Analytical treatment interruption in children living with HIV: position statement from the EPIICAL consortium,The Lancet HIV

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Analytical treatment interruption in children living with HIV: position statement from the EPIICAL consortium
The Lancet HIV ( IF 12.8 ) Pub Date : 2024-07-23 , DOI: 10.1016/s2352-3018(24)00157-7
Louise Kuhn ₁ , Shaun Barnabas ₂ , Nicola Cotugno ₃ , Holly Peay ₄ , Philip Goulder ₅ , Mark Cotton ₂ , Avy Violari ₆ , Savita Pahwa ₇ , Kavidha Reddy ₈ , Alfredo Tagarro ₉ , Kennedy Otwombe ₆ , Samantha Fry ₂ , Paula Vaz ₁₀ , Maria Grazia Lain ₁₀ , Tacilta Nhampossa ₁₁ , Moherndran Archary ₁₂ , Almoustapha Issiaka Maiga ₁₃ , Thanyawee Puthanakit ₁₄ , Cissy M Kityo ₁₅ , Caroline Foster ₁₆ , Pablo Rojo ₁₇ , Nigel Klein ₁₈ , Eleni Nastouli ₁₉ , Caroline T Tiemessen ₂₀ , Anita de Rossi ₂₁ , Thumbi Ndung'u ₂₂ , Deborah Persaud ₂₃ , Mathias Lichterfeld ₂₄ , Carlo Giaquinto ₂₅ , Paolo Palma ₃ , Paolo Rossi ₃ ,

Affiliation

Gertrude H Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, NY, USA.
Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Academic Hospital, Cape Town, South Africa.
Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy; Department of Systems Medicine, Tor Vergata University of Rome, Rome, Italy.
RTI International, Durham, NC, USA.
Department of Paediatrics, University of Oxford, Oxford, UK; HIV Pathogenesis Programme, Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; Africa Health Research Institute, Durban, South Africa; Ragon Institute of MGH, MIT and Harvard, Boston, MA, USA.
Perinatal HIV Research Unit, Chris Hani Baragwanath Academic Hospital, Faculty of Health Sciences, University of the Witwatersrand, Soweto, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Department of Microbiology and Immunology, University of Miami Miller School of Medicine, Miami, FL, USA.
Africa Health Research Institute, Durban, South Africa.
Fundación de Investigación Biomédica, Hospital 12 de Octubre, Instituto de Investigación 12 de Octubre, Madrid, Spain; Department of Pediatrics, Infanta Sofía University Hospital, Fundación para la Investigación Biomédica e Innovación Hospital Universitario Infanta Sofía y Hospital del Henares, Madrid, Spain; Universidad Europea de Madrid, Madrid, Spain.
Fundação Ariel Glaser contra o SIDA Pediátrico, Maputo, Mozambique.
Centro de Investigação em Saúde de Manhiç, Maputo, Mozambique.
Africa Health Research Institute, Durban, South Africa; Department of Paediatrics and Department of Infectious Diseases, University of KwaZulu Natal, Durban, South Africa.
Department of Medical Biology, CHU Gabriel Toure, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali.
Department of Pediatrics and Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Joint Clinical Research Centre, Kampala, Uganda.
Department of Paediatric Infectious Diseases, Imperial College Healthcare NHS Trust, London, UK.
Universidad Complutense Madrid, Hospital 12 de Octubre, Instituto de Investigación 12 de Octubre, Madrid, Spain.
Africa Health Research Institute, Durban, South Africa; Infection, Immunity and Inflammation, UCL Great Ormond Street Institute of Child Health, London, UK.
Department of Infection, Immunity and Inflammation, UCL Great Ormond Street Institute of Child Health, University College London, London, UK.
Centre for HIV and STIs, National Institutes of Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Department of Surgery, Oncology and Gastroenterology, Section of Oncology and Immunology, University of Padua, Padua, Italy.
HIV Pathogenesis Programme, Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; Africa Health Research Institute, Durban, South Africa; Ragon Institute of MGH, MIT and Harvard, Boston, MA, USA; Division of Infection and Immunity, University College London, London, UK.
Johns Hopkins University School of Medicine; Department of Pediatrics, Division of Infectious Diseases, Baltimore, MD, USA.
Ragon Institute of MGH, MIT and Harvard, Boston, MA, USA; Infectious Disease Division, Brigham and Women's Hospital Harvard, Cambridge, MA, USA.
Department of Women's and Children's Health, University of Padua, Padua, Italy.

Analytical treatment interruption (ATI) is widely acknowledged as an essential component of studies to advance our understanding of HIV cure, but discussion has largely been focused on adults. To address this gap, we reviewed evidence related to the safety and utility of ATI in paediatric populations. Three randomised ATI trials using CD4 T-cell and clinical criteria to guide restart of antiretroviral therapy (ART) have been conducted. These trials found low risks associated with ATI in children, including reassuring findings pertaining to neurocognitive outcomes. Similar to adults treated during acute infection, infants treated early in life have shifts in virological and immunological parameters that increase their likelihood of achieving ART-free viral control. Early ART limits the size and diversity of the viral reservoir and shapes effective innate and HIV-specific humoral and cellular responses. Several cases of durable ART-free viral control in early treated children have been reported. We recommend that, where appropriate for the study question and where adequate monitoring is available, ATI should be integrated into ART-free viral control research in children living with HIV. Paediatric participants have the greatest likelihood of benefiting and potentially the most years to prospectively realise those benefits. Excluding children from ATI trials limits the evidence base and delays access to interventions.

中文翻译：

HIV 感染儿童的分析性治疗中断：EPIICAL 财团的立场声明

分析性治疗中断（ATI）被广泛认为是促进我们对 HIV 治愈的理解的研究的重要组成部分，但讨论主要集中在成年人身上。为了解决这一差距，我们评价了与 ATI 在儿科人群中的安全性和实用性相关的证据。已经进行了 3 项使用 CD4 T 细胞和临床标准指导重新开始抗逆转录病毒治疗（ART）的随机 ATI 试验。这些试验发现儿童 ATI 相关风险较低，包括与神经认知结果相关的令人放心的发现。与急性感染期间接受治疗的成人类似，在生命早期接受治疗的婴儿病毒学和免疫学参数发生变化，这增加了他们实现无 ART 病毒控制的可能性。早期 ART 限制了病毒库的大小和多样性，并塑造了有效的先天性和 HIV 特异性体液和细胞反应。据报道，在早期治疗儿童中，有几例持久的无 ART 病毒控制病例。我们建议，在适合研究问题且有充分监测的情况下，应将 ATI 整合到 HIV 感染儿童的无 ART 病毒对照研究中。儿科受试者最有可能受益，并且可能最有可能前瞻性地实现这些益处。将儿童排除在 ATI 试验之外会限制证据基础并延迟获得干预措施的机会。

更新日期：2024-07-23

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