1 / 10

STAR Study: RPV/FTC/TDF vs. EFV/FTC/TDF Comparison in ARV-Naïve HIV Patients

Explore the non-inferiority and tolerability of RPV/FTC/TDF compared to EFV/FTC/TDF in ARV-naïve HIV patients. Results show RPV/FTC/TDF's superior efficacy for patients with baseline HIV-1 RNA ≤100,000 c/mL. RPV/FTC/TDF demonstrated improved tolerability with lower rates of nervous system and psychiatric adverse events. Both treatments had similar virologic efficacy.

carrw
Download Presentation

STAR Study: RPV/FTC/TDF vs. EFV/FTC/TDF Comparison in ARV-Naïve HIV Patients

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. Comparison of NNRTI vs NNRTI • ENCORE • EFV vs RPV • ECHO-THRIVE • STAR • EFV vs ETR • SENSE

  2. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF • Design Randomisation* 1 : 1 Open-label W48 W96 > 18 years ARV-naïve HIV RNA > 2,500 c/mL Any CD4 cell count eGFR > 50 mL/min Sensitivity to EFV, FTC and TDF on genotype No RPV resistance mutations** N = 394 N = 392 Concomitant use of proton pump inhibitors was not allowed * Randomisation was stratified by HIV RNA (< or > 100,000 c/mL) ** K101E/P, E138A/G/K/Q/R, Y181C/I/V, H221Y • Objective • Non inferiority of RPV/FTC/TDF at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (1-sided significance level of 2.5%, lower margin of the 97.5% CI for the difference = -12%, 95% power) STAR Cohen C. AIDS 2014;28:989-97

  3. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF Baseline characteristics and patient disposition STAR Cohen C. AIDS 2014;28:989-97

  4. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF Response to treatment (HIV RNA < 50 c/mL) at week 48 RPV/FTC/TDF EFV/FTC/TDF % Primary analysis 100 88.8 85.3 85.8 79.9 81.6 81.6 79.6 81.7 75 50 25 0 ITT, TLOVR ITT, snapshot ITT snapshot, by baseline HIV-1 RNA Adjusted difference (95% CI)= 4.1% (-1.1 ; 9.2) > 100,000 c/mL < 100,000 c/mL Adjusted difference (95% CI)= 5.9% (0.6 ; 11.2) Difference (95% CI)= 7.2% (1.1 ; 13.4) Difference (95% CI)= -1.8% (-11.1 ; 7.5) Median CD4/mm3 increase at W48 : + 200 RPV/FTC/TDF vs + 191 EFV/FTC/TDF STAR Cohen C. AIDS 2014;28:989-97

  5. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF • Resistance analysis through week 48 * HIV RNA > 400 c/mL and suboptimal virologic response (confirmed < 1 log10 c/mL decrease in HIV RNA at W8) virologic rebound (2 consecutive visits with HIV RNA > 50 c/mL after achieving < 50 c/mL, 2 consecutive visits with > 1 log10 c/mL increase in HIV RNA from the nadir) or HIV RNA > 400 c/mL at W48 or last visit STAR Cohen C. AIDS 2014;28:989-97

  6. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF • Safety through week 48 • Treatment-emergent adverse events of specific interest in > 5% in either arm STAR Cohen C. AIDS 2014;28:989-97

  7. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF Mean changes in fasting lipids (mg/dL) at week 48 RPV/FTC/TDF EFV/FTC/TDF P<0.001 for all between treatment groups using ANOVA Mean baseline values (mg/dL) 164 163 104 103 121 129 44 44 Change in total cholesterol/HDL-cholesterol at week 48 was -0.2 in both arms STAR Cohen C. AIDS 2014;28:989-97

  8. Conclusion at week 48 In treatment-naive HIV-infected patients, RPV/FTC/TDF demonstrated non inferior efficacy and improved tolerability compared with EFV/FTC/TDF, at week 48 RPV/FTC/TDF was statistically significant superiority in efficacy for patients with baseline HIV-1 RNA ≤ 100,000 c/mL Virologic efficacy was similar for patients with baseline HIV-1 RNA > 100,000 c/mL More discontinuations due to adverse events in the EFV/FTC/TDF arm Significantly lower rates of nervous system and psychiatric adverse events in the RPV/FTC/TDF arm than in the EFV/FTC/TDF arm Differences primarily due to dizziness and abnormal dreams Virologic failures rates were similar between the 2 treatment arms A greater proportion of patients in the RPV/FTC/TDF arm developed primary emergent NRTI or NNRTI resistance mutations at virologic failure STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF STAR Cohen C. AIDS 2014;28:989-97

  9. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF Response to treatment (HIV RNA < 50 c/mL) at week 96 RPV/FTC/TDF at W48 EFV/FTC/TDF at W48 % RPV/FTC/TDF at W96 EFV/FTC/TDF at W96 100 FavorsEFV/FTC/TDF FavorsRPV/FTC/TDF 89 82 82 80 79 76 75 80 71 HIV RNA at baseline 60 < 100,000 c/mL 1.1 7.2 13.4 W48 7.6 15.1 40 0.2 W96 P=0.046 > 100,000 c/mL 20 -11.1 -1.8 7.5 W48 1.5 11.6 -8.7 W96 P=0.78 0 231/260 204/250 205/260 178/250 107/134 116/142 102/134 106/142 -12% 0 12% < 100,000 c/mL > 100,000 c/mL Baseline HIV RNA STAR Cohen C. IAC 2014 Melbourne, Abs. WEPE064

  10. STAR Study: RPV/FTC/TDF vs EFV/FTC/TDF Resistance analysis at week 96 STAR Cohen C. IAC 2014 Melbourne, Abs. WEPE064

More Related