Latest news with #IAS2025
The Star
a day ago
- Health
- The Star
WHO announces lenacapavir as a groundbreaking HIV prevention method
Tracy-Lynn Ruiters | Published 1 week ago The World Health Organization (WHO) announced a landmark policy at the 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda, releasing new guidelines that recommend injectable lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option for HIV prevention. This development has the potential to significantly reshape the global HIV response. LEN is the first twice-yearly injectable PrEP product, offering a highly effective, long-acting alternative to daily oral pills and shorter-acting prevention methods. With just two doses a year, LEN marks a transformative step in HIV prevention, particularly for individuals who face challenges with daily adherence, stigma, or limited access to health care. '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," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 'The launch of WHO's new guidelines, alongside the FDA's recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.' The new guidelines come at a pivotal time, as global HIV prevention efforts have stalled, with 1.3 million new infections recorded in 2024. Key and priority populations — including sex workers, men who have sex with men, transgender individuals, people who inject drugs, those in prisons, as well as children and adolescents — continue to be disproportionately affected. WHO's endorsement of LEN marks a significant step toward broadening and diversifying HIV prevention strategies, empowering people with more choices to protect their health in ways that align with their needs and circumstances. WHO has recommended a simpler, more accessible approach to HIV testing using rapid tests to support the rollout of long-acting injectable PrEP like LEN and CAB-LA. This change removes a major barrier by cutting out complex, expensive procedures and allowing delivery through local clinics, pharmacies, and tele-health. LEN now joins other WHO-approved HIV prevention options — including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring. Although access to LEN outside clinical trials is still limited, WHO is calling on governments and health partners to begin implementing it within national HIV prevention programmes while gathering data on its real-world use and impact. For the first time, WHO now recommends long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an option for adults and adolescents who are already virally suppressed on oral antiretroviral therapy (ART) and don't have hepatitis B. This is especially helpful for people who struggle with daily pill-taking. WHO also updated its guidance on inte grating HIV care with other health services, such as treating high blood pressure, diabetes, mental health conditions (like depression, anxiety, and alcohol use disorders), and improving ART adherence. The organisation now recommends STI screening (gonorrhoea and chlamydia) for key and priority populations, even when no symptoms are present. For people living with HIV who have or are at risk of mpox (formerly monkeypox), WHO strongly recommends starting ART quickly, especially if they've never started treatment or have had long interruptions. HIV and syphilis testing is also advised for anyone with suspected or confirmed mpox. Given funding challenges facing global HIV programmes, WHO released new guidance to help countries maintain essential HIV services. This includes advice on how to prioritise services, manage risks, and keep health systems resilient. Dr Meg Doherty, WHO's HIV programme director, emphasised the urgency of acting on these guidelines: 'We have the tools and the knowledge to end AIDS as a public health problem. What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.' HIV continues to be a major public health issue, with an estimated 40.8 million people living with the virus globally by the end of 2024. While treatment access is growing — 31.6 million people are now on ART — new infections and deaths remain high, particularly in the WHO African Region. With these updated guidelines, WHO said it is offering countries practical tools to make HIV responses more efficient, equitable, and sustainable. The focus now shifts to putting these strategies into action. [email protected] Weekend Argus
IOL News
15-07-2025
- Health
- IOL News
WHO announces lenacapavir as a groundbreaking HIV prevention method
WHO announced a groundbreaking HIV preventative measure Image: Supplied The World Health Organization (WHO) announced a landmark policy at the 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda, releasing new guidelines that recommend injectable lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option for HIV prevention. This development has the potential to significantly reshape the global HIV response. LEN is the first twice-yearly injectable PrEP product, offering a highly effective, long-acting alternative to daily oral pills and shorter-acting prevention methods. With just two doses a year, LEN marks a transformative step in HIV prevention, particularly for individuals who face challenges with daily adherence, stigma, or limited access to health care. '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," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 'The launch of WHO's new guidelines, alongside the FDA's recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.' The new guidelines come at a pivotal time, as global HIV prevention efforts have stalled, with 1.3 million new infections recorded in 2024. Key and priority populations — including sex workers, men who have sex with men, transgender individuals, people who inject drugs, those in prisons, as well as children and adolescents — continue to be disproportionately affected. WHO's endorsement of LEN marks a significant step toward broadening and diversifying HIV prevention strategies, empowering people with more choices to protect their health in ways that align with their needs and circumstances. WHO has recommended a simpler, more accessible approach to HIV testing using rapid tests to support the rollout of long-acting injectable PrEP like LEN and CAB-LA. This change removes a major barrier by cutting out complex, expensive procedures and allowing delivery through local clinics, pharmacies, and tele-health. LEN now joins other WHO-approved HIV prevention options — including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring. Although access to LEN outside clinical trials is still limited, WHO is calling on governments and health partners to begin implementing it within national HIV prevention programmes while gathering data on its real-world use and impact. For the first time, WHO now recommends long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an option for adults and adolescents who are already virally suppressed on oral antiretroviral therapy (ART) and don't have hepatitis B. This is especially helpful for people who struggle with daily pill-taking. WHO also updated its guidance on integrating HIV care with other health services, such as treating high blood pressure, diabetes, mental health conditions (like depression, anxiety, and alcohol use disorders), and improving ART adherence. The organisation now recommends STI screening (gonorrhoea and chlamydia) for key and priority populations, even when no symptoms are present. For people living with HIV who have or are at risk of mpox (formerly monkeypox), WHO strongly recommends starting ART quickly, especially if they've never started treatment or have had long interruptions. HIV and syphilis testing is also advised for anyone with suspected or confirmed mpox. Given funding challenges facing global HIV programmes, WHO released new guidance to help countries maintain essential HIV services. This includes advice on how to prioritise services, manage risks, and keep health systems resilient. Dr Meg Doherty, WHO's HIV programme director, emphasised the urgency of acting on these guidelines: 'We have the tools and the knowledge to end AIDS as a public health problem. What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.' HIV continues to be a major public health issue, with an estimated 40.8 million people living with the virus globally by the end of 2024. While treatment access is growing — 31.6 million people are now on ART — new infections and deaths remain high, particularly in the WHO African Region. With these updated guidelines, WHO said it is offering countries practical tools to make HIV responses more efficient, equitable, and sustainable. The focus now shifts to putting these strategies into action. [email protected] Weekend Argus
Scoop
15-07-2025
- Health
- Scoop
Momentum Builds For Long-Acting HIV Solutions As IAS 2025 Spotlights Scientific Progress, Funding Challenges
14 July 2025 (Kigali, Rwanda) – IAS 2025, the 13th IAS Conference on HIV Science, opened today with a call to accelerate access to long-acting HIV prevention and treatment innovations amid growing global funding challenges. Four thousand participants are attending IAS 2025 in Kigali, Rwanda, and virtually. The IAS Conference on HIV Science is the world's most influential meeting on HIV research and its applications. Dr Sabin Nsanzimana, Minister of Health of Rwanda, delivered welcoming remarks at a press conference, entitled 'Breakthroughs amid crisis: The future of HIV innovation', directly preceding the opening session. 'Rwanda's experience in the HIV response over the past few decades – alongside our recent pandemic response – demonstrates what is possible when countries prioritize people-centred approaches and invest in strategic partnerships,' Dr Sabin Nsanzimana, the Minister of Health of Rwanda, said. 'Together, we met the UNAIDS 95-95-95 targets ahead of schedule and continue to harness cutting-edge science – including long-acting medications – to deliver more targeted, integrated interventions. As we look ahead, our shared responsibility is to ensure that these innovations are not only developed, but also equitably accessible to all who need them.' 'Today marks a significant moment in the journey to expand choices and improve outcomes for people living with and vulnerable to HIV,' Dr Beatriz Grinsztejn, IAS President, said. 'New WHO guidelines, groundbreaking licensing agreements and promising research signal that long-acting HIV prevention and treatment are moving closer to becoming part of everyday care. This is a testament to what is possible when researchers, industry, global health institutions and communities work together. Our next challenge is clear: leaders must commit the funding and resources needed to integrate these scientific advances into health systems quickly and equitably so that people everywhere can benefit from these life-changing options.' Among the key announcements during the opening session were new World Health Organization (WHO) guidelines recommending long-acting injectable lenacapavir for HIV prevention, underscoring WHO's commitment to equitable access to these innovations. 'We have the tools and the knowledge to end AIDS as a public health problem,' DrMeg Doherty, Director of WHO's Department of Global HIV, Hepatitis and STI Programmes and incoming Director of Science, Research, Evidence and Quality for Health, said. 'What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.' A statement from Dr Tedros Adhanom Ghebreyesus, WHO Director-General, was also issued in support of the new guidance. '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,' Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said. 'The launch of WHO's new guidelines, alongside the FDA's recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.' A new licensing agreement between the Medicines Patent Pool and ViiV Healthcare was announced to expand access to long-acting injectable cabotegravir for HIV treatment. 'Expanding our licence with ViiV Healthcare to include long-acting cabotegravir for HIV treatment marks a significant step forward for equitable access,' Esteban Burrone, Director of Strategy, Policy and Market Access at the Medicines Patent Pool, said. 'As the first full long-acting HIV treatment regimen, now recommended by WHO, it answers a long-standing call from communities for an option that would maintain viral suppression without the need for daily medication. This expansion shows that innovation and access not only should – but also can – go hand in hand. We now look forward to working closely with our generic licensees to accelerate the development of an affordable, quality-assured version that will serve as an important tool in the HIV treatment toolbox.' Promising new research from MSD on MK-8527, an investigational once-monthly oral pill for HIV prevention, was also presented. The candidate is advancing to Phase 3 trials in Africa. Study co-author Dr Rebeca Plank, distinguished scientist, Global Clinical Development at MSD Research Laboratories, shared new data. "The results of the Phase 2 study of MK-8527 shared at IAS 2025 demonstrate a favourable safety and tolerability profile with pharmacokinetic data supporting once-monthly oral dosing in our Phase 3 studies,' Rebeca Plank, MD, study co-author, Distinguished Scientist, Global Clinical Development, MSD Research Laboratories, said. 'The two upcoming Phase 3 EXPrESSIVE studies are designed to evaluate the preventive efficacy and safety profile of MK-8527 across populations who could most benefit from PrEP. We are proud to partner with the Gates Foundation and the International Clinical Research Center to help advance HIV prevention research.' Advocates urged global leaders to ensure equitable access to new HIV prevention and treatment options. 'Long-acting HIV prevention and treatment can transform lives only if people can actually get them,' Yvette Raphael, Executive Director of Advocates for the Prevention of HIV and AIDS, said. 'We cannot repeat the mistakes of the past, where new medicines existed but stayed out of reach for the people who needed them most. We need clear plans and real funding to make sure these drugs are affordable, available in our clinics and trusted by our communities. Science has given us powerful tools. Now we must do the work to put them in people's hands.' Data presented by the UNAIDS Director for Data Impact, Mary Mahy, highlighted continued gaps in prevention and treatment access for key populations and regions most heavily affected by HIV. 'By the end of 2024, 73% of all people living with HIV had achieved viral suppression. This impressive progress ensures that people living with HIV are healthy and reduces onward HIV transmission. However, the funding crisis is jeopardizing this hard-won progress in the response to HIV,' Mahy said. UNAIDS Executive Director Winnie Byanyima issued a global update, highlighting persistent gaps in HIV prevention and treatment access, particularly for key populations and hardest-hit regions. 'We are seeing a massive interruption in international HIV financing which has created a systemic shock to the global HIV response, triggering huge disruptions to HIV treatment and prevention programmes around the world,' said Winnie Byanyima. 'However, our AIDS response was created in crisis–it is in our DNA to face crisis and to fight our way out of crisis. Countries are resilient, we do not give up and we continue to stand with governments and communities as they commit to finish the fight to end AIDS.' IAS 2025 will continue until 17 July, featuring hundreds of sessions and presentations focused on translating scientific breakthroughs into real-world impact, with a particular emphasis on solutions for regions and populations most affected by HIV. In addition to today's announcements, the Journal of the International AIDS Society (JIAS) has released several important thematic supplements ahead of IAS 2025. These are: 'PEP in Africa: prospects, opportunities and challenges', guest edited by Euphemia Sibanda, Julie Fox and Peter Godfrey-Faussett; 'Expanding access to a choice-based HIV prevention market', guest edited by Virginia A. Fonner, Nicolette P. Naidoo and James Ayieko; and 'Differentiated service delivery – beyond HIV treatment for integration and other health needs', guest edited by Anna Grimsrud, Charles B. Holmes and Linda Sande. Each collection looks at key challenges and opportunities for the future of the HIV response. About the IAS Conference on HIV Science The IAS Conference on HIV Science is the world's most influential meeting on HIV research and its applications. Through its open and inclusive programme, the meeting sets the gold standard of HIV science, featuring latest HIV research and innovations that move science into policy and practice. IAS 2025, the 13th IAS Conference on HIV Science, will take place in Kigali, Rwanda, and virtually from 13 to 17 July 2025, with pre-conferences on 13 July. IAS 2025 will also address the current political and financial issues affecting the HIV response, including the implications for Africa and around the world. About the International AIDS Society IAS – the International AIDS Society – convenes, educates and advocates for a world in which HIV no longer presents a threat to public health and individual well-being. After the emergence of HIV and AIDS, concerned scientists created the IAS to bring together experts from across the world and disciplines to promote a concerted HIV response. Today, the IAS and its members unite scientists, policy makers and activists to galvanise the scientific response, build global solidarity and enhance human dignity for all those living with and affected by HIV. The IAS also hosts the world's most prestigious HIV conferences: the International AIDS Conference, the IAS Conference on HIV Science and the HIV Research for Prevention Conference.
Yahoo
14-07-2025
- Health
- Yahoo
Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for HIV Prevention at IAS 2025
– 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, Calif., July 14, 2025--(BUSINESS WIRE)--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 13th 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 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 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. 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 realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's earnings; 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; 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 Yeztugo, including Boxed Warning, is available at Gilead and the Gilead logo, and Yeztugo 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
Scoop
14-07-2025
- Health
- Scoop
WHO Urges Rollout Of First Long-Acting HIV Prevention Jab
14 July 2025 Injectable lenacapavir – LEN, for short – is a highly effective, long-acting antiretroviral alternative to daily oral pills and other shorter-acting options, according to the World Health Organization (WHO). '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,' said Tedros Adhanom Ghebreyesus, WHO Director-General. Test kit advantage WHO's support for the injectable drug is significant because HIV prevention efforts are stagnating around the world. To make it easier for people to receive the injection close to home, the UN agency also recommends the use of rapid testing kits for the disease, as opposed to 'complex, costly procedures'. According to the agency, 1.3 million people contracted HIV in 2024; people most impacted were sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, and children and teens. 'WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible,' insisted Tedros, in comments during the 13th International AIDS Society Conference (IAS 2025) on HIV Science, in Kigali, Rwanda. The recommendation for LEN is also in line with the US health authorities which approved it in June. Call for implementation Although access to the LEN injection remains limited outside clinical trials today, WHO urged governments, donors and partners to incorporate LEN 'immediately' within national combination HIV-prevention programmes. Other WHO-supported HIV-prevention options include daily oral tablets, injectable cabotegravir – which is injected once every two months – and the dapivirine vaginal ring, as part of a growing number of tools to end the HIV epidemic. Funding dilemma Amid massive funding cuts to the global effort to end HIV-AIDS – including the leading US Government programme launched in 2003, PEPFAR, focusing on combating the disease in Africa - WHO also issued new operational guidance on how to sustain priority HIV services. 'We have the tools and the knowledge to end AIDS…what we need now is bold implementation of these recommendations, grounded in equity and powered by communities,' said DrMeg Doherty, Director of WHO's Department of Global HIV, Hepatitis and STI Programmes and incoming Director of Science, Research, Evidence and Quality for Health. HIV remains a major global public health issue. By the end of 2024, an estimated 40.8 million people were living with HIV with an estimated 65 per cent in Africa. Approximately 630,000 people died from HIV-related causes globally, and an estimated 1.3 million people acquired HIV, including 120,000 children. More positively, access to HIV drugs continues to expand, with 31.6 million people receiving treatment in 2024, up from 30.3 million a year earlier. Without anti-retroviral medication, the HIV virus attacks the body's immune system, leading ultimately to the onset of AIDS.
