Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection

Shots: The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537) Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…

ByRidhi RastogiNovember 20, 2025

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: 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…

ByRidhi RastogiMarch 13, 2025

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: 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…

ByRidhi RastogiMarch 13, 2025

Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

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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