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ARV-trial.com Switch to RPV/FTC/TAF Studies 1216 and 1160 1.

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Presentation on theme: "ARV-trial.com Switch to RPV/FTC/TAF Studies 1216 and 1160 1."— Presentation transcript:

1 ARV-trial.com Switch to RPV/FTC/TAF Studies 1216 and 1160 1

2 Studies 1216 and 1160: switch to RPV/FTC/TAF
Design Randomisation 1: 1 Double-blind W48 W96 RPV/FTC/TAF QD + placebo (with food) N = 660 Study 1216 RPV/FTC/TDF QD + placebo (with food) ≥ 18 years Stable regimen ≥ 6 months RPV/FTC/TDF (study 1216) EFV/FTC/TDF (study 1160) HIV RNA < 50 c/mL > 6 months Creatinine clearance ≥ 50 mL/min RPV/FTC/TAF QD am with food + placebo pm (without food) N = 875 Study 1160 EFV/FTC/TDF QD pm (without food) + placebo pm (with food) Objective Primary Endpoint: proportion with treatment success at W48 (HIV RNA < 50 c/mL, ITT- FDA snapshot) SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

3 Studies 1216 and 1160: switch to RPV/FTC/TAF
Baseline characteristics Study 1216 Study 1160 RPV/F/TAF N = 316 RPV/F/TDF N = 314 N = 438 EFV/F/TDF N = 437 Median age, years 46 44 49 48 Female, % 13 8 15 11 Ethnicity : White / Black, % 75 / 21 75 / 17 66 / 27 67 / 27 CD4/mm3, median 673 668 666 Median eGFR (CG), mL/min 104 100 110.4 107.6 Proteinuria, % 10 9 6 Diabetes mellitus, % 2 3 5 Hypertension, % 21 18 27 28 SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

4 Studies 1216 and 1160: switch to RPV/FTC/TAF
HIV-1 RNA < 50 c/mL at W48 (ITT, FDA snapshot) Study 1216 Study 1160 RPV/F/TDF RPV/F/TAF EFV/F/TDF RPV/F/TAF ≠ (95% CI) : (- 4.2 ; 3.7) 100 94 20 40 60 80 % ≠ (95% CI) : (- 5.9 ; 1.8) 90 92 No emergent resistance mutations in either group No emergent resistance mutations in RPV/F/TAF group 1 patient in EFV/F/TDF group developed emergent mutations (M184V, V106I/L, Y188L) SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

5 Studies 1216 and 1160: switch to RPV/FTC/TAF
Adverse events, % (≥ 5% in either group) Study 1216 Study 1160 RPV/F/TAF N = 316 RPV/F/TDF N = 314 N = 438 EFV/F/TDF N = 437 Upper respiratory tract infection 9 8 10 Diarrhea 7 5 Nasopharyngitis 4 Headache Cough 3 6 Bronchitis Sinusitis 2 Arthralgia SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

6 Studies 1216 and 1160: switch to RPV/FTC/TAF
Adverse events leading to discontinuation, N (%) Study 1216 Study 1160 RPV/F/TAF N = 316 RPV/F/TDF N = 314 N = 438 EFV/F/TDF N = 437 4 (1.3%) 3 (1.0%) 11 (2.5%) 8 (1.8%) Gastroesophageal reflux disease Ulcerative oesophagitis with hiatal hernia Fatigue Depression Elevated AST and ALT Chronic myeloid leukemia Drug hypersensitivity Anemia, ulcer hemorrhage Diarrhea Vomiting, anxiety Oesophagitis Dysgueusia Localised infection Fractures, traumatic Decreased GFR Cough Generalized pruritus Abdominal pain Dysphagia Rash Nausea, vomiting Hypersensitivity Atrial fibrillation SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

7 Studies 1216 and 1160: switch to RPV/FTC/TAF
Grade 3-4 laboratory abnormalities, % Study 1216 Study 1160 RPV/F/TAF N = 316 RPV/F/TDF N = 314 N = 438 EFV/F/TDF N = 437 Any abnormality 13 6 10 9 LDL elevation 4 1 2 3 Creatine kinase elevation Urine glucose Total cholesterol elevation < 1 AST elevation ALT elevation Serum fasting glucose elevation Urine red blood cells SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

8 Studies 1216 and 1160: switch to RPV/FTC/TAF
Median change in eGFR [Cockroft-Gault] (mL/min) at W48 (Q1-Q3) Study 1216 -15 4 12 24 36 48 -10 -5 5 10 15 Week 4.5 p = 0.002 0.7 RPV/FTC/TAF RPV/FTC/TDF Study 1160 -15 4 12 24 36 48 -10 -5 5 10 15 Week - 0.6 - 4.1 p < 0.001 RPV/FTC/TAF EFV/FTC/TDF SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

9 Studies 1216 and 1160: switch to RPV/FTC/TAF
Change in Proteinuria at W48 (median % change) Study 1216 Study 1160 RPV/FTC/TAF RPV/FTC/TDF EFV/FTC/TDF 7.3 Protein: Cr -2.0 -18.8 -30.0 16.8 12.2 Albumin: Cr -7.8 -13.5 29.1 21.5 RBP:Cr -18.0 -27.6 17.1 12.0 β2M:Cr -29.0 -41.1 All differences (RPV/F/TAF vs RPV/F/TDF or EFV/F/TDF) : p < ; no reported cases of tubulopathy SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

10 Studies 1216 and 1160: switch to RPV/FTC/TAF
Median % change in Hip BMD through W48 (95% CI) Study 1216 1.04 -0.25 p < 0.001 1 2 -1 -2 W0 W24 W48 RPV/FTC/TAF RPV/FTC/TDF Study 1160 1.28 -0.13 p < 0.001 1 2 -1 -2 W0 W24 W48 RPV/FTC/TAF EFV/FTC/TDF 184 175 168 N 173 171 165 388 369 347 399 382 367 RPV/FTC/TAF RPV/FTC/TDF EFV/FTC/TDF ≥ 3% increase 16% 4% p < 0.001 19% 6% ≥ 3% decrease 3% 7% p = 0.13 2% 10% SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

11 Studies 1216 and 1160: switch to RPV/FTC/TAF
Median % change in Spine BMD through W48 (95% CI) Study 1216 Study 1160 1.61 0.08 p < 0.001 1 2 -1 -2 W24 W48 RPV/FTC/TAF RPV/FTC/TDF 187 178 172 N 176 174 168 1.65 -0.05 p < 0.001 1 2 -1 -2 W24 W48 RPV/FTC/TAF EFV/FTC/TDF 394 373 351 400 382 369 N RPV/FTC/TAF RPV/FTC/TDF EFV/FTC/TDF ≥ 3% increase 27% 11% p < 0.001 29% 13% ≥ 3% decrease 6% p = 0.044 7% 14% p = 0.001 SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

12 Studies 1216 and 1160: switch to RPV/FTC/TAF
Median fasting lipids (mg/dL) at baseline and W48 RPV/FTC/TAF RPV/FTC/TDF Baseline W48 p < 0.001 p = 0.18 Total cholesterol LDL-cholesterol HDL-cholesterol TC:HDL Ratio 189 p < 0.001 50 100 150 200 1 2 3 4 5 173 167 109 105 47 45 3.6 3.5 RPV/FTC/TAF RPV/FTC/TDF Patients initiating lipid-lowering agents 4% 1% SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

13 Studies 1216 and 1160: switch to RPV/FTC/TAF
Median fasting lipids (mg/dL) at baseline and W48 RPV/FTC/TAF EFV/FTC/TDF Baseline W48 p = 0.20 Total-cholesterol LDL-cholesterol HDL-cholesterol TC:HDL Ratio 191 p = 0.001 50 100 150 200 1 2 3 4 250 183 187 114 117 51 3.6 3.5 RPV/FTC/TAF EFV/FTC/TDF Patients initiating lipid-lowering agents 4% SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

14 Studies 1216 and 1160: switch to RPV/FTC/TAF
Conclusion Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF was effective High rates of virologic suppression No emergent resistance mutations on RPV/FTC/TAF RPV/FTC/TAF was well tolerated Low rate of adverse events Low rate of discontinuation RPV/FTC/TAF provided improved renal and bone safety Decreased total and tubular proteinuria (p < 0.001) No proximal tubulopathy Increased BMD at hip and spine (p < 0.001) SWITCH TO RPV/FTC/TAF Orkin C. HIV Drug Therapy 2016, Glasgow, Abs. O124

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