The United States Food and Drug Administration (FDA) has approved a new antiretroviral formulation that can be mixed with food, making it easier for children living with HIV to take their life-saving medicines, the Joint UN Programme on HIV/AID (UNAIDS) and the UN Children’s Fund (UNICEF) announced today.
“Treatment innovations such as this that replace unpleasant and bad tasting medicines are a real breakthrough, accelerating access to treatment for children and keeping our youngest healthy,” said Executive Director of UNAIDS, Michel Sidibé. “It is unacceptable that only 24 per cent of children living with HIV have access to antiretroviral medicines,” he added.
Manufactured by Indian generic medicines manufacturer CIPLA, the oral pellets contain an antiretroviral formulation of lopinavir and ritonavir that can be mixed into a child’s food, the joint press release explains.
The treatment is heat stable and more palatable than medicines currently available, making it particularly suitable for treating very young children.
“This new formulation is a step in the right direction towards saving more lives of children living with HIV,” said Craig McClure, UNICEF’s Chief of HIV/AIDS section. “We expect it to greatly improve treatment access for many more children and support UNICEF’s equity focused programming aimed at reaching the most disadvantaged children throughout the world.”
HIV infection progresses rapidly in children and, in highly impacted countries, is a major contributor to child morbidity and mortality. Without treatment, one in three children who become infected with HIV will die before their first birthday. Half will die before their second birthday.
Early initiation of antiretroviral treatment in children substantially reduces the risk of death. Many countries have not been able to fully implement this World Health Organization (WHO) recommendation because of the challenge of not having a more appropriate, heat stable and palatable paediatric formulation of lopinavir/ritonavir used as part of the treatment options for children under 3 years of age.
Despite global efforts to accelerate access to HIV paediatric care and treatment, fewer than 800,000 of the 3.2 million children living with HIV worldwide had access to antiretroviral medicines in 2013.