476. Gilead Sciences’ Commitment to the COVID-19 Pandemic

Abstract

Background: COVID-19 has spread rapidly: from the first case in Dec 2019, the declaration of a global pandemic in Mar 2020, to Jun 18, 2020 with >8 M confirmed cases and >400,000 deaths worldwide. Throughout this rapid spread, Gilead has focused on contributing antiviral expertise and resources to help patients (pts) and communities fighting COVID-19 Methods: Gilead is supporting the efforts of governments, partnering with professionals, and community-based org., and collaborating with healthcare providers to accelerate research and access to remdesivir (RDV), the first medicine with demonstrated efficacy in treatment of COVID-19. This is a review of the programs initiated in RDV research, access, research grants and collaborative education Results: In Jan 2020 Gilead began working with government and regulatory authorities to make RDV accessible to pts globally through the compassionate use and expanded access programs. These programs has treated >2000 COVID-19 pts. By Feb 2020, several phase 3 randomized trials on RDV were initiated. Based on trials completed and published data (n= >2000), RDV was granted emergency use authorization in the US on May 1, 2020 with full approval in 5 countries thereafter and several under review elsewhere. Collectively there will be >12,000 pts enrolled in RDV clinical programs by Dec 2020. Increasing manufacturing of RDV began at-risk in Jan 2020. By May 2020 Gilead has decreased production time, increased supply and committed to donating all its 1.5 M doses. Under the licensing agreements with generic drug manufacturers, RDV will be available in 127 countries upon approval. Gilead has committed to supporting research grants to enhance the understanding of the clinical course and outcomes in vulnerable population, long-term sequelae, and evaluate real world safety and effectiveness of COVID-19 therapies. Finally, Gilead has provided corporate grants to support the efforts of community-based orgs and public health entities to expand education on COVID-19 Conclusion: Gilead has initiated a global, multifaceted rapid response that reflects the unprecedented emergency posed by SARS-COV-2. This includes increasing RDV production, access, timely initiation of phase 3 RDV trials, and establishment of grants programs for community projects, research and education.