As a pioneer and leader in antiviral drug development, Gilead developed the first approved antiviral medicine for the treatment of COVID-19. Building on more than three decades of resources and research, we were able to quickly demonstrate its effectiveness and ramp up production to help reduce the burden of the pandemic.
Today, this therapy has been made available to millions of people around the world and is considered an antiviral standard of care for the treatment of COVID-19 – helping both hospitalized and non-hospitalized adult and pediatric patients to recover faster. It also continues to retain activity in vitro against SARS-CoV-2 as it evolves, including recent Omicron sub-variants of concern.
As we continue to research options to address unmet needs in COVID-19, we also have a dedicated team researching other emerging viruses and antiviral therapeutics to ensure we are well placed to respond to emerging and future viral threats.
Developing Urgently Needed Treatments
When a new pneumonia-like illness was identified as a novel coronavirus in December 2019, Gilead moved quickly to determine if our expertise in virology and experience studying coronaviruses could play a role.
The research that led to our medicine began in 2009 as a potential treatment option for hepatitis C. We continued to explore various uses for the compound, and in 2013 we identified its activity against coronaviruses. This medicine is a nucleotide analog that directly inhibits viral replication inside of the cell of SARS-CoV-2 by targeting the viral RNA polymerase.
Given the uncertain trajectory of the pandemic and the possibility that future variants may develop resistance to one or more of the currently authorized treatments, there remains a significant need to develop convenient oral formulations to expand treatment options for patients. We remain committed to studying our novel investigational oral COVID-19 antiviral. The clinical program for our oral antiviral has been expedited directly to Phase 3 based on Phase 1 results, guidance from regulatory bodies and the current unmet patient need. When designing these studies, we strive to ensure clinical trial enrollment includes outpatient populations that span geographies and patient types, so our studies reflect the population at risk.
Delivering at Speed and Scale
Since 2020, we’ve invested significantly in establishing a supply chain capable of producing our COVID-19 medicine at a large scale.
The production of this medicine is a long, complex process that requires specialized manufacturing capabilities. We knew rapidly producing large quantities of drug supply in an emergency situation like the COVID-19 pandemic would be a challenge, so we worked early on, before any clinical trials had started, to procure a steady flow of raw materials that helped accelerate large-scale production by Gilead and our partners.
We have also worked to shorten the manufacturing timeline. Typically, manufacturing a medicine like this at scale would take nine to 12 months; we have reduced that to six to eight months. We continue to work on process improvements to accelerate product delivery and volume.
We’ve worked with equal urgency to make our medicine as broadly available as possible and help reduce the global burden of the pandemic. To date, we have donated nearly two million vials of our medicine globally and made a generic version available in 127 low- or middle-income countries through our voluntary licensing agreements. We also provided our licensing partners with technical assistance and manufacturing support to rapidly scale production.
Partnering with the Community
We recognize the pandemic has taken a major toll on the wellbeing of both individuals and their communities. We have engaged with patients, communities and organizations to address the broader impact of this pandemic through actions and initiatives such as:
- Creating the global CARES Grantee Fund, which provided $20 million to nonprofits facing imminent closure or termination of vital services due to COVID-19.
- Establishing a Patient Council comprised of people with diverse perspectives and COVID-19 experiences. The Patient Council helps us understand and address the unmet needs of people impacted by this virus and informs education efforts on the impact of COVID-19 using plain language.
- Collaborating with the Morehouse School of Medicine’s Satcher Health Leadership Institute and Google.org to develop the Health Equity Tracker (HET), a first-of-its-kind, public-facing data platform that displays and contextualizes health disparities facing communities of color throughout the United States, with an initial focus on COVID-19. Read more about this work.
Our partners are essential to the communities we serve, now more than ever, and we look forward to our continued collaboration to help improve access to care by eliminating barriers and advancing education.