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Today, Gilead celebrates one year since the U.S. Food and Drug Administration’s approval of the company’s twice-yearly HIV prevention medication. For more than 35 years, Gilead has been a pioneer in virology and has helped transform the treatment and prevention landscape in HIV. Thanks in large part to the company’s work, HIV has evolved from what was once considered a life-threatening disease into a treatable and preventable condition.
Nearly 20 years ago, Gilead scientists began a search of a new way to help combat HIV, ultimately synthesizing and screening 4,000 molecules before 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 was an innovative HIV pre-exposure prophylaxis (PrEP) optionthat’s now been available for one year in the U.S.
Before the first regulatory filing, Gilead 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, the company committed to a dedicated supply of our HIV prevention medication at no profit for up to three million people in those countries over the next three years, and we partnered with the Global Fund and PEPFAR to deliver the supply.
In the past year, Gilead’s innovative PrEP option has also been approved by regulatory authorities in the European Union (EU) (with applicability across the European Economic Area) and the United Kingdom, as well as in a number of other countries globally, where the need is greatest.
Last November, the company’s HIV prevention medication was delivered to Eswatini and Zambia- marking the first-time that a new HIV medicine reached communities in sub-Sarahan Africa within the same year as approvals in the U.S. Gilead’s Chairman and Chief Executive Officer, Daniel O’Day was on hand then, as well as when it arrived in South Africa earlier this month.
Within this year, the company’s innovative therapy has also been approved in Australia, Brazil, Botswana, Canada, Kenya, Malawi, Mozambique, Namibia, Rwanda, Saudi Arabia, Tanzania, the United Arab Emirates, Uganda, and Zimbabwe. Regulatory filings are also currently underway in nearly a dozen more nations.
Gilead knows that scientific innovation alone can’t end the epidemic. Stigma, inequities, access and barriers to care must also be addressed. That’s why the company also partners alongside various communities and organizations around the world to meet people where they are to help close these gaps in care. Together, these efforts are how Gilead hopes to move closer to ending the HIV epidemic.