GILEAD SCIENCES POLICY POSITION - Pre-Exposure Prophylaxis (PrEP) for HIV Prevention

Sep 27, 2026

Uploaded by Oliver

Gilead Sciences outlines its policy position on pre-exposure prophylaxis (PrEP) for HIV prevention, centered on Truvada for a PrEP indication. It summarizes key milestones in U.S. approval, emphasizes Truvada’s role as part of a broader prevention strategy, and cites CDC and WHO guidance targeting individuals and key populations at substantial risk. The statement describes supporting clinical trial evidence, real-world research commitments, and implementation guidance on eligibility, adherence, HIV-negative confirmation, and ongoing monitoring. It also explains Gilead’s support for safe uptake and access programs, and notes additional regulatory approvals.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages2

Reading Time5 min

AccessFree to download

Key points

Approval and prevention strategy context

Research in support of PrEP

Public health guidance on implementation

Gilead’s role

Additional regulatory approvals

GILEAD SCIENCES POLICY POSITION Pre-Exposure Prophylaxis (PrEP) for HIV Prevention Key points: • In July 2012, Gilead’s Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) became the first antiretroviral product to be approved in the United States for use in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in uninfected adults at high risk – a strategy called pre-exposure prophylaxis (PrEP) . • Truvada for a PrEP indication is not intended to replace other prevention tools such as condoms, but when taken as directed and used in combination with other prevention strategies, Truvada for a PrEP indication has demonstrated the potential to help reduce new HIV infections. • The U.S. Centers for Disease Control and Prevention (CDC) recommends Truvada for a PrEP indication for individuals at substantial risk for contracting HIV. • The World Health Organization (WHO)“strongly recommends” that men who have sex with men (MSM) consider taking PrEP as an additional prevention strategy. • Gilead is helping to ensure that Truvada for a PrEP indication is implemented safely and effectively. Globally, more than two million adults became infected with HIV in 2014, and in the United States the number of new infections – some 50,000 annually – has not declined significantly in more thana decade.1 Pre-exposure prophylaxis (PrEP) is the use of antiretroviral medication by HIV-negative individuals to stay uninfected. It is a prevention strategy that has been shown to be effective in clinical trials in reducing the risk of contracting HIV when it is adhered to correctly. Research in Support of PrEP Gilead is committed to developing strategies that prevent the transmission of HIV and continues to support ongoing research and demonstration projects to evaluate the effectiveness of Truvada for a PrEP indication in real-world settings. Support for the U.S. Food and Drug Administration’s approval of Truvada for a PrEP indication came from two large-scale clinical trials:2 iPrEx, conducted by the U.S. National Institutes of Health among men who have sex with men, and Partners PrEP, conducted by the University of Washington among heterosexual couples. Both studies found that for HIV-negative individuals taking Truvada the risk of HIV infection was reduced. Gilead donated study drug for PrEP clinical trials and assisted the researchers with medical and clinical information about Truvada. Public Health Guidance on Implementation WHO, CDC and the U.S. Panel of the International Antiviral (formerly AIDS) Society (IAS) have all issued public health guidance on PrEP. CDC’s final guidance, released in May 2014, recommends PrEP for individuals at substantial risk for contracting HIV.3 The guidance advises physicians and healthcare providers on how to assess and identify individuals who may be appropriate candidates for PrEP, based on their reported risk behaviors. It also provides guidance on how to support adherence to PrEP among individuals taking Truvada, because it is essential that people take the medication on a daily basis if it is to be effective asan HIV prevention tool. CDC also stresses that PrEP is not for everyone – it should be targeted to individuals at substantial risk for HIV infection and carefully monitored by a physician. It is critical that people using PrEP be confirmed to be HIV-negative prior to use and on an ongoing basis. In July 2014, WHO released consolidated prevention guidelines for key populations at greatest risk for HIV infection, including MSM. In the updated guidelines, WHO for the first time “strongly recommends” that MSM consider taking PrEP as an additional method of preventing HIV, along with the use of condoms. WHO estimates that PrEP could achieve a 20- to 25-percent reduction in new HIV infections among MSM globally over 10 years, averting one million new infections.4 Also in July 2014, the U.S. Panel of the IAS published clinical practice gui

FAQs

What does the document say about Truvada’s purpose in PrEP?

Truvada for a PrEP indication is not intended to replace other prevention tools such as condoms. When taken as directed and used alongside other prevention strategies, it has demonstrated potential to help reduce new HIV infections.

Which organizations provide public health guidance mentioned in the statement?

The document states that WHO, CDC, and the U.S. Panel of the International Antiviral Society (formerly IAS) have issued public health guidance on PrEP.

How does the guidance describe selecting and monitoring candidates for PrEP?

CDC’s guidance recommends PrEP for individuals at substantial risk and advises assessment based on reported risk behaviors. It stresses that PrEP is not for everyone, requires confirmation of HIV-negative status prior to use and on an ongoing basis, and emphasizes adherence to daily dosing.

Sep 27, 2026

Uploaded by Oliver