Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96

Keikawus Arastéh, Patrick Yeni, Anton Pozniak, Beatriz Grinsztejn, Dushyantha Jayaweera, Afsoon Roberts, Jennifer Hoy, Sandra De Meyer, Tony Vangeneugden, Frank Tomaka

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Abstract

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.

Original languageEnglish
Pages (from-to)859-864
Number of pages6
JournalAntiviral Therapy
Volume14
Issue number6
DOIs
Publication statusPublished - 21 Dec 2009

Cite this

Arastéh, K., Yeni, P., Pozniak, A., Grinsztejn, B., Jayaweera, D., Roberts, A., ... Tomaka, F. (2009). Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antiviral Therapy, 14(6), 859-864. https://doi.org/10.3851/IMP1301
Arastéh, Keikawus ; Yeni, Patrick ; Pozniak, Anton ; Grinsztejn, Beatriz ; Jayaweera, Dushyantha ; Roberts, Afsoon ; Hoy, Jennifer ; De Meyer, Sandra ; Vangeneugden, Tony ; Tomaka, Frank. / Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. In: Antiviral Therapy. 2009 ; Vol. 14, No. 6. pp. 859-864.
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title = "Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96",
abstract = "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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Arastéh, K, Yeni, P, Pozniak, A, Grinsztejn, B, Jayaweera, D, Roberts, A, Hoy, J, De Meyer, S, Vangeneugden, T & Tomaka, F 2009, 'Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96', Antiviral Therapy, vol. 14, no. 6, pp. 859-864. https://doi.org/10.3851/IMP1301

Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. / Arastéh, Keikawus; Yeni, Patrick; Pozniak, Anton; Grinsztejn, Beatriz; Jayaweera, Dushyantha; Roberts, Afsoon; Hoy, Jennifer; De Meyer, Sandra; Vangeneugden, Tony; Tomaka, Frank.

In: Antiviral Therapy, Vol. 14, No. 6, 21.12.2009, p. 859-864.

Research output: Contribution to journalArticleResearchpeer-review

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

PY - 2009/12/21

Y1 - 2009/12/21

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

VL - 14

SP - 859

EP - 864

JO - Antiviral Therapy

JF - Antiviral Therapy

SN - 1359-6535

IS - 6

ER -