop Pediatr. 2014;60(1):74–78.
   PubMed Web of Science ®Google Scholar
• Mathers CD, Fat DM, Inoue M, Rao C, Lopez AD. Counting the dead and what they died from: an assessment of the global status of cause of death data. Bull World Health Organ. 2005;83(3):171–177.
   PubMed Web of Science ®Google Scholar
• Ordi J, Ismail MR, Carrilho C, et al. Clinico-pathological discrepancies in the diagnosis of causes of maternal death in sub-saharan Africa: retrospective analysis. PLoS Med. 2009;6(2):e1000036.
   PubMed Web of Science ®Google Scholar
• Cox JA, Lukande RL, Kateregga A, Mayanja-Kizza H, Manabe YC, Colebunders R. Autopsy acceptance rate and reasons for decline in Mulago Hospital, Kampala, Uganda. Trop Med Int Health. 2011;16(8):1015–1018.
   PubMed Web of Science ®Google Scholar
• Oluwasola OA, Fawole OI, Otegbayo AJ, Ogun GO, Adebamowo CA, Bamigboye AE. The autopsy: knowledge, attitude, and perceptions of doctors and relatives of the deceased. Arch Pathol Lab Med. 2009;133(1):78–82.
   PubMed Web of Science ®Google Scholar
• Tan GC, Hayati AR, Khong TY. Low perinatal autopsy rate in Malaysia: time for a change. Pediatr Dev Pathol. 2010;13(5):362–368.
   PubMed Web of Science ®Google Scholar
• Troeger C, Blacker B, Khalil IA, et al. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet Infect Dis. 2018;18(11):1191–1210.
   PubMed Web of Science ®Google Scholar
• Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2012;380(9859):2095–2128.
   PubMed Web of Science ®Google Scholar
• Liu L, Johnson HL, Cousens S, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012;379(9832):2151–2161.
   PubMed Web of Science ®Google Scholar
• World Health Organization. WHO strategy for the global respiratory syncytial virus surveillance based on influenza surveillance. Geneva: World Health Organization; 2019. Available from: https://www.who.int/publications-detail-redirect/who-strategy-for-global-respiratory-syncytial-virus-surveillance-project-based-on-the-influenza-platform. Accessed January 16, 2023.
   Google Scholar
• Pebody R, Moyes J, Hirve S, et al. Approaches to use the WHO respiratory syncytial virus surveillance platform to estimate disease burden. Influenza Other Respi Viruses. 2020;14(6):615–621.
   PubMed Web of Science ®Google Scholar
• Saha S, Pandey BG, Choudekar A, et al. Evaluation of case definitions for estimation of respiratory syncytial virus associated hospitalizations among children in a rural community of northern India. J Glob Health. 2015;5(2):010419.
   PubMed Web of Science ®Google Scholar
• Nyawanda BO, Mott JA, Njuguna HN, et al. Evaluation of case definitions to detect respiratory syncytial virus infection in hospitalized children below 5 years in Rural Western Kenya, 2009–2013. BMC Infect Dis. 2016;16(1):218.
   PubMedGoogle Scholar
• Atwell JE, Geoghegan S, Karron RA, Polack FP. Clinical predictors of critical lower respiratory tract illness due to respiratory syncytial virus in infants and children: data to inform case definitions for efficacy trials. J Infect Dis. 2016;214(11):1712–1716.
   PubMed Web of Science ®Google Scholar
• Openshaw PJM, Chiu C, Culley FJ, Johansson C. Protective and Harmful Immunity to RSV Infection. Annu Rev Immunol. 2017;35:501–532.
   PubMed Web of Science ®Google Scholar
• Mina MJ, Kula T, Leng Y, et al. Measles virus infection diminishes preexisting antibodies that offer protection from other pathogens. Science. 2019;366(6465):599–606.
   PubMed Web of Science ®Google Scholar
• Munoz FM, Cramer JP, Dekker CL, et al. Vaccine-associated enhanced disease: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2021;39(22):3053–3066.
   PubMed Web of Science ®Google Scholar
• Acosta PL, Caballero MT, Polack FP. Brief history and characterization of enhanced respiratory syncytial virus disease. Clin Vaccine Immunol. 2016;23(3):189–195.
   Google Scholar
• Sedeyn K, Schepens B, Saelens X. Respiratory syncytial virus nonstructural proteins 1 and 2: exceptional disrupters of innate immune responses. PLoS Pathog. 2019;15(10):e1007984.
   PubMed Web of Science ®Google Scholar
• McLellan JS, Ray WC, Peeples ME. Structure and function of respiratory syncytial virus surface glycoproteins. Curr Top Microbiol Immunol. 2013;372:83–104.
   PubMed Web of Science ®Google Scholar
• Tripp RA, Jones LP, Haynes LM, Zheng H, Murphy PM, Anderson LJ. CX3C chemokine mimicry by respiratory syncytial virus G glycoprotein. Nat Immunol. 2001;2(8):732–738.
   PubMed Web of Science ®Google Scholar
• Bukreyev A, Yang L, Fricke J, et al. The secreted form of respiratory syncytial virus G glycoprotein helps the virus evade antibody-mediated restriction of replication by acting as an antigen decoy and through effects on Fc receptor-bearing leukocytes. J Virol. 2008;82(24):12191–12204.
   PubMed Web of Science ®Google Scholar
• Johnson TR, McLellan JS, Graham BS. Respiratory syncytial virus Glycoprotein G interacts with DC-SIGN and L-SIGN to activate ERK1 and ERK2. J Virol. 2012;86(3):1339–1347.
   PubMed Web of Science ®Google Scholar
• Tognarelli EI, Bueno SM, González PA. Immune-modulation by the human respiratory syncytial virus: focus on dendritic cells. Front Immunol. 2019;10:5.
   PubMed Web of Science ®Google Scholar
• van Erp EA, Feyaerts D, Duijst M, et al. Respiratory syncytial virus infects primary neonatal and adult natural killer cells and affects their antiviral effector function. J Infect Dis. 2019;219(5):723–733.
   PubMed Web of Science ®Google Scholar
• Zhivaki D, Lemoine S, Lim A, et al. Respiratory syncytial virus infects regulatory B cells in human neonates via chemokine receptor CX3CR1 and promotes lung disease severity. Immunity. 2017;46(2):301–314.
   PubMed Web of Science ®Google Scholar
• Raiden S, Sananez I, Remes-Lenicov F, et al. Respiratory syncytial virus (RSV) Infects CD4+ T cells: frequency of circulating CD4+ RSV+ T cells as a marker of disease severity in young children. J Infect Dis. 2017;215(7):1049–1058.
   PubMed Web of Science ®Google Scholar
• Jozwik A, Habibi MS, Paras A, et al. RSV-specific airway resident memory CD8+ T cells and differential disease severity after experimental human infection. Nat Commun. 2015;6(1):10224.
   PubMedGoogle Scholar
• Rivera-Toledo E, Gómez B. Respiratory syncytial virus persistence in macrophages alters the profile of cellular gene expression. Viruses. 2012;4(12):3270–3280.
   PubMed Web of Science ®Google Scholar
• González PA, Prado CE, Leiva ED, et al. Respiratory syncytial virus impairs T cell activation by preventing synapse assembly with dendritic cells. Proc Nat Acad Sci. 2008;105(39):14999–15004.
   PubMed Web of Science ®Google Scholar
• Blanco JCG, Boukhvalova MS, Morrison TG, Vogel SN. A multifaceted approach to RSV vaccination. Hum Vaccin Immunother. 2018;14(7):1734–1745.
   PubMed Web of Science ®Google Scholar
• Chin J, Magoffin RL, Shearer LA, Schieble JH, Lennette EH. Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population. Am J Epidemiol. 1969;89(4):449–463.
   PubMed Web of Science ®Google Scholar
• Polack FP, Alvarez-Paggi D, Libster R, et al. Fatal enhanced respiratory syncytial virus disease in toddlers. Sci Transl Med. 2021;13(616):eabj7843.
   PubMed Web of Science ®Google Scholar
• Delgado MF, Coviello S, Monsalvo AC, et al. Lack of antibody affinity maturation due to poor Toll-like receptor stimulation leads to enhanced respiratory syncytial virus disease. Nat Med. 2009;15(1):34–41.
   PubMed Web of Science ®Google Scholar
• Polack FP, Teng MN, Collins L, et al. A role for immune complexes in enhanced respiratory syncytial virus disease. J Exp Med. 2002;196(6):859–865.
   PubMed Web of Science ®Google Scholar
• Graham BS, Henderson GS, Tang YW, Lu X, Neuzil KM, Colley DG. Priming immunization determines T helper cytokine mRNA expression patterns in lungs of mice challenged with respiratory syncytial virus. J Immunol. 1993;151(4):2032–2040.
   PubMed Web of Science ®Google Scholar
• Tripp RA, Power UF. Original antigenic sin and respiratory syncytial virus vaccines. Vaccines. 2019;7(3):107.
   Web of Science ®Google Scholar
• RSV vaccine and mAb snapshot; 2022. Available from: https://www.path.org/resources/rsv-vaccine-and-mab-snapshot/. Accessed January 16, 2023.
   Google Scholar
• Wheeler SM, Dotters-Katz S, Heine RP, Grotegut CA, Swamy GK. Maternal effects of respiratory syncytial virus infection during pregnancy. Emerg Infect Dis. 2015;21(11):1951–1955.
   PubMed Web of Science ®Google Scholar
• Aranda SS, Polack FP. Prevention of pediatric respiratory syncytial virus lower respiratory tract illness: perspectives for the next decade. Front Immunol. 2019;10:3.
   PubMed Web of Science ®Google Scholar
• Steinhoff MC, Omer SB, Roy E, et al. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. CMAJ. 2012;184(6):645–653.
   PubMed Web of Science ®Google Scholar
• Brady MT, Byington CL; Committee On Infectious Diseases And Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):415–420.
   PubMedGoogle Scholar
• Ofman G, Pradarelli B, Caballero MT, et al. Respiratory failure and death in vulnerable premature children with lower respiratory tract illness. J Infect Dis. 2020;2020:5.
   Google Scholar
• Sadoff J, De Paepe E, DeVincenzo J, et al. Prevention of respiratory syncytial virus infection in healthy adults by a single immunization of Ad26.RSV.preF in a human challenge study. J Infect Dis. 2022;226(3):396–406.
   PubMed Web of Science ®Google Scholar
• Simões EAF, Center KJ, Tita ATN, et al. Prefusion F protein–based respiratory syncytial virus immunization in pregnancy. N Eng J Med. 2022;386(17):1615–1626.
   PubMed Web of Science ®Google Scholar
• GSK. GSK presents positive clinical data on maternal and older adults RSV candidate vaccines; 2022. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-clinical-data-on-maternal-and-older-adults-rsv-candidate-vaccines/. Accessed January 16, 2023.
   Google Scholar
• Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Eng J Med. 2022;386(9):837–846.
   PubMed Web of Science ®Google Scholar
• Maas BM, Lommerse J, Plock N, et al. Forward and reverse translational approaches to predict efficacy of neutralizing respiratory syncytial virus (RSV) antibody prophylaxis. eBioMedicine. 2021;73:6.
   Web of Science ®Google Scholar
• Thornhill EM, Salpor J, Verhoeven D. Respiratory syntycial virus: current treatment strategies and vaccine approaches. Antivir Chem Chemother. 2020;28:2040206620947303.
   Google Scholar
• Kalergis AM, Soto JA, Gálvez NMS, et al. Pharmacological management of human respiratory syncytial virus infection. Expert Opin Pharmacother. 2020;21(18):2293–2303.
   PubMed Web of Science ®Google Scholar
• Chiou H-E, Liu C-L, Buttrey MJ, et al. Adverse effects of ribavirin and outcome in severe acute respiratory syndrome: experience in two medical centers. Chest. 2005;128(1):263–272.
   PubMed Web of Science ®Google Scholar
• Tejada S, Martinez-Reviejo R, Karakoc HN, Peña-López Y, Manuel O, Rello J. Ribavirin for treatment of subjects with respiratory syncytial virus-related infection: a systematic review and meta-analysis. Adv Ther. 2022;39(9):4037–4051.
   PubMed Web of Science ®Google Scholar
• Shang Z, Tan S, Ma D. Respiratory syncytial virus: from pathogenesis to potential therapeutic strategies. Int J Biol Sci. 2021;17(14):4073–4091.
   PubMed Web of Science ®Google Scholar
• Beigel JH, Nam HH, Adams PL, et al. Advances in respiratory virus therapeutics – a meeting report from the 6th isirv Antiviral group conference. Antiviral Res. 2019;167:45–67.
   PubMed Web of Science ®Google Scholar
• Bergeron HC, Tripp RA. Emerging small and large molecule therapeutics for respiratory syncytial virus. Expert Opin Investig Drugs. 2020;29(3):285–294.
   PubMed Web of Science ®Google Scholar
• DeVincenzo JP, Whitley RJ, Mackman RL, et al. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014;371(8):711–722.
   PubMed Web of Science ®Google Scholar
• Gottlieb J, Torres F, Haddad T, et al. A phase 2b randomized controlled trial of presatovir, an Oral RSV fusion inhibitor, for the treatment of Respiratory Syncytial Virus (RSV) in lung transplant (LT) recipients. J Heart Lung Transplant. 2018;37(4):S155.
   Web of Science ®Google Scholar
• Chemaly RF, Dadwal SS, Bergeron A, et al. A phase 2, randomized, double-blind, placebo-controlled trial of presatovir for the treatment of respiratory syncytial virus upper respiratory tract infection in hematopoietic-cell transplant recipients. Clin Infect Dis. 2020;71(11):2777–2786.
   PubMed Web of Science ®Google Scholar
• Stevens M, Rusch S, DeVincenzo J, et al. Antiviral activity of oral JNJ-53718678 in healthy adult volunteers challenged with respiratory syncytial virus: a placebo-controlled study. J Infect Dis. 2018;218(5):748–756.
   PubMed Web of Science ®Google Scholar
• Martinón-Torres F, Rusch S, Huntjens D, et al. Pharmacokinetics, safety, and antiviral effects of multiple doses of the Respiratory Syncytial Virus (RSV) fusion protein inhibitor, JNJ-53718678, in infants hospitalized with RSV infection: a randomized phase 1b study. Clin Infect Dis. 2020;71(10):e594–603.
   PubMed Web of Science ®Google Scholar
• DeVincenzo J, Tait D, Efthimiou J, et al. A randomized, placebo-controlled, respiratory syncytial virus human challenge study of the antiviral efficacy, safety, and pharmacokinetics of RV521, an inhibitor of the RSV-F Protein. Antimicrob Agents Chemother. 2020;64(2):e01884–19.
   PubMed Web of Science ®Google Scholar
• Ahmad A, Eze K, Noulin N, et al. EDP-938, a respiratory syncytial virus inhibitor, in a human virus challenge. N Eng J Med. 2022;386(7):655–666.
   PubMed Web of Science ®Google Scholar