PrEP Medication Donated to the CDC for 200,000 Patients a Year

Gilead Sciences has agreed to donate to the CDC emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets (Truvada) for pre-exposure prophylaxis (PrEP) for use by up to 200,000 individuals each year, for up to 11 years.^1-2

The agreement between the US Department of Health and Human Services (HHS) and Gilead will last until at least December 31, 2025, and possibly through December 31, 2030. This action will provide medication to treat individuals who are at risk for HIV and who are uninsured.^1-2

“We are proud to partner with CDC to dramatically expand access to medication that can help prevent new HIV infections,” Gregg Alton, chief patient Officer of Gilead Sciences, said in a statement.² “We believe today’s donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia, and transphobia, can play an important role in ending the HIV epidemic in the United States, particularly in parts of the country with the highest burden of disease.”

PrEP has been shown to reduce the risk of new HIV infection by up to 97% when taken consistently by patients at risk.²

Gilead’s emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets carries a list price of more than $20,000 per patient per year, to up to 200,000 people per year, according to HHS.¹

The federal government has agreed to cover costs associated with distributing the drugs.

Funds in fiscal 2020 budget have been allocated to efforts to help end the HIV epidemic, according to HHS.¹

The agreement with Gilead is a major step in the Trump administration’s efforts to use prevention and treatment tools available for ending the HIV epidemic in the United States by 2030, according to HHS Secretary Alex M. Azar II,

HHS worked with Gilead to secure PrEP for individuals who might not otherwise have access to or be able to afford it, Azar said.¹

“The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication. This agreement will help close that gap substantially and deliver on President Trump’s promise to end the HIV epidemic in America,” he said in a statement.¹

When it becomes available, Gilead’s emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets (Descovy) will be donated in place of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets. ¹

Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets are indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative and weigh ≥35 kg.¹

Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets are approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥25 kg and is not approved for PrEP anywhere globally. The use of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets for an HIV PrEP indication is investigational and has not been determined to be efficacious or safe.¹

The agreement between the CDC and Gilead would end either after 11 years or when a generic version of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets becomes commercially available.¹

References

• Trump administration secures historic donation of billions of dollars in HIV prevention drugs [news release]. Washington, DC; May 9, 2019: HHS.gov website. hhs.gov/about/news/2019/05/09/trump-administration-secures-historic-donation-of-billions-of-dollars-in-hiv-prevention-drugs.htmlAccessed May 10, 2019.
• Gilead Sciences to provide free Truvada for PrEP® to support U.S. initiative to end the HIV epidemic [news release]. Foster City, CA; May 9, 2019: Gilead. gilead.com/news-and-press/press-room/press-releases/2019/5/gilead-sciences-to-provide-free-truvada-for-prep-to-support-us-initiative-to-end-the-hiv-epidemic. Accessed May 10, 2019.