TY - JOUR
T1 - Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96
AU - Arastéh, Keikawus
AU - Yeni, Patrick
AU - Pozniak, Anton
AU - Grinsztejn, Beatriz
AU - Jayaweera, Dushyantha
AU - Roberts, Afsoon
AU - Hoy, Jennifer
AU - De Meyer, Sandra
AU - Vangeneugden, Tony
AU - Tomaka, Frank
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2009
Y1 - 2009
N2 - Background: Long-term (96-week) efficacy and safety of the protease inhibitor (PI) darunavir coadministered with low-dose ritonavir (DRV/r) was evaluated in HIV type-1 (HIV-1)-infected patients with extensive prior treatment experience in the POWER 1, 2 and 3 trials. Methods: Patients with HIV-1 RNA≥1,000 copies/ml and ≥1 primary PI mutation were randomized to receive either DRV/r 600/100 mg twice daily plus an optimized background regimen (OBR), or an investigator-selected control PI (CPI) plus OBR (POWER 3 was a DRV/r 600/100 mg twice daily single-arm study). The proportion of patients with HIV-1 RNA<50 copies/ml at week 96 was assessed (intent-to-treat [ITT], time-to-loss of virological response algorithm). Results: In total, 467 patients received DRV/r 600/100 mg twice daily; 124 patients received CPI(s). At week 96, 39% of DRV/r patients in POWER 1 and 2 (pooled analysis) versus 9% of CPI patients achieved HIV-1 RNA<50 copies/ ml (ITT, time-to-loss of virological response algorithm; P<0.001). A similar proportion of DRV/r patients (42%) in POWER 3 achieved HIV-1 RNA<50 copies/ml at week 96. Mean absolute CD4+ T-cell count increase for DRV/r at 96 weeks was 133 cells/mm3 in POWER 1 and 2 and 103 cells/mm3 in POWER 3. Grade 2-4 treatmentemergent adverse events at least possibly related to DRV/r (≥2% incidence, excluding laboratory abnormalities) were diarrhoea (3%), vomiting (3%), nausea (2%) and headache (2%). Conclusions: Treatment with DRV/r 600/100 mg twice daily was well tolerated and led to sustained virological and immunological responses in treatment-experienced HIV-1-infected patients over 96 weeks.
AB - Background: Long-term (96-week) efficacy and safety of the protease inhibitor (PI) darunavir coadministered with low-dose ritonavir (DRV/r) was evaluated in HIV type-1 (HIV-1)-infected patients with extensive prior treatment experience in the POWER 1, 2 and 3 trials. Methods: Patients with HIV-1 RNA≥1,000 copies/ml and ≥1 primary PI mutation were randomized to receive either DRV/r 600/100 mg twice daily plus an optimized background regimen (OBR), or an investigator-selected control PI (CPI) plus OBR (POWER 3 was a DRV/r 600/100 mg twice daily single-arm study). The proportion of patients with HIV-1 RNA<50 copies/ml at week 96 was assessed (intent-to-treat [ITT], time-to-loss of virological response algorithm). Results: In total, 467 patients received DRV/r 600/100 mg twice daily; 124 patients received CPI(s). At week 96, 39% of DRV/r patients in POWER 1 and 2 (pooled analysis) versus 9% of CPI patients achieved HIV-1 RNA<50 copies/ ml (ITT, time-to-loss of virological response algorithm; P<0.001). A similar proportion of DRV/r patients (42%) in POWER 3 achieved HIV-1 RNA<50 copies/ml at week 96. Mean absolute CD4+ T-cell count increase for DRV/r at 96 weeks was 133 cells/mm3 in POWER 1 and 2 and 103 cells/mm3 in POWER 3. Grade 2-4 treatmentemergent adverse events at least possibly related to DRV/r (≥2% incidence, excluding laboratory abnormalities) were diarrhoea (3%), vomiting (3%), nausea (2%) and headache (2%). Conclusions: Treatment with DRV/r 600/100 mg twice daily was well tolerated and led to sustained virological and immunological responses in treatment-experienced HIV-1-infected patients over 96 weeks.
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U2 - 10.3851/IMP1301
DO - 10.3851/IMP1301
M3 - Article
C2 - 19812449
AN - SCOPUS:72049085508
VL - 14
SP - 859
EP - 864
JO - Antiviral Therapy
JF - Antiviral Therapy
SN - 1359-6535
IS - 6
ER -