Shots:
- The US FDA approved MSD‘s Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance
- Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from BIKTARVY to Idvynso or stayed on therapy, & Trial 051 (n=551), where oral ART-treated pts switched to Idvynso or remained on the same regimen
- In Trial 052, 1% on Idvynso (n=342) vs 1% on BIKTARVY (n=171) had HIV-1 RNA ≥50 copies/mL at Wk. 48, with 92% vs 94% maintaining suppression; in Trial 051, 1% on Idvynso (n=366) vs 5% on bART (n=185) had ≥50 copies/mL, with 96% vs 92% maintaining suppression. Results were consistent across all subgroups
Ref: Merck | Image: Merck | Press Release
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