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Switch to EVG/c/FTC/TDF STRATEGY-PI Study STRATEGY-NNRTI Study

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Design Endpoints –Primary: proportion of patients maintaining HIV RNA 0, assessment for superiority –Secondary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (TLOVR algorithm), CD4, safety, tolerability to W96 Switch to EVG/c/FTC/TDF Continue PI/r + FTC + TDF Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI Randomisation 2 : 1 Open-label HIV+ ≥ 18 years On FTC + TDF + PI/r HIV RNA 6 months No virologic failure Genotype testing before ART with no resistance to study drugs Integrase inhibitor naïve eGFR > 70 mL/min N = 145 N = 293 W48W96 STRATEGY-PI Study: Switch PI/r to EVG/c

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EVG/c/FTC/TDF N = 293 PI/r + FTC + TDF N = 140 Median age, years4140 Female15%14% Time since HIV diagnosis, median years44 On first ARV regimen77%83% PI at randomisation Atazanavir42%37% Darunavir39%43% Lopinavir17%16% Fosamprenavir2%4% Saquinavir1%0 CD4 cell count (/mm 3 ), median564585 Hepatitis B / hepatitis C coinfection3% / 7%2% / 7% Discontinuation by W4825 (8.5%)26 (18.6%) Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI Baseline characteristics and patient disposition

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Virologic outcome at W48 (mITT, snapshot) EVG/c/FTC/TDF PI/r + FTC + TDF 94 87 % 0 20 40 60 80 100 HIV RNA < 50 c/mL Difference (95% CI) = 6.7% (0.4 ; 13.7) HIV RNA ≥ 50 c/mL 1 1 N = 2 6 12 No virologic data Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI STRATEGY-PI Study: Switch PI/r to EVG/c

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EGV/c/FTC/TDFPI/r + FTC + TDF Per-proctol99.5%99.2% Difference: 0.1% (95% CI = - 2.1 ; 3.7) ITT-TLOVR91.7%84.2% Difference: 7.6% (95% CI = 0.9 ; 15.0) Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI HIV RNA < 50 c/mL Sensitivity and secondary analysis No participants met the criteria for resistance testing (HIV RNA > 400 c/mL at virologic failure or early discontinuation) STRATEGY-PI Study: Switch PI/r to EVG/c

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Virologic sucess overall and by subgroup at W48 (mITT) Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI Overall Age < 40 years Age > 40 years Male Female White Non-white Atazanavir Darunavir Lopinavir On first regimen at baseline On second regimen at baseline 0102030405060708090100 Virological success (%) 272/290 121/139 122/130 61/68 150/160 60/71 231/247 103/120 41/43 18/19 217/231 98/113 53/57 22/24 114/121 41/51 107/113 55/60 45/49 20/23 213/225 104/115 53/59 16/23 n/N Favours not switching Switch group No-switch group -50-40-30-20-1001020304050 Difference (%) Favours switching STRATEGY-PI Study: Switch PI/r to EVG/c

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EVG/c/FTC/TDFPI/r + FTC + TDF Any adverse event,79%74% Grade 3 or 4 AE4%8% Serious adverse event6% Discontinuation because of AEN = 6 (2%)N = 4 (3%) Death0N = 1 Any Grade 3 or 4 laboratory abnormality14%23% Gamma-GT > 5 x ULN3%1% CK ≥ 10 x ULN2%6% ALAT > 5 x ULN2%1% Haematuria2%1% Bilirubin > 2.5 x ULN012% Adverse events and grade3-4 laboratory abnormalities Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI Improvement in lipids in the switch group HIV Symptom Index : rates of diarrhea and bloating decreased in the switch group Higher tretament satisfaction scores in the switch group

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Conclusion –Coformulated EVG/c/FTC/TDF is an effective, safe, and tolerable simplification from a PI/r plus FTC and TDF regimen in virologically suppressed, HIV-infected adults with no history of virological failure or resistance to FTC or TDF –Low frequency of virologic failure and absence of emergent resistance in the group switched to EVG/c/FTC/TDF –Rare discontinuations because of adverse events –Nausea more frequent in the switch group ; diarrhea and bloating improved –Small increase in creatinine, moderate improvement in lipids –EVG/c/FTC/TDF is a switch option in virologically suppressed patients with no history of virological failure who want to simplify their existing PI/r regimen, or who have concerns about the long-term safety and side-effects of their existing regimen Arribas J.R. Lancet Infect Dis 2014;14:581-9 STRATEGY-PI STRATEGY-PI Study: Switch PI/r to EVG/c

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