Study on Switching to DTG/ABC/3TC for HIV Treatment

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Explore the results of the STRIIVING Study, focusing on the switch to DTG/ABC/3TC for HIV treatment. The study evaluates the maintenance of HIV RNA levels, CD4 cell count changes, safety profiles, and more in patients with stable ART regimens. Results show non-inferiority in maintaining HIV RNA levels with the new regimen, along with various secondary endpoints examined. Adverse event data and patient disposition details are also included.

  • HIV Treatment
  • Antiretroviral Therapy
  • DTG/ABC/3TC
  • Clinical Study
  • Virologic Success
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  1. Switch to DTG/ABC/3TC STRIIVING NEAT 022

  2. STRIIVING Study: switch to DTG/ABC/3TC Design Randomisation * 1 : 1 Open-label W24 W48 N = 275 HIV+ 18 years HIV RNA < 50 c/mL On 2 NRTI + PI/r or NNRTI or INSTI stable 6 months HLA-B*5701 negative HBs Ag negative Switch to DTG/ABC/3TC Switch to DTG/ABC/3TC Continue current ART N = 278 * Randomisation was stratified by 3rd agent (PI, INSTI or NNRTI) Endpoints Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W24 (ITT-E, snapshot) ; non-inferiority if lower margin of the two-sided 95% CI for the difference = - 10%, 90% power Secondary: CD4 cell count changes, safety, lipid, renal, bone and cardiovascular changes, development of resistance, treatment satisfaction Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  3. STRIIVING Study: switch to DTG/ABC/3TC Baseline characteristics and patient disposition Continuation of current ART (deferred switch) N = 278 47 14 5 51 597 DTG/ABC/3TC N = 275 Median age, years Female, % Hepatitis C coinfection, % Median time on current ART, months CD4 cell count (/mm3), median ART at randomisation, % PI NNRTI INSTI TDF/FTC backbone Discontinuation, N W0-W24 / W24-W48 For adverse event For protocol deviation Lost to follow-up For other reasons 45 14 8 54 618 43 32 25 76 42 31 27 79 36 / 9 10 / 0 15 / 0 3 / 5 8 / 4 33 / 14 0 / 4 17 / 1 3 / 3 13 / 6 Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  4. STRIIVING Study: switch to DTG/ABC/3TC HIV RNA < 50 c/mL (ITT-e) % At week 24 - Lower bound for the adjusted difference : - 9.1 % (non-inferiority), by ITT-E - Success in 93 % in both groups in the per-protocol analysis (difference : - 0.2; 95% CI : - 5.0 to 4.6) DTG/ABC/3TC Immediate switch D1-W24 (N = 275) 100 92 88 85 Continuation cART D1-W24 (N = 278) 83 80 DTG/ABC/3TC Immediate switch D1-W48 (N = 275) DTG/ABC/3TC Deferred switch W24-W48 (N = 244 *) 60 * Analysis restricted to patients with deferred switch 40 20 17 14 10 7 1 1 < 1 1 0 Virologic success Virologic non response No virologic data No subjects met protocol-defined virologic failure in either study arm ; 4 subjects with HIV RNA > 50 c/mL at W48 (1 early switch, 3 deferred switch) ; all 4 resuppressed < 50 c/mL Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  5. 111 STRIIVING Study: switch to DTG/ABC/3TC Adverse events at W24, n (%) DTG/ABC/3TC (N = 276) Continuation of cART (N = 277) Any adverse event 183 (66) 129 (47) Drug-related adverse event 59 (21) 4 (1) Adverse event grade 3-4 8 (3) 5 (2) Serious adverse event 6 (2) 5 (2) Discontinuation for adverse event 11 (4) 0 Adverse event in 5% in either group Cough 14 (5) 8 (3) Diarrhea 17 (6) 4 (1) Fatigue 19 (7) 3 (1) Headache 13 (5) 4 (1) Nausea 27 (10) 3 (1) Upper respiratory tract infection 21 (8) 20 (7) Psychiatric 35 (13) 8 (3) Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  6. 112 STRIIVING Study: switch to DTG/ABC/3TC Adverse events leading to discontinuation of DTG/ABC/3TC (N = 10) Prior ARV (3rddrug) LPV/r Grade Onset Insomnia Diarrhea, flatulence, rash, Abdominal pain, anxiety, nausea, body ache Euphoric mood, Headache Abdominal cramps, chills, diarrhea, dizziness, headache Pruritus Upper abdominal pain, diarrhea Fatigue1, malaise Flu-like syndrome Depression Profuse sweating, change in body odor Nasal congestion Worsening fatigue Nausea Alopecia Fatigue1 10 Homicide1 2 1 2 1 2 2 2 1 2 1 2 1 1 2 3 1 1 W1 W1 W1 1 2 RPV 3 W1 ATV/r W1 W1 W1 W1 W9 W12 W17 4 5 6 RAL NFV NVP 7 W2 EVG/c W4 W8 W10 8 9 ATV/r DRV/r RAL NA 1Not drug-related Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  7. STRIIVING Study: switch to DTG/ABC/3TC Fasting Lipids, mean mg/dL DTG/ABC/3TC at Baseline Continuation ART at Baseline DTG/ABC/3TC at W24 Continuation ART at W24 5 200 4.5 180 4 160 3.5 140 3 120 2.5 100 2 80 1.5 60 1 40 0.5 20 0 0 Total cholesterol:HDL ratio Total cholesterol HDL LDL Triglycerides Total HDL - LDL- Total cholesterol: HDL ratio Triglycerides cholesterol cholesterol cholesterol DTG/ABC/3TC ART DTG/ABC/3TC ART DTG/ABC/3TC ART DTG/ABC/3TC ART DTG/ABC/3TC ART Change from baseline at W24 (SD) 3.33 (31.88) -0.59 (25.05) -0.47 (8.77) -1.45 (8.43) 4.47 (24.08) 0.93 (21.95) 0.17 (99.59) -5.74 (76.93) 0.14 (0.88) 0.05 (0.78) Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  8. STRIIVING Study: switch to DTG/ABC/3TC Mean change from baseline in serum creatinine (mg/dL) through 24 weeks 0,3 DTG/ABC/3TC Continuation ART 0,2 0,1 0,087 0,087 0,01 0 -0,1 -0,2 BL 4 8 16 24 Week Number of patients 275 276 262 257 256 257 237 246 240 249 DTG/ABC/3TC ART Small, non-progressive changes in serum creatinine were observed in the DTG/ABC/3TC arm due to known inhibition of tubular creatinine secretion by DTG Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  9. STRIIVING Study: switch to DTG/ABC/3TC Treatment Satisfaction (HIVTSQ) Adjusted mean change in total score at W24 DTG/ABC/3TC Continuation ART 4 Adjusted mean difference at W24 (95% CI): 2.4 (1.3, 3.5) ; p < 0.001 3 2 1 0 DTG/ABC/3TC (N = 269) ART (N = 276) At baseline, overall treatment satisfaction scores were similar between groups Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

  10. 113 STRIIVING Study: switch to DTG/ABC/3TC Conclusion Efficacy Similar virologic response for DTG/ABC/3TC and continuation of current ART at W24, with non-inferiority Success rate was maintained through 48 weeks in the early switch group In the late switch group, virologic suppression was observed in 92% of subjects on DTG/ABC/3TC (24 weeks post-switch) There were no protocol-defined virologic failure in the study Tolerability 4% of subjects discontinued due to adverse events by W24 in the DTG/ABC/3TC arm vs 0% in the continuation group There were no further discontinuations due to adverse events in the early switch arm post-week 24 Rates of discontinuation for adverse events in the late switch arm was 2% Trottier B. Antivir Ther. 2017;22(4):295-305. STRIIVING

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