Switching to TAF from TDF with RPV and FTC Study GS-366-1216
This study, GS-366-1216, explores the transition from TDF to TAF in HIV-1-infected adults, focusing on safety and tolerability with RPV and FTC. The randomized trial investigates virologic response, changes in bone mineral density, markers of proximal tubulopathy, and plasma lipid levels at Week 48. Results indicate positive outcomes with the switch to RPV-TAF-FTC compared to remaining on RPV-TDF-FTC. Source: Lancet HIV, 2017.
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Switching to TAF from TDF, each with RPV and FTC Study GS-366-1216
Switch from TDF to TAF, each with RPV and FTC Study GS-366-1216: Design Background: Phase 3b, multinational, randomized, double- blind, placebo-controlled, noninferiority trial to investigate safety and tolerability of switching to the single-tablet regimen rilpivirine-tenofovir alafenamide-emtricitabine (RPV-TAF-FTC) Switch Group RPV-TAF-FTC (n= 316) Inclusion Criteria (n = 632 randomized) - HIV-1-infected adults - HIV RNA <50 copies/mL 6 months on RPV-TDF-FTC - Creatinine clearance at least 50 mL/min - No resistance to RPV, TDF, or FTC No Switch Group RPV-TDF-FTC (n = 314) Treatment Arms - Switch to RPV-TAF-FTC (Switch group) - Remain on RPV-TDF-FTC (No switch group) *NOTE: of 632 participants randomized, 2 were never treated (630 individuals treated) Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.
Switch to TAF from TDF, each with RPV and FTC Study GS-366-1216: Design Week 48 Virologic Response (FDA Snapshot Analysis) RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch) 100 HIV RNA <50 copies/mL (%) 94 94 90 80 70 60 296/316 294/313 50 Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.
Switch to TAF from TDF, each with RPV and FTC Study GS-366-1216: Results Week 48: Changes in Bone Mineral Density (BMD) RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch) 2 Mean Change in BMD (%) 1.61 1.04 1 0.08 0 -0.25 -1 Hip Spine Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.
Switch to TAF from TDF, each with RPV and FTC Study GS-366-1216: Results Week 48: Changes in Markers of Proximal Tubulopathy RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch) 40 Median Change from Baseline (%) 22 17 20 12 7 0 -8 -20 -18 -19 -29 -40 Proteinuria (UPCR) Albuminuria (APCR) Retinol binding protein 2 microglobulin Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.
Switch to TAF from TDF, each with RPV and FTC Study GS-366-1216: Results Week 48: Change in Plasma Lipids from Baseline RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch) 20 16 Change in Median Value 10 10 (mg/dL) 5 2 0 0 -1 -2 -6 -10 Total Cholesterol LDL HDL Triglycerides Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.
Switch to TAF from TDF, each with RPV and FTC Study GS-366-1216: Conclusions Interpretation: Switching to rilpivirine, emtricitabine, and tenofovir alafenamide was non-inferior to continuing rilpivirine, emtricitabine, tenofovir disoproxil fumarate in maintaining viral suppression and was well tolerated at 48 weeks. These findings support guidelines recommending tenofovir alafenamide-based regimens, including coformulation with rilpivirine and emtricitabine, as initial and ongoing treatment for HIV-1 infection. Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.
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.
