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

Comparison of NNRTI vs NNRTI
SENSE Study: ETR QD + 2 NRTI vs EFV QD + 2 NRTI
Original article : AIDS. 2011 Nov 28;25(18):2249-58 - B Gazzard, AIDS. 2011 Jan 28;25(3):335-40 - M Nelson
Last update : 09/10/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • First-line treatment with etravirine 400 mg once daily and two nucleoside reverse transcriptase inhibitors (NRTI) led to similar rates of HIV RNA suppression, compared with efavirenz and two NRTI
  • None of the patients with virological failure in the etravirine arm developed resistance to NNRTI
  • Etravirine was associated with significantly fewer neuropsychiatric adverse events than EFV. The difference was still statistically significant at the week 48 visit
  • There were greater rises in lipids in the EFV arm
  • The risk of grade 2-4 skin or subcutaneous adverse events was similar in the two arms

Design :


Randomisation was stratified by HIV RNA (< or > 100,000 c/mL) at screening
* Open-label NRTI combination selected by investigator : ZDV/3TC BID or ABC/3TC QD or TDF/FTC QD

Primary endpoint :

  • Difference in percentage of patients with at least one grade 1-4 treatment-emergent, drug related neuropsychiatric adverse event by week 12 (adjusted ITT analysis, two-sided test, 90% power)

Baseline characteristics and patient disposition :


* E138A, N = 5, V106I, N = 4, V108I, N = 1, V90I, N = 6

Neuropsychiatric adverse events during 12 weeks :

  • Serious adverse events : ETR, N = 5, EFV, N = 3
  • Grade 2-4 skin or subcutaneous AE : ETR, N = 8, EFV, N = 9 ; discontinuation for rash : 4/8 and 4/9
  • Grade 2-4 elevations in total cholesterol and LDL cholesterol : ETR = 3 and 6 ; EFV = 18 and 13

Response to treatment at week 48 :


Protocol-defined criteria for genotype testing :

  • Discontinuation with detectable HIV RNA
  • HIV RNA decrease < 1 log10 c/mL or > 400 c/mL at week 12
  • HIV RNA > 50 c/mL at week 48
  • Virologic failure (2 consecutive HIV RNA > 50 c/mL) by TLOVR algorithm


Among patients with baseline IAS-USA NNRTI mutations, 10/10 in the ETR arm and 4/4 in the EFV arm had HIV RNA < 50 c/mL at week 48

 

   

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