Global Alliance for Pediatric Therapeutics (GAPT)

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IPI is looking for partner organizations to join the Global Alliance for Pediatric Therapeutics (GAPT). We recognize the manifold difficulties of administering medications to children, and we are working to address those difficulties. The primary focus of GAPT is pediatric HIV and developing new antiretroviral therapy (ART) formulations. In partnering with HIV-focused organizations and other collaborators, IPI is creating a safe haven for collaboration between organizations and with other stakeholders free of anti-trust and compliance constraints. Partners can pool resources, expertise, and technology for the benefit of children worldwide.

The Burden of Pediatric HIV

An estimated 1.8 million children were living with HIV in 2015, with 87% of those living in sub-Saharan Africa. While adults may live for years without symptoms or complications, children's developing immune systems make them especially vulnerable to other infections, such as tuberculosis and cholera, which they may not normally contract. Although huge strides have been made in getting ART to HIV patients, less than half of children worldwide receive the essential medications, with numbers as low as 20% in some parts of sub-Saharan Africa. About half of HIV-positive children who do not receive ART will die before their second birthday, and 80 percent by their fifth.

While social and cultural barriers prevent many people from accessing HIV patients from accessing and adhering to ART, specific challenges face children and their caregivers. Children may be averse to taking their medications every day, especially if they are in the form of pills or unpleasant tasting syrups. In fact, per WHO pediatric ART guidelines, "It is of critical importance to conduct studies to explore improved and safer [drug] formulations…that provide highly effective and well-tolerated drugs in formulations that are palatable and suitable, particularly for administration to newborns, as well as infants and young infants." In limited-resource areas, access to pediatric formulations may not be available, in which case smaller doses of adult medication are required, making over- or underdosing more likely.

Additionally, some HIV medications require cold-chain storage until administration, while others require potable water. But many people in low-resource settings lack access to refrigeration, and 35% of the world’s population lacks access to potable water.

IPI's Response

In a separate initiative, Pfizer has developed a multiparticulate (MP) pediatric drug formulation that addresses medicine administration factors for children in low-resource global health settings. Pfizer has been openly sharing this technology platform with others to encourage greater implementation of the approach. IPI and Pfizer have recently been collaborating on an open innovation challenge to identify delivery systems that might work with the MP platform. MP drug formulations are particularly well-suited for pediatric ART administration and adherence in low-resource settings because:

  • The technology can be applied to the active ingredients of almost any drug.
  • Drugs formulated as MP powders can be combined to form homogenous mixtures, allowing the administration of multiple drugs in any ratio or dosage.
  • MP powder flows as easily as a liquid and with a similar mouth feel, is tasteless, and can be mixed with any food or liquid or administered directly
  • MP powders are lightweight, inexpensively transported, stable in warm and moist environments, and do not depend on a cold chain or potable water.
  • The technology can be applied to existing generic and proprietary compounds; as new ART is developed and validated, they, too, can be formulated with MP technology

Now IPI has created GAPT to collaborate with experts in the pediatric HIV field to identify first-line and second-line ART drugs for MP reformulation. With this new technology, we look to improve access and adherence to ART throughout the world, but especially in those parts of sub-Saharan Africa that are hardest hit.