On May 27, 2024, the results of the Early Anti-Retroviral Treatment in Children (EARTH) study on HIV-related events was published in eClinical Medicine, part of THE LANCET Discovery Science.
The EARTH paediatric clinical study was carried out in the context of the EPIICAL project, a large research consortium coordinated by Penta ID Network and funded by ViiV Healthcare.
The study, in which our researcher Viviana Giannuzzi advised on the ethics and regulatory issues, examined the long-term HIV-related events in more than 200 infants who acquired HIV at birth and started antiretroviral therapy early in three African countries (Mali, Mozambique and South Africa).
The EARTH study highlights a serious problem: a significant number of children still die within the first three years of life, even when antiretroviral therapy is started early.
Despite monitoring at two, six, 12, and 24 weeks after enrollment and every six months thereafter for up to four years, the study revealed alarming rates of mortality, loss to follow-up, and suboptimal virologic suppression, particularly in the first six months of life.
The study shows that infants with perinatally acquired HIV, despite early initiation of antiretroviral therapy, face a high risk of death in their first few months. The risk is higher in those who are disadvantaged by a high viral load at baseline in a suboptimal health care system, along with adverse social events among caregivers. These factors lead to a downward spiral of poor treatment adherence, lack of virologic suppression, immunosuppression, and death. Interventions should focus on strengthening health systems, reducing viral load at baseline, and providing strong health and social support to the mother and child during pregnancy and the early years of the child's life.
The study is available for free here.