Press Releases
June 04, 2024
MEDIA UPDATE: Gilead Sciences Advances Enrollment in Collaborative Studies to Assess Twice-Yearly HIV Prevention Option for Both Cisgender Women in the U.S. and People Who Inject Drugs in the U.S.
– The studies, conducted in partnership with the U.S. National Institutes of Health and the HIV Prevention Trials Network, are evaluating the potential of lenacapavir as a twice-yearly prevention option for people who could benefit from pre-exposure prophylaxis (PrEP) –
FOSTER CITY, Calif. – Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company is advancing enrollment in two groundbreaking collaborative studies to evaluate the tolerability of an investigational long-acting HIV prevention option in groups of people in the United States who are disproportionately affected by HIV but who are often underrepresented in HIV clinical trials.
The Phase 2 studies, PURPOSE 3 (HPTN-102, NCT06101329) and PURPOSE 4 (HPTN-103, NCT06101342), are part of Gilead’s PURPOSE program. The PURPOSE program, which also includes two ongoing Phase 3 clinical trials, is assessing the potential of twice-yearly subcutaneous injections of lenacapavir to help a diverse range of people around the world who could benefit from HIV-
1 pre-exposure prophylaxis (PrEP). PURPOSE 3/HPTN-102 is enrolling cisgender women in the U.S. who are disproportionately affected by HIV, with a focus on Black women and other women of color. PURPOSE 4/HPTN-103 is enrolling people in the U.S. who inject drugs.
The studies, sponsored and funded by Gilead, are being implemented through the HIV Prevention Trials Network (HPTN). HPTN is supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.
“HIV prevention is only effective when people are able to access and adhere to the prevention methods that fit within their lives, and a twice-yearly subcutaneous injectable could be an important option for some people for whom existing PrEP modalities—for varying reasons—are not feasible. Gilead is proud to partner with NIH, HPTN and members of communities across the U.S. on these important studies, recognizing that lenacapavir for PrEP, if deemed safe and effective, could potentially help more people, in more populations, prevent HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “These collaborations are a vital part of Gilead’s vision and commitment to developing innovative, person-centric options that help contribute to our goal of ending the HIV epidemic for everyone, everywhere—including helping the U.S. move closer toward achieving the goals of the Ending the HIV Epidemic in the U.S. initiative.”
According to the U.S. Centers for Disease Control and Prevention (CDC), 18% (6,666) of new HIV diagnoses in the U.S. in 2021 were among cisgender women. More than half (54%) of those diagnoses were among Black/African American women, and 18% were among Hispanic/Latina women. PrEP uptake among women in the U.S. has so far lagged behind uptake among men: According to preliminary CDC data, only 15% of women in the U.S. who could benefit from PrEP were prescribed it in 2022, compared with 41% of men who could benefit from PrEP.
“Ending the HIV epidemic means ending it for everyone—including and especially women, who are often underrepresented in HIV research and clinical trials and whose need for new HIV prevention options is critical. This is particularly true for women of color, who bear a disproportionate burden of new HIV infections and who often face structural barriers that can inhibit uptake and adherence to available PrEP methods,” said PURPOSE 3/HPTN-102 protocol chair Shobha Swaminathan, MD, Professor of Medicine and Director of HIV Services at Rutgers New Jersey Medical School. “This collaborative study is an important milestone in HIV prevention research and, if the results are positive, could help provide an additional PrEP option to a number of women across the U.S. that may fit into their lifestyles.”
PURPOSE 3/HPTN-102 was also led by protocol co-chair Ada Adimora, MD, MPH, the Sarah Graham Kenan Distinguished Professor of Medicine at the University of North Carolina School of Medicine and Professor of Epidemiology at the UNC Gillings School of Global Public Health. Dr. Adimora passed away on January 1, 2024. “Dr. Adimora dedicated her life to shining a light on the societal barriers facing many people—especially women of color—who are affected by HIV, as well as helping them overcome those barriers to help them live healthier lives,” said Myron “Mike” Cohen, MD, Co-Principal Investigator of the HPTN and the Director of the UNC Institute for Global Health and Infectious Diseases. “PURPOSE 3/HPTN-102 is already an important part of her legacy.”
The first participants in PURPOSE 3/HPTN-102 were enrolled at a site at the University of California San Diego led by Jill Blumenthal, MD, an Associate Professor of Medicine at UCSD and also a principal investigator for Gilead’s pivotal PURPOSE 2 clinical trial, which is assessing the potential of lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in seven countries around the world. “If our collective goal is to end the HIV epidemic for everyone, everywhere, we need to include as many different populations in HIV prevention studies as possible,” Blumenthal said. “The diversity of locations and populations is a hallmark of Gilead’s PURPOSE program, and I’m thrilled that Gilead is now able to include cisgender women and people who inject drugs in the U.S. in its PURPOSE 3/HPTN-102 and PURPOSE 4/HPTN-103 trials.”
In addition to focusing on cisgender women, reaching people who inject drugs will be critical to ending the HIV epidemic. According to CDC data, more than 2,500 people who inject drugs were diagnosed with HIV in 2021, comprising about 7% of total diagnoses in the U.S. Among this group, PrEP uptake has been severely limited: A July 2022 JAMA Network Open study showed that, between 2010-2019, fewer than 1 in 500 people who inject drugs had pharmacy claims for PrEP.
“The vast majority of people in the U.S. who inject drugs are not taking advantage of current PrEP options, signaling that we must identify more appropriate HIV prevention solutions for them,” said PURPOSE 4/HPTN-103 investigator Sally Hodder, MD, Director of the West Virginia Clinical & Translational Science Institute at West Virginia University. “PURPOSE 4 is the first trial to evaluate a long-acting PrEP modality in this disenfranchised and commonly overlooked population. Findings from this trial could be critical to advancing the Ending the HIV Epidemic in the U.S. initiative.”
About Gilead’s PURPOSE program
PURPOSE 3/HPTN-102 and PURPOSE 4/HPTN-103 are part of Gilead’s PURPOSE program, which is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. The pivotal trials for the PURPOSE program are PURPOSE 1 and 2. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.
PURPOSE 1 (NCT04994509) is evaluating lenacapavir for PrEP and emtricitabine/tenofovir alafenamide (F/TAF) for PrEP in cisgender adolescent girls and young women ages 16-25 in South Africa and Uganda. This pivotal registrational trial completed full enrollment in late 2023, and results are expected in the second half of 2024.
PURPOSE 2 (NCT04925752) is assessing lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the U.S. This pivotal registrational trial completed enrollment in late 2023, and results are expected in late 2024/early 2025.
PURPOSE 5 will assess the persistence—defined as consistent and continuous use—of lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people who may benefit from PrEP and who are not currently taking PrEP in France and the United Kingdom. Enrollment will begin in 2024.
Additional information about the PURPOSE program can be found at www.purposestudies.com.
About Gilead
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.
Learn more about Gilead’s unique collaborations worldwide and the work to help end the global HIV epidemic.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 3 and PURPOSE 4); the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com.
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