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Table of contents

Switch to ATV-containing regimen
ASSURE
Original article : Wohl D. PLoS One. 2014 May 13;9(5):e96187.
Last update : 31/01/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

• Similar nature and rate of Grade 2-4 clinical adverse events
• Grade 2-4 adverse event leading to study withdrawal
  • ATV + ABC/3TC, n = 8 (rash = 2, nausea = 3, vomiting = 2) ;
  • ATV/r + TDF/FTC, n = 2
• Grade 3-4 laboratory abnormalities
  • ATV + ABC/3TC : 19% (hyperbilirubinemia 6%)
  • ATV/r + TDF/FTC : 36% (hyperbilirubinemia 29%) [p < 0.001 vs ATV + ABC/3TC]
• Significant improvements observed in bone biomarkers (BAP, PTH, C­telopeptide, and osteocalcin), renal urine b2 microglobulin/ creatinine ratio in the ATV + ABC/3TC group

Design :

Primary Endpoints :

• Non inferiority in the proportion of patients with HIV RNA < 50 c/mL at W24 (TLOVR algorithm), lower limit of the 95% CI for the difference = - 12%

Baseline characteristics and patient disposition :

Outcome at week 24

Outcome at week 48 :

Confirmed virologic failure

• ATV + ABC/3TC : 2%
• ATV/r + TDF/FTC : 1%

 

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