{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T16:23:01Z","timestamp":1784823781578,"version":"3.55.0"},"reference-count":40,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2025,3,19]],"date-time":"2025-03-19T00:00:00Z","timestamp":1742342400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/publicdomain\/zero\/1.0\/"}],"funder":[{"name":"USAID"},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["K08HD101342"],"award-info":[{"award-number":["K08HD101342"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD079214"],"award-info":[{"award-number":["R01HD079214"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"name":"MGH Research Scholars Award"},{"DOI":"10.13039\/100017973","name":"International Maternal Pediatric Adolescent AIDS Clinical Trials Network","doi-asserted-by":"publisher","award":["DR808"],"award-info":[{"award-number":["DR808"]}],"id":[{"id":"10.13039\/100017973","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"NIAID","doi-asserted-by":"crossref","award":["R01AI093269"],"award-info":[{"award-number":["R01AI093269"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>\nBackground\n<\/jats:title>\n<jats:p>Approximately 130 000 infants acquire HIV annually despite global maternal antiretroviral therapy scale-up. We evaluated the potential clinical impact and cost-effectiveness of offering long-acting, anti-HIV broadly neutralizing antibody (bNAb) prophylaxis to infants in three distinct settings.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>\nMethods\n<\/jats:title>\n<jats:p>We simulated infants in C\u00f4te d\u2019Ivoire, South Africa, and Zimbabwe using the Cost-Effectiveness of Preventing AIDS Complications-Pediatric (CEPAC-P) model. We modeled strategies offering a three-bNAb combination in addition to WHO-recommended standard-of-care oral prophylaxis to infants: a) with known, WHO-defined high-risk HIV exposure at birth (<jats:italic>HR-HIVE<\/jats:italic>); b) with known HIV exposure at birth (<jats:italic>HIVE<\/jats:italic>); or c) with or without known HIV exposure (<jats:italic>ALL<\/jats:italic>). Modeled infants received <jats:italic>1-dose<\/jats:italic>, <jats:italic>2-doses<\/jats:italic>, or <jats:italic>Extended<\/jats:italic> (every 3 months through 18 months) bNAb dosing. Base case model inputs included 70% bNAb efficacy (sensitivity analysis range: 10\u2013100%), 3-month efficacy duration\/dosing interval (1\u20136 months), and $20\/dose cost ($5\u2013$100\/dose). Outcomes included pediatric HIV infections, life expectancy, lifetime HIV-related costs, and incremental cost-effectiveness ratios (ICERs, in US$\/year-of-life-saved [YLS], assuming a \u2264\u200950% GDP per capita cost-effectiveness threshold).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>\nFindings\n<\/jats:title>\n<jats:p>The base case model projects that bNAb strategies targeting <jats:italic>HIVE<\/jats:italic> and <jats:italic>ALL<\/jats:italic> infants would prevent 7\u201326% and 10\u201342% additional pediatric HIV infections, respectively, compared to standard-of-care alone, ranging by dosing approach. <jats:italic>HIVE-Extended<\/jats:italic> would be cost-effective (cost-saving compared to standard-of-care) in C\u00f4te d\u2019Ivoire and Zimbabwe; <jats:italic>ALL-Extended<\/jats:italic> would be cost-effective in South Africa (ICER: $882\/YLS). BNAb strategies targeting <jats:italic>HR-HIVE<\/jats:italic> infants would result in greater lifetime costs and smaller life expectancy gains than <jats:italic>HIVE-Extended<\/jats:italic>. Throughout most bNAb efficacies and costs evaluated in sensitivity analyses, targeting <jats:italic>HIVE<\/jats:italic> infants would be cost-effective in C\u00f4te d\u2019Ivoire and Zimbabwe, and targeting <jats:italic>ALL<\/jats:italic> infants would be cost-effective in South Africa.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>\nInterpretation\n<\/jats:title>\n<jats:p>Adding long-acting bNAbs to current standard-of-care prophylaxis would be cost-effective, assuming plausible efficacies and costs. The cost-effective target population would vary by setting, largely driven by maternal antenatal HIV prevalence and postpartum incidence.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0318940","type":"journal-article","created":{"date-parts":[[2025,3,19]],"date-time":"2025-03-19T17:49:49Z","timestamp":1742406589000},"page":"e0318940","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Cost-effectiveness of broadly neutralizing antibodies for HIV prophylaxis for infants born in settings with high HIV burdens"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8692-7656","authenticated-orcid":true,"given":"Christopher","family":"Alba","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7457-386X","authenticated-orcid":true,"given":"Shelly","family":"Malhotra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Horsfall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew E.","family":"Barnhart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrie","family":"Bekker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5413-2058","authenticated-orcid":true,"given":"Katerina","family":"Chapman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Coleen K.","family":"Cunningham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia E.","family":"Fast","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Genevieve G.","family":"Fouda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth A.","family":"Freedberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameena","family":"Goga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lusine R.","family":"Ghazaryan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3542-8616","authenticated-orcid":true,"given":"Val\u00e9riane","family":"Leroy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6445-507X","authenticated-orcid":true,"given":"Carlyn","family":"Mann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret M.","family":"McCluskey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0653-8955","authenticated-orcid":true,"given":"Elizabeth J.","family":"McFarland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Muturi-Kioi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sallie R.","family":"Permar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Shapiro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devin","family":"Sok","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynda","family":"Stranix-Chibanda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milton C.","family":"Weinstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea L.","family":"Ciaranello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6604-6111","authenticated-orcid":true,"given":"Caitlin M.","family":"Dugdale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,3,19]]},"reference":[{"key":"pone.0318940.ref001","article-title":"The path that ends AIDS: UNAIDS Global AIDS Update 2023","author":"Joint United Nations Programme on HIV\/AIDS (UNAIDS)"},{"key":"pone.0318940.ref002","article-title":"2021 UNAIDS Global AIDS Update \u2013 Confronting inequalities \u2013 Lessons for pandemic responses from 40 years of AIDS","author":"Joint United Nations Programme on HIV\/AIDS"},{"issue":"11","key":"pone.0318940.ref003","doi-asserted-by":"crossref","first-page":"1003","DOI":"10.1056\/NEJMoa2031738","article-title":"Two randomized trials of neutralizing antibodies to prevent HIV-1 acquisition","volume":"384","author":"HVTN 704\/HPTN 085 and HVTN 703\/HPTN 081 Study Teams","year":"2021","journal-title":"N Engl J Med"},{"issue":"11","key":"pone.0318940.ref004","doi-asserted-by":"crossref","first-page":"1916","DOI":"10.1093\/infdis\/jiab229","article-title":"Safety, tolerability, and pharmacokinetics of a long-acting broadly neutralizing human immunodeficiency virus type 1 (HIV-1) monoclonal antibody VRC01LS in HIV-1\u2013exposed newborn infants","volume":"224","author":"International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1112 Team","year":"2021","journal-title":"J Infect Dis"},{"issue":"1","key":"pone.0318940.ref005","doi-asserted-by":"crossref","first-page":"e1002493","DOI":"10.1371\/journal.pmed.1002493","article-title":"Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: a phase 1 open-label clinical trial in healthy adults","volume":"15","author":"VRC 606 Study Team","year":"2018","journal-title":"PLoS Med"},{"issue":"10","key":"pone.0318940.ref006","doi-asserted-by":"crossref","first-page":"e667","DOI":"10.1016\/S2352-3018(19)30181-X","article-title":"Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial","volume":"6","author":"MR Gaudinski","year":"2010","journal-title":"Lancet HIV"},{"key":"pone.0318940.ref007","article-title":"Extended safety and PK of anti-HIV monoclonal Ab VRC07-523LS in HIV-exposed infants","author":"C Cunningham"},{"issue":"4","key":"pone.0318940.ref008","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1038\/nm.4063","article-title":"Early short-term treatment with neutralizing human monoclonal antibodies halts SHIV infection in infant macaques","volume":"22","author":"AJ Hessell","year":"2016","journal-title":"Nat Med"},{"issue":"1","key":"pone.0318940.ref009","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1038\/s41467-019-13972-y","article-title":"Single-dose bNAb cocktail or abbreviated ART post-exposure regimens achieve tight SHIV control without adaptive immunity","volume":"11","author":"MB Shapiro","year":"2020","journal-title":"Nat Commun"},{"issue":"3","key":"pone.0318940.ref010","doi-asserted-by":"crossref","first-page":"370","DOI":"10.1093\/infdis\/jiaa377","article-title":"Clinical trials of broadly neutralizing monoclonal antibodies for human immunodeficiency virus prevention: a review","volume":"223","author":"S Mahomed","year":"2021","journal-title":"J Infect Dis"},{"issue":"1","key":"pone.0318940.ref011","doi-asserted-by":"crossref","first-page":"e26052","DOI":"10.1002\/jia2.26052","article-title":"Cost\u2010effectiveness of broadly neutralizing antibody prophylaxis for HIV\u2010exposed infants in sub\u2010Saharan African settings","volume":"26","author":"CM Dugdale","year":"2023","journal-title":"J Int AIDS Soc"},{"issue":"12","key":"pone.0318940.ref012","doi-asserted-by":"crossref","first-page":"e83389","DOI":"10.1371\/journal.pone.0083389","article-title":"Validation and calibration of a computer simulation model of pediatric HIV infection","volume":"8","author":"AL Ciaranello","year":"2013","journal-title":"PLoS One"},{"key":"pone.0318940.ref013","article-title":"Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach","author":"World Health Organization"},{"key":"pone.0318940.ref014","article-title":"Expanded programme on immunisation\u2013South Africa (EPI-SA) revised - childhood immunisation schedule from december 2015.","author":"South Africa National Department of Health"},{"issue":"4","key":"pone.0318940.ref015","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1093\/infdis\/jiz532","article-title":"Safety, tolerability, and pharmacokinetics of the broadly neutralizing human immunodeficiency virus (HIV)-1 monoclonal antibody VRC01 in HIV-exposed newborn infants","volume":"222","author":"IMPAACT P1112 team","year":"2020","journal-title":"J Infect Dis"},{"key":"pone.0318940.ref016","article-title":"C\u00f4te d\u2019Ivoire population-based HIV impact assessment (CIPHIA) 2017-2018: final report.","author":"Minist\u00e8re de la Sant\u00e9 et de l\u2019Hygi\u00e8ne Publique (MSHP)"},{"key":"pone.0318940.ref017","article-title":"National antenatal sentinel HIV survey key findings.","author":"South Africa National Department of Health"},{"key":"pone.0318940.ref018","article-title":"Approaching eMTCT in Zimbabwe: Expansion of PMTCT services and declining MTCT, 2012-2018","author":"S McCoy"},{"key":"pone.0318940.ref019","article-title":"Countdown to 2030 - Countdown Country Dashboards","author":"UNICEF"},{"issue":"1","key":"pone.0318940.ref020","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1093\/cid\/cis808","article-title":"Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission","volume":"56","author":"MG Hudgens","year":"2013","journal-title":"Clin Infect Dis"},{"issue":"2","key":"pone.0318940.ref021","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1056\/NEJMoa0801941","article-title":"Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission","volume":"359","author":"NI Kumwenda","year":"2008","journal-title":"N Engl J Med"},{"issue":"1","key":"pone.0318940.ref022","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1186\/s12887-015-0340-9","article-title":"Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life","volume":"15","author":"AC Desmond","year":"2015","journal-title":"BMC Pediatr"},{"issue":"Suppl 4","key":"pone.0318940.ref023","doi-asserted-by":"crossref","first-page":"S562","DOI":"10.1093\/cid\/ciac754","article-title":"Potential of long-acting products to transform the treatment and prevention of human immunodeficiency virus (HIV) in infants, children, and adolescents","volume":"75","author":"EJ Abrams","year":"2022","journal-title":"Clin Infect Dis"},{"issue":"5","key":"pone.0318940.ref024","first-page":"e01909","article-title":"Neutralizing activity of broadly neutralizing anti-HIV-1 antibodies against primary African isolates","volume":"95","author":"JCC Lorenzi","year":"2021","journal-title":"J Virol"},{"issue":"6","key":"pone.0318940.ref025","doi-asserted-by":"crossref","first-page":"e1011469","DOI":"10.1371\/journal.ppat.1011469","article-title":"Neutralization profiles of hiv-1 viruses from the vrc01 antibody mediated prevention (AMP) trials","volume":"19","author":"NN Mkhize","year":"2023","journal-title":"PLoS Pathog"},{"issue":"11","key":"pone.0318940.ref026","doi-asserted-by":"crossref","first-page":"1505","DOI":"10.1097\/QAD.0000000000001521","article-title":"Systemic and topical use of monoclonal antibodies to prevent the sexual transmission of HIV","volume":"31","author":"DJ Anderson","year":"2017","journal-title":"AIDS"},{"key":"pone.0318940.ref027","article-title":"Costs of delivering COVID-19 vaccine in 92 AMC countries","author":"COVAX Working Group on delivery costs"},{"issue":"23","key":"pone.0318940.ref028","doi-asserted-by":"crossref","first-page":"2697","DOI":"10.1016\/j.vaccine.2015.03.084","article-title":"Estimating the costs of the vaccine supply chain and service delivery for selected districts in Kenya and Tanzania","volume":"33","author":"M Mvundura","year":"2015","journal-title":"Vaccine"},{"issue":"12","key":"pone.0318940.ref029","doi-asserted-by":"crossref","first-page":"1553","DOI":"10.1111\/tmi.13493","article-title":"Provider\u2010and patient\u2010level costs associated with providing antiretroviral therapy during the postpartum phase to women living with HIV in South Africa: a cost comparison of three postpartum models of care","volume":"25","author":"L Cunnama","year":"2020","journal-title":"Trop Med Int Health"},{"issue":"7","key":"pone.0318940.ref030","doi-asserted-by":"crossref","first-page":"e0003418","DOI":"10.1371\/journal.pgph.0003418","article-title":"Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries","volume":"4","author":"S Malhotra","year":"2024","journal-title":"PLOS Glob Public Health"},{"key":"pone.0318940.ref031","doi-asserted-by":"crossref","DOI":"10.1093\/acprof:oso\/9780190492939.001.0001","volume-title":"Cost-Effectiveness in Health and Medicine, Second Edition","author":"P Neumann","year":"2016"},{"issue":"1","key":"pone.0318940.ref032","doi-asserted-by":"crossref","first-page":"20520","DOI":"10.7448\/IAS.19.1.20520","article-title":"Safety of combination antiretroviral prophylaxis in high\u2010risk HIV\u2010exposed newborns: a retrospective review of the Canadian experience","volume":"19","author":"FW Kakkar","year":"2016","journal-title":"J Int AIDS Soc"},{"issue":"7","key":"pone.0318940.ref033","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1097\/INF.0000000000002357","article-title":"Reducing hematologic toxicity with short course postexposure prophylaxis with zidovudine for HIV-1 exposed infants with low transmission risk","volume":"38","author":"TTT Nguyen","year":"2019","journal-title":"Pediatr Infect Dis J"},{"key":"pone.0318940.ref034","article-title":"Speed dialing neonates to the ideal postnatal prophylaxis regimen","author":"A Bekker"},{"key":"pone.0318940.ref035","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1016\/j.eclinm.2019.04.006","article-title":"Cost-effectiveness of HIV prevention interventions in sub-Saharan Africa: a systematic review","volume":"10","author":"S Sarkar","year":"2019","journal-title":"EClinicalMedicine"},{"issue":"46","key":"pone.0318940.ref036","doi-asserted-by":"crossref","first-page":"6874","DOI":"10.1016\/j.vaccine.2019.09.059","article-title":"A cost-effectiveness analysis of antenatal influenza vaccination among HIV-infected and HIV-uninfected pregnant women in South Africa","volume":"37","author":"M Biggerstaff","year":"2019","journal-title":"Vaccine"},{"issue":"Suppl 2","key":"pone.0318940.ref037","doi-asserted-by":"crossref","first-page":"S145","DOI":"10.1097\/QAI.0000000000001063","article-title":"Cost-effectiveness of pre-exposure HIV prophylaxis during pregnancy and breastfeeding in Sub-Saharan Africa","volume":"72","author":"JT Price","year":"2016","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"9","key":"pone.0318940.ref038","doi-asserted-by":"crossref","first-page":"1319","DOI":"10.1093\/infdis\/jiw379","article-title":"Clinical impact and cost-effectiveness of diagnosing HIV infection during early infancy in South Africa: test timing and frequency","volume":"214","author":"JA Francke","year":"2016","journal-title":"J Infect Dis"},{"issue":"12","key":"pone.0318940.ref039","doi-asserted-by":"crossref","first-page":"925","DOI":"10.2471\/BLT.15.164418","article-title":"Cost\u2013effectiveness thresholds: pros and cons","volume":"94","author":"MY Bertram","year":"2016","journal-title":"Bull World Health Organ"},{"key":"pone.0318940.ref040","article-title":"Zimbabwe Population-Based HIV Impact Assessment (ZIMPHIA) 2015-2016: final report","author":"Zimbabwe Ministry of Health and Child Care (MOHCC)"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0318940","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,19]],"date-time":"2025-03-19T17:51:20Z","timestamp":1742406680000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0318940"}},"subtitle":[],"editor":[{"given":"Nagarajan","family":"Raju","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,3,19]]},"references-count":40,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2025,3,19]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0318940","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,19]]}}}