Gilead Sciences, Inc. is pleased to announce two public-private partnerships. The first will accelerate the development of an investigational dispersible pediatric formulation containing emtricitabine and tenofovir alafenamide (F/TAF). The second aims to develop investigational pediatric formulations of TAF and sofosbuvir (SOF) designed to eliminate bitterness.
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead is partnering with the Clinton Health Access Initiative (CHAI) and the Penta ID network, a scientific organization dedicated to child health research, to accelerate the development, regulatory approval and commercialization of a dispersible, fixed-dose combination treatment for the treatment of children with HIV who weigh at least 3 kg and live in low- and middle-income countries (LMICs). This regimen will include Gilead’s products F/TAF. Under the terms of the agreement, Gilead will provide a technology transfer of currently available data for a dispersible formulation of F/TAF and supporting pharmacokinetic (PK) data. Penta, within the UNIVERSAL project which is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), will develop PK modelling and clinical studies for the investigational combination formulation, and CHAI, with support from global health agency Unitaid, will be responsible for the global access strategy in collaboration with two generic manufacturers.
It is estimated that globally 1.7 million children under the age of 15 live with HIV. However, just over 50% of them are on antiretroviral treatment compared to 76% of adults living with HIV on treatment today. Many LMICs have a high burden of mother-to-child transmission and the prevalence of HIV among children remains high.
Gilead is also partnering with Monell Chemical Senses Center (Monell), Eurofins’ Translational Cell Models group (formerly known as DiscoveryBiomed, Inc. (DBM)) and CHAI to identify bitter blockers for pediatric formulations of the medications TAF and SOF. Identifying bitter blockers for these medications may help to improve adherence to medication among children. Pediatricians, caregivers, industry and global health donors all acknowledge that bitter taste in medication for children, who are particularly sensitive to bitterness, can contribute to low adherence rates, which in turn increase the potential for morbidities and mortality in young patients. Once candidate bitter blockers are confirmed, the partners will then work together to see these agents move on to product development and eventual introduction, if approved.
This partnership brings a unique approach to a challenging problem. The work will leverage Monell’s deep knowledge of human taste biology and novel human taste cell culture technology that was developed in collaboration with Eurofins’ Translational Cell Models group. Eurofins’ Translational Cell Models group are experts in human tissue-derived cell-based assays. The collaboration between Monell and Eurofins’ Translational Cell Models group, with support from the Bill and Melinda Gates Foundation and the National Institutes for Health, has showed that their approach leads to a reliable and efficient screening platform for discovering bitter blockers.
These efforts are aligned with the WHO-led Global Accelerator for Pediatric Formulation (GAP-f) and the HIV and Hepatitis C WHO-led PAediatric Drug Optimization (PADO) groups. Collectively, GAP-f and the PADO processes aim to implement universal health coverage by accelerating the development of better medicines for children who need them. As such, their goals are to prioritize and align partners and then facilitate all efforts to identify better and pediatric appropriate fixed-dose combinations that reduce pill burden, promote treatment adherence and simplify treatment administration to babies and children.
“Pediatric HIV remains a serious global health challenge. By working together with these key partnerships and combining our respective expertise, we can get closer to ending this epidemic for everyone, everywhere,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “By developing medicine formulations that meet the needs of children, and by improving palatability, through these partnership, we have the ability to potentially increase adherence rates in children. This collaboration, along with the recent launch of Gilead’s Pediatric Centre of Excellence in Dublin, reflects our deep commitment to the discovery and development of urgently needed treatment options for children living with HIV and other viral infections across the world.”