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Analytical treatment interruption in children living with HIV: position statement from the EPIICAL consortium
Louise Kuhn1, Shaun Barnabas2, Nicola Cotugno3
1Gertrude 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.
Insights
Analytical treatment interruption (ATI) is safe and useful in children for HIV cure research. Early antiretroviral therapy (ART) in infants improves chances of long-term viral control without ART.
Area of Science:
- Pediatric Infectious Diseases
- HIV Cure Research
- Clinical Trials
Background:
- Analytical treatment interruption (ATI) is crucial for HIV cure studies but primarily researched in adults.
- Limited data exists on the safety and efficacy of ATI in pediatric populations.
Purpose of the Study:
- To review evidence on the safety and utility of ATI in children.
- To assess the potential of ATI in advancing pediatric HIV cure research.
Main Methods:
- Review of three randomized ATI trials in children.
- Analysis of CD4 T-cell counts and clinical criteria for antiretroviral therapy (ART) re-initiation.
- Evaluation of neurocognitive outcomes and virological/immunological parameters.
Main Results:
- ATI demonstrated low risks in pediatric participants, with reassuring neurocognitive findings.
- Early ART in infants was associated with smaller viral reservoirs and enhanced immune responses.
- Several cases of durable ART-free viral control were observed in early-treated children.
Conclusions:
- ATI should be integrated into pediatric HIV cure research where feasible and ethically appropriate.
- Including children in ATI trials is vital for expanding the evidence base and accelerating access to potential interventions.
- Pediatric participants may gain the most benefit from ART-free viral control strategies.
Abstract:
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.
