Gilead Announces New England Journal of Medicine Publication of PURPOSE 2 Results
Gilead Sciences announced the publication of its Phase 3 PURPOSE 2 trial results in The New England Journal of Medicine, evaluating twice-yearly lenacapavir for HIV prevention. The study demonstrated 96% reduction in HIV infections compared to background incidence, with only two cases among 2,179 participants. The treatment proved superior to once-daily Truvada and was well-tolerated with no significant safety concerns.
These results align with the previous PURPOSE 1 trial, which showed 100% efficacy in cisgender women in sub-Saharan Africa. Gilead plans to begin global regulatory filings for lenacapavir for PrEP by the end of 2024, implementing an access strategy developed with input from over 100 global health advocates.
Gilead Sciences ha annunciato la pubblicazione dei risultati del suo trial di fase 3 PURPOSE 2 nel The New England Journal of Medicine, valutando l'uso di lenacapavir due volte all'anno per la prevenzione dell'HIV. Lo studio ha dimostrato una riduzione del 96% delle infezioni da HIV rispetto all'incidenza di base, con solo due casi tra 2.179 partecipanti. Il trattamento si è rivelato superiore al Truvada assunto una volta al giorno ed è stato ben tollerato, senza preoccupazioni significative per la sicurezza.
Questi risultati sono in linea con il precedente trial PURPOSE 1, che ha mostrato un'efficacia del 100% nelle donne cisgender nell'Africa subsahariana. Gilead prevede di iniziare le richieste normative globali per il lenacapavir per la PrEP entro la fine del 2024, implementando una strategia di accesso sviluppata con il contributo di oltre 100 sostenitori della salute globale.
Gilead Sciences anunció la publicación de los resultados de su ensayo de fase 3 PURPOSE 2 en The New England Journal of Medicine, evaluando lenacapavir para la prevención del VIH administrado dos veces al año. El estudio demostró una reducción del 96% en las infecciones por VIH en comparación con la incidencia de fondo, con solo dos casos entre 2,179 participantes. El tratamiento fue superior al Truvada tomado una vez al día y se toleró bien, sin preocupaciones significativas sobre la seguridad.
Estos resultados se alinean con el ensayo anterior PURPOSE 1, que mostró una eficacia del 100% en mujeres cisgénero en África subsahariana. Gilead planea comenzar los trámites regulatorios globales para lenacapavir para PrEP a finales de 2024, implementando una estrategia de acceso desarrollada con la opinión de más de 100 defensores de la salud global.
길리아드 사이언스는 HIV 예방을 위한 연간 2회 lenacapavir 평가에 대한 3상 PURPOSE 2 시험 결과를 뉴 잉글랜드 의학 저널에 발표했습니다. 연구는 HIV 감염 96% 감소를 입증했으며, 2,179명의 참가자 중 단 2건의 사례만 있었습니다. 이 치료법은 하루에 한 번 복용하는 Truvada보다 우수하며, 안전성에 대한 주요 걱정 없이 잘 견디는 것으로 나타났습니다.
이 결과는 이전의 PURPOSE 1 시험과 일치하며, 이는 사하라 이남 아프리카의 cisgender 여성에서 100%의 효능을 보여주었습니다. 길리아드는 2024년 말까지 lenacapavir의 PrEP 사용을 위한 전 세계 규제 신청을 시작할 계획이며, 100명 이상의 글로벌 건강 옹호자들의 의견을 반영한 접근 전략을 실행할 예정입니다.
Gilead Sciences a annoncé la publication des résultats de son essai de phase 3 PURPOSE 2 dans le New England Journal of Medicine, évaluant lenacapavir administré deux fois par an pour la prévention du VIH. L'étude a montré une réduction de 96% des infections à VIH par rapport à l'incidence de base, avec seulement deux cas parmi 2 179 participants. Le traitement s'est avéré supérieur à Truvada pris une fois par jour et a été bien toléré, sans préoccupations de sécurité majeures.
Ces résultats sont conformes à l'essai précédent PURPOSE 1, qui a montré une efficacité de 100% chez les femmes cisgenres en Afrique subsaharienne. Gilead prévoit de commencer les demandes réglementaires mondiales pour lenacapavir à des fins de PrEP d'ici la fin de 2024, en mettant en œuvre une stratégie d'accès élaborée avec l'avis de plus de 100 défenseurs de la santé mondiale.
Gilead Sciences gab die Veröffentlichung der Ergebnisse seiner Phase 3-Studie PURPOSE 2 im The New England Journal of Medicine bekannt, in der lenacapavir zur HIV-Prävention bewertet wurde, das zweimal jährlich verabreicht wird. Die Studie zeigte eine Reduktion von 96% der HIV-Infektionen im Vergleich zur Hintergrundinzidenz, mit nur zwei Fällen unter 2.179 Teilnehmern. Die Behandlung erwies sich als überlegen gegenüber dem einmal täglich eingenommenen Truvada und wurde gut vertragen, ohne signifikante Sicherheitsbedenken.
Diese Ergebnisse stimmen mit der vorherigen PURPOSE 1-Studie überein, die eine Wirksamkeit von 100% bei cisgender Frauen in Subsahara-Afrika zeigte. Gilead plant, bis Ende 2024 mit den globalen Zulassungsanträgen für lenacapavir zur PrEP zu beginnen, und implementiert eine Zugangsstrategie, die mit dem Input von über 100 globalen Gesundheitsvertretern entwickelt wurde.
- 96% reduction in HIV infections compared to background incidence
- Superior efficacy compared to once-daily Truvada
- Excellent safety profile with no significant concerns
- High participation rate with 2,179 subjects
- Regulatory filings planned for global markets by end of 2024
- Two incident cases reported in the treatment group
- Product not yet approved by regulators
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, with only 2 cases among 2,179 participants. This efficacy rate, combined with the convenience of bi-annual dosing, could revolutionize PrEP adoption and adherence.
The data is particularly compelling when considered alongside the PURPOSE 1 trial's 100% efficacy in cisgender women. The robust safety profile and superior performance compared to daily Truvada establish lenacapavir as a potential game-changer in HIV prevention. The planned regulatory submissions starting in 2024 could lead to a major shift in HIV prevention strategies globally.
This development significantly strengthens Gilead's position in the HIV prevention market. The superior efficacy compared to Truvada, which generated significant historical revenues for Gilead, suggests strong commercial potential. The twice-yearly administration provides a competitive advantage over daily oral alternatives, potentially driving better adherence and market adoption.
The planned global regulatory filings indicate a clear path to commercialization, with potential market entry as early as 2025. This could help offset Gilead's HIV franchise revenue pressures from generic competition, particularly in the PrEP segment. The comprehensive access strategy, developed with global health advocates, suggests a well-planned commercial approach.
The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by
The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in
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. 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.
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.
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 statement 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 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).
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Jacquie Ross, Investors
investor_relations@gilead.com
Ashleigh Koss, Media
public_affairs@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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