Switch to DTG/3TC TANGO Study Results and Analysis
Explore the findings from the TANGO Study where patients underwent a switch to DTG/3TC regimen, revealing promising outcomes in virologic response and tolerability. Key metrics include HIV RNA levels, CD4 cell count changes, and adverse event profiles. Discover the implications of transitioning to DTG/3TC in the context of ART management for HIV patients.
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Switch to DTG/3TC TANGO
TANGO Study: switch to DTG/3TC Design Randomisation * 1 : 1 Open-label W144 W196 HIV+ 18 years N = 371 Stable first-line ART with TAF/FTC (TDF to TAF switch 3 months before screening allowed) + PI/b or NNRTI or INSTI 2 HIV-1 RNA < 50 c/mL in the past 12 months HIV-1 RNA < 50 c/mL at screening HBs Ag negative Switch to DTG/3TC Switch to DTG/3TC Continue current ART N = 372 * Randomisation was stratified by 3rdagent (PI, INSTI or NNRTI) Endpoints Primary: proportion of patients with HIV RNA 50 c/mL at W48 (ITT-E, snapshot) ; non-inferiority if upper margin of the two-sided 95% CI for the difference = 4%, 97.3% power Secondary: proportion of patients with HIV RNA < 50 c/mL at W48 (ITT-E, snapshot) ; non-inferiority if lower margin of the two-sided 95% CI for the difference = - 8% TANGO Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print]
TANGO Study: switch to DTG/3TC Baseline characteristics and patient disposition Continuation of current TAF/FTC-containing ART N = 372 DTG/3TC N = 369 Median age, years 40 39 Female, % 7 9 Median time on ART, months 33.8 35.1 Median time on TAF-based ART, months 17.7 18.2 CD4 cell count (/mm3), median 682 720 ART at randomisation, % INSTI / EVG/c NNRTI / RPV PIb / DRV 78 / 66 14 / 12 8 / 7 80 / 67 13 / 12 8 / 7 Discontinuation, N (%) For adverse event For lack of efficacy For other reasons 27 (7.3%) 13 0 14 29 (7.8%) 2 3 24 Excluded from per-protocol analysis, N Pregnancy, N 17 1 14 0 Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
36 TANGO Study: switch to DTG/3TC Adjusted difference (95% CI) Virologic outcome at W48 ITT-e snapshot Primary endpoint: HIV RNA 50 c/mL DTG/3TC (N = 369) TAF/FTC-based ART (N = 372) % -1.2 0.7 93.2 93 Non inferiority 100 - 0.3 80 -8 -6 -4 -2 0 2 4 6 8 DTG/3TC TAF/FTC-based ART 60 40 Secondary endpoint: HIV RNA < 50 c/mL 20 6.5 6.5 Non inferiority 0.3 0.5 - 3.4 3.9 0.2 0 HIV RNA 50 c/mL HIV RNA < 50 c/mL No virologic data -8 -6 -4 -2 0 2 4 6 8 1 discontinuation for HIV RNA 200 c/ml (TAF/FTC arm) No emergence of resistance DTG/3TC TAF/FTC-based ART Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
TANGO Study: switch to DTG/3TC Other efficacy results HIV RNA 50 c/mL at W48, per-protocol population DTG/3TC = 0 vs TAF-based ART = 0.6% (difference [95% CI] : -0.6 % [- 1.3 to 0.2]) Post-hoc analysis on baseline proviral DNA genotyping Pre-existing archived M184V/I : 4/322 DTG/3TC and 3/321 TAF-based ART HIV RNA < 50 c/mL at W48 in 7/7 Median CD4/mm3increase at W48 DTG/3TC = + 22.5 vs TAF-based ART = + 11 Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
37 TANGO Study: switch to DTG/3TC Adverse events DTG/3TC (N = 369) TAF/FTC-based ART (N = 372) 80 12 8 8 7 7 6 5 2 79 11 9 7 5 4 8 1 5 Any adverse event, % Nasopharyngitis Upper respiratory tract infection Diarrhea Headache Syphilis Back pain Fatigue Bronchitis 5 1 Grade 2-5 adverse event, % Drug-related grade 2-5 adverse event in 0,5%, % Insomnia Constipation Flatulence Headache 1 1 1 1 0 < 1 0 0 6 0 4 0 Serious adverse event, % Drug-related 13 * (3.5) 9 2 (0.5) 1 Adverse event leading to withdrawal from the study, N (%) Drug-related, N * Including anxiety (N = 3), insomnia (N = 3), weight increased (N = 2), fatigue (N = 2) Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
TANGO Study: switch to DTG/3TC Weight increase and metabolic parameters Continuation of current TAF/FTC-containing ART N = 372 DTG/3TC N = 369 6 (1.6%) Adverse event of increased weight 3 (0.8%) EVG/c = 2, RPV = 2, DTG = 1, RAL = 1 Adjusted mean weight increase at W48 + 0.8 kg + 0.8 kg Adjusted mean BMI increase at W48 + 0.25 kg/m2 + 0.26 kg/m2 Adjusted mean HOMA-IR change - 9.7% + 4.5% HOMA-IR 2 At baseline At W48 69% 65% 68% 74% (p = 0.008) Mean change from baseline in lipids at W48 Total cholesterol HDL-cholesterol LDL-cholesterol Triglycerides Total cholesterol / HDL-cholesterol ratio - 4.5% - 1.2% - 5.5% - 11.2% - 3.3% + 2.3% (p < 0.001) + 1.7% (ns) + 2.2% (p < 0.001) + 6.0% (p < 0.001) + 0.5% (p = 0.017) Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
TANGO Study: switch to DTG/3TC Variables associated with HOMA-IR 2 at W48 Parameter % OR (95% CI) p Treatment TAF-based regimen DTG/3TC 74.1 64.7 0.59 (0.40 - 0.87) 0.008 Sex Male Female 69.7 63.2 0.51 (0.22 - 1.14) 0.101 Baseline HOMA-IR NA 1.88 (1.56 - 2.27) < 0.01 Baseline BMI NA 1.11 (1.05 - 1.17) < 0.01 Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
38 TANGO Study: switch to DTG/3TC Renal biomarkers at W48 Serum Urine: proteinuria/creatininuria Adjusted mean change from baseline Change from baseline, % DTG/3TC (N = 369) TAF/FTC-based cART (N = 371) 10 20 p < 0.001 6.3 6.7 6.67 5 10 2.19 1.6 p < 0.001 0.1 0 0 - 1.6 - 2.9 -10 -5 - 3.0 - 2.7 - 7.8 -20 - 7.7 Protein/ Creatinine (g/moL) Retinol-binding protein/ creatinine ( g/mmoL) Beta-2 -10 Creatinine ( mol/L) eGFRcreatinine, CKD-EPI (mL/min/1.73 m2) eGFRcystatin C, CKD-EPI (mL/min/1.73 m2) microglobulin/ creatinine (mg/mmoL) -30 Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
113 TANGO Study: switch to DTG/3TC Conclusion Switching to DTG/3TC FDC was non-inferior to remaining on a TAF/FTC-based regimen through Week 48 in ART-experienced, virologically suppressed adults No confirmed virologic withdrawals in the DTG/3TC group Zero resistance development in the DTG/3TC group Good safety profile of DTG/3TC FDC Van Wyk J. Clin Infect Dis 2020 Jan 6 (Epub ahead of print] TANGO
