Lenacapavir Sodium

– New Data from PURPOSE Trials Further Demonstrate that Lenacapavir (Yeztugo ® ) was Effective and Well Tolerated Across a Broad Range of Populations, Including Pregnant and Lactating Women, Adolescents and Young People – – Data Also Showed Twice-Yearly Injectable PrEP was Preferred vs. Daily Oral Medication Among PURPOSE Trial Participants – – Gilead’s Research Presentations and Community Events at IAS Reflect Commitment to Partnerships in Developing Person-Centered Options for a Diverse Range of Populations – FOSTER CITY, CA, USA I July 14, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Gilead researchers and collaborators will present new Phase 3 PURPOSE trial data at IAS 2025 showing that twice-yearly lenacapavir (Yeztugo ® ) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention, including pregnant and lactating women, adolescents and young people, and supports lenacapavir dosing recommendations for people in special situations, such as those taking medication to treat tuberculosis (TB) and other conditions. Researchers will also present new quantitative and qualitative data showing that participants in both Phase 3 PURPOSE trials indicated a preference for twice-yearly PrEP injections over daily oral medication. The new data, from the company’s pivotal Phase 3 PURPOSE 1 ( NCT04994509 ) and PURPOSE 2 ( NCT04925752 ) trials that assessed the efficacy and safety of twice-yearly Yeztugo for PrEP, will be presented via poster sessions and during a Yeztugo-dedicated oral session at the International AIDS Society (IAS) 2025, the 13 th IAS Conference on HIV Science in Kigali, Rwanda on Thursday, July 17. The data presentations come less than a month after the U.S. Food and Drug Administration (FDA) approved Yeztugo as the first and only twice-yearly HIV prevention option. The data underscore Gilead’s focus on intentional inclusion in the PURPOSE program to ensure broad and robust population data at the trials’ primary analyses, as well as spotlight the community and organizational collaborations that guided the trial design and implementation process. “It’s a thrill to be back in Kigali with so many of the community, advocacy and research partners who helped make PURPOSE the most intentionally inclusive HIV prevention trial program ever conducted,” said Moupali Das, Vice President of Clinical Development, HIV Prevention & Pediatrics at Gilead Sciences. “As the first and only twice-yearly PrEP option, Yeztugo continues to demonstrate efficacy and tolerability among diverse populations, and we’re excited to highlight new data on this breakthrough HIV prevention option here at IAS 2025.” Yeztugo was Efficacious and Well Tolerated in Trials Among Pregnant and Lactating Women, Adolescents and Young People, and Can Be Administered in People Receiving Treatment for TB and Other Conditions Pregnant and lactating women—who face a heightened likelihood of acquiring HIV—have historically been excluded from HIV prevention trials. Based on input from community meetings in locations including Kigali, Gilead ensured that pregnant and lactating women were included in the Phase 3 PURPOSE 1 trial, which evaluated twice-yearly Yeztugo in cisgender women and adolescent girls in Sub-Saharan Africa. PURPOSE data presented at IAS 2025 show that Yeztugo was efficacious in pregnant and breastfeeding or lactating women, with no new cases of HIV reported among 184 participants in the Yeztugo group (there were a total of 509 pregnancies among 487 participants in PURPOSE 1). Data also show that Yeztugo was well tolerated by these women, that there were similar safety profiles between pregnant and non-pregnant women, and that there were no clinically significant differences in predicted Yeztugo exposure by pregnancy trimester or postpartum status. Additionally, exposure in breastfed infants was minimal. Young people aged 16-25 years are also at an increased likelihood of experiencing HIV acquisition globally, but, like pregnant women, are often not proactively included in Phase 3 HIV prevention trials. Gilead intentionally included this population in the PURPOSE 1 trial and the PURPOSE 2 trial, which evaluated twice-yearly Yeztugo among a broad and geographically diverse range of cisgender men and gender-diverse people. Data presented at IAS 2025 show that Yeztugo was efficacious in people aged 16-25 years, with zero reported HIV infections in young people receiving Yeztugo in PURPOSE 1 and two HIV infections among young people in PURPOSE 2. Additionally, there were no clinically significant pharmacokinetic differences between the 16-25-year-old group and adults aged over 25 years. Yeztugo was well tolerated across both trials among participants of all ages, with no new safety concerns identified. Globally, those at higher likelihood of HIV acquisition may also be vulnerable to TB, which can be treated by rifamycin-class drugs including rifampin and rifabutin. Yeztugo is a substrate of CYP3A, and strong CYP3A inducers such as rifampin, or moderate inducers such as rifabutin, may potentially lower Yeztugo plasma concentrations. Gilead will present modeling data showing supplemental Yeztugo dosing for strong and moderate CYP3A inducers to allow people receiving Yeztugo to receive rifamycin-containing TB treatment, if necessary. Yeztugo is also a moderate inhibitor of CYP3A and could theoretically increase levels of drugs such as statins for lowering cholesterol or PDE5 inhibitors for treating erectile dysfunction; dosing recommendations for these special situations will also be reviewed. Preference for Twice-Yearly Prevention Option Over Daily Oral PrEP New qualitative and quantitative self-reported data from PURPOSE 1 and PURPOSE 2 show significant preference for twice-yearly injectable PrEP compared with daily oral PrEP among study participants. More than 75% of study participants who were surveyed preferred twice-yearly injectable administration; of these, more than 50% reported a strong preference. Reasons given for favoring twice-yearly injectable PrEP versus daily oral PrEP include feeling more protected from HIV (69%) and feeling more confident about not missing a dose (77%). “Certain groups—including pregnant and lactating women, adolescents and young people—are disproportionately affected by HIV, yet have long been underrepresented in HIV clinical trials,” said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and former President of the International AIDS Society. “The PURPOSE program set a new standard for innovative, intentional inclusion by ensuring we would have safety and efficacy data in these populations from the outset. The results not only show that Yeztugo provides strong protection against HIV and was well tolerated in these groups, but also highlight the critical need for PrEP options that reflect people’s preferences—reducing barriers to uptake and helping close persistent gaps in prevention.” Continued Global Regulatory Filings for Lenacapavir for PrEP, as Well as Milestone Partnerships On June 18, 2025, Gilead received FDA approval for Yeztugo as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. Gilead has also submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA), both of which the EMA has validated and will review under an accelerated assessment timeline. Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil , Canada, South Africa and Switzerland. Additionally, now that lenacapavir has received FDA approval for PrEP, Gilead is preparing additional filings in countries that rely on stringent regulatory authority approvals for regulatory submission, including Argentina, Mexico and Peru. Gilead will continue to share updates on additional regulatory filings. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. Last week, Gilead announced a strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria to supply enough doses of lenacapavir, at no profit to Gilead, to reach up to two million people over three years in countries supported by the Global Fund and that are included in Gilead’s voluntary licensing agreements for lenacapavir . There is currently no cure for HIV or AIDS. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning , for Yeztugo. About the PURPOSE Program Gilead’s landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of the, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com . About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.” U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. 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 13 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 has been recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences 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, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. SOURCE: Gilead Sciences

KIGALI, RWANDA — Weeks after the FDA’s watershed approval of Gilead’s twice-yearly HIV prevention injection, the World Health Organization recommended the product to further stop the spread of HIV. The WHO on Monday added Gilead Sciences’ lenacapavir to its HIV PrEP guidelines as part of a highly anticipated announcement at the International AIDS Society Conference on HIV Science, taking place in Rwanda. The WHO’s presentation was over-attended, with more than 250 IAS attendees filtering into a second room to watch the livestream. “While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” WHO Director-General Tedros Adhanom Ghebreyesus said in a press release. The WHO’s decision arrives at a time when governments around the world are struggling to ramp up HIV prevention. The number of new HIV diagnoses worldwide remained stable from 2023 to 2024. But the inclusion of lenacapavir, which is marketed in the US as Yeztugo, in the guidelines is particularly notable following the Trump Administration’s major funding cuts to government programs like PEPFAR, which has long provided resources to help implement treatment and prevention tools in more than 50 countries . The WHO guidelines team first met to discuss lenacapavir for PrEP in January, Michelle Rodolph, a WHO technical officer on HIV prevention, said during the IAS presentation. WHO isn’t the first organization to recommend the injection, but its global reach means its recommendation carries weight. The International Antiviral Society–USA Panel announced its support for lenacapavir PrEP in December , based on Phase 3 trial results presented earlier that year. At the IAS conference, one of the field’s most prominent gatherings for HIV science, leaders hailed the importance of lenacapavir. But they also noted that innovation in PrEP must be coupled with new ways to get those therapies to the public, particularly in hard-to-reach areas. Giving people a choice in therapies is also key now that there are multiple PrEP injectables and pills to choose from. “This does not mean that all PrEP options need to be available. This is not feasible in all countries,” Rodolph said during her presentation. “What is important is choice because what we’ve seen through some data recently shown in South Africa is that when people have a choice of prevention options, there is a greater uptick of PrEP” use. The guidelines for lenacapavir are a full-circle moment for Moupali Das, VP of clinical development and leader of Gilead’s HIV prevention trials. The last time Das was in Kigali, in 2019, she and other Gilead executives met with a wide range of stakeholders, including community activists, trial investigators and ministries of health, to gather intel about how to design the pivotal PURPOSE trials for lenacapavir, Das said in an interview at IAS. This included discussions about enrolling pregnant and lactating people and younger populations. The global health authority’s decision came at breakneck speed compared to its past recommendations for other PrEP products like ViiV Healthcare’s cabotegravir and the daily pills that have been available for more than a decade. “We need to be pushing each other and holding each other accountable. We also have to celebrate the successes when we get them, because they come too rarely in our field,” said Mitchell Warren, executive director of the nonprofit AVAC, during an IAS session on Monday morning. Two injections a year is a major departure from the every-other-month injectable from ViiV and daily pills. So far, it’s only been approved by the FDA. Gilead has forged agreements with six generic manufacturers and the Global Fund to eventually roll out the PrEP option in low- and middle-income countries. Gilead said Monday that the European Medicines Agency is reviewing lenacapavir under an “accelerated assessment timeline,” which includes an application with “EU-Medicines for all.” That program allows the EU to work with regulatory bodies in low- and middle-income countries to assist in drug reviews. “This will accelerate access because sometimes resource-limited nations have limited resources for regulatory approvals and review,” Das said. The California biopharma has also submitted the shot for approval in Australia, Brazil, Canada, South Africa and Switzerland, and it expects to soon submit lenacapavir for approval in Argentina, Mexico and Peru. Also at the conference on Monday, Gilead shared new data for lenacapavir, including in pregnant and lactating people, adolescents and people aged 16 to 25 years, from its Phase 3 PURPOSE-1 and PURPOSE-2 studies. Gilead initially revealed efficacy data from those trials last year, which was used to support the approval in the US. “It was the most globally, racially, ethnically, age and gender diverse PrEP clinical trial program to date,” Das said. Pregnant and lactating people have long been excluded from studies of HIV prevention medicines, but this population faces increased risk of acquiring HIV. In the PURPOSE-1 data, Gilead said Yeztugo was well tolerated by pregnant and lactating participants. The company said the safety profiles were similar between those who were pregnant and non-pregnant in the study. There were 509 pregnancies among 487 people, Gilead said. Das noted that some people in the study had multiple children, and some had twins. “If you allow people to have reproductive choice, people want to get pregnant, especially our rural Ugandan populations, who are really interested in getting pregnant,” Das said. “That was a deterrent to enrolling in PrEP clinical trials in the past because you’d be required to use contraception.” Gilead will begin a Phase 3 trial of a once-yearly form of lenacapavir later this year, Das said, and the company hopes to enroll a diverse patient population in that study as well.