DRIVE-SHIFT Study: Switch to DOR/3TC/TDF in HIV Patients - Efficacy and Drug Resistance Analysis
The DRIVE-SHIFT study evaluated switching to DOR/3TC/TDF in HIV patients with suppressed viral loads. The study aimed to assess the efficacy of DOR/3TC/TDF compared to continuation of current antiretroviral therapy (cART) at both 24 and 48 weeks. Results showed non-inferiority of DOR/3TC/TDF in maintaining viral suppression. Additionally, drug resistance analysis found no development of resistance to DOR or NRTIs in the study population. The study provides valuable insights into treatment strategies for HIV patients.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
Switch to NNRTI Switch to DOR/3TC/TDF DRIVE-SHIFT Study
DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Design Randomisation * 2:1 Open-label W24 W48 HIV+ 18 years HIV RNA < 40 c/mL 6 months On 2 NRTI + PI/b or EVG/c or NNRTI No prior virologic failure No major resistance mutation to DOR, 3TC or TDF eGFR 50 mL/min N = 447 DOR/3TC/TDF Continuation of cART DOR/3TC/TDF N = 223 Endpoints Primary: % of patients maintaining HIV RNA < 50 c/mL (ITT-snapshot) ; non- inferiority of DOR/3TC/TDF at W48 (and at W24) compared to continuation of cART at W24 if lower margin of a two-sided 95% CI for the adjusted difference = - 8% Secondary : % of patients with HIV RNA 50 c/mL: non-inferiority of DOR/3TC/TDF at W48 (and at W24) compared to continuation of cART at W24, non-inferiority margin of 4% Johnson M. J Acquir Immune Defic Syndr. 2019 Apr 11. [Epub ahead of print] DRIVE-SHIFT
DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Baseline characteristics and patient disposition DOR/3TC/TDF N = 447 43 17 77 665 Continuation cART N = 223 42 13 75 650 Mean age, years Female, % Race: white, % CD4/mm3, mean Baseline cART, % Boosted PI EVG/c NNRTI Discontinuation by W24, N (%) Adverse event Lack of efficacy Investigator decision Consent withdrawal Lost to follow-up Protocol deviation Death Discontinued at W48, N (%) Adverse event Lack of efficacy 71 6 24 70 5 25 20 (4.4%) 7 0 2 6 3 1 1 14 (6.3%) 1 1 3 1 4 4 0 20/427 continued (4.6%) 6 5 7/209 deferred switch (3.3%) 2 1 Johnson M. J Acquir Immune Defic Syndr. 2019 Apr 11. [Epub ahead of print] DRIVE-SHIFT
DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Primary endpoint: efficacy at 2 different time points, ITT Snapshot DOR/3TC/TDF immediate switch W48 Continuation cART W24 Immediate switch W24 Primary time point Secondary time point % 94.6 93.7 94.6 100 90.8 80 60 40 20 1.8 1.8 1.8 1.6 223 223 447 447 0 HIV RNA < 50 c/mL - 3.8% HIV RNA > 50 c/mL - 0.2% (- 2.5 to 2.1) HIV RNA < 50 c/mL HIV RNA > 50 c/mL - 0.9% (- 4.7 to 3.0) 0% (IC 95 %: - 7.9 to 0.3) (- 2.3 to 2.3) Johnson M. J Acquir Immune Defic Syndr. 2019 Apr 11. [Epub ahead of print] DRIVE-SHIFT
DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Drug resistance Resistance analysis population, DOR/3TC/TDF immediate and deferred switch Protocol-defined virologic failure, N = 7 Discontinuation without protocol-defined virologic failure, N = 40 No participant developed DOR or NRTI resistance All 24 participants with baseline NNRTI mutations (K103N, Y181C, G190A) remained suppressed Johnson M. J Acquir Immune Defic Syndr. 2019 Apr 11. [Epub ahead of print] DRIVE-SHIFT
DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Adverse events, W24 DOR/3TC/TDF N = 447 Continuation cART N = 223 Any adverse event, % 68.9 52.5 Drug-related adverse event, % 19.5 2.2 Most common drug-related adverse event Headache, % 1.6 0.4 Discontinuation due to adverse event, % Due to drug-related adverse event, % 2.5 1.6 0.4 0 Mean change from baseline in fasting lipids (baseline boosted PI group), mg/dL LDL-cholesterol - 16.5 * - 1.9 * Non HDL-cholesterol - 24.7 * - 1.3 * * p < 0.0001 Johnson M. J Acquir Immune Defic Syndr. 2019 Apr 11. [Epub ahead of print] DRIVE-SHIFT
DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Conclusion Switching to DOR/3TC/TDF demonstrated non-inferior efficacy, at W24 and W48, compared to continuation of baseline cART through W24 No emergence of resistance to DOR, 3TC or TDF Favorable safety profile Higher incidence of adverse events in participants who switched to DOR/3TC/TDF compared with those who continued their baseline regimen Superior lipid profile for LDL-cholesterol and non-HDL cholesterol of DOR/3TC/TDF compared to continuation of a boosted-PI regimen Johnson M. J Acquir Immune Defic Syndr. 2019 Apr 11. [Epub ahead of print] DRIVE-SHIFT
