Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96.
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>or=1,000 copies/ml and >or=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/mm(3) in POWER 1 and 2 and 103 cells/mm(3) in POWER 3. Grade 2-4 treatment-emergent adverse events at least possibly related to DRV/r (>or=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.
Arastéh
Keikawus
K
EPIMED, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany. keikawus.arasteh@vivantes.de
Yeni
Patrick
P
Pozniak
Anton
A
Grinsztejn
Beatriz
B
Jayaweera
Dushyantha
D
Roberts
Afsoon
A
Hoy
Jennifer
J
De Meyer
Sandra
S
Vangeneugden
Tony
T
Tomaka
Frank
F
D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069454:Darunavir; D004334:Drug Administration Schedule; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir