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Switch ABC/3TC to TAF/FTC

This study evaluates the non-inferiority of switching from ABC/3TC to TAF/FTC in maintaining virologic suppression in HIV-positive adults. It also compares renal biomarkers, bone mineral density, and fasting lipids between the two regimens.

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Switch ABC/3TC to TAF/FTC

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  1. Switch ABC/3TC to TAF/FTC • GS-US-1717 Study

  2. GS-US-1717 Study: Switch ABC/3TC to TAF/FTC Randomisation 1 : 1 Double-blind • Design W48 W96 TAF/FTC * + continuation 3rd agent + ABC/3TC placebo HIV+ adults On ABC/3TC + 3rd agent ≥ 6 months HIV-1 RNA < 50 c/mL ≥ 6 months Any CD4Creatinine clearance ≥ 50 mL/min N = 280 ABC/3TC + continuation 3rd agent + TAF/FTC placebo N = 276 * TAF/FTC : 100/200 mg when coadministered with ATV boosted, DRV boosted or LPV/r ; 25/200 mg when co-administered with NNRTI, RAL, DTG or MVC • Objective • Primary endpoint: non-inferiority of TAF/FTC at W48: % HIV-1 RNA < 50 c/mL by ITT, snapshot analysis ; lower limit of the 95% CI for the difference = - 10%, 90% power GS-US-1717 Winston A, Lancet HIV.2018 ; 5:e162-71

  3. GS-US-1717 Study: Switch ABC/3TC to TAF/FTC Baseline characteristics and patient disposition GS-US-1717 Winston A, Lancet HIV.2018 ; 5:e162-71

  4. 88 GS-US-1717 Study: Switch ABC/3TC to TAF/FTC Efficacy at W48 (ITT, snapshot) Per protocol analysis TAF/FTC (N = 253) ABC/3TC (N = 248) • HIV RNA < 50 c/mL at W48 • TAF/FTC : 99.1% • ABC/3TC : 99.1% • Difference : 0.0% (95% CI: -2.5 to 2.3) % 93 100 90 80 60 Difference (95% CI) : 0.8% (- 1.5 to 3.3) 40 20 9 6 2 1 0 HIV RNA < 50 c/mL HIV RNA > 50 c/mL No virologic data Emergence of resistance, N Difference : - 3.0% (95%CI : - 8.2 to 2.0) * Confirmed HIV RNA > 50 c/mL or unconfirmed > 400 c/mL at last visit GS-US-1717 Winston A, Lancet HIV.2018 ; 5:e162-71

  5. GS-US-1717 Study: Switch ABC/3TC to TAF/FTC Adverse events * Consideredrelated to studydrug (n = 8) : abdominal distension + myalgia, nausea + vomiting + dehydration, nausea + feeling jittery + decreaseappetite, anxiety, Brugada syndrome, increasedcreatinine, burning sensation + headache + paresthesia, vision blurred + visualfielddefect + eye pain ; not related to studydrug : cough, tuberculosis, suddencardiacdeath, neutropenia ** Consideredrelated to studydrug (n = 8) : affective disorder, panic attack, depression + bone pain + arthralgia, dermatitis + pruritus, rash + pruritus, diarrhea, myalgia + dysesthesia, tinnitus + dry mouth + dyspnea ; not related to studydrug: depression + suicide attempt GS-US-1717 Winston A, Lancet HIV.2018 ; 5:e162-71

  6. 89 GS-US-1717 Study: Switch ABC/3TC to TAF/FTC Median changes in creatinine clearance (Q1, Q3), mL/min TAF/FTC ABC/3TC 10 • No difference between groups in changes at W48: • in renal biomarkers (urine RBP:creatinine and B2M:creatinine ratios) • in bone mineral density • (hip and lumbar spine) 1.3 mL/min p = 0.05 0 - 1.1 mL/min -10 0 12 24 36 48 Weeks Median changes in fastinglipids at W48, mg/dL TAF/FTC Total cholesterol LDL-cholesterol HDL-cholesterol Triglycerides 10 ABC/3TC 4 3 2 2 0 0 0 -1 -2 p = 0.18 p = 0.54 p < 0.001 p = 0.48 -10 GS-US-1717 Winston A, Lancet HIV.2018 ; 5:e162-71

  7. GS-US-1717 Study: Switch ABC/3TC to TAF/FTC • Conclusion • Switch from ABC/3TC to TAF/FTC was non inferior to ABC/3TC in maintaining virologic suppression in combination with a variety of third agents • No differences of TAF/FTC vs ABC/3TC in • Renal biomarkers • Bone mineral density • Fasting lipids • In virologically suppressed patients with creatinine clearance > 50 mL/min, TAF/FTC provides an alternative backbone to ABC/3TC with similar effects on kidney and bone GS-US-1717 Winston A, Lancet HIV.2018 ; 5:e162-71

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