This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled Phase III trials in highly pre-treated patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors, where INTELENCE was investigated in combination with an optimised background regimen (OBR) which included darunavir/ ritonavir (see section 5.1).
Uuringus hinnati INTELENCE’ i kombinatsioonis optimeeritud taustravi skeemiga (optimised background regimen, OBR), mis sisaldas darunaviiri/ ritonaviiri (vt lõik 5. 1).