ASPIRE Study: Switch to DTG + 3TC Virologic Outcome at W24 and W48

The ASPIRE study evaluated the efficacy of switching to DTG + 3TC in HIV patients with stable triple ART regimens. The primary endpoint was treatment failure proportion at W24, with non-inferiority demonstrated at W48. Virologic outcomes, adverse events, and patient dispositions were reported, with one confirmed virologic failure in the DTG + 3TC arm. Overall, the study showed promising results with minimal adverse events and virologic failures.

• ASPIRE Study
• DTG
• 3TC
• HIV treatment
• Virologic outcomes

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1. Switch to DTG + 3TC ASPIRE Study

2. ASPIRE Study: switch to DTG + 3TC Design Randomisation 1: 1 Open-label W24 W48 18 years Stable triple ART 48 weeks with 2 HIV RNA < 50 c/mL during past 48 weeks Screening HIV RNA < 20 c/mL No NRTI resistance mutation on pre-treatment genotype No history of virologic failure HBs Ag negative N = 44 DTG 50 mg + 3TC 300 mg QD Continuation of current 3-drug ARV regimen N = 45 Objective Primary Endpoint: proportion with treatment failure (virologic failure, loss to follow-up, discontinuation/modification of treatment) at W24 Virologic failure: confirmed HIV RNA > 50 c/mL Non-inferiority of DTG + 3TC (margin of 12%, 80% power) Taiwo B. Clin Infect Dis. 2018 May 17;66(11):1794-1797 ASPIRE

3. ASPIRE Study: switch to DTG + 3TC Baseline characteristics and disposition DTG + 3TC N = 44 Continuation triple ART N = 45 Median age, years 46 50 Female, % Baseline CD4/mm3, median (IQR) 11 13 694 (533-1034) 646 (380-819) Nadir CD4/mm3, median (IQR) Current antiretroviral therapy, % NNRTI PI/r INI TDF/FTC / ABC/3TC Discontinued at W48, N Adverse event 333 (184-408) 228 (91-341) 27 32 41 33 33 33 80 / 18 3 1 91 / 9 3 0 Virologic rebound Lost to follow-up 1 1 0 1 Physician decision 0 2 Taiwo B. Clin Infect Dis. 2018 May 17;66(11):1794-1797 ASPIRE

4. 107 ASPIRE Study: switch to DTG + 3TC Virologic outcome at W24 and W48(ITT, snapshot) Primary endpoint: Treatment failure % 100 DTG + 3TC (N = 44) Continuation Triple ART (N = 45) % 90.9 93.2 88.9 91.1 100 80 80 60 60 Difference : 0.2% (95% CI : - 9.8 to 10.2) 40 40 20 20 8.9 8.9 6.8 6.8 6.7 4.5 2.3 0 2.3 2.2 0 0 W24 W48 W24 W48 W24 W48 HIV RNA < 50 c/mL HIV RNA > 50 c/mL No virologic data One confirmed virologic failure (DTG + 3TC arm) HIV RNA (c/mL): W4: 21 ; W12: 48 ; W24: 375 confirmed at 235 ; W36 (on ABC/3TC + DRV/r): 264 ; W48: 85 At virologic failure (W24): no resistance mutation on RT or integrase ; therapeutic plasma concentration of DTG (3115 ng/mL) One discontinuation for adverse event (DTG + 3TC arm): constipation grade 2 Taiwo B. Clin Infect Dis. 2018 May 17;66(11):1794-1797 ASPIRE