EARTH study reveals high mortality rates among infants with HIV despite early treatment 

24 May, 2024

Padova, Italy – 24 May 2024

Alarmingly high mortality rates persist for African infants with HIV despite early treatment, the Early Anti-Retroviral Treatment in Children (EARTH) study finds. The study (funded by ViiV Healthcare and sponsored by Penta), published in eClinical Medicine, reports that a significant number of children still die within the first three years of life, even when antiretroviral therapy (ART) is initiated early. 

According to UNICEF estimates from 2022, an alarming 2.58 million children aged between 0-19 globally are living with HIV, with a staggering 85% residing in Africa. While children only make up 6.6% of the global population living with HIV, they tragically account for 16% of HIV-associated deaths. Current guidelines strongly advocate for rapid HIV diagnosis and early ART initiation for all infants. However, the reality falls short, with only 57% of children receiving ART compared to a much higher rate of 77% for adults. This significant gap highlights the need for improved access to early diagnosis and treatment services for children. 

Part of a larger research effort called EPIICAL (Early Treated Perinatally HIV Infected Individuals: Improving Children’s Actual Life) designed to identify potential participants for future HIV cure research, the EARTH study, examined the long-term health of over 200 infants in Mali, Mozambique, and South Africa who acquired HIV at birth and began early ART.  

The infants were monitored and tested for HIV within 6 weeks of birth, started on ART immediately after a positive confirmation and enrolled in the study. The infants were closely followed through check-ups at 2, 6, 12, and 24 weeks after enrolment, followed by biannual visits for up to four years. Additionally, the mothers of the infants received comprehensive healthcare services, including routine check-ups, programs to prevent vertical transmission, and were themselves receiving ART.  

Following the four-year follow-up of the children, the EARTH study found that the risk of death remained concerning throughout the first three years of life. While 10% of infants on ART died within the first year of life, the risk of death increased to 12% and remained so at the second-and third-year mark of the study.  

The study identified several factors associated with a higher risk of death from HIV-related complications: infants with higher levels of HIV virus in their bodies at birth (baseline viral load) had a greater risk of death.  Participant adherence to ART medication was suboptimal, and less than half of the children maintained undetectable levels of the virus throughout the study due to factors like high baseline viral load and social problems faced by the mother. Other factors that increased the chance of mortality and poor control of the virus included, disadvantaged settings, or being born female.  

Alfredo Tagarro, EARTH cohort lead, states that “These findings reflect the still sad and often forgotten reality of infants born with HIV, and should prompt health professionals, researchers and policy-makers to find better ways to help this vulnerable population.” 

While significant progress has been made, infants with HIV in Africa still face significant challenges and the EARTH study calls for a multifaceted approach to improve their lives. Firstly, strengthening healthcare systems is essential to ensure that these children have access to high-quality medical care and early diagnosis of HIV. Secondly, reducing a mother’s viral load before or shortly after birth is crucial as a higher viral load increases the risk of transmission to the baby.  Interventions aimed at achieving this goal need to be prioritised. Thirdly, the study emphasises the importance of comprehensive support throughout pregnancy and early childhood, including social and healthcare support for both mothers and infants. Finally, exploring new approaches like long-acting ART or broadly neutralizing antibodies is vital to achieve earlier viral suppression in these vulnerable children. 

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Notes for editors 

About EPIICAL 

EPIICAL is a research consortium funded by ViiV Healthcare and led by Penta. The EPIICAL consortium comprises 27 African and European institutions, namely; Penta Foundation, Ospedale Pediatrico Bambino Gesù, University College London, Hospital 12 de Octubre, Hospital General Universitario Gregorio Marañón, Imperial College Health Care, University of Miami, Università degli Studi di Padova, University of Stellenbosch, Africa Health Research Institute, John Hopkins University, Utrecht University, Fondazione Gianni Benzi Onlus, University of Massachusetts, Università degli Studi di Roma Tor Vergata, University of Columbia, Perinatal HIV Research Unit, Fundação Ariel Glaser,Centro de investigação de Saúde de Manhiça, Barcelona Institute for Global Health, Boston Children’s Hospital, Umkhuseli Innovation and Research Management RF NPC, Brigham Women’s Hospital, RTI International, Centre hospital universitaire Gabriel Touré, Joint Clinical Research Centre, Chulalongkorn University. 

www.epiical.org 

About Penta – Child Health Research 

Penta is an international independent scientific network dedicated to advancing research on optimising the prevention, diagnosis and treatment of infectious diseases in children and in pregnancy. With over 110 centres in 31 countries, Penta collaborates to develop and deliver world-class research and training, ultimately improving the lives of women and children worldwide.  Penta’s portfolio includes investigations into HIV and other viral infections, severe sepsis and antimicrobial resistance, infections in pregnancy and neglected and emerging childhood infections. To date, Penta has sponsored 33 clinical trials, which have involved with more than 50,000 women and children. 

www.penta-id.org