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 primary safety objective; data to be presented at a future conference & shared with global health authorities
- Additionally, the US FDA has accepted an NDA for DOR/ISL to treat HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen, with a PDUFA target action date of Apr 28, 2026
Ref: Merck | Image: Merck | Press Release
Related News:- Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF
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