Gilead Presents Additional Efficacy, Safety and Demographic Data From PURPOSE 2 Trial at 5th HIV Research for Prevention Conference
Gilead Sciences presented additional data from its Phase 3 PURPOSE 2 trial at the 5th HIV Research for Prevention Conference. The trial evaluated the efficacy and safety of twice-yearly lenacapavir for HIV prevention among cisgender men and gender-diverse people. Key findings include:
1. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence.
2. Only 2 incident cases among 2,179 participants receiving lenacapavir (0.10/100 person-years).
3. Lenacapavir was 89% more effective than once-daily Truvada.
4. The trial included a diverse population across 7 countries, with 67% non-White participants.
Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024. The company has also signed voluntary licensing agreements with six pharmaceutical companies to manufacture low-cost versions for 120 low- and lower-middle income countries.
Gilead Sciences ha presentato ulteriori dati dal suo studio di Fase 3 PURPOSE 2 durante la 5ª Conferenza sulla Ricerca per la Prevenzione dell'HIV. Lo studio ha valutato l'efficacia e la sicurezza del lenacapavir per la prevenzione dell'HIV con somministrazione semestrale tra uomini cisgender e persone di genere diverso. I risultati principali includono:
1. Il lenacapavir ha ridotto le infezioni da HIV del 96% rispetto all'incidenza di base dell'HIV.
2. Solo 2 casi incidenti tra 2.179 partecipanti che ricevevano lenacapavir (0.10/100 anni-persona).
3. Il lenacapavir è stato superiore del 89% rispetto a Truvada assunto una volta al giorno.
4. Lo studio ha incluso una popolazione diversificata proveniente da 7 paesi, con il 67% di partecipanti non bianchi.
Gilead prevede di iniziare le pratiche regolatorie per il lenacapavir per la PrEP entro la fine del 2024. L'azienda ha anche firmato accordi di concessione volontaria con sei aziende farmaceutiche per produrre versioni a basso costo per 120 paesi a reddito basso e medio-basso.
Gilead Sciences presentó datos adicionales de su ensayo de Fase 3 PURPOSE 2 en la 5ª Conferencia sobre Investigación para la Prevención del VIH. El ensayo evaluó la eficacia y seguridad del lenacapavir para la prevención del VIH en hombres cisgénero y personas de género diverso. Los hallazgos clave incluyen:
1. El lenacapavir redujo las infecciones por VIH en un 96% en comparación con la incidencia de VIH de fondo.
2. Solo 2 casos incidentes entre 2,179 participantes que recibieron lenacapavir (0.10/100 años-persona).
3. El lenacapavir fue un 89% más efectivo que Truvada administrado una vez al día.
4. El ensayo incluyó una población diversa de 7 países, con un 67% de participantes no blancos.
Gilead planea comenzar a presentar solicitudes regulatorias para el lenacapavir para PrEP a finales de 2024. La empresa también ha firmado acuerdos de licencia voluntaria con seis compañías farmacéuticas para fabricar versiones de bajo costo para 120 países de ingresos bajos y medios bajos.
길리어드 사이언스는 제5회 예방을 위한 HIV 연구 회의에서 3상 PURPOSE 2 시험의 추가 데이터를 발표했습니다. 이 시험은 남성 및 젠더 다양성을 가진 사람들 사이에서 HIV 예방을 위한 반기 투여 레나카파비르의 효능과 안전성을 평가했습니다. 주요 발견 사항은 다음과 같습니다:
1. 레나카파비르는 배경 HIV 발생률에 비해 HIV 감염율을 96% 감소시켰습니다.
2. 레나카파비르를 투여받은 2,179명의 참가자 중 2건의 새로운 사례 (0.10/100 인년)만 발생했습니다.
3. 레나카파비르는 하루 한 번 복용하는 트루바다보다 89% 더 효과적이었습니다.
4. 이 시험은 7개 국가에서 다양한 인구를 포함하였으며, 67%는 비백인이었습니다.
길리어드는 2024년 말까지 레나카파비르의 PrEP을 위한 규제 신청을 시작할 계획입니다. 이 회사는 또한 120개 저소득 및 중간 소득 국가를 위해 저비용 버전을 제조할 6개 제약사와 자발적 라이센스 계약을 체결했습니다.
Gilead Sciences a présenté des données supplémentaires de son essai de phase 3 PURPOSE 2 lors de la 5e Conférence de recherche sur la prévention du VIH. L'essai a évalué l'efficacité et la sécurité du lenacapavir pour la prévention du VIH chez les hommes cisgenres et les personnes de genre divers. Les résultats clés incluent :
1. Le lenacapavir a réduit les infections à VIH de 96% par rapport à l'incidence de base du VIH.
2. Il n'y a eu que 2 cas incidentels parmi 2 179 participants recevant du lenacapavir (0.10/100 années-personnes).
3. Le lenacapavir était 89% plus efficace que Truvada pris une fois par jour.
4. L'essai a inclus une population diversifiée de 7 pays, avec 67% de participants non blancs.
Gilead prévoit de commencer les dépôts réglementaires pour le lenacapavir pour PrEP d'ici la fin de 2024. La société a également signé des accords de licence volontaire avec six entreprises pharmaceutiques pour produire des versions à faible coût pour 120 pays à revenu faible et intermédiaire.
Gilead Sciences hat auf der 5. HIV-Forschungskonferenz zur Prävention zusätzliche Daten aus der Phase-3-Studie PURPOSE 2 vorgestellt. Die Studie bewertete die Wirksamkeit und Sicherheit von halbjährlichem Lenacapavir zur HIV-Prävention bei cisgeschlechtlichen Männern und gender-diversen Personen. Zu den wichtigsten Ergebnissen gehören:
1. Lenacapavir reduzierte HIV-Infektionen um 96% im Vergleich zur Hintergrundinzidenz von HIV.
2. Nur 2 neue Fälle unter 2.179 Teilnehmern, die Lenacapavir erhielten (0.10/100 Personenjahre).
3. Lenacapavir war 89% effektiver als das einmal täglich eingenommene Truvada.
4. Die Studie umfasste eine vielfältige Population aus 7 Ländern, wobei 67% der Teilnehmer nicht-weißer Herkunft waren.
Gilead plant, bis Ende 2024 mit den regulatorischen Anmeldungen für Lenacapavir für PrEP zu beginnen. Das Unternehmen hat auch freiwillige Lizenzvereinbarungen mit sechs Pharmaunternehmen unterzeichnet, um kostengünstige Versionen für 120 einkommensschwache und untere Mittelklasseländer herzustellen.
- Lenacapavir demonstrated a 96% reduction in HIV infections compared to background HIV incidence
- Lenacapavir was 89% more effective than once-daily Truvada for HIV prevention
- The trial included a diverse population across 7 countries, enhancing the study's applicability
- Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024
- Voluntary licensing agreements signed with six pharmaceutical companies for low-cost versions in 120 countries
- Two incident cases of HIV infection occurred among participants receiving lenacapavir
- Injection site reactions were common, with 63.4% of lenacapavir recipients experiencing subcutaneous nodules
Insights
The PURPOSE 2 trial results for lenacapavir are highly significant for HIV prevention. The data shows a 96% reduction in HIV infections compared to background incidence, demonstrating superior efficacy to daily oral Truvada. Key points:
- Only 2 incident cases among 2,179 participants receiving lenacapavir (0.10/100 person-years)
- 89% more effective than once-daily Truvada
- Well-tolerated with few serious adverse events
- Diverse participant pool across 7 countries, including adolescents and gender-diverse individuals
This twice-yearly injectable could revolutionize HIV prevention, potentially improving adherence and accessibility. Gilead's plan to begin regulatory filings by end of 2024 and their voluntary licensing agreements for low-cost versions in 120 countries demonstrate a commitment to global access. However, challenges in implementation and cost in higher-income countries remain to be addressed.
This news is significantly positive for Gilead (GILD), potentially opening a large new market in HIV prevention. Key financial implications:
- Expands Gilead's HIV franchise beyond treatment into a growing prevention market
- Long-acting formulation could command premium pricing in developed markets
- Voluntary licensing for 120 countries balances access with maintaining pricing power in key markets
- Could offset future Truvada revenue losses from generic competition
- Regulatory filings planned for end of 2024 suggest potential launch in 2025-2026, impacting medium-term growth prospects
While exact revenue potential is unclear without pricing information, the large addressable market and superior efficacy to current standards could make lenacapavir for PrEP a multi-billion dollar opportunity. Investors should monitor regulatory progress and initial uptake in early markets post-approval.
– Efficacy and Safety Data Demonstrated
– Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by End of 2024 –
– Gilead Recently Announced Voluntary Licensing Partners to Expand Future Access in High-Incidence, Resource-Limited Countries –
The new data are being presented during an oral abstract session on October 8 at the 5th HIV Research for Prevention Conference (HIVR4P) in
“These data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic,” said Colleen Kelley, MD, MPH, Professor of Medicine at Emory University and a PURPOSE 2 Principal Investigator. “PURPOSE 2 was intentionally designed to reflect the lives and locations of many people who are disproportionately affected by HIV around the world by focusing on gender, racial, ethnic and geographic diversity.”
Lenacapavir was highly effective in PURPOSE 2, reducing HIV infections by
Lenacapavir was highly effective at reducing infections among trial participants:
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 3,273 cisgender gay, bisexual, and other men, transgender women, transgender men, and gender nonbinary individuals aged 16 years or older who have sex with partners assigned male at birth. The trial spanned 88 sites in
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, 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.
Lenacapavir was well-tolerated among trial participants with few serious adverse events
Safety and tolerability findings from PURPOSE 2 demonstrated no significant or new safety concerns identified, and lenacapavir was generally well-tolerated.
Aside from injection site reactions (ISRs), the most common adverse events (AEs) observed were rectal chlamydia infection (lenacapavir:
Serious AEs were reported in
Few discontinuations due to injection site reactions
Lenacapavir is injected into the subcutaneous layer of fat in the abdomen to form a drug depot, which should get smaller and resolve, or reduce in size substantially, prior to the next lenacapavir injection. The drug depot may be palpable as a bump or nodule but is usually not visible.
A total of 15,239 lenacapavir and placebo injections were administered during the trial. The most commonly reported ISRs were subcutaneous nodules (lenacapavir:
High level of diversity among trial participants and geographic regions
The importance of studying HIV prevention across diverse global communities and populations, including gender-diverse populations, was one of the key recommendations from the PURPOSE 2 Global Community Advisory Group (G-CAG) and other community members. As a result, the study enrolled participants from seven countries across four continents and was the first Phase 3 HIV prevention trial to intentionally include transgender men and non-binary individuals.
Among trial participants,
Community advocates also stressed the importance of including adolescents and young people in PURPOSE 2, which, along with PURPOSE 1, is the first Phase 3 HIV prevention trial to intentionally include adolescents. About one-third of PURPOSE 2 trial participants were aged 25 years or younger, and the median age of participants was 29.
More detailed data from PURPOSE 2 will be presented at a future conference and in a future publication.
Gilead to begin regulatory filings for lenacapavir for PrEP by the end of 2024 and recently announced voluntary licensing partners to increase access in high-incidence, resource-limited countries
To ensure the results from PURPOSE 1 and PURPOSE 2 help translate into decreased HIV incidence globally if lenacapavir for PrEP is approved, 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 trials will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024.
On October 2, 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 primarily low- and lower-middle income countries. These agreements are just one component of Gilead’s overall global strategy to enable broad, sustainable access to lenacapavir for PrEP, if approved. 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 timely regulatory filings, engagement with partners and governments, and manufacturing planning. This includes the countries with PURPOSE 2 trial sites, including
“The PURPOSE clinical trial program continues to set new standards for innovative science, trial design, community input and intentional recruitment, all coming together to yield stellar results,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development and Virology Therapeutic Area Head, Gilead Sciences. “Gilead is committed to employing the same kind of rigorous, thoughtful and collaborative approach to ensure that lenacapavir for PrEP has the most transformative impact possible if approved.”
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 Statement
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 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).
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Ashleigh Koss, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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