Gilead Presents Full PURPOSE 2 Data Results for Twice-Yearly Lenacapavir for HIV Prevention at HIV Glasgow
Gilead Sciences presented full results from its Phase 3 PURPOSE 2 trial studying twice-yearly lenacapavir for HIV prevention. The trial showed that lenacapavir reduced HIV infections by 96% compared to background HIV incidence, with only two cases among 2,179 participants. The drug demonstrated 89% higher effectiveness than daily Truvada.
Trial participants showed high adherence to lenacapavir injections, with 91% receiving on-time injections at week 26 and 92.8% at one year. The FDA granted Breakthrough Therapy Designation for lenacapavir for PrEP, and Gilead plans to begin regulatory filings by end of 2024.
Gilead Sciences ha presentato i risultati completi del suo studio di Fase 3 PURPOSE 2, che ha esaminato l'uso di lenacapavir due volte all'anno per la prevenzione dell'HIV. Lo studio ha dimostrato che lenacapavir ha ridotto le infezioni da HIV del 96% rispetto all'incidenza di base dell'HIV, con soli due casi tra 2.179 partecipanti. Il farmaco ha mostrato un'efficacia 89% superiore rispetto al Truvada giornaliero.
I partecipanti allo studio hanno mostrato un'elevata adesione alle iniezioni di lenacapavir, con un 91% che ha ricevuto iniezioni puntuali alla settimana 26 e 92.8% a un anno. La FDA ha concesso la Designazione di Terapia Innovativa per lenacapavir per la PrEP, e Gilead prevede di avviare le pratiche normative entro la fine del 2024.
Gilead Sciences presentó los resultados completos de su ensayo de Fase 3 PURPOSE 2, que estudió el uso de lenacapavir dos veces al año para la prevención del VIH. El ensayo mostró que lenacapavir redujo las infecciones por VIH en un 96% en comparación con la incidencia de VIH de referencia, con solo dos casos entre 2.179 participantes. El fármaco demostró una efectividad 89% superior en comparación con Truvada diario.
Los participantes del ensayo mostraron una alta adherencia a las inyecciones de lenacapavir, con un 91% recibiendo inyecciones a tiempo en la semana 26 y un 92.8% al año. La FDA otorgó la Designación de Terapia Innovadora para lenacapavir para PrEP, y Gilead planea comenzar a realizar los trámites regulatorios a finales de 2024.
길리어드 사이언스(Gilead Sciences)는 HIV 예방을 위한 반년 간의 레나카파비르(lenacapavir) 연구의 3상 PURPOSE 2 시험 결과를 발표했습니다. 이 시험은 레나카파비르가 HIV 감염을 96% 감소시켰으며, 2,179명의 참가자 중 단 두 건이었다고 보여줍니다. 이 약물은 매일 복용하는 트루바다(Truvada)보다 89% 높은 효능을 보였습니다.
시험 참가자들은 레나카파비르 주사에 대한 높은 순응도를 보여주었으며, 주 26에서 91%가 정시 주사를 받았고 1년 후에는 92.8%가 되었습니다. FDA는 PrEP을 위한 레나카파비르에 대한 획기적인 치료제 지정서를 부여했고, 길리어드는 2024년 말까지 규제 신청을 진행할 계획입니다.
Gilead Sciences a présenté les résultats complets de son essai de phase 3 PURPOSE 2 étudiant le lenacapavir administré deux fois par an pour la prévention du VIH. L'essai a montré que le lenacapavir a réduit les infections par le VIH de 96% par rapport à l'incidence de base du VIH, avec seulement deux cas parmi 2 179 participants. Le médicament a montré une efficacité 89% supérieure à celle du Truvada pris quotidiennement.
Les participants à l'essai ont montré une bonne adhésion aux injections de lenacapavir, avec 91% recevant des injections à temps à la semaine 26 et 92.8% après un an. La FDA a accordé la désignation de thérapie innovante au lenacapavir pour la PrEP, et Gilead prévoit de commencer les dépôts réglementaires d'ici la fin de 2024.
Gilead Sciences hat die vollständigen Ergebnisse seiner Phase 3-Studie PURPOSE 2 zur zweimal jährlich verabreichten Anwendung von Lenacapavir zur HIV-Prävention vorgestellt. Die Studie zeigte, dass Lenacapavir die HIV-Infektionen im Vergleich zur Hintergrundinzidenz von HIV um 96% reduzierte, mit nur zwei Fällen unter 2.179 Teilnehmern. Das Medikament zeigte eine 89% höhere Wirksamkeit im Vergleich zu täglich eingenommenem Truvada.
Die Teilnehmer der Studie zeigten eine hohe Compliance bei den Lenacapavir-Injektionen, wobei 91% die Injektionen in Woche 26 pünktlich erhielten und 92.8% nach einem Jahr. Die FDA erteilte Lenacapavir für PrEP die Breakthrough-Therapieauszeichnung, und Gilead plant, bis Ende 2024 mit den regulatorischen Anträgen zu beginnen.
- 96% reduction in HIV infections compared to background incidence
- 89% more effective than once-daily Truvada
- High adherence rates: 91% on-time injections at week 26, 92.8% at one year
- FDA Breakthrough Therapy Designation received
- Non-exclusive licensing agreements signed with six pharmaceutical companies for low-cost versions
- Two HIV infections occurred in the lenacapavir group despite proper drug concentrations
- Truvada adherence declined from 82% at week 8 to 62% at one year
Insights
The PURPOSE 2 trial results represent a significant breakthrough in HIV prevention. The 96% reduction in HIV infections with twice-yearly lenacapavir compared to background incidence is remarkable, especially considering the high-risk participant population. The 91% adherence rate to the injection schedule at week 26 and 92.8% at one year demonstrates strong real-world feasibility.
The pharmacokinetic data and safety profile are particularly encouraging. Only two infections occurred among 2,179 participants, both between first and second injections, with no delayed diagnosis issues - a critical concern for long-acting PrEP. The FDA's Breakthrough Therapy Designation and rolling review status significantly accelerate the path to potential approval.
The global access strategy, including agreements with six manufacturers for low-cost versions in 120 countries, positions lenacapavir to potentially transform HIV prevention in high-burden regions.
For Gilead, lenacapavir represents a major commercial opportunity in the $2.5 billion global HIV prevention market. The twice-yearly dosing offers significant advantages over daily oral PrEP, addressing the critical adherence challenge evidenced by declining Truvada compliance in the trial (from 82% to 62% over one year).
The comprehensive licensing strategy for low/middle-income countries, while royalty-free, positions Gilead to capture value in developed markets while building global market presence. The robust efficacy data and convenient dosing schedule could drive significant market share gains, particularly in regions with high HIV burden and healthcare infrastructure.
– Newly Presented Results, to be Published in The New England Journal of Medicine, Include Adherence and Pharmacokinetics Data; Data Underscore High Efficacy and Safety Profile of Lenacapavir Among Broad and Geographically Diverse Range of Individuals –
– FDA Recently Granted Breakthrough Therapy Designation for Lenacapavir for PrEP; Gilead to Begin Regulatory Filings by End of 2024 –
– Gilead Spearheading Lenacapavir Access Strategies to Ensure Scientific Innovation Translates to Global Access and Real-World Impact –
The data were presented during an oral abstract session at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) and will be published in The New England Journal of Medicine. The release of the full PURPOSE 2 data follows the unblinding of the trial at interim analysis in September and a presentation of additional efficacy and safety data last month at the HIV Research for Prevention Conference in
“We’re at a crossroads in the HIV epidemic, and a twice-yearly choice for HIV prevention, if approved, could be transformative as we work toward achieving the UNAIDS 2030 targets around the world,” said PURPOSE 2 Principal Investigator Onyema Ogbuagu, MBBCh, FACP, FIDSA, Associate Professor of Medicine and Pharmacology at Yale School of Medicine and Director of the Yale Antivirals and Vaccines Research Program. “Lenacapavir for PrEP could provide an important alternative to existing preventative medications that require more frequent dosing, and could help transform the HIV prevention landscape by addressing a range of unmet needs for individuals who need or want PrEP globally.”
Participants demonstrated high adherence to lenacapavir and injections
Adherence to lenacapavir and to the placebo injections that were part of the oral PrEP study group was high:
Lenacapavir reduced HIV infections by
Lenacapavir was highly effective at reducing HIV infections among trial participants:
Lenacapavir plasma concentrations for the two participants who acquired HIV in this group were within the range of the overall lenacapavir concentrations in the pre-selected, representative subset of participants whose blood plasma levels were tested. Lenacapavir plasma concentrations were also similar to those in prior studies that included lenacapavir. Trial data confirm that both participants acquired HIV after receiving their first injections of lenacapavir but prior to their second injections, and both participants were diagnosed using standard HIV tests. Importantly, based on retrospective standard HIV-1 RNA viral load testing of prior visit samples, there was no delayed HIV diagnosis for either person. The HIV PrEP field has paid particular attention to the potential for delayed diagnosis for individuals who acquire HIV when using long-acting PrEP.
Cases of HIV infection despite high adherence to other forms of PrEP, including Truvada, have been reported, often in the context of high exposures to HIV and repeated mucosal injury. Gilead has offered open-label lenacapavir to all trial participants in PURPOSE 1 (evaluating lenacapavir for PrEP among cisgender women) and is offering open-label lenacapavir to all participants in PURPOSE 2, and will continue to follow participants and test for incident HIV infection.
Truvada adherence was initially high but declined over time
Adherence to Truvada, measured through detection of tenofovir diphosphate in blood samples from a subset of random participants, was initially high but declined over time: tenofovir diphosphate levels consistent with high adherence (four or more tablets per week) were seen in
In the Truvada group, nine incident HIV infections occurred, all in participants with low or no adherence
There were nine incident cases among 1,086 individuals in the Truvada group (0.93/100 person-years;
PURPOSE 2 trial background
PURPOSE 2 is a Phase 3, double-blind, multicenter, randomized study evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP versus bHIV and once-daily oral Truvada in 3,271 cisgender gay, bisexual, and other men, transgender women, transgender men, and gender non-binary individuals aged 16 years or older who have sex with partners assigned male at birth. The trial spanned 88 sites in
PURPOSE 2 is the second pivotal Phase 3 trial to demonstrate superior efficacy for twice-yearly lenacapavir for the investigational use of HIV prevention as PrEP, and to be unblinded early because it met its key efficacy endpoints. In June 2024, the PURPOSE 1 trial (NCT04994509), studying lenacapavir for PrEP among cisgender women in sub-Saharan Africa, was also unblinded early because it met its key efficacy endpoints.
Gilead continues to focus on global access strategies, including for low-, middle- and high-income countries
Data from both PURPOSE 1 and PURPOSE 2 will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024. Last month, the FDA granted lenacapavir for PrEP Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy. Also last month, the FDA granted a rolling review for lenacapavir for PrEP, a process that allows the FDA to expedite the review of a drug application by allowing a company to submit sections of the application for review as they are completed.
Gilead is executing an access strategy, informed by more than 100 global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review and approval of lenacapavir for PrEP in regions around the world. Last month, Gilead announced that it had signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries.
Additionally, Gilead is actively working on additional ways to support access in upper-middle and high-income countries to establish fast, efficient pathways to help reach people who need or want PrEP, including expediting regulatory filings, engagement with partners and governments, and manufacturing infrastructure planning. Additionally, in countries with PURPOSE 2 trial sites, including
“Gilead recognizes the importance of prevention in ending the HIV epidemic and is deeply committed to ensuring broad, sustainable global access to lenacapavir for PrEP, if approved,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development and Virology Therapeutic Area Head, Gilead Sciences.
Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress.
The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.
There is currently no cure for HIV or AIDS.
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 an investigational, 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 adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.
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.
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 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; Gilead’s ability to effectively manage the supply and distribution of lenacapavir, including through direct supply as well as indirect supply through the voluntary licensing agreements, and the ability of the parties to meet potential demand for lenacapavir, in each case, 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 September 30, 2024, as filed with the
Gilead and the Gilead logo, Truvada, and Truvada for PrEP are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112740576/en/
Ashleigh Koss, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
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