Latest news with #Yeztugo
UPI
5 hours ago
- Health
- UPI
FDA approves long-lasting HIV-prevention drug
1 of 2 | A man photographs a portion of the AIDS quilt during an HIV/AIDS rally on the National Mall in Washington, D.C., in 2021. The Food and Drug Administration has said that it has approved a new drug that could prevent HIV infections with just two shots every year. File Photo by Kevin Dietsch/UPI | License Photo June 18 (UPI) -- The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and possibly eradicate the disease. The drug's scientific name is lenacapavir and it will be marketed as Yeztugo, which requires one injection every six months to maintain its effectiveness in preventing HIV infections. Other drugs exist that also prevent HIV, but they require daily dosages in pill form and have not significantly affected the disease on a global level. "We're on the precipice of now being able to deliver the greatest prevention option we've had in 44 years of this epidemic," AVAC executive director Mitchell Warren told the New York Times. AVAC is an anti-HIV organization. He said recent funding cuts by the Trump administration will make it hard to distribute the drug globally. "It's as if that opportunity is being snatched from out of our hands by the policies of the last five months," Warren said. Gilead Sciences is producing the drug, which is the second long-lasting HIV prevention drug available. The other option is cabotegravir, which is sold under the brand name Apretude and requires an injection every two months. About 21,000 Americans use Apretude, while about 500,000 use daily oral medications to prevent HIV. Clinical trials showed most participants who received two shots of lenacapavir every year had nearly full protection against HIV. More than 39,000 people in the United States contracted HIV in 2023, which carries an estimated lifetime treatment cost of $1.1 million per patient, Gilead Chairman and Chief Executive Officer Daniel O'Day told the New York Times. Lenacapavir already is being prescribed to treat people with HIV infections that resist other medications and at an annual cost of $42,000 per patient, but most patients don't pay the full cost. Health insurance coverage and patient-assistance programs would cover the cost for most people using lenacapavir, according to Gilead. The cost for oral pills taken daily is just $1 per pill, while Apretude carries an annual cost of about $24,000. Proposed funding reductions for Medicaid and the President's Emergency Program for AIDs Relief, commonly called PEPFAR, might greatly reduce access to the drug, according to advocacy groups. The PrEP oral treatment still would be available, but it does not work for many people, Health Gap Executive Director Asia Russell told the New York Times.
Wall Street Journal
7 hours ago
- Health
- Wall Street Journal
FDA Approves Powerful Twice-Yearly Treatment to Prevent HIV
The Food and Drug Administration on Wednesday approved a powerful new prevention drug for HIV called Yeztugo that promises to keep most people virus-free with two shots a year. Made by Gilead Sciences, Yeztugo is the latest product approved in the lucrative market for HIV-prevention drugs, sometimes called pre-exposure prophylaxis, or PrEP, drugs. In clinical trials, 99.9% of participants receiving the drug didn't acquire HIV, the virus that causes AIDS.
Int'l Business Times
7 hours ago
- Health
- Int'l Business Times
US Approves Gilead's Twice-yearly Injection To Prevent HIV
The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded -- a 99.9 percent prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Despite the impressive results, optimism may be tempered by the drug's expected high cost. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. While Gilead hasn't disclosed a price for Yeztugo, analysts estimate the US launch cost could reach $25,000 per year. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, though that is expected to drop when used as a preventive. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
Time Magazine
8 hours ago
- Health
- Time Magazine
FDA Approves a Twice-Yearly Shot to Prevent HIV
On June 18, the U.S. Food and Drug Administration (FDA) approved the first medicine to prevent HIV that only has to be taken twice a year. People who are at high risk for HIV can now take the injection—called lenacapavir and sold as Yeztugo—just once every six months. The approval is a milestone in the fight against HIV and could transform the epidemic. While anti-HIV drug treatments have helped millions of people suppress the virus to undetectable levels so that they don't spread it to others—and have also allowed people who are HIV-negative to maintain their status when used to prevent infection—a regimen of daily pills means that compliance, and therefore effectiveness, is often not as strong as it should be. In two studies, scientists at Gilead, which developed lenacapavir, showed that the drug was 96% effective at protecting cisgender women from becoming HIV positive as compared to daily oral pills (called PrEP, short for pre-exposure prophylaxis). In men who have sex with men and gender-diverse people, the drug was 100% effective. 'Lenacapavir used by itself for prevention is a huge breakthrough,' says Dr. David Ho, professor of microbiology, immunology, and medicine at Columbia University who pioneered combining anti-HIV drugs to suppress the virus and its ability to mutate to become resistant to treatment. 'Its potential is great in curtailing the epidemic.' But advocacy groups and global AIDS organizations raise concerns about whether that potential will be fully realized, given recent cuts to U.S.-supported programs for HIV treatment and prevention around the world. From treatment to prevention Lenacapavir was approved by the FDA in 2022 to treat people with HIV whose virus has become resistant to other antiviral drugs. As they were developing that treatment, Gilead's scientists noticed that lenacapavir had two important properties that could make it potentially useful in preventing HIV as well: its ability to remain in the body for a longer time than other antiviral drugs, and its power to interfere with several steps in the process that the virus uses to make copies of itself. 'We observed a fantastic effect after a single injection," says Tomas Cihlar, senior vice president of virology at Gilead. "Basically, it protected non-human primates from acquiring HIV. That's when we realized we really needed to get full speed and full force behind the prevention idea.' But because people taking a drug to prevent infection are HIV negative, 'the bar for safety for people who don't have the disease is quite high,' says Jared Baeten, vice president of HIV development at Gilead. 'Still, based on all the pharmacology, science, and demonstrated antiviral activity and safety in the HIV treatment sphere, by the end of 2020 we made the decision to move lenacapavir into prevention,' he says. While it's the same drug, when doctors use lenacapavir to treat HIV, they often combine it with other drugs to limit HIV's potential for developing resistance. But to prevent disease in people who are HIV negative, lenacapavir can be used alone, since there isn't already an actively reproducing population of virus in the body. How lenacapavir could quash HIV vaccine efforts Lenacapavir is not an HIV vaccine, but its effect in preventing infection is similar to one. Vaccines enlist and train the immune system to recognize and target pathogens like viruses, so the body becomes a factory for generating the appropriate defenses to fight infections. Lenacapavir's ability to fend off infection comes from having circulating levels of the drug in the body to fight off any virus that might enter. Whether it's the immune system or the drug, the effect is very similar—which is a huge advance. In the more than 40 years since HIV was discovered, scientists have not been able to develop a vaccine against it. 'So far the candidate vaccines do not show this kind of promise for preventing HIV infection,' says Ho. 'We're nowhere close to an efficacious vaccine.' With lenacapavir approved to prevent HIV, the bar for developing a vaccine becomes even higher. It could be ethically difficult to justify asking people to take a placebo to establish the effects of a vaccine, since both oral PrEP and now lenacapavir as PrEP are so effective in protecting against HIV infection. Depriving those in a vaccine trial from taking lenacapavir by assigning them to receive a placebo would be problematic. 'This might take a bit of the wind out of the sails of vaccine research, because there is something so effective at preventing HIV infection,' says Ho. The future of HIV treatment and prevention The long-acting nature of lenacapavir represents a new direction for anti-HIV drugs that could make preventing infections more tenable and accessible to more people, says Hui Yang, head of supply operations of the Global Fund to Fight HIV, TB, and Malaria. 'We learned from decades-long experience that in prevention programs, adherence is a big issue. And that is an aspect we are hoping to address with the introduction of lenacapavir for PrEP.' The Global Fund's goal is to get two million more people in prevention programs over the next three years, and lenacapavir could accelerate reaching that target. But the shot still must be administered by a health care provider, and people need to test negative for HIV before receiving each shot. Those are hurdles for many of the most vulnerable populations in low- and middle-income countries, many of whom are young adults. To further increase access, Yang says, a form of lenacapavir that people could inject themselves with twice a year would be even more appropriate for such settings. 'It could become something like an insulin injection that people can do themselves,' she says. Gilead is working on a once-a-year version of lenacapavir that would cut down on the need for multiple clinic visits. The unrealized potential of lenacapavir While the advance is scientifically exciting, the drug may take years or even decades to significantly curb the global HIV epidemic. 'We just built the best plane in the world, but unfortunately tore up all the runways,' says Kevin Frost, CEO of amfAR, the Foundation for AIDS Research. 'Lenacapavir is coming at the worst moment in the last 30 years of the AIDS epidemic. We are seeing ourselves time traveling back decades because of the dismantling of the infrastructure around the treatment and prevention of HIV." Cuts to USAID, PEPFAR, and the National Institutes of Health "mean lenacapavir will never have a shot coming out of the gate. The very architecture that could deliver lenacapavir on a global scale to be transformative is being dismantled." While Gilead would not specify a price for lenacapavir, a company spokesperson said it would likely be 'in line with existing branded PrEP options.' Still, that could be out of reach for those in lower income countries who could benefit the most, says Frost. Addressing cost and other issues related to access will be critical to realizing the full potential of the drug. In the U.S., states that offer and cover PrEP options have reported a 38% decrease in new infections, whereas states that don't make PrEP as available saw a 27% increase in infections from 2012 to 2022, according to a recent report published in the Lancet HIV. Gilead has negotiated royalty-free licensing deals with six generic manufacturers to manufacture lenacapavir for prevention for 120 low- and middle-income countries. 'Hopefully in those places where they have that kind of manufacturing capacity, we will see cheap, inexpensive lenacapavir," says Frost—but given that the normal distribution channels are newly gutted programs like USAID and PEPFAR, "I still expect access will be extraordinarily limited.'
Yahoo
8 hours ago
- Health
- Yahoo
Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection
– Approval Based on Phase 3 PURPOSE 1 and PURPOSE 2 Data that Showed ≥99.9% of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo – – Yeztugo, Nearly 20 Years in the Making, Represents a Major Breakthrough in the Fight Against HIV – FOSTER CITY, Calif., June 18, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company's injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. "This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," said Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences. "This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life's work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality." The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC's eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers—contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023, more than 100 people were diagnosed with HIV every day in the U.S. "Yeztugo could be the transformative PrEP option we've been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic," said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta. "A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing." FDA approval of Yeztugo is supported by high efficacy and demonstrated safety data in two clinical trials The FDA approval of Gilead's New Drug Applications (NDAs) for Yeztugo was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy. Gilead's U.S. access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo. Additionally, for eligible commercially insured individuals with commercial insurance, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars. Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead's Advancing Access medication assistance program will provide Yeztugo free of charge. Additional regulatory filings are underway in countries around the world Outside of the U.S., Gilead is executing an access strategy, informed by global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. Gilead has 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 and South Africa. Additionally, now that Yeztugo has received FDA approval, Gilead is preparing additional filings in countries that rely on FDA approval 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. There is currently no cure for HIV or AIDS. Please see below for the U.S. Indication and Important Safety Information for Yeztugo, including Boxed Warning. 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. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. 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 was 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. 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 Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; 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; the risk that physicians may not see the benefits of prescribing Yeztugo for PrEP; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; 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, 2025, 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. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at Advancing Access, Truvada, Truvada for PrEP, Yeztugo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ Sign in to access your portfolio
