Comparison of DRV/r + 3TC vs DRV/r + 3TC/TDF in ANDES Study
"ANDES Study compares the efficacy and safety of DRV/r + 3TC dual therapy versus DRV/r + 3TC/TDF standard therapy in ARV-naive patients, showing non-inferior virologic results but differences in adverse events. Explore details here."
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Comparison of PI vs PI ATV vs ATV/r LPV/r mono vs LPV/r + ZDV/3TC LPV/r QD vs BID BMS 089 MONARK M02-418 M05-730 A5073 GARDEL ALERT ATADAR KLEAN GEMINI CASTLE ARTEMIS ANDES LPV/r + 3TC vs LPV/r + 2 NRTI ATV/r vs FPV/r ATV/r vs DRV/r FPV/r vs LPV/r SQV/r vs LPV/r ATV/r vs LPV/r DRV/r vs LPV/r DRV/r + 3TC vs DRV/r + 3TC/TDF
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF Design Randomisation* 1 : 1 Open-label W48 N = 75 > 18 years ARV-na ve DRV/r 800/100 mg FDC + 3TC 300 mg QD HIV RNA > 1 000 c/mL Any CD4 cell count HBsAg negative No R to study drugs N = 74 DRV/r 800/100 mg FDC + 3TC/TDF QD *Randomisation was stratified by HIV RNA (< or > 100 000 c/mL) at screening Objective Non inferiority of DRV/r + 3TC at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis Figueroa MI, CROI 2018, Abs. 489 ANDES
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF Baseline characteristics and patient disposition DRV/r + 3TC N = 75 DRV/r + 3TC/TDF N = 74 Median age, years 30 30 Female, % 7 12 HIV RNA (log10 c/mL), median 4.6 4.5 HIV RNA > 100 000 c/mL, % 27 22 CD4 cell count (/mm3), median 419 367 Discontinuation by W24, N Adverse event Lost to follow-up Withdrew consent 4 2 1 1 1 0 1 0 Figueroa MI, CROI 2018, Abs. 489 ANDES
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF Efficacy outcome at W48 DRV/r + 3TC N = 75 DRV/r + 3TC/TDF N = 74 Difference : - 1.0 % (95% CI : - 7.5 to 5.6) HIV RNA < 50 c/mL, % 93 94 HIV RNA < 50 c/mL in patients with baseline HIV RNA > 100 000 c/mL, % Median CD4 increase (/mm3) 91 92 246 200 p = 0.20 Safety at W48 DRV/r + 3TC N = 75 DRV/r + 3TC/TDF N = 74 Grade 2-4 adverse events possibly/probably related, N 11 17 Gastro-intestinal adverse events, % Rash, % Total cholesterol elevation LDL-cholesterol elevation Triglycerides elevation No treatment-related serious adverse event 7% 8% 19% 14% 25% 14% 7% 4% (p = 0.01) 6% (ns) 14% (ns) Figueroa MI, CROI 2018, Abs. 489 ANDES
ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF Summary DRV/r + 3TC dual therapy was virologically non inferior to a standard therapy of DRV/r + 3TC/TDF in na ve patients Similar virologic response of the 2 regimens in patients with HIV RNA > 100 000 c/mL at enrolment Only 1 case of virologic failure (DRV/r + 3TC/TDF) with no emergence of resistance Incidence of gastro-intestinal adverse events higher in triple therapy group Lipid elevations higher in the DRV/r + 3TC group, significantly higher than in DRV/r + 3TC/TDF group for total cholesterol Figueroa MI, CROI 2018, Abs. 489 ANDES
