Gilead’s Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada® in Second Pivotal Phase 3 Trial
Gilead Sciences (Nasdaq: GILD) announced groundbreaking results from its PURPOSE 2 trial, evaluating twice-yearly injectable lenacapavir for HIV prevention. The drug reduced HIV infections by 96% compared to background HIV incidence, with only 2 incident cases among 2,180 participants. Lenacapavir also demonstrated superiority to daily Truvada, showing 89% greater effectiveness. The trial included diverse participants from seven countries.
Key findings:
- 99.9% of participants did not acquire HIV in the lenacapavir group
- Lenacapavir was 96% more effective than background HIV incidence
- 89% more effective than once-daily Truvada
- Generally well-tolerated with no significant safety concerns
Gilead plans to begin global regulatory filings by the end of 2024, potentially launching the first twice-yearly HIV prevention option in 2025.
Gilead Sciences (Nasdaq: GILD) ha annunciato risultati rivoluzionari dal suo trial PURPOSE 2, che valuta il lenacapavir iniettabile due volte l'anno per la prevenzione dell'HIV. Il farmaco ha ridotto le infezioni da HIV del 96% rispetto all'incidenza di HIV di base, con solo 2 casi incidenti su 2.180 partecipanti. Il lenacapavir ha anche dimostrato superiorità rispetto al Truvada giornaliero, mostrando un'efficacia superiore del 89%. Il trial ha incluso partecipanti diversi provenienti da sette paesi.
Risultati chiave:
- Il 99,9% dei partecipanti non ha contratto l'HIV nel gruppo lenacapavir
- Il lenacapavir è stato efficace il 96% in più rispetto all'incidenza di HIV di base
- È stato efficace l'89% in più rispetto al Truvada assunto una volta al giorno
- Generalmente ben tollerato senza preoccupazioni significative per la sicurezza
Gilead prevede di iniziare le autorizzazioni regolatorie globali entro la fine del 2024, con la possibilità di lanciare la prima opzione di prevenzione dell'HIV due volte all'anno nel 2025.
Gilead Sciences (Nasdaq: GILD) anunció resultados innovadores de su ensayo PURPOSE 2, que evalúa el lenacapavir inyectable dos veces al año para la prevención del VIH. El medicamento redujo las infecciones por VIH en un 96% en comparación con la incidencia de VIH de fondo, con solo 2 casos incidentes entre 2,180 participantes. El lenacapavir también demostró superioridad frente a Truvada diario, mostrando un 89% de efectividad adicional. El ensayo incluyó participantes diversos de siete países.
Hallazgos clave:
- El 99.9% de los participantes no adquirieron VIH en el grupo de lenacapavir
- El lenacapavir fue un 96% más efectivo que la incidencia de VIH de fondo
- Fue un 89% más efectivo que Truvada una vez al día
- Generalmente bien tolerado sin preocupaciones significativas de seguridad
Gilead planea comenzar los trámites regulatorios globales a finales de 2024, con la posibilidad de lanzar la primera opción de prevención del VIH dos veces al año en 2025.
길리어드 사이언스 (Nasdaq: GILD)는 HIV 예방을 위한 연 2회 주사형 레나카파비르에 대한 PURPOSE 2 임상 시험에서 혁신적인 결과를 발표했습니다. 이 약물은 배경 HIV 발생률에 비해 96%의 HIV 감염을 줄였으며, 2,180명의 참가자 중 2건의 사건이 발생했습니다. 레나카파비르는 매일 복용하는 트루바다보다 우수성을 입증하며 89% 더 효과적임을 보여줍니다. 이 시험에는 7개국의 다양한 참가자가 포함되었습니다.
주요 발견:
- 레나카파비르 그룹에서 참가자의 99.9%가 HIV에 감염되지 않았습니다
- 레나카파비르는 배경 HIV 발생률보다 96% 더 효과적이었습니다
- 하루 한 번 복용하는 트루바다보다 89% 더 효과적이었습니다
- 일반적으로 잘 견뎌지며 중요한 안전 우려는 없었습니다
길리어드는 2024년 말까지 글로벌 규제 제출을 시작할 계획이며, 2025년에는 연 2회의 첫 HIV 예방 옵션을 출시할 가능성이 있습니다.
Gilead Sciences (Nasdaq: GILD) a annoncé des résultats révolutionnaires de son essai PURPOSE 2, évaluant le lenacapavir injectable deux fois par an pour la prévention du VIH. Ce médicament a réduit les infections par le VIH de 96% par rapport à l'incidence de VIH de fond, avec seulement 2 cas incidents parmi 2 180 participants. Le lenacapavir a également démontré une supériorité par rapport au Truvada quotidien, affichant une efficacité supérieure de 89%. L'essai a inclus des participants divers venus de sept pays.
Résultats clés :
- 99,9% des participants n'ont pas contracté le VIH dans le groupe lenacapavir
- Le lenacapavir était 96% plus efficace que l'incidence de VIH de fond
- 89% plus efficace que le Truvada pris une fois par jour
- Généralement bien toléré, sans préoccupations de sécurité significatives
Gilead prévoit de commencer les dépôts réglementaires mondiaux d'ici la fin 2024, avec un lancement potentiel de la première option de prévention du VIH deux fois par an en 2025.
Gilead Sciences (Nasdaq: GILD) hat bahnbrechende Ergebnisse aus seiner Studie PURPOSE 2 bekannt gegeben, die zweimal jährlich injizierbares Lenacapavir zur HIV-Prävention bewertet. Das Medikament verringerte die HIV-Infektionen um 96% im Vergleich zur Grundinzidenz von HIV, mit nur 2 neu aufgetretenen Fällen unter 2.180 Teilnehmern. Lenacapavir zeigte auch Überlegenheit gegenüber täglichem Truvada mit einer 89% höheren Wirksamkeit. Die Studie umfasste eine diverse Teilnehmergruppe aus sieben Ländern.
Wichtige Erkenntnisse:
- 99,9% der Teilnehmer im Lenacapavir-Gruppe haben kein HIV erworben
- Lenacapavir war 96% wirksamer als die Grundinzidenz von HIV
- 89% wirksamer als täglich eingenommenes Truvada
- Allgemein gut verträglich ohne signifikante Sicherheitsbedenken
Gilead plant, bis Ende 2024 mit den globalen regulatorischen Einreichungen zu beginnen, um möglicherweise 2025 die erste HIV-Präventionsoption, die zweimal jährlich angewendet wird, auf den Markt zu bringen.
- Lenacapavir reduced HIV infections by 96% compared to background HIV incidence
- 99.9% of participants did not acquire HIV in the lenacapavir group
- Lenacapavir demonstrated 89% greater effectiveness compared to daily Truvada
- The drug was generally well-tolerated with no significant safety concerns
- Potential launch of the first twice-yearly HIV prevention option in 2025
- Gilead plans to begin global regulatory filings by the end of 2024
- The trial included diverse participants from seven countries, enhancing the study's applicability
- 2 incident cases of HIV infection occurred among 2,180 participants in the lenacapavir group
- Lenacapavir for HIV prevention is still investigational and not yet approved globally
Insights
The PURPOSE 2 trial results for lenacapavir are highly impactful for HIV prevention. With a
Gilead's lenacapavir results present a substantial market opportunity. The potential for a twice-yearly PrEP option could significantly expand Gilead's HIV prevention market share. With plans for global regulatory filings by end-2024 and possible launch in 2025, Gilead is positioned for near-term revenue growth. The company's commitment to access in high-incidence, low-resource countries may impact pricing strategies but could lead to volume-driven growth. Investors should monitor regulatory progress and Gilead's ability to execute its access strategy. The positive data could strengthen Gilead's competitive position in the HIV market, potentially driving stock appreciation and long-term value creation.
Lenacapavir's efficacy in the PURPOSE 2 trial represents a potential game-changer for global HIV prevention. The twice-yearly dosing could significantly improve adherence, a major barrier in current PrEP strategies. The diverse study population, including cisgender men, transgender individuals and multiple countries, enhances its potential impact across various demographics. Gilead's prioritization of high-incidence, low-resource countries aligns with global health equity goals. However, implementation challenges such as healthcare infrastructure and cost barriers must be addressed. If approved and widely accessible, lenacapavir could accelerate progress towards ending the HIV epidemic, marking a major public health milestone.
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– PURPOSE 2 Trial Results for Cisgender Men and Gender-Diverse People Add to the Body of Evidence for the Investigational Use of Lenacapavir for HIV Prevention –
– Gilead Stopped the Blinded Phase of the Trial at Interim Analysis and Will Offer Open-Label Lenacapavir to All Participants –
The trial, PURPOSE 2 (NCT04925752), includes cisgender men, transgender men, transgender women, and gender non-binary individuals in
“With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP.”
This is the second pivotal Phase 3 trial to demonstrate superior efficacy for twice-yearly lenacapavir for the investigational use of HIV prevention as PrEP. In June 2024, the PURPOSE 1 trial, studying lenacapavir for PrEP among cisgender women in sub-Saharan Africa, was also unblinded early because it met its key efficacy endpoints.
The data from the PURPOSE 1 and PURPOSE 2 trials will support upcoming regulatory filings so that twice-yearly lenacapavir for PrEP, if approved, can be made available to multiple populations and communities around the world who are most in need of additional HIV prevention choices. Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress. Gilead will begin a series of global regulatory filings by the end of 2024. This could support the initial launch of the first and only twice-yearly HIV prevention choice in 2025.
Gilead is executing an access strategy that prioritizes speed and enables the most efficient paths for the regulatory review and approval of lenacapavir for PrEP in regions around the world. This strategy will prioritize high-incidence, low-resource countries, which are primarily low- and lower-middle income countries. Gilead is committed to making lenacapavir available in the countries where the need is greatest, including expediting voluntary licensing partners to supply high-quality, low-cost versions of lenacapavir. Gilead is actively working to finalize these contracts.
Topline PURPOSE 2 Data
PURPOSE 2, a phase 3, double-blind, multicenter, randomized study, is evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP versus once-daily oral Truvada and background HIV incidence (bHIV) in more than 3,200 cisgender men, transgender men, transgender women and gender non-binary individuals aged 16 years or older who have sex with partners assigned male at birth. There were 88 trial sites in
Study participants were randomized in a 2:1 ratio to lenacapavir and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.
There were 2 incident cases among 2,180 participants in the lenacapavir group (incidence 0.10 per 100 person-years);
More detailed data from PURPOSE 2 will be presented at a future conference.
“The difficulty some people can experience with taking an oral pill every day, including challenges with adherence and stigma, have hindered uptake and persistence of the standard of care for too long, thus blunting PrEP’s impact on HIV prevention,” 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. “The incredible efficacy demonstrated in the PURPOSE 2 trial, the potential benefits of a twice-yearly injection, and the diversity of trial sites and participants show the impact that lenacapavir for PrEP could have for people around the world who need new choices to reduce their chances of acquiring HIV. This breakthrough adds significantly to our arsenal of tools to move us closer to achieving an AIDS-free generation.”
“In the United States, the stubbornly high rate of HIV diagnoses—especially in the
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 Truvada and 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; 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 June 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/20240911262458/en/
Ashleigh Koss, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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