Switch to RPV-TDF-FTC from Ritonavir-boosted PI Regimen SPIRIT Study
The SPIRIT study is a phase 3b trial evaluating switching from ritonavir-boosted PI plus 2 NRTIs to a single-tablet regimen of rilpivirine-tenofovir DF-emtricitabine. Results at week 24 showed high virologic response rates and favorable lipid profile changes. Immediate and delayed switch arms were compared, with RPV-TDF-FTC showing promising outcomes. Visit the provided links for more detailed information and study findings.
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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 Background: Open-label, randomized, phase 3b trial evaluating switching from ritonavir-boosted PI plus 2 NRTIs to single-tablet regimen of rilpivirine- tenofovir DF-emtricitabine once daily ImmediateSwitch Arm RPV-TDF-FTC QD (n = 317) Inclusion Criteria - Age 18 years - HIV RNA <50 copies/mL for 6 months - On PI with ritonavir 6 months - No known resistance to study drugs 2x 1x Delayed Switch Arm PI/r + 2 NRTIs x 24 weeks, then RPV-TDF-FTC QD (n = 159) Treatment Arms - Rilpivirine-tenofovir DF-emtricitabine - PI with ritonavir (PI/r) + 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 (n = 317) Delayed Switch Arm (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: Results 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: Results Virologic Failure (HIV RNA 50 copies/mL) at Weeks 24 and 48 Immediate switch Delayed switch 6.0 5.0 Virologic Failure (%) 5.0 4.0 3.0 2.5 2.0 1.3 0.9 1.0 3/317 8/159 8/317 2/152 0.0 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: Results 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 0 Mean change from baseline (mg/dl) -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* 100 RPV-TDF-FTC-treated patients 83 80 Patients (%) 60 40 20 11 6 29/35 2/35 4/35 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.
Acknowledgments The National HIV Curriculum is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $1,021,448 with 0% financed with non-governmental sources. The contents 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. For more information, please visit HRSA.gov. This project is led by the University of Washington s Infectious Diseases Education and Assessment (IDEA) Program.
