Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults
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- Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025
- MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It also met its 2EP, with 91.5% vs 94.2% maintaining viral suppression at 48wks
- MK-8591A-051 assessed it vs bART in adults (n=551), meeting its 1EP with 1.4% vs 4.9% subjects having viral load of ≥50 copies/mL at 48wks., while also achieving its 2EP of sustained viral suppression at 48wks (95.6% vs 91.9%); data was presented at CROI 2025
Ref: Merck | Image: Merck
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