Shots:
- Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos.
- Decision to initiate P-III trial was supported by a P-II trial (vs PBO) in 350 low-risk adults, where MK-8527 showed a favorable PK, with comparable AE rates & no significant lab changes incl. total lymphocyte and CD4 T-cell counts; data was shared at IAS 2025
- MK-8527 inhibits reverse transcriptase through multiple mechanisms, incl. translocation inhibition & delayed chain termination for HIV PrEP
Ref: Merck| Image: Merck| Press Release
Related News:- Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA
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