Pozniak A 1, Jayaweera D 2, Hoy J 3, De Meyer S 4, De Paepe E 4, Spinosa-Guzman S 4
1 Chelsea and Westminster Hospital, London, UK
2 University of Miami, Miami, FL, USA
3 The Alfred Hospital, Melbourne, Australia
4 Tibotec BVBA, Mechelen, Belgium
Abstract
Introduction: Darunavir (DRV; TMC114) is a HIV protease inhibitor (PI) with potent activity against both wild-type and resistant HIV strains, including multidrug – and cross-res ist ant strains, and has a high genetic barrier to the development of resistance . The present study combined analysis of POWER 1 and 2 evaluated the efficacy of DRV / r 600/lO0mg bid compared with CPI(s) at Week 96. Methods: Patients were male or female, aged >18 years, with HIV-1 RNA >1, 000 copies/mL and > l primary PI mutation (D3 0N, M46I/L, G48V, IS0V/L, V82A /F/T /S, 184V and L90M)9 at screening. Hepatitis B or C co-infected patients were included in POWER 1 if clinically stable and not requiring treatment, but such patients were excluded from POWER 2. The primary efficacy endpoint was confirmed viral load reduction >1.0 log10 copies/mL at Week 96 from baseline (time -to-loss of virologi cal response [TLOVR) algorithm). The efficacy analysis was based on the intent-to -treat (ITT) popu lation. The secondary efficacy endpoints were the proportion of patients reaching a viral load <50 copies/mL (TLOVR), change in viral load from baseline (non-completer=failure [NC = F] analysis) and change in CD4 cell count from baseline (last observation carr ied forward analysis [LOCF]). Conclusions: Treatment with DRV / r 600/ 100mg bid led to sustained virological and immunological responses in treatment-experienced patients with advanced HIV infection over 96 weeks .Patients receivin g DRV/r 600/lO0mg bid had statistically significantly greater reductions in viral load and increases in CD4 cell count at Week 96 than patients receiv ing
CPI(s). These results support and extend the findings of POWER 1 and 2 at both Weeks 24 and 48, confirming that DRV /r 600/ l OOmg bid is a highly effe ctive treatment option in treatment-experienced patients.