1 / 6

Switch to TDF/FTC/RPV - SPIRIT Study

Switch to TDF/FTC/RPV - SPIRIT Study. SPIRIT study: switch PI/r + 2 NRTI to TDF/FTC/RPV STR. Design. Randomisation 2 : 1 Open-label. TDF/FTC/RPV STR. N = 317. 476 HIV+ adults Stable PI + RTV + 2 NRTI ≥ 6 months with HIV RNA < 50 c/mL On 1 st or 2 nd regimen No prior NNRTI use

domani
Download Presentation

Switch to TDF/FTC/RPV - SPIRIT Study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Switch to TDF/FTC/RPV • - SPIRIT Study

  2. SPIRIT study: switch PI/r + 2 NRTI to TDF/FTC/RPV STR • Design Randomisation 2 : 1 Open-label TDF/FTC/RPV STR N = 317 • 476 HIV+ adults • Stable PI + RTV + 2 NRTI ≥ 6 months with HIV RNA < 50 c/mL • On 1st or 2nd regimen • No prior NNRTI use • No known resistance to study agents TDF/FTC/RPV STR PI/r +2 NRTIs TDF/FTC/RPV STR N = 159 24 weeks Primary Endpoint 48 weeks Secondary Endpoint 24 weeks 48 weeks Primary Endpoint Secondary Endpoint • Objective • Primary Endpoint : Non-inferiority in the proportion of patients with HIV-1 RNA < 50 c/mL at W24 (FDA snapshot analysis) ; upper limit of the 95% CI for the difference = 12% • Secondary Endpoints: Proportion of HIV1 RNA < 50 copies/mL at W48 ; Change in fasting lipid and CD4 cell count at W24 and W48 ; Safety and tolerability Fisher M, HIV11, Glasgow 2012, Abs. P285 SPIRIT

  3. SPIRIT study: switch PI/r + 2 NRTI to TDF/FTC/RPV STR Baseline characteristics ART at screening Fisher M, HIV11, Glasgow 2012, Abs. P285 SPIRIT

  4. SPIRIT study: switch PI/r + 2 NRTI to TDF/FTC/RPV STR HIV RNA < 50 c/mL at W24 (ITT, snapshot) TDF/FTC/RPV 2 NRTI + PI/r TDF/FTC/RPV (delayed switch, W24 to W48) % % 95 100 95.5 93.7 100 92.3 92.1 89.9 89.2 80 80 60 60 40 40 20 20 152/ 160 83/ 93 128/ 134 48/ 52 0 0 Virologic failure > 100 000 c/ml < 100 000 c/ml difference (95% CI) TDF/FTC/RPV - PI/r 3.8 (- 1.6 ; 9.1) : non inferiority HIV RNA, pre-ART (23 patients TDF/FTC/RPV and 14 PI/r excluded from analysis (data not avalaible)) % 5 HIV RNA < 50 c/mL, ITT, M = Excluded RPV = 99.7 % vs PI/r = 94.7 % 1.3 difference (95% CI) : 5.8 (- 1.4 ; 12.9) difference (95% CI) : 3.2 (- 4.8 ; 11.3) 0.9 3/317 8/159 2/152 Non inferiority Palella F, IAC 2012, Abs. TUAB0104 ; Fisher M, HIV11, Glasgow 2012, Abs. P285 SPIRIT

  5. SPIRIT study: switch PI/r + 2 NRTI to TDF/FTC/RPV STR • Among the 24 patients with the K103N mutation on historical genotype • 22 achieve HIV RNA < 50 c/mL at W48 • 1 virologic failure (pre-existing mutations : K103N + V179I, emergence : M184V, E138K and V108V/I) • 1 without data at W48 (HIV RNA < 50 c/mL at last study visit) • Virologic failure on TDF/FTC/RPV, n = 7 (1.5%) • 3 without emergence of resistance mutations • 4 with emergence of resistance mutations • K103N + L100I + M184I • M184I • E138E/K + M184M/V • E138K + V108V/I + M184V White K, IWHHDR 2012, Abs. 49 ; Palella F, IAC 2012, Abs. TUAB0104 ; Fisher, HIV11, Glasgow 2012, Abs. P285 SPIRIT

  6. SPIRIT study: switch PI/r + 2 NRTI to TDF/FTC/RPV STR • Discontinuation for adverse event (W24) • TDF/FTC/RPV, n = 6 • tubulopathy, n = 1 • neuro-psychiatric events, n = 4 (depression, headache, insomnia, psychiatric event) • 2 NRTI + PI/r, n = 0 • GFR decrease significantly more important with RPV Mean change from baseline at W24 Chol-tot (mg/dl) LDL-c(mg/dl) TG (mg/dl) HDL-c (mg/dl) Rapport TC : HDL 10 0.08 3 0 0 - 1 - 4 - 1 -10 -20 -16 - 0.27 - 25 -30 Grade 3-4 Adverse events and laboratoratory abnormalities to W48 -40 p < 0.001 for all comparisons -50 - 53 -60 2 NRTI + PI/r TDF/FTC/RPV Palella F, IAC 2012, Abs. TUAB0104 ; Fisher, HIV11, Glasgow 2012, Abs. P285 SPIRIT

More Related