Gilead Sciences: Designing Inclusive Clinical Trials in an Effort To Upend the HIV Epidemic
Gilead Sciences' PURPOSE 1 trial, focusing on HIV prevention in young African women and adolescent girls, represents a significant step in inclusive clinical research. The trial studies a PrEP medication administered every six months via injection and is part of the most comprehensive HIV prevention program ever conducted. The study enrolled thousands of cisgender women and girls aged 16-25 in South Africa and Uganda, including pregnant and lactating women - a first for a Phase 3 HIV prevention trial. The initiative addresses the disproportionate impact of HIV on women in sub-Saharan Africa, where approximately 3,100 women acquire HIV weekly. Preliminary results have been encouraging.
Il trial PURPOSE 1 di Gilead Sciences, focalizzato sulla prevenzione dell'HIV nelle giovani donne africane e nelle ragazze adolescenti, rappresenta un passo significativo nella ricerca clinica inclusiva. Lo studio esamina un farmaco PrEP somministrato ogni sei mesi tramite iniezione ed è parte del programma di prevenzione dell'HIV più completo mai condotto. Lo studio ha arruolato migliaia di donne e ragazze cisgender di età compresa tra 16 e 25 anni in Sud Africa e Uganda, comprese donne in gravidanza e in allattamento - un primo per un trial di fase 3 per la prevenzione dell'HIV. L'iniziativa affronta l'impatto sproporzionato dell'HIV sulle donne nell'Africa sub-sahariana, dove circa 3.100 donne contraggono l'HIV ogni settimana. I risultati preliminari sono stati incoraggianti.
El ensayo PURPOSE 1 de Gilead Sciences, centrado en la prevención del VIH en mujeres jóvenes africanas y niñas adolescentes, representa un paso significativo en la investigación clínica inclusiva. El ensayo estudia un medicamento PrEP administrado cada seis meses mediante inyección y forma parte del programa de prevención del VIH más completo jamás realizado. El estudio incluyó a miles de mujeres y niñas cisgénero de entre 16 y 25 años en Sudáfrica y Uganda, incluidas mujeres embarazadas y lactantes - un primer caso para un ensayo de fase 3 de prevención del VIH. La iniciativa aborda el impacto desproporcionado del VIH en las mujeres de África subsahariana, donde aproximadamente 3,100 mujeres contraen VIH semanalmente. Los resultados preliminares han sido alentadores.
Gilead Sciences의 PURPOSE 1 시험은 아프리카의 젊은 여성과 청소년 소녀를 대상으로 하는 HIV 예방에 중점을 두고 있으며, 포괄적인 임상 연구에서 중요한 진전을 나타냅니다. 이 시험은 6개월마다 주사로 투여되는 PrEP 약물을 연구하며, 지금까지 진행된 HIV 예방 프로그램 중 가장 포괄적인 프로그램의 일환입니다. 이 연구에서는 남아프리카와 우간다에서 16세에서 25세 사이의 많은 여성과 소녀들이 참여했으며, 임신한 여성과 수유 중인 여성도 포함되었습니다. 이는 3상 HIV 예방 시험 첫 사례입니다. 이 이니셔티브는 사하라 이남 아프리카 여성들에게 HIV가 미치는 불균형적인 영향을 해결하고 있으며, 매주 약 3,100명의 여성이 HIV에 감염되고 있습니다. 예비 결과는 고무적이었습니다.
L'essai PURPOSE 1 de Gilead Sciences, qui se concentre sur la prévention du VIH chez les jeunes femmes africaines et les adolescentes, représente une étape importante dans la recherche clinique inclusive. Cet essai étudie un médicament PrEP administré tous les six mois par injection et fait partie du programme de prévention du VIH le plus complet jamais réalisé. L'étude a recruté des milliers de femmes et de filles cisgenres âgées de 16 à 25 ans en Afrique du Sud et en Ouganda, y compris des femmes enceintes et allaitantes - une première pour un essai de phase 3 sur la prévention du VIH. Cette initiative répond à l'impact disproportionné du VIH sur les femmes en Afrique subsaharienne, où environ 3 100 femmes contractent le VIH chaque semaine. Les résultats préliminaires ont été encourageants.
Die PURPOSE 1 Studie von Gilead Sciences, die sich auf die HIV-Prävention bei jungen afrikanischen Frauen und jugendlichen Mädchen konzentriert, stellt einen wichtigen Schritt in der inklusiven klinischen Forschung dar. Die Studie untersucht ein PrEP-Medikament, das alle sechs Monate per Injektion verabreicht wird und ist Teil des umfassendsten HIV-Präventionsprogramms, das jemals durchgeführt wurde. Die Studie umfasst tausende cisgender Frauen und Mädchen im Alter von 16 bis 25 Jahren in Südafrika und Uganda, einschließlich schwangeren und stillenden Frauen - ein Novum für eine Phase-3-Studie zur HIV-Prävention. Die Initiative befasst sich mit den unverhältnismäßigen Auswirkungen von HIV auf Frauen in Subsahara-Afrika, wo wöchentlich etwa 3.100 Frauen HIV erwerben. Die vorläufigen Ergebnisse waren ermutigend.
- Encouraging preliminary results from PURPOSE 1 trial
- First Phase 3 HIV prevention trial to include pregnant and lactating women
- Addresses large market opportunity with 3,100 weekly HIV cases in target demographic
- None.
Insights
This clinical trial update, while focused on an important healthcare issue, lacks immediate market-moving implications. The PURPOSE 1 trial represents positive progress in HIV prevention research, but the preliminary results mentioned are not quantified and no specific data or regulatory milestones are discussed. Key points:
- The trial focuses on HIV prevention in African women and girls
- It's testing a 6-month injectable PrEP medication
- Includes pregnant and lactating women - a first for Phase 3 HIV prevention trials
This development could strengthen Gilead's long-term position in HIV prevention, but without specific efficacy data, regulatory timelines, or market potential estimates, the immediate impact on GILD's valuation is minimal. The market size for HIV prevention in sub-Saharan Africa, while significant from a public health perspective, may have commercial implications due to pricing and accessibility considerations in developing markets.
NORTHAMPTON, MA / ACCESSWIRE / November 26, 2024 / Women - especially teen girls and young women living in sub-Saharan Africa - are disproportionately impacted by HIV globally, with about 3,100 acquiring HIV each week. They've also historically been excluded from or underrepresented in HIV clinical trials. That's why Gilead's PURPOSE 1 trial, which studied the safety and efficacy of an investigational HIV pre-exposure prophylaxis or PrEP medication, set out to exclusively focus on young African women and adolescent girls.
Lead PURPOSE researcher Moupali Das, Vice President, Clinical Development, HIV Prevention & Pediatrics, designed the PURPOSE program with Gilead's person-centric approach in mind to reach underserved communities and groups around the world. In all, there are currently five PURPOSE clinical trials, with more in design phases, and the program is the most comprehensive and diverse program for an investigational HIV prevention medication ever conducted.
"Whenever we study a new innovation, we must be intentional about both the scientific and health equity aspects of it to ensure that it doesn't exacerbate existing disparities," explains Moupali. "Based on this approach, it's critical to ensure that we include people in our trials who are most disproportionately affected by HIV and who most need new choices for PrEP."
Thousands of cisgender women and girls between the ages of 16 and 25 in South Africa and Uganda were enrolled in the trial, which studied a medication that is administered once every six months via injection. Encouraging preliminary results were released earlier this year.
"As a researcher, you dream of these ‘pinch-me' moments that help provide a pathway toward new opportunities," says Moupali.
Before the trial was launched in 2021, Moupali and her colleagues worked closely with Global Community Accountability Groups. The groups' members are active in HIV advocacy and clinical development work and provide important insights on recruitment, retention, communication and how to best support participants while also taking into account cultural considerations. Based on input from these community partners, the PURPOSE 1 trial included pregnant and lactating women - making it the first Phase 3 HIV prevention trial to do so.
PURPOSE 1 has set a new standard for HIV prevention trials, demonstrating what can happen when a drug candidate, a thoughtful scientific and community-focused trial design, and an inclusive trial implementation plan come together.
"I'm filled with such hope as I think about what the PURPOSE program could mean for people who are members of groups that are disproportionally affected by HIV," Moupali says. "Potential new PrEP choices could be a key resource in helping to end the epidemic."
Originally published by Gilead Sciences
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