Friday, July 14, 2023
Gilead Sciences, is excited to announce two new partnerships aimed at accelerating the development of pediatric HIV treatments and improving medication formulations.
In the first partnership, Gilead is collaborating with the Clinton Health Access Initiative (CHAI) and the Penta ID network to fast-track the development, regulatory approval, and commercialization of a dispersible pediatric formulation containing emtricitabine and tenofovir alafenamide (F/TAF). This formulation is specifically designed for children weighing at least 3 kg and living in low- and middle-income countries (LMICs). Gilead will provide the necessary data for the dispersible formulation, while Penta will conduct PK modeling and clinical studies. CHAI, in collaboration with generic manufacturers and with support from global health agency Unitaid, will be responsible for the global access strategy.
The second partnership involves Gilead, Monell Chemical Senses Center, Eurofins' Translational Cell Models group, and CHAI, with the aim of identifying bitter blockers for pediatric formulations of TAF and sofosbuvir (SOF). Bitter taste in medications can pose challenges for children and impact adherence rates. By finding bitter blockers, the partnership seeks to improve medication compliance. The collaboration will work on identifying these blockers and advancing them through product development and potential approval.
These partnerships align with the Global Accelerator for Pediatric Formulation (GAP-f) and the HIV and Hepatitis C WHO-led PAediatric Drug Optimization (PADO) groups, which focus on developing better medicines for children and achieving universal health coverage. The objective is to prioritize efforts in creating pediatric-appropriate fixed-dose combinations that reduce pill burden, enhance treatment adherence, and simplify administration.
Jared Baeten, MD, PhD, Vice President of HIV Clinical Development at Gilead Sciences, emphasized the company's commitment to addressing pediatric HIV through these partnerships. The aim is to increase adherence rates in children by developing formulations that meet their needs and improve palatability. These collaborations, coupled with the recent launch of Gilead's Pediatric Centre of Excellence in Dublin, reflect the company's dedication to discovering effective treatment options for children living with HIV and other viral infections worldwide.