Merck Reports Topline Data from P-III Studies of Doravirine/Islatravir (DOR/ISL) Regimen to Treat Virologically Suppressed HIV-1 Infection
Shots:
- The P-III [MK-8591A-051 (n=551) & MK-8591A-052 (n=513)] studies assessed a switch to DOR/ISL (100mg/0.25mg, PO, QD) in subjects with HIV-1 infection virologically suppressed on ART through wk.48 and BIC/FTC/TAF (50mg/200mg/25mg) through wk.144, respectively
- Both studies achieved the primary safety objectives & 1EP of patient proportion with HIV-1 RNA levels ≥50 copies/mL, showing non-inferiority of DOR/ISL to bART & BIC/FTC/TAF. Superiority was not achieved in MK-8591A-052
- Merck will highlight the results at upcoming conferences and will share with regulatory bodies, seeking its approval
Ref: Merck | Image: Merck
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