Darunavirr vs Tipranavirr in Treatment Experienced POTENT Trial

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Darunavir/r vs. Tipranavir/r in Treatment Experienced POTENT Trial

Darunavir/r vs. Tipranavir/r in Treatment Experienced POTENT Trial

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Study Design: POTENT • Background: Randomized, open-label trial

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Study Design: POTENT • Background: Randomized, open-label trial to compare the efficacy and safety of ritonavir-boosted tipranavir with ritonavir-boosted darunavir in tripleclass treatment-experienced HIV-infected patients with PI resistance Tipranavir + Ritonavir BID + OBR (n = 19) • Inclusion Criteria (n=39)^ - Triple class ARV treatment experience - HIV RNA ≥ 500 copies/m. L - CD 4 ≥ 50 cells/mm 3 - Documented resistance to more than one PI • Treatment Arms - Tipranavir 500 mg BID + RTV 200 mg BID + OBR* - Darunavir 600 mg BID + RTV 100 mg bid + OBR* Darunavir + Ritonavir BID + OBR (n = 20) ^Trial stopped early due to slow enrollment (only 39/800 randomized) *OBR = Optimized background regimen: ≥ 2 active antiretroviral agents Source: Elgadi MM, et al. Drugs R D. 2011; 11: 295 -302.

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Result Week 24: Virologic Data HIV RNA Levels

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Result Week 24: Virologic Data HIV RNA Levels Below Threshold Tipranavir + RTV + OBR 100 100 Darunavir + RTV + OBR 95 100 80 60 40 20 0 HIV RNA <400 copies/m. L Source: Elgadi MM, et al. Drugs R D. 2011; 11: 295 -302. HIV RNA <50 copies/m. L

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Result Week 32: Drug-Related Adverse Events Tipranavir +

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Result Week 32: Drug-Related Adverse Events Tipranavir + RTV + OBR Darunavir + RTV + OBR 50 Patients (%) 40 30 25 21 20 10 0 Adverse Events Source: Elgadi MM, et al. Drugs R D. 2011; 11: 295 -302.

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Conclusions/Significance: “TPV/r- and DRV/r-based regimens showed similar short-term

Tipranavir/r versus Darunavir/r in Treatment-Experienced POTENT: Conclusions/Significance: “TPV/r- and DRV/r-based regimens showed similar short-term safety and efficacy. These data support the use of next -generation PIs such as tipranavir or darunavir with novel class antiretroviral agents (integrase inhibitors, CCR 5 antagonists, or fusion inhibitors). ” Source: Elgadi MM, et al. Drugs R D. 2011; 11: 295 -302.

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center. The content in this slide set does not represent the official views of the U. S. Department of Health and Human Services, Health Resources & Services Administration.