An international team led by the Global Pediatric Infectious Diseases Innovation Group at the public University Hospital 12 de Octubre, in collaboration with research centers in Europe and Africa, has demonstrated that a treatment based on the administration of valganciclovir can significantly reduce child mortality from pneumonia in infants with HIV.
The results of the EMPIRICAL clinical trial (https://www.empiricaledctp.eu) represent a major medical breakthrough and could offer a lifeline for many children suffering from this disease, especially in numerous African countries, where severe pneumonia in this patient profile is the leading cause of death.
The EMPIRICAL project – Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia – funded by the European Union (EDCTP2) and carried out in Côte d’Ivoire, Uganda, Malawi, Mozambique, Zambia, and Zimbabwe, is the first global clinical trial to assess the benefits of empirical treatment against cytomegalovirus (CMV) using valganciclovir, and against tuberculosis (TB) using anti-tuberculosis drugs, in infants living with HIV and suffering from severe pneumonia.
The trial results, presented this Monday at the International AIDS Society (IAS) World Conference held in Rwanda, showed that adding valganciclovir syrup to the standard antibiotic treatment for pneumonia significantly reduced mortality at 15 days of treatment. In contrast, empirical treatment with tuberculosis drugs did not show a reduction in mortality.
Nevertheless, both treatments proved to be safe, with no increased toxicity observed in the children who received them.
The study was coordinated by Drs. Pablo Rojo, Cinta Moraleda, and Alfredo Tagarro of the Global Pediatric Infectious Diseases Innovation Group at Hospital 12 de Octubre.
“This finding represents a milestone in the fight against HIV-related child mortality. The World Health Organization (WHO) is already reviewing these results to decide whether to officially recommend the use of valganciclovir in all children under one year of age living with HIV who present with severe pneumonia and advanced disease,” said Dr. Rojo, who believes that “this measure could transform pneumonia treatment protocols for children in high-burden, resource-limited countries.”