Optimising Paediatric HIV Treatment: Recent Developments and Future Directions.


Journal

Paediatric drugs
ISSN: 1179-2019
Titre abrégé: Paediatr Drugs
Pays: Switzerland
ID NLM: 100883685

Informations de publication

Date de publication:
22 Oct 2024
Historique:
accepted: 10 09 2024
medline: 22 10 2024
pubmed: 22 10 2024
entrez: 22 10 2024
Statut: aheadofprint

Résumé

Treatment options for children living with HIV have historically been less effective, less practical and more difficult to implement compared with those for adults, as the research and development of new drugs for children has lagged behind. Significant progress has been achieved in response to the paediatric HIV epidemic over the last decade. Several optimised paediatric antiretroviral formulations are currently available or in development, including fixed-dose combination tablets containing a complete World Health Organization-recommended regimen. Despite these advancements, virological suppression rates in children are generally lower than in adults. Even when oral fixed-dose combinations with the optimal target profiles are developed, for some children virological suppression is not achievable for reasons such as adherence challenges, intolerance, toxicity and genotypic resistance. New safe, effective, well-tolerated antiretroviral agents from existing and novel classes, as well as innovative administration strategies are essential. To achieve the UNAIDS target of virological suppression in 95% of children receiving antiretroviral therapy, concerted efforts are required. This includes identifying priority drugs in line with latest developments, focusing drug development studies on these priorities, ensuring a timely technical knowledge transfer between originator and generic companies, accelerating regulatory approvals and facilitating procurement and implementation in countries. Success in these efforts depends on collaboration among all stakeholders, including communities, researchers, pharmaceutical companies, guideline and policymakers, governments, funders, regulators and healthcare providers. This review outlines which paediatric antiretroviral therapies are currently available, those which are under development and the future directions of paediatric HIV treatment.

Identifiants

pubmed: 39436531
doi: 10.1007/s40272-024-00656-4
pii: 10.1007/s40272-024-00656-4
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

Références

UNAIDS. UNAIDS epidemiological estimates, 2024. Available from: https://aidsinfo.unaids.org/ . [Accessed 21 Sep 2024].
UNAIDS. The urgency of now: AIDS at a crossroads. Geneva: Joint United Nations Programme on HIV/AIDS; 2024. Available from: https://www.unaids.org/sites/default/files/media_asset/2024-unaids-global-aids-update_en.pdf . [Accessed 21 Sep 2024].
World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2013. Available from: https://iris.who.int/bitstream/handle/10665/85321/9789241505727_eng.pdf?sequence=1 . [Accessed 21 Sep 2024].
Bolton Moore C, Capparelli EV, Samson P, et al. CYP2B6 genotype-directed dosing is required for optimal efavirenz exposure in children 3–36 months with HIV infection. AIDS. 2017;31(8):1129–36. https://doi.org/10.1097/QAD.0000000000001463 .
doi: 10.1097/QAD.0000000000001463 pubmed: 28323755
Palumbo P, Lindsey JC, Hughes MD, et al. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010;363(16):1510–20. https://doi.org/10.1056/NEJMoa1000931 .
doi: 10.1056/NEJMoa1000931 pubmed: 20942667 pmcid: 3021781
Violari A, Lindsey JC, Hughes MD, et al. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. N Engl J Med. 2012;366(25):2380–9. https://doi.org/10.1056/NEJMoa1113249 .
doi: 10.1056/NEJMoa1113249 pubmed: 22716976 pmcid: 3443859
Turkova A, Webb RH, Lyall H. When to start, what to start and other treatment controversies in pediatric HIV infection. Paediatr Drugs. 2012;14(6):361–76. https://doi.org/10.2165/11599640-000000000-00000 .
doi: 10.2165/11599640-000000000-00000 pubmed: 23013459
World Health Organization. March 2014 supplement to the 2013 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach 2013. Available from: http://www.who.int/hiv/pub/guidelines/arv2013/arvs2013upplement_march2014/en/ . [Accessed 6 Jun 2024].
Bacha JM, Dlamini S, Anabwani F, et al. Realizing the promise of dolutegravir in effectively treating Children and adolescents living with HIV in real-world settings in 6 countries in Eastern and Southern Africa. Pediatr Infect Dis J. 2023;42(7):576–81. https://doi.org/10.1097/inf.0000000000003878 .
doi: 10.1097/inf.0000000000003878 pubmed: 36795586 pmcid: 10259212
De Waal R, Bolton C, Boulle A, et al. Viral suppression at 12 months in children and adolescents on dolutegravir from 14 Southern African ART cohorts [abstract 49]. International Workshop on HIV & Pediatrics; 27-28 July, 2022; Montreal (QC).
Turkova A, Waalewijn H, Chan MK, et al. Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial. Lancet HIV. 2022;9(9):e627–37. https://doi.org/10.1016/S2352-3018(22)00160-6 .
doi: 10.1016/S2352-3018(22)00160-6 pubmed: 35868341 pmcid: 9630157
World Health Organization, Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. 2021. Available from: https://www.who.int/publications/i/item/9789240031593 . [Accessed 21 Sep 2024].
US Food and Drug Administration. Abacavir sulfate and lamuvidine [package insert]. 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/202381PI.pdf . [Accessed 21 Sep 2024].
US Food and Drug Administration. Descovy (emtricitabine and tenofovir alafenamide) [package insert]. 2015. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf . [Accessed 21 Sep 2024].
Paton NI, Musaazi J, Kityo C, et al. Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial. Lancet HIV. 2022;9(6):e381–93. https://doi.org/10.1016/S2352-3018(22)00092-3 .
doi: 10.1016/S2352-3018(22)00092-3 pubmed: 35460601
de Waal R, Rabie H, Technau KG, et al. Abacavir safety and effectiveness in young infants with HIV in South African observational cohorts. Antivir Ther. 2023;28(2):13596535231168480. https://doi.org/10.1177/13596535231168480 .
doi: 10.1177/13596535231168480 pubmed: 37038365 pmcid: 10961679
US Food and Drug Administration. Triumeq PD (Abacavir sulfate; dolutegravir sodium; lamivudine) [package insert]. 2022. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205551s032,215413s003lbl.pdf . [Accessed 21 Sep 2024].
Chandasana H, Brooks KM, Buchanan A., et al. A single once daily ABC/DTG/3TC tablet predicts safe and effective exposures in children 3 to <6 kg. CROI; 3-6 March, 2024. Denver (CO).
US Food and Drug Administration. Biktarvy [package insert]. 2018. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210251 . [Accessed 21 Sep 2024].
Bwakura-Dangarembizi M, Szubert AJ, Mumbiro V, et al. CHAPAS-4 trial: second-line anchor drugs for children with HIV in Africa. medRxiv. 2024. https://doi.org/10.1101/2024.04.12.24305333 .
doi: 10.1101/2024.04.12.24305333
US Food and Drug Administration. Darunavir (Prezista) [package insert]. 2022. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s067,202895s035lbl.pdf . [Accessed 21 Sep 2024].
Clinton Health Access Initiative. HIV new product introduction toolkit, pediatric DRV/r (pDRV/r) product profile. 2023. Available from: https://www.newhivdrugs.org/post/pediatric-drv-r-pdrv-r-product-profile . [Accessed 8 Jul 2024].
World Health Organization. 21st invitation to manufactureres and suppliers of medicinal products for HIV infections and related diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit - Medicines Team. 2024.
UNIVERSAL, the project. Goals and objectives. Available from: https://universalproject.org/the-project/ . [Accessed 21 Sep 2024].
ClinicalTrials.gov. UNIVERSAL 1: pharmacokinetic study of a novel DTG/​FTC/​TAF dose ratio for children (UNIVERSAL1), NCT05993767. 2023. Available from: https://www.clinicaltrials.gov/study/NCT05993767?cond=hiv&term=universal&intr=dtg%2Fftc%2Ftaf&rank=1 . [Accessed 21 Sep 2024].
ClinicalTrials.gov. UNIVERSAL 2: pharmacokinetics safety and acceptability of DRV/r for children living with HIV (UNIVERSAL2), NCT06139796. 2023. Available from: https://clinicaltrials.gov/study/NCT06139796?cond=hiv&term=universal2&intr=drv&rank=1 . [Accessed 21 Sep 2024].
Musiime V, Szubert AJ, Mujuru HA, et al. Second-line tenofovir alafenamide for children with HIV in Africa. medRxiv. 2024. https://doi.org/10.1101/2024.04.12.24304337 .
doi: 10.1101/2024.04.12.24304337
Waalewijn H, Szubert AJ, Wasmann RE, et al. First pharmacokinetic data of tenofovir alafenamide fumarate and tenofovir with dolutegravir or boosted protease inhibitors in African children: a substudy of the CHAPAS-4 Trial. Clin Infect Dis. 2023;77(6):875–82. https://doi.org/10.1093/cid/ciad267 .
doi: 10.1093/cid/ciad267 pubmed: 37315296 pmcid: 10506774
ClinicalTrials.gov. Study to evaluate emtricitabine/​tenofovir alafenamide (F/​TAF) in human immunodeficiency virus 1 (HIV-1) infected children and adolescents virologically suppressed on a 2-nucleoside/​nucleotide reverse transcriptase inhibitor (2-NRTI)-containing regimen, NCT02285114. 2024. Available from: https://www.clinicaltrials.gov/study/NCT02285114?cond=HIV&term=children%20&intr=ftc%2Ftaf&rank=5#participation-criteria . [Accessed 21 Sep 2024].
Gibas KM, Kelly SG, Arribas JR, et al. Two-drug regimens for HIV treatment. Lancet HIV. 2022;9(12):e868–83. https://doi.org/10.1016/s2352-3018(22)00249-1 .
doi: 10.1016/s2352-3018(22)00249-1 pubmed: 36309038 pmcid: 10015554
Cahn P, Madero JS, Arribas JR, et al. Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune Defic Syndr. 2020;83(3):310–8. https://doi.org/10.1097/QAI.0000000000002275 .
doi: 10.1097/QAI.0000000000002275 pubmed: 31834000
Osiyemi O, Ajana F, Bisshop F, et al. 900. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 144 weeks (TANGO Study). Open Forum Infect Dis. 2021;8(1):S541. https://doi.org/10.1093/ofid/ofab466.1095 .
doi: 10.1093/ofid/ofab466.1095 pmcid: 8644729
Llibre JM, Brites C, Cheng CY, et al. Efficacy and safety of switching to the 2-drug regimen dolutegravir/lamivudine versus continuing a 3- or 4-drug regimen for maintaining virologic suppression in adults living with human immunodeficiency virus 1 (HIV-1): week 48 results from the phase 3, noninferiority SALSA randomized trial. Clin Infect Dis. 2023;76(4):720–9. https://doi.org/10.1093/cid/ciac130 .
doi: 10.1093/cid/ciac130 pubmed: 35235656
Letang E. Effectiveness and tolerability of the 2-drug regimen dolutegravir plus lamivudine in people with HIV1: a systematic literature review of real-worl evidence from clinical practice. BHIV (British HIV Association) Spring Conference; 2022; Manchester.
Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018;391(10123):839–49. https://doi.org/10.1016/S0140-6736(17)33095-7 .
doi: 10.1016/S0140-6736(17)33095-7 pubmed: 29310899
van Wyk J, Orkin C, Rubio R, et al. Brief report: durable Suppression and Low Rate of Virologic Failure 3 Years After Switch to Dolutegravir + Rilpivirine 2-Drug Regimen: 148-Week Results From the SWORD-1 and SWORD-2 Randomized Clinical Trials. J Acquir Immune Defic Syndr. 2020;85(3):325–30. https://doi.org/10.1097/QAI.0000000000002449 .
doi: 10.1097/QAI.0000000000002449 pubmed: 32675772 pmcid: 7446981
Turkova A, Chan MK, Kityo C, et al. D3/Penta 21 clinical trial design: a randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years. Contemp Clin Trials. 2024;142: 107540. https://doi.org/10.1016/j.cct.2024.107540 .
doi: 10.1016/j.cct.2024.107540 pubmed: 38636725
Puthanakit T, Aurpibul L, Lopez M, et al. Efficacy and safety of dolutegravir/lamivudine (DTG/3TC) in antiretroviral therapy (ART)-naive adolescents living with HIV-1: DANCE Study Week 96 Results. 12th IAS Conference on HIV Science; 23-26 July, 2023; Brisbane (QLD)
Compagnucci A, Chan MK, Saidi Y, et al. Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV: week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial. EClinicalMedicine. 2023;60: 102025. https://doi.org/10.1016/j.eclinm.2023.102025 .
doi: 10.1016/j.eclinm.2023.102025 pubmed: 37304494 pmcid: 10251070
Dolutegravir plus boosted darunavir versus recommended standard-of-care antiretroviral regimens in people with HIV-1 for whom recommended first-line non-nucleoside reverse transcriptase inhibitor therapy has failed (D(2)EFT): an open-label, randomised, phase 3b/4 trial. Lancet HIV. 2024. https://doi.org/10.1016/s2352-3018(24)00089-4 .
Turkova A, White E, Mujuru HA, et al. Dolutegravir as first- or second-line treatment for HIV-1 infection in children. N Engl J Med. 2021;385(27):2531–43. https://doi.org/10.1056/NEJMoa2108793 .
doi: 10.1056/NEJMoa2108793 pubmed: 34965338 pmcid: 7614690
Transforming vision into reality: the 2024 Global Alliance progress report on ending AIDS in children by 2030. Geneva: Joint United Nations Programma on HIV/AIDS; 2024. Available from: https://www.unaids.org/sites/default/files/media_asset/transforming-vision-into-reality_en.pdf . [Accessed 21 Sep 2024].
European Medicines Agency. Vocabria (cabotegravir) [summary of product characterisics]. 2020. Available from: https://www.ema.europa.eu/en/documents/product-information/vocabria-epar-product-information_en.pdf . [Accessed 21 Sep 2024].
European Medicines Agency. Rekambys (rilpivirine) [summary of product characterisics]. 2020. Available from: https://www.ema.europa.eu/en/documents/product-information/rekambys-epar-product-information_en.pdf . [Accessed 21 Sep 2024].
US Food and Drug Administration. Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) [package insert]. Food and Drug Administration. 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf . [Accessed 21 Sep 2024].
Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. 2020;382(12):1112–23. https://doi.org/10.1056/NEJMoa1904398 .
doi: 10.1056/NEJMoa1904398 pubmed: 32130809
Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021;396(10267):1994–2005. https://doi.org/10.1016/S0140-6736(20)32666-0 .
doi: 10.1016/S0140-6736(20)32666-0 pubmed: 33308425
Orkin C, Oka S, Philibert P, et al. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021;8(4):e185–6. https://doi.org/10.1016/S2352-3018(20)30340-4 .
doi: 10.1016/S2352-3018(20)30340-4 pubmed: 33794181
Gaur AH, Capparelli EV, Calabrese K, et al. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2024;11(4):e211–21. https://doi.org/10.1016/S2352-3018(23)00300-4 .
doi: 10.1016/S2352-3018(23)00300-4 pubmed: 38538160
Gaur A, Capparelli E, Baltrusaitis K, et al. Long-acting cabotegravir plus rilpivirine in adolescents with HIV: week 24 IMPAACT 2017(MOCHA) Study. CROI; 3-6 March, 2024; Denver (CO).
ClinicalTrials.gov. Long-acting treatment in adolescents (LATA), NCT05154747. 2024. Available from: https://clinicaltrials.gov/study/NCT05154747 . [Accessed 21 Sep 2024].
ClinicalTrials.gov. Study of oral and long-acting injectable cabotegravir and rilpivirine in virologically suppressed children living with HIV-1, two to less than 12 years of age, NCT05660980. 2024. Available from:
Kityo C, Mambule IK, Musaazi J, et al. Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomised, multicentre, open-label, non-inferiority trial. Lancet Infect Dis. 2024. https://doi.org/10.1016/s1473-3099(24)00289-5 .
doi: 10.1016/s1473-3099(24)00289-5 pubmed: 38821073
Abuogi L, Oyaro P, Wakjira G, et al. HIV drug resistance patterns and characteristics associated with clinically significant drug resistance among children with virologic failure on antiretroviral treatment in Kenya: findings from the Opt4Kids randomized controlled trial. Viruses. 2023;15(10):2083. https://doi.org/10.3390/v15102083 .
doi: 10.3390/v15102083 pubmed: 37896860 pmcid: 10612029
Getaneh Y, Getnet F, Ning F, et al. HIV-1 Disease progression and drug resistance mutations among children on first-line antiretroviral therapy in Ethiopia. Biomedicines. 2023;11(8):2293.
doi: 10.3390/biomedicines11082293 pubmed: 37626789 pmcid: 10452141
Konu YR, Takassi E, Peytavin G, et al. Pharmaco-virological outcomes and genotypic resistance profiles among children and adolescents receiving a dolutegravir (DTG)-based regimen in Togo. Clin Infect Dis. 2024. https://doi.org/10.1093/cid/ciae278 .
doi: 10.1093/cid/ciae278 pubmed: 38748464
HIV drug resistance: brief report 2024. Geneva: World Health Organization; 2024. Available from: https://iris.who.int/bitstream/handle/10665/376039/9789240086319-eng.pdf?sequence=1 . [Accessed 21 Sep 2024].
Penazzato M, Townsend CL, Sam-Agudu NA, et al. Advancing the prevention and treatment of HIV in children: priorities for research and development. Lancet HIV. 2022;9(9):e658–66. https://doi.org/10.1016/S2352-3018(22)00101-1 .
doi: 10.1016/S2352-3018(22)00101-1 pubmed: 35863362
2023 WHO think tank on treatment optimization of HIV: meeting report, Seattle, Washington, United States of America, 23 February 2023. Geneva: World Health Organization; 2024. Available from: https://iris.who.int/bitstream/handle/10665/376759/9789240093386-eng.pdf?sequence=1 . [Accessed 21 Sep 2024].
Rana AI, Bao Y, Zheng L, et al. Long-acting injectable CAB/RPV is superior to oral ART in PWH with adherence challenges: ACTG A5359. CROI; 3-6 March, 2024; Denver (CO).
Sax PE, Thompson MA, Saag MS, Panel I-UTG. Updated treatment recommendation on use of cabotegravir and rilpivirine for people with HIV from the IAS-USA Guidelines Panel. JAMA. 2024;331(12):1060–1. https://doi.org/10.1001/jama.2024.2985 .
doi: 10.1001/jama.2024.2985 pubmed: 38427337
Medicines Patent Pool. Access to medicines tracker. Available from: https://medicinespatentpool.org/progress-achievements/access-to-medicines-tracker . [Accessed 21 Sep 2024].
US Food and Drug Administration. Sunlenca (lenacapavir) [package insert]. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215973s000lbl.pdf . [Accessed 21 Sep 2024].
European Medicines Agency. Sunlenca (lenacapavir) [summary of product characteristics]. 2022. Available from: https://www.ema.europa.eu/en/documents/product-information/sunlenca-epar-product-information_en.pdf . [Accessed 21 Sep 2024].
Colson A, Crofoot G, Ruane PJ, et al. Efficacy and safety of weekly islatravir plus lenacapavir in PWH at 24 weeks: a phase II study. CROI; 3-6 March, 2024. Denver (CO).
ClinicalTrials.gov. Study evaluating the safety and efficacy of islatravir in combination with lenacapavir in virologically suppressed people with HIV, NCT05052996. 2024. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05052996 . [Accessed 21 Sep 2024].
ClinicalTrials.gov. Study to compare bictegravir/​lenacapavir versus current therapy in people with HIV-1 who are successfully treated with a complicated regimen (ARTISTRY-1), NCT05502341. 2024. Available from: https://clinicaltrials.gov/study/NCT05502341 . [Accessed 21 Sep 2024].
Mounzer K, Slim J, Ramgopal M, et al. Phase II study of switch to daily BIC + LEN in individuals on a multitablet HIV treatment regimen. CROI; 3-6 March, 2024; Denver (CO).
Gandhi M, Hill L, Grochowski J, et al. Case series of people with HIV on the long-acting combination of lenacapavir and cabotegravir: call for a trial. Open Forum Infect Dis. 2024;11(4): ofae125. https://doi.org/10.1093/ofid/ofae125 .
doi: 10.1093/ofid/ofae125 pubmed: 38628952 pmcid: 11020301
Gupta SK, Berhe M, Crofoot G, et al. Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial. Lancet HIV. 2023;10(1):e15-23. https://doi.org/10.1016/S2352-3018(22)00291-0 .
doi: 10.1016/S2352-3018(22)00291-0 pubmed: 36566079
ClinicalTrials.gov. Study of bictegravir/lenacapavir in children and adolescents with HIV-1, NCT06532656. 2024. Available from: https://clinicaltrials.gov/study/NCT06532656 . [Accessed 21 Sep 2024].
European Medicines Agency. EMEA-002740-PIP01-19: paediatric investigation plan, lenacapavir 2021. Available from: https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002740-pip01-19 . [Accessed 21 Sep 2024].
Bekker LG, Das M, Abdool Karim Q, et al. Twice-yearly lenacapavir or daily F/TAF for HIV pevention in cisgender women. N Engl J Med. 2024. https://doi.org/10.1056/NEJMoa2407001 .
doi: 10.1056/NEJMoa2407001 pubmed: 39046157
Gilead (September 12, 2024). Gilead's Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada in Second Pivotal Phase 3 Trial [News Release]. Available from: https://www.gilead.com/news/news-details/2024/gileads-twiceyearly-lenacapavir-for-hiv-prevention-reduced-hiv-infections-by-96-and-demonstrated-superiority-to-dailytruvada .
Velloza J, Kapogiannis B, Bekker LG, et al. Interventions to improve daily medication use among adolescents and young adults: what can we learn for youth pre-exposure prophylaxis services? AIDS. 2021;35(3):463–75. https://doi.org/10.1097/qad.0000000000002777 .
doi: 10.1097/qad.0000000000002777 pubmed: 33252486
Molina JM, Rizzardini G, Orrell C, et al. Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial. Lancet HIV. 2024;11(6):e369–79. https://doi.org/10.1016/s2352-3018(24)00031-6 .
doi: 10.1016/s2352-3018(24)00031-6 pubmed: 38734015
Mills AM, Rizzardini G, Ramgopal MN, et al. Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial. Lancet HIV. 2024;11(6):e357–68. https://doi.org/10.1016/s2352-3018(24)00030-4 .
doi: 10.1016/s2352-3018(24)00030-4 pubmed: 38734016
Hoy J, McMahon J. Is this the end of the road for daily islatravir 0.75 mg? Lancet HIV. 2024;11(6):e346–7. https://doi.org/10.1016/s2352-3018(24)00120-6 .
doi: 10.1016/s2352-3018(24)00120-6 pubmed: 38734014
Fichtenbaum CJ, Berhe M, Bordon J, et al. Antiviral activity, safety, and pharmacokinetics of GS-1720: a novel weekly oral InSTI. CROI; 3-6 March, 2024; Denver (CO).
Gillespie G, Carstens RP, Zang X, et al. Safety and pharmacokinetics of MK-8527, a novel nRTTI, in adults without HIV. CROI; 3-6 March, 2024; Denver (CO).
US Food and Drug Administration. Rukobia (fostemsavir) [package insert]. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212950s000lbl.pdf . [Accessed 21 Sep 2024].
Rukobia (fostemsavir) [summary of product characteristics]. European Medicines Agency. 2021. Available from: https://www.ema.europa.eu/en/documents/product-information/rukobia-epar-product-information_en.pdf . [Accessed 21 Sep 2024].
Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med. 2020;382(13):1232–43. https://doi.org/10.1056/NEJMoa1902493 .
doi: 10.1056/NEJMoa1902493 pubmed: 32212519
ClinicalTrials.gov. Safety and pharmacokinetics evaluation of fostemsavir + (OBT) in HIV-1 infected children and adolescents who are failing their cART and have dual- or triple-class antiretroviral resistance, NCT04648280. 2024. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04648280 . [Accessed 21 Sep 2024].
Gaebler C, Nogueira L, Stoffel E, et al. Prolonged viral suppression with anti-HIV-1 antibody therapy. Nature. 2022;606(7913):368–74. https://doi.org/10.1038/s41586-022-04597-1 .
doi: 10.1038/s41586-022-04597-1 pubmed: 35418681 pmcid: 9177424
Vrignaud LL, Schwartz O, Bruel T. Polyfunctionality of broadly neutralizing HIV-1 antibodies. Curr Opin HIV AIDS. 2023;18(4):178–83. https://doi.org/10.1097/coh.0000000000000799 .
doi: 10.1097/coh.0000000000000799 pubmed: 37249912
Tagarro A, Domínguez-Rodríguez S, Cotton M, et al. High mortality following early initiation of antiretroviral therapy in infants living with HIV from three African countries. eClinicalMedicine. 2024. https://doi.org/10.1016/j.eclinm.2024.102648 .
doi: 10.1016/j.eclinm.2024.102648 pubmed: 39411486 pmcid: 11473196
Technau KG, Strehlau R, Patel F, et al. 12-month outcomes of HIV-infected infants identified at birth at one maternity site in Johannesburg, South Africa: an observational cohort study. Lancet HIV. 2018;5(12):e706–14. https://doi.org/10.1016/s2352-3018(18)30251-0 .
doi: 10.1016/s2352-3018(18)30251-0 pubmed: 30416043 pmcid: 6336389
Millar JR, Bengu N, Vieira VA, et al. Early initiation of antiretroviral therapy following in utero HIV infection is associated with low viral reservoirs but other factors determine viral rebound. J Infect Dis. 2021;224(11):1925–34. https://doi.org/10.1093/infdis/jiab223 .
doi: 10.1093/infdis/jiab223 pubmed: 33963757 pmcid: 8643423
Ajibola G, Maswabi K, Hughes MD, et al. Brief report: long-term clinical, immunologic, and virologic outcomes among early-treated children with HIV in Botswana: a nonrandomized controlled clinical trial. J Acquir Immune Defic Syndr. 2023;92(5):393–8. https://doi.org/10.1097/qai.0000000000003147 .
doi: 10.1097/qai.0000000000003147 pubmed: 36729692 pmcid: 10006291
Kuhn L, Strehlau R, Shiau S, et al. Early antiretroviral treatment of infants to attain HIV remission. EClinicalMedicine. 2020;18: 100241. https://doi.org/10.1016/j.eclinm.2019.100241 .
doi: 10.1016/j.eclinm.2019.100241 pubmed: 31993578 pmcid: 6978195
Lain MG, Vaz P, Sanna M, et al. Viral response among early treated HIV perinatally infected infants: description of a cohort in southern Mozambique. Healthcare (Basel). 2022;10(11):2156. https://doi.org/10.3390/healthcare10112156 .
doi: 10.3390/healthcare10112156 pubmed: 36360495 pmcid: 9691232
Amuge P, Lugemwa A, Wynne B, et al. Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial. Lancet HIV. 2022;9(9):e638–48. https://doi.org/10.1016/S2352-3018(22)00163-1 .
doi: 10.1016/S2352-3018(22)00163-1 pubmed: 36055295 pmcid: 9646993
Ateba Ndongo F, Texier G, Ida Penda C, et al. Virologic response to early antiretroviral therapy in HIV-infected infants: evaluation after 2 years of treatment in the Pediacam Study, Cameroon. Pediatr Infect Dis J. 2018;37(1):78–84. https://doi.org/10.1097/inf.0000000000001745 .
doi: 10.1097/inf.0000000000001745 pubmed: 28841582
Julg B, Stephenson KE, Wagh K, et al. Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial. Nat Med. 2022;28(6):1288–96. https://doi.org/10.1038/s41591-022-01815-1 .
doi: 10.1038/s41591-022-01815-1 pubmed: 35551291 pmcid: 9205771
Stephenson KE, Julg B, Tan CS, et al. Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial. Nat Med. 2021;27(10):1718–24. https://doi.org/10.1038/s41591-021-01509-0 .
doi: 10.1038/s41591-021-01509-0 pubmed: 34621054 pmcid: 8516645
Caskey M, Klein F, Lorenzi JC, et al. Viraemia suppressed in HIV-1-infected humans by broadly neutralizing antibody 3BNC117. Nature. 2015;522(7557):487–91. https://doi.org/10.1038/nature14411 .
doi: 10.1038/nature14411 pubmed: 25855300
Caskey M, Schoofs T, Gruell H, et al. Antibody 10–1074 suppresses viremia in HIV-1-infected individuals. Nat Med. 2017;23(2):185–91. https://doi.org/10.1038/nm.4268 .
doi: 10.1038/nm.4268 pubmed: 28092665 pmcid: 5467219
Scheid JF, Horwitz JA, Bar-On Y, et al. HIV-1 antibody 3BNC117 suppresses viral rebound in humans during treatment interruption. Nature. 2016;535(7613):556–60. https://doi.org/10.1038/nature18929 .
doi: 10.1038/nature18929 pubmed: 27338952 pmcid: 5034582
Bar KJ, Sneller MC, Harrison LJ, et al. Effect of HIV antibody VRC01 on viral rebound after treatment Interruption. N Engl J Med. 2016;375(21):2037–50. https://doi.org/10.1056/NEJMoa1608243 .
doi: 10.1056/NEJMoa1608243 pubmed: 27959728 pmcid: 5292134
Rosás-Umbert M, Gunst JD, Pahus MH, et al. Administration of broadly neutralizing anti-HIV-1 antibodies at ART initiation maintains long-term CD8(+) T cell immunity. Nat Commun. 2022;13(1):6473. https://doi.org/10.1038/s41467-022-34171-2 .
doi: 10.1038/s41467-022-34171-2 pubmed: 36309514 pmcid: 9617872
Sneller MC, Blazkova J, Justement JS, et al. Combination anti-HIV antibodies provide sustained virological suppression. Nature. 2022;606(7913):375–81. https://doi.org/10.1038/s41586-022-04797-9 .
doi: 10.1038/s41586-022-04797-9 pubmed: 35650437 pmcid: 11059968
Mendoza P, Gruell H, Nogueira L, et al. Combination therapy with anti-HIV-1 antibodies maintains viral suppression. Nature. 2018;561(7724):479–84. https://doi.org/10.1038/s41586-018-0531-2 .
doi: 10.1038/s41586-018-0531-2 pubmed: 30258136 pmcid: 6166473
Crowell TA, Colby DJ, Pinyakorn S, et al. Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet HIV. 2019;6(5):e297-306. https://doi.org/10.1016/s2352-3018(19)30053-0 .
doi: 10.1016/s2352-3018(19)30053-0 pubmed: 31000477 pmcid: 6693657
McFarland EJ, Cunningham CK, Muresan P, et al. Safety, tolerability, and pharmacokinetics of a long-acting broadly neutralizing human immunodeficiency virus type 1 (HIV-1) monoclonal antibody VRC01LS in HIV-1-exposed newborn infants. J Infect Dis. 2021;224(11):1916–24. https://doi.org/10.1093/infdis/jiab229 .
doi: 10.1093/infdis/jiab229 pubmed: 34009371 pmcid: 8643399
Shapiro RL, Ajibola G, Maswabi K, et al. Broadly neutralizing antibody treatment maintained HIV suppression in children with favorable reservoir characteristics in Botswana. Sci Transl Med. 2023;15(703): eadh0004. https://doi.org/10.1126/scitranslmed.adh0004 .
doi: 10.1126/scitranslmed.adh0004 pubmed: 37406137 pmcid: 10683791
Cunningham CK, McFarland EJ, Morrison RL, et al. Safety, tolerability, and pharmacokinetics of the broadly neutralizing human immunodeficiency virus (HIV)-1 monoclonal antibody VRC01 in HIV-exposed newborn infants. J Infect Dis. 2020;222(4):628–36. https://doi.org/10.1093/infdis/jiz532 .
doi: 10.1093/infdis/jiz532 pubmed: 31681963
Waters L, de Miguel-Buckley R, Poulin S, Arribas JR. Broadly neutralizing antibodies for human immunodeficiency virus treatment: broad in theory, narrow in reality. Clin Infect Dis. 2023;76(6):1136–41. https://doi.org/10.1093/cid/ciac835 .
doi: 10.1093/cid/ciac835 pubmed: 36303321
Alba C, Malhotra S, Horsfall S, et al. Cost-effectiveness of broadly neutralizing antibodies for infant HIV prophylaxis in settings with high HIV burdens: a simulation modeling study. medRxiv. 2023. https://doi.org/10.1101/2023.11.06.23298184 .
doi: 10.1101/2023.11.06.23298184 pubmed: 37986879 pmcid: 10659508
Dugdale CM, Ufio O, Alba C, et al. Cost-effectiveness of broadly neutralizing antibody prophylaxis for HIV-exposed infants in sub-Saharan African settings. J Int AIDS Soc. 2023;26(1): e26052. https://doi.org/10.1002/jia2.26052 .
doi: 10.1002/jia2.26052 pubmed: 36604316 pmcid: 9816086
Progress in the development of dosing strategies for pediatric populations. Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program (LEAP) Investigator Meeting and Annual Workshop; 2024; Denver (CO).
Development and acceptability of a biodegradable implant for long-acting delivery of ARVs. Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program (LEAP) Investigator Meeting and Annual Workshop; 2024; Denver (CO).
Gengiah TN, Karim QA, Lewis L, et al. Phase I safety, tolerability and pharmacokinetics of tenofovir alafenamide implants in African women. CROI Conference; 3-6 March, 2024; Denver (CO).
US Food and Drug Administration. Dolutegravir oral film, 5 mg and 10 mg [tentatively approval]. 2023. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215319Orig1s000TAltr.pdf . [Accessed 21 Sep 2024].
Bekker A, Capparelli EV, Violari A, et al. Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study. Lancet HIV. 2022;9(1):e24-31. https://doi.org/10.1016/s2352-3018(21)00266-6 .
doi: 10.1016/s2352-3018(21)00266-6 pubmed: 34883066
Bekker A, Capparelli E, Mirochnick M, et al. Lamivudine (3TC) dosing for preterm neonates exposed to HIV. CROI Conference; 3-6 March, 2024; Denver (CO).
Bekker A, Rabie H, Salvadori N, et al. Pharmacokinetics and safety of the abacavir/lamivudine/lopinavir/ritonavir fixed-dose granule formulation (4-in-1) in neonates: PETITE Study. J Acquir Immune Defic Syndr. 2022;89(3):324–31. https://doi.org/10.1097/qai.0000000000002871 .
doi: 10.1097/qai.0000000000002871 pubmed: 34855626
Bekker A, Salvadori N, Rabie H, et al. Paediatric abacavir-lamivudine fixed-dose dispersible tablets and ritonavir-boosted lopinavir granules in neonates exposed to HIV (PETITE study): an open-label, two-stage, single-arm, phase 1/2, pharmacokinetic and safety trial. Lancet HIV. 2024;11(2):e86-95. https://doi.org/10.1016/S2352-3018(23)00289-8 .
doi: 10.1016/S2352-3018(23)00289-8 pubmed: 38296364
Panjasawatwong N, Bekker A, Rabie H, et al. High drug exposures in neonates using ABC/3TC dispersible tablets during the first week of life. CROI Conference; 3-6 March, 2024; Denver (CO).
Clinicaltrials.gov. Pharmacokinetics and safety of dolutegravir in neonate (PETITE-DTG), NCT05590325. 2023. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05590325?term=petite&cond=hiv&draw=2&rank=1 . [Accessed 21 Sep 2024].
Clinicaltrials.gov. A study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1, NCT05406583. 2024. Available from: https://clinicaltrials.gov/study/NCT05406583?cond=hiv&term=Impaact%202023&rank=1 . [Accessed 21 Sep 2024].
Ruel T, Penazzato M, Zech JM, et al. Novel approaches to postnatal prophylaxis to eliminate vertical transmission of HIV. Glob Health Sci Pract. 2023;11(2): e2200401. https://doi.org/10.9745/GHSP-D-22-00401 .
doi: 10.9745/GHSP-D-22-00401 pubmed: 37116934 pmcid: 10141432
van der Wekken-Pas L, Weiss F, Simon-Zuber C, et al. Long-acting injectable cabotegravir and rilpivirine in a pregnant woman living with human immunodeficiency virus. Clin Infect Dis. 2024. https://doi.org/10.1093/cid/ciae242 .
doi: 10.1093/cid/ciae242 pubmed: 38703388
IMPAACT. IMPAACT 2040: phase I/II Pharmacokinetics and safety of long-acting injectable cabotegravir and rilpivirine in people with virally suppressed HIV-1 during pregnancy and postpartum. Available from: https://www.impaactnetwork.org/studies/impaact2040 . [Accessed 21 Sep 2024].
Penazzato M, Lewis L, Watkins M, et al. Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries. J Int AIDS Soc. 2018;21 Suppl. 1(Suppl. Suppl 1):e25049. https://doi.org/10.1002/jia2.25049 .
World Health Organization. Paediatric ARV Drug Optimization 2 meeting report, 8-9 December 2014. Available from: https://cdn.who.int/media/docs/default-source/hq-hiv-hepatitis-and-stis-library/pado2.pdf?sfvrsn=9ddd24e1_9 . [Accessed 21 Sep 2024].
World Health Organization. Paediatric ARV Drug Optimization 3 review: summary report. 2018. Available from: https://iris.who.int/bitstream/handle/10665/272292/WHO-CDS-HIV-18.8-eng.pdf?sequence=1&isAllowed=y . [Accessed 21 Sep 2024].
World Health Organization. Paediatric Antiretroviral Drug Optimization (PADO) Meeting 4; 10-12 December, 2018; Geneva.
Medicines Patent Pool. Available from: https://medicinespatentpool.org/ . [Accessed 3 Jul 2024].
US Department of Health and Human Services, editor. Pediatric HIV infection: drug product development for treatment: guidance for industry. 2019.
Rojo P, Carpenter D, Venter F, et al. The HIV drug optimization agenda: promoting standards for earlier investigation and approvals of antiretroviral drugs for use in adolescents living with HIV. J Int AIDS Soc. 2020;23(Suppl. 5): e25576. https://doi.org/10.1002/jia2.25576 .
doi: 10.1002/jia2.25576 pubmed: 32869500 pmcid: 7459170
Virtual workshop on postnatal prophylaxis to reach elimination of HIV vertical transmission: optimizing research and accelerating access to innovation, meeting report, 11 May-10 December 2021. 2022. Available from: https://iris.who.int/bitstream/handle/10665/359538/9789240052871-eng.pdf?sequence=1 . [Accessed 21 Sep 2024].
WHO Consultation of the use of broadly neutralizing antibodies for postnatal prophylaxis agains vertical transmission of HIV. Online.
Abrams EJ, Capparelli E, Ruel T, Mirochnick M. Potential of long-acting products to transform the treatment and prevention of human immunodeficiency virus (HIV) in infants, children, and adolescents. Clin Infect Dis. 2022;75(Suppl. 4):S562–70. https://doi.org/10.1093/cid/ciac754 .
doi: 10.1093/cid/ciac754 pubmed: 36410381 pmcid: 10200315
Rana A, Bao Y, Zheng L, et al. Long-acting injectable CAB/RPV is superior to oral ART in PWH with adherence challenges: ACTG A5359. CROI; 2024; Denver (CO).
Medicines Patent Pool. Prioritised medicines for MPP licensing. Available from: https://medicinespatentpool.org/progress-achievements/prioritisation . [Accessed 24 Jun 2024].
Gilead Sciences. Gilead's twice-yearly lenacapavir demonstrated 100% efficacy and superiority to daily Truvada for HIV prevention. June 20, 2024. Available from: https://investors.gilead.com/news/news-details/2024/Gileads-Twice-Yearly-Lenacapavir-Demonstrated-100-Efficacy-and-Superiority-to-Daily-Truvada-for-HIV-Prevention/default.aspx . [Accessed 21 Sep 2024].
World Health Organization. Global Accelerator for Paediatric Formulations Network (GAP-f). Available from: https://www.who.int/initiatives/gap-f . [Accessed 21 Sep 2024].
World Health Organization. Supplementary section to the 2013 WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Chapter 7: antiretroviral therapy, optimizing antiretroviral drugs for children: medium- and long-term priorities. Available from: https://cdn.who.int/media/docs/default-source/hiv-hq/arv2013_chapter7_pado1.pdf?sfvrsn=9a13e4d2_7 . [Accessed 21 Sep 2024].
Penazzato M, Townsend CL, Rakhmanina N, et al. Prioritising the most needed paediatric antiretroviral formulations: the PADO4 list. Lancet HIV. 2019;6(9):e623–31. https://doi.org/10.1016/s2352-3018(19)30193-6 .
doi: 10.1016/s2352-3018(19)30193-6 pubmed: 31498110
Lowenthal ED, Chapman J, Ohrenschall R, et al. Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study. Lancet HIV. 2024;11(4):e222–32. https://doi.org/10.1016/s2352-3018(23)00301-6 .
doi: 10.1016/s2352-3018(23)00301-6 pubmed: 38538161
US Food and Drug Administration. Vocabria (cabotegravir) [package insert]. 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212887s004lbl.pdf . [Accessed 21 Sep 2024].
Bunglawala FS, Cottura N, Montanha MC, et al. Dose optimisation of long-acting injectables in neonates via PBPK modelling. CROI; 2021; Virtual: abstract 606.
Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection. N Engl J Med. 2022;386(19):1793–803. https://doi.org/10.1056/NEJMoa2115542 .
doi: 10.1056/NEJMoa2115542 pubmed: 35544387
Khaitan A, Lindsey J, Capparelli E, et al. IMPAACT 2008: phase I/II Study of monoclonal antibody VRC01 with early antiretroviral therapy to promote clearance of HIV-1 infected cells in infants. International AIDS Conference; 29 July–2 August, 2022; Montreal (QC).
PedMAb. Pediatric monoclonal antibody. Available from: https://pedmab.samrc.ac.za/index.html . [Accessed 25 Jun 2024].
Goga A, Ramraj T, Naidoo L, et al. OA-498 PedMAb1 clinical trial: safety assessment of CAP256V2LS to prevent breastmilk HIV transmission in HIV-1 exposed uninfected neonates. BMJ Glob Health. 2023;8(Suppl. 10):A16-17. https://doi.org/10.1136/bmjgh-2023-EDC.38 .
doi: 10.1136/bmjgh-2023-EDC.38
IMPAACT. IMPAACT 2037: open-label, phase I study of the safety and pharmacokinetics of PGT121.414.LS alone and in combination with VRC07-523LS in infants exposed to HIV-1. Available from: https://www.impaactnetwork.org/studies/impaact2037 . [Accessed 21 Sep 2024].
IMPAACT. IMPAACT 2039: phase I/II study of the safety, immunogenicity, and efficacy of HIVconsvX vaccines and broadly neutralizing antibodies in children living with HIV. Available from: https://www.impaactnetwork.org/studies/impaact2039 . [Accessed 21 Sep 2024].
Capparelli EV, Ajibola G, Maswabi K, et al. Safety and pharmacokinetics of intravenous 10–1074 and VRC01LS in young children. J Acquir Immune Defic Syndr. 2022;91(2):182–8. https://doi.org/10.1097/qai.0000000000003033 .
doi: 10.1097/qai.0000000000003033 pubmed: 36094485 pmcid: 10224771
US Food and Drug Administration. Retrovir (zidovudine) [package insert]. 1994. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf . [Accessed 21 Sep 2024].
Department of Health and Human Services. Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. Department of Health and Human Services. 2023. Available from: https://clinicalinfo.hiv.gov/en/guidelines/perinatal . [Accessed 18 Jun].
US Food and Drug Administration. Isentress (raltegravir) [package insert]. 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_Isentress.cfm . [Accessed 21 Sep 2024].
Department of Health and Human Services. Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. 2023. Available from: https://clinicalinfo.hiv.gov/en/guidelines/perinatal . [Accessed 18 Jun 2024].
US Food and Drug Administration. Kaletra (lopinavir/ritonavir) [package insert]. 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf . [Accessed 21 Sep 2024].
Department of Health and Human Services. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available from: https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv . [Accessed 18 Jun 2024].
US Food and Drug Administration. Emtriva (emtricitabine) [package insert]. 2003. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf . [Accessed 21 Sep 2024].
Department of Health and Human Services. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Department of Health and Human Services. Available from: https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv . [Accessed 18 Jun 2024].
US Food and Drug Administration. Selzentry (maraviroc) [approval package]. 2007. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022128_selzentry_toc.cfm . [Accessed 21 Sep 2024].
Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Department of Health and Human Services. Available from: https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv . [Accessed 18 Jun 2024]. [page L-178].
US Food and Drug Administation. Epivir (lamivudine) [package insert]. 1995. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf . [Accessed 21 Sep 2024].
Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. Department of Health and Human Services. 2023. Available from: https://clinicalinfo.hiv.gov/en/guidelines/perinatal . [Accessed 18 Jun 2024]
US Food and Drug Administration. Viramune (nevirapine) [package insert]. 1996. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf . [Accessed 21 Sep 2024].
US Food and Drug Administration. Ziagen (abacavir sulfate) [package insert]. 2015. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf . [Accessed 21 Sep 2024].

Auteurs

Anne E M Kamphuis (AEM)

Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands. Anne.Kamphuis@radboudumc.nl.

Alasdair Bamford (A)

Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.
Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, London, UK.

Alfredo Tagarro (A)

Fundación de Investigación Biomédica Hospital 12 de Octubre, Instituto de Investigación 12 de Octubre (imas12), Madrid, Spain.
Department of Pediatrics, Infanta Sofía University Hospital, Fundación para la Investigación Biomédica e Innovación, Hospital Universitario Infanta Sofía y Hospital del Henares (FIIB HUIS HHEN), Madrid, Spain.
Universidad Europea de Madrid, Madrid, Spain.

Tim R Cressey (TR)

AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.

Adrie Bekker (A)

Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.

Pauline Amuge (P)

Baylor College of Medicine Children's Foundation-Uganda, Kampala, Uganda.
Joint Clinical Research Centre, Kampala, Uganda.

Hilda Angela Mujuru (HA)

Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.

Francis Ateba Ndongo (FA)

Day Care Unit, Chantal Biya Foundation, Yaounde, Cameroon.

Aminata Diack (A)

Pediatric HIV Care Unit, Centre Hospitalier National d'enfants Albert Royer, Dakar Réseau EVA, Dakar, Senegal.

Alexandra Compagnucci (A)

French National Institute of Health and Medical Research (INSERMSC10-US19-Clinical trials and Infectious Diseases), Villejuif, Paris, France.

Marc Lallemant (M)

AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.

Angela Colbers (A)

Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.

Anna Turkova (A)

Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.
Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, London, UK.

Classifications MeSH