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LEN PrEP PURPOSE-2 Twice-Yearly Gilead Glasgow Press Release
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Link to full release
https://www.gilead.com/news/news-details/2024/gilead-presents-full-purpose-2-data-results-for-twice-yearly-lenacapavir-for-hiv-prevention-at-hiv-glasgow
- 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 InnovationTranslates to Global Access and Real-World Impact -
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 Argentina, Brazil, Mexico, Peru and the United States, trial participants are being offered and will be able to stay on open-label lenacapavir until it is available in their country.
"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," "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." 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 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 Lima, Peru. Those previously reported data showed that lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV), with two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir also demonstrated superiority to once-daily Truvada ® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for pre-exposure prophylaxis (PrEP) and was generally well-tolerated, with no significant or new safety concerns identified.
Adherence to lenacapavir and to the placebo injections that were part of the oral PrEP study group was high: 91.0% of all trial participants received on-time injections at week 26, and 92.8% of participants received on-time injections at one year. On-time injection rates (within 28 weeks of prior injection) were similar across both study groups, whether receiving lenacapavir or placebo injections.
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.
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.
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