Head-to-head comparative trials for first line ART since 2006

Comparison of INSTI vs PI
Study WAVES : EVG/C/FTC/TDF QD vs ATV + r
+ FTC/TDF QD in Women
Original article : Squires K. IAS 2015 Vancouver, Abs. MOLBPE08 ;
Squires K. Lancet HIV 2016; 3(9):e410-e420
Last update : 18/07/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • EVG/C/FTC/TDF QD was virologically non inferior and superior to ATV + r + FTC/TDF
  • Similar virologic response of the 2 regimens in different subgroups of patients, including those with high HIV RNA or CD4 < 350/mm3 at enrolment
  • Development of major resistance mutations occurred in
    • No patients on EVG/C/FTC/TDF
    • 3 patients on ATV + r + /FTC/TDF: NRTI mutations, no PI mutations
  • Discontinuation because of adverse events was lower with EVG/C/FTC/TDF
  • Less incidence of icterus and hyperbilirubinemia with EVG/C/FTC/TDF
  • Comparable changes in fasting lipids in both groups, except for total cholesterol which elevation was higher with EVG/C/FTC/TDF
  • Median decreases in estimated glomerular filtration rate and in spine and hip BMD were modest and not different between the 2 groups

Design


* Randomisation was stratified by HIV RNA ( ≤ 100,000 or 100,000-400,000 or > 400,000 c/ mL )
at screening and race (black or non-black)

Objective

  • Non inferiority of EVG/C/FTC/TDF at W48: % HIV RNA < 50 c/ mL by intention to treat, snapshot analysis (lower margin of the 2-sided 95% CI for the difference = -12%)

Baseline characteristics and patient disposition

Response to treatment at week 48

Mean CD4/mm3 increase at W48 :

  • + 221 (EVG/C/FTC/TDF) vs
  • + 212 (ATV + r + FTC/TDF)

HIV RNA < 50 c/ mL at W48 by baseline HIV RNA and CD4 count

Emergence of resistance


* Criteria :
- Suboptimal response (HIV RNA ≥ 50 c/ mL and < 1 log10 reduction from baseline by W8, confirmed)
- Virologic rebound (> 400 c/ mL after achieving HIV RNA < 50 c/ mL , or 2 consecutive visits with > 1 log10 increase from nadir)
- HIV RNA > 400 c/ mL at W48
Exclusion of patients with HIV RNA < 50 c/ mL at subsequent visits

Renal and bone mineral density (DXA) assessments

Median change from baseline in fasting lipids (mg/ dL )

Adverse events and Grade 3-4 laboratory abnormalities

 

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