Access Strategy for Investigational Long-Acting HIV Pre-Exposure Prophylaxis (PrEP) in High-Incidence, Resource-Limited Countries (Contingent on regulatory approval)

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Despite decades of progress, the world is still far from stopping the spread of HIV. We’re committed to doing our part to end the epidemic – especially in areas with the greatest need.
We understand that long-acting HIV PrEP options are critical for people around the world who need alternative choices to reduce their chances of acquiring HIV. We’ve conducted Phase 3 studies of an investigational long-acting PrEP option to help address this need.
We’re committed to achieving broad, sustainable access to long-acting HIV PrEP in high-incidence, resource-limited countries – primarily low- and lower-middle-income countries.

We'll support access to our long-acting PrEP, if approved, in high-incidence, resource-limited countries through a two-part strategy:

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Voluntary Licensing to Generic Companies

We’ve signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers for them to make and sell generic versions of long-acting PrEP, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries. The generic companies that will manufacture and supply long-acting PrEP to the 120 countries are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris. The agreements were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic long-acting PrEP, if approved.

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Direct Provision by Gilead

Our direct voluntary licensing agreements will enable supply of generic versions of long-acting PrEP to all 120 countries. Our licensees will build manufacturing capacity as quickly as possible. This process will take time, and we are committed to providing Gilead-supplied long-acting PrEP (if approved), until generic versions are available. To ensure that we are addressing the areas with the greatest need, we are prioritizing registration in 18 countries that represent 70% of the HIV burden of the 120 countries named in the agreements. These countries are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.

Our strategy reflects input from more than 100 global health stakeholders. Through these discussions, four essential priorities have consistently emerged: delivering long-acting PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability and in coordination with partners on the ground. These priorities are guiding every step of our strategy.

Our History of Supporting Global Access to Medicines

We’re proud of our two decades of innovation and leadership in global access to medicines. Our partnerships with generic drug manufacturers have helped enable millions of people to benefit from high-quality, low-cost therapies for HIV, viral hepatitis and COVID-19.

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8.1 Million

Individuals received COVID-19 treatment to date through voluntary licensing

2.9 Million

HCV treatments manufactured by voluntary licensees to date

20 Million

HIV and HBV treatments made by generic drug manufacturers made available by voluntary licensees in 2023

In total, more than 30 million treatments for HIV, HBV, HCV and COVID-19 have been made available in low- and middle-income countries as a result of partnerships with generic licensees, government and NGOs.

Latest news on our investigational long-acting PrEP and statements on our proposed access strategy

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