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Switch to NNRTI

The DRIVE-SHIFT study evaluates the efficacy and safety of switching to DOR/3TC/TDF compared to continuation of baseline cART. Results demonstrate non-inferior efficacy, no emergence of resistance, and a favorable safety profile. Higher incidence of adverse events observed in participants who switched to DOR/3TC/TDF compared to continuation of baseline regimen. Superior lipid profile for LDL-cholesterol and non-HDL cholesterol with DOR/3TC/TDF.

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Switch to NNRTI

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  1. Switch to NNRTI • Switch to DOR/3TC/TDF • DRIVE-SHIFTStudy

  2. 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 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% DRIVE-SHIFT Johnson M. J Acquir Immune DeficSyndr. 2019 Apr 11. [Epub ahead of print]

  3. DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Baseline characteristics and patient disposition DRIVE-SHIFT Johnson M. J Acquir Immune DeficSyndr. 2019 Apr 11. [Epub ahead of print]

  4. 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 94.6 93.7 100 90.8 80 60 40 20 1.8 1.8 1.8 1.6 223 223 447 447 0 HIV RNA < 50 c/mL HIV RNA > 50 c/mL HIV RNA < 50 c/mL HIV RNA > 50 c/mL ≠ - 3.8% (IC 95 %: - 7.9 to 0.3) ≠ - 0.2% (- 2.5 to 2.1) ≠ - 0.9% (- 4.7 to 3.0) ≠ 0% (- 2.3 to 2.3) DRIVE-SHIFT Johnson M. J Acquir Immune DeficSyndr. 2019 Apr 11. [Epub ahead of print]

  5. 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 DRIVE-SHIFT Johnson M. J Acquir Immune DeficSyndr. 2019 Apr 11. [Epub ahead of print]

  6. DRIVE-SHIFT Study: Switch to DOR/3TC/TDF Adverse events, W24 * p < 0.0001 DRIVE-SHIFT Johnson M. J Acquir Immune DeficSyndr. 2019 Apr 11. [Epub ahead of print]

  7. 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 DRIVE-SHIFT Johnson M. J Acquir Immune DeficSyndr. 2019 Apr 11. [Epub ahead of print]

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