Switch to Bictegravir-TAF-FTC in Viral Suppression Study
Explore a randomized, phase 3 study evaluating switching from a boosted PI plus 2 NRTIs to Bictegravir-TAF-FTC regimen in adults with viral suppression. The study focuses on efficacy and safety with baseline characteristics and 48-week virologic response results.
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Switch from Boosted PI + 2 NRTIs to BIC-TAF-FTC with Viral Suppression GS-380-1878
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Design Background - Randomized, phase 3, multicenter, open-label switch study evaluating the efficacy and safety of switching adults with viral suppression taking a boosted PI plus 2 NRTIs to BIC-TAF-FTC Switch Regimen Bictegravir-TAF-FTC (n = 290) Inclusion Criteria - Age 18 years - HIV RNA <50 copies/mL for 6 months - Taking stable antiretroviral regimen for 6 months - No history of virologic failure - No prior treatment with an INSTI - eGFR 50 mL/min - HBV and HCV allowed - Taking atazanavir or darunavir (each boosted by ritonavir or cobicistat) + TDF-FTC or ABC-3TC Maintain Regimen Boosted PI + 2 NRTIs (n = 287) Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Baseline Characteristics Study GS-380-1878 Baseline Characteristics BIC-TAF-FTC (n = 290) 48 Boosted PI + 2 NRTIs (n = 287) 47 Characteristic Median age, years (range) 84 82 Male, % 27 25 Black or African descent, % 21 16 Hispanic/Latino, % 617 626 Median CD4, cells/mL 8 6 HBV coinfection, % 5 5 HCV coinfection, % 107 105 Median eGFR, mL/min 84, 16 85, 15 Baseline TDF-FTC, ABC-3TC, % 57, 43 54, 46 Baseline DRV, ATV, % Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Baseline Characteristics Study GS-380-1878 Baseline Antiretroviral Regimen BIC-TAF-FTC (n = 290) Boosted PI + 2 NRTIs (n = 287) Baseline Antiretroviral Medications NRTI Tenofovir DF-emtricitabine, % 84 85 Abacavir-lamivudine, % 16 15 21 16 Protease Inhibitor Darunavir, % 57 54 Atazanavir, % 43 46 Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Results Week 48 Virologic Response (Intention-to-Treat Analysis) Bictegravir-TAF-FTC Boosted PI + 2 NRTIs 100 HIV RNA <50 copies/mL (%) 92 89 80 60 40 20 267/290 255/287 0 Primary outcome of HIV RNA 50 copies/mL at 48 weeks: 2% each arm Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Adverse Events Most Common Treatment-Related Adverse Events (AE s) Through 48 Weeks BIC-TAF-FTC (n = 290) Boosted PI + 2 NRTI s (n = 287) Headache, % 12 4 Diarrhea, % 8 8 Nasopharyngitis, % 7 12 URI, % 7 8 Back pain, % 5 6 Arthralgia, % 4 5 Change in eGFR -4.3 mL/min 0.2 mL/min Abbreviations: eGFR = estimated glomerular filtration Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Results Change in Lipids at 48 Weeks Bictegravir-TAF-FTC Boosted PI + 2 NRTI's 8 Median Change from Baseline (mg/dL) 5 6 4 3 3 4 1 1 2 0 0 -2 -4 -6 -6 -8 Total Cholesterol LDL HDL Triglycerides Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
Switch from Boosted PI + 2 NRTIs to Bictegravir-TAF-FTC GS-380-1878: Conclusions Interpretation: Fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide might be a safe and efficacious alternative to continued boosted protease inhibitor therapy in adults with HIV-1 infection. Source: Daar E, et al. Lancet HIV. 2018;5:e347-e356.
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.
