Scientific Innovation

First Deliveries of Gilead's Twice-Yearly HIV Prevention Therapy in Sub-Saharah Africa - and What it Means for Ending the HIV Epidemic

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Nearly 20 years ago, Gilead scientists began a search of a new way to help prevent HIV, ultimately synthesizing and screening 4000 molecules, developing a formulation that could be given just twice a year, and conducting the most representative global clinical trial program for HIV prevention ever. The result is an innovative HIV pre-exposure prophylaxis (PrEP) option.

This week, Gilead Chairman and Chief Executive Officer, Daniel O’Day, and I were on hand with our partners as we delivered the first shipments of our twice-yearly HIV prevention medicine to Eswatini and Zambia. For the very first time, a new HIV medicine is reaching communities in sub-Saharan Africa in the same year as its approvals in the U.S. and the European Union. It was an incredibly meaningful moment and an opportunity to reflect on all the efforts to make this moment a reality.

The story of this HIV prevention therapy is one of determined innovation: from groundbreaking medicinal chemistry and virology to the PURPOSE clinical trial program, which spans five continents. It was intentionally designed to reflect the broadest possible spectrum of geography, race, ethnicity, gender and age. Years of deep engagement and partnership with advocates, clinicians, scientists and policymakers guided us all along the way, aiming to make a new PrEP option that could have a meaningful impact for people and communities.

I’ve dedicated my career to ending HIV around the world and have been a part of the development of every approved PrEP option. This novel option can be discretely given twice a year and has the potential to overcome obstacles that make the use of other PrEP options challenging for many people. The PURPOSE program incorporated learnings from 20 years of PrEP research, with a clinical trial program reflecting the global nature of PrEP needs and the inclusion of adolescents and pregnant and lactating women.

When the PURPOSE 1 and 2 data were released in 2024, they supported what so many had long hoped for — that a twice-yearly PrEP option could be both highly effective and be considered for a broad population. From that moment, our focus was singular: work urgently, collaboratively and transparently to help provide a therapy that can reach the people who need it most.

Before the first regulatory filing, we entered into voluntary, royalty-free licensing agreements with generics manufacturers to enable broad access in 120 primarily low- and lower-middle-income countries. To bridge the period before generics are available we guaranteed a dedicated supply of our HIV prevention therapy at no profit for at least two million people in those countries over the next three years, and we partnered with the Global Fund and PEPFAR to deliver the supply.

Being on hand to see the first shipment arrive in Eswatini was incredibly meaningful. The country has the highest prevalence of HIV in the world and has been a leader in HIV testing and treatment access. Hearing the excitement this week from community members, clinicians and policymakers about the therapy’s potential was emotionally powerful. Twenty years of relentless science was all to get to this moment.

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These deliveries are the first result of years of sustained commitment from regulators, global aid partners, community organizations, trial participants, advocates and Gilead teams across the world. Every one of them helped turn scientific evidence into access – at a pace we’ve never seen before in HIV prevention.

Later in the week, we visited a PURPOSE trial site in South Africa and talked with implementation scientists about work starting up to understand how best to deliver the HIV prevention therapy at scale, and sat down with youth advocates to talk about next steps for HIV prevention. The momentum is incredible and a testament to years of working in partnership.

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And this is only the beginning. By the end of this year, we will complete regulatory submissions in 18 countries where roughly 70% of new HIV infections occur. We expect our twice-yearly HIV medication to arrive in other parts of sub-Saharan Africa in 2026, including South Africa, which has the largest burden of HIV in the world.

As we continue building toward broader availability, our guiding principles remain unchanged: listen closely, partner widely and move urgently so long-acting HIV prevention options can reach everyone who needs it. This week helps us move  a step closer to ending the HIV epidemic for everyone, everywhere.

Jared Baeten is Senior Vice President, Clinical Development, Virology Therapeutic Area Head at Gilead.

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