Battle for HIV PrEP Market: Gilead’s Twice-Yearly Injection Challenges GSK’s Apretude

Gilead's lenacapavir, a twice-yearly injectable for HIV prevention, showed 96% efficacy in reducing HIV infections compared to background HIV incidence in the PURPOSE 2 trial1.

Lenacapavir demonstrated 100% efficacy in preventing HIV in cisgender women in the PURPOSE 1 trial4.

GSK and ViiV Healthcare's Apretude, a bi-monthly injectable PrEP, showed over 99% effectiveness in preventing HIV infections in real-world studies3.

Gilead plans to submit regulatory filings for lenacapavir by the end of 2024, with a potential launch in 20251.

Apretude, approved in 2021, is the first long-acting PrEP option on the U.S. market3.

Both companies are working on extending dosing intervals, with Gilead's lenacapavir offering a twice-yearly option compared to Apretude's current two-month dosing schedule3.

The introduction of long-acting PrEP options is considered a pivotal moment for global HIV prevention efforts5.

Ensuring equitable access to these new prevention options in low- and middle-income countries remains a challenge5.

The global HIV prevention goal is to ensure 95% of people at risk of HIV infection are using combination prevention options by 20255.

The competition between Gilead and GSK in the long-acting PrEP market is expected to drive innovation and potentially improve access to HIV prevention options3.

Sources:

1. https://www.gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-for-hiv-prevention-reduced-hiv-infections-by-96-and-demonstrated-superiority-to-daily-truvada-in-second-pivotal-phase-3-trial

3. https://www.biospace.com/drug-development/gsk-viiv-tout-99-effectiveness-for-long-acting-prep-as-gilead-gains-ground

4. https://www.gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention

5. https://www.csis.org/analysis/closing-prevention-gap

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