Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen SPIRIT STUDY
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Study Design Study Design: SPIRIT STUDY • Background : Open label, randomized phase 3b trial evaluating switching from ritonavir-boosted Immediate Switch Arm PI plus 2 NRTIs to single-tablet regimen of rilpivirine-tenofovir DF-emtricitabine once daily RPV-TDF-FTC QD (n = 317) • Inclusion Criteria (n = 476) 2x - Age >18 years - HIV RNA <50 copies/mL for >6 months 1x - On PI/r >6 months Delayed Switch Arm - No known resistance to study drugs PI/r + 2 NRTIs x 24 weeks, then RPV-TDF-FTC QD • Treatment Arms (n = 159) - Rilpivirine-tenofovir DF-emtricitabine - Ritonavir-boosted PI + 2 NRTIs x 24 weeks, then rilpivirine-tenofovir DF-emtricitabine Source: Palella FJ, et al. AIDS. 2014;28:335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Study Design Baseline Antiretroviral Regimens Immediate Switch Arm Delayed Switch Arm (n = 317) (n= 159) NRTI at Screening TDF-FTC 80.4% 81.8% ABC-3TC 13.2% 13.2% Ritonavir-Boosted PI at Screening Atazanavir 38.5% 34.0% Lopinavir 30.6% 36.5% Darunavir 19.9% 20.8% Fosamprenavir 7.9% 7.5% Saquinavir 1.9% 1.3% Source: Palella FJ, et al. AIDS. 2014;28:335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Result Week 24 Virologic Response (Intent-to-Treat Analysis) RPV-FTC-TDF PI/r + 2NRTIs 100 HIV RNA <50 copies/mL (%) 95 95 94 92 90 89 80 60 40 20 297/317 143/159 155/163 83/93 125/131 48/52 0 Overall >100,000 copies/mL ≤100,000 copies/mL Baseline HIV RNA Level Source: Palella FJ, et al. AIDS. 2014;28:335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Result Virologic Failure (HIV RNA ≥50 copies/mL) at Weeks 24 and 48 Immediate switch Delayed switch 8 Virologic Failure (%) 6 5.0 4 2.5 2 1.3 0.9 3/317 8/159 8/317 2/152 0 24 Weeks 48 Weeks Study Week Source: Palella FJ, et al. AIDS. 2014;28:335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Result Week 24: Change in Plasma Lipids from Baseline RPV-FTC-TDF PI/r + 2NRTIs 20 Mean change from baseline (mg/dl) 3 1 0 0 -1 -6 -20 -16 -25 -40 -53 -60 -80 Total Cholesterol LDL Triglycerides HDL Source: Palella FJ, et al. AIDS. 2014;28:335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Result Week 48: Change in Plasma Lipids from Baseline Immediate switch Delayed switch Mean change from baseline (mg/dl) 0 -2 -4 -20 -14 -16 -24 -24 -40 -60 -64 -80 -80 -100 Total Cholesterol LDL HDL Triglycerides Source: Palella FJ, et al. AIDS. 2014;28(3):335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Result Week 48 Virologic Outcomes in Patients with Resistance Mutations* RPV-FTC-TDF-treated patients 100 83 80 Patients (%) 60 40 20 11 6 29/35 4/35 2/35 0 Virologic Suppression Virologic Failure No Data in Window *Pre-existing NRTI or NNRTI resistance mutations by baseline proviral DNA or historical RNA genotype Source: Porter DP, et al. HIV Clin Trials. 2016;17:29-37.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Conclusions Conclusion : “Switching to the STR RPV/FTC/TDF from an RTV- boosted protease inhibitor regimen in virologically suppressed, HIV-1- infected participants maintained virologic suppression with a low risk of virologic failure, while improving total cholesterol, LDL, and triglycerides.” Source: Palella FJ, et al. AIDS. 2014;28:335-44.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Patient-Reported Outcomes 17 Weight loss 13 PI/r + 2NRTIs 36 Sex problems 23 RPV-TDF-FTC 32 Muscle pain 28 35 Bloating 21 27 Headache 19 30 Skin Problems 25 31 Anxiety 29 36 Sadness 28 50 Diarrhea 19 12 Nausea 9 34 Memory Loss 29 17 Fever 17 46 Fatigue 38 0 10 20 30 40 50 60 Occurrence of HIV-Related Symptoms (%) Source: Brunetta J, et al. Patient. 2015;8:257-67.
Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen Spirit: Conclusions Conclusions : “These data suggest that switching to the STR RPV/FTC/TDF from a PI-based multi-pill regimen is associated with greater patient-reported treatment satisfaction and improved tolerability in HIV-1-infected, virologically suppressed individuals.” Source: Brunetta J, et al. Patient. 2015;8:257-67.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program. The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.
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