Washington, D.C.--June 8, 2015-- The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) applauds the announcement of tentative approval by the U.S. Food and Drug Administration of a new antiretroviral treatment (ART) formulation that will make it easier for children living with HIV to ingest their medication. The oral pellets, manufactured by Indian generic medicines manufacturer CIPLA, contain an antiretroviral formulation of lopinavir and ritonavir (LPV/r) that can be mixed into a child's food.
The treatment is heat-stable and more palatable than medicines currently available, making it particularly suitable for treating very young children. Previously, the only available version of this combination treatment was a harsh-tasting syrup that required refrigeration and contained 40 percent alcohol.
"Children living with HIV have unique treatment needs that require innovations such as these oral pellets," said Stephen Lee, M.D., vice president of program implementation and country management at EGPAF. "This new formulation represents a critical step in the effort to close the treatment gap for children living with HIV and ensure that these children will survive to see the world's first AIDS-free generation."
Children have been left behind in the global effort to scale up treatment for HIV/AIDS, with only one quarter of the 3.2 million children living with HIV able to access ART. Without treatment, half of all children living with HIV will die by age 2, and 80 percent will die before their fifth birthday.
This formulation will help achieve the World Health Organization (WHO)'s guidelines which recommend immediate initiation of ART for all HIV-positive children younger than 5 years. It also aligns with key goals outlined by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) to improve pediatric HIV treatment, including the Accelerating Children's HIV/AIDS Treatment Initiative and the Global Pediatric ARV Commitment to Action.
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About the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF):
EGPAF is the global leader in the fight against pediatric HIV/ AIDS and has reached more than 20 million women with services to prevent transmission of HIV to their babies. It currently supports more than 7,000 health facilities and works in 15 countries to implement prevention, care, and treatment services; to further advance innovative research; and to execute global advocacy activities that bring dramatic change to the lives of millions of women, children, and families worldwide. For more information, visit http://www.pedaids.org.