Switch studies in virologically suppressed patients

Switch to PI/r monotherapy
Original article : Ciaffi, HIV Drig Therapy 2016, Glasgow, Abs. O122
Last update : 02/01/2017

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • After viral suppression with a second-line cART of PI/r plus 2 NRTIs, maintenance with PI/r plus 3TC is associated with
    • A higher rate of success than PI/r monotherapy despite the presence of M184V mutation
      • Significant more virological failures with PI/r (24.8% vs 3.0%)
    • A similar CD4 response and adherence
    • No differences in safety outcomes



  • Primary Endpoint: failure rate at W96 by ITT, defined as 1) a confirmed HIV RNA ≥ 500 c/mL, 2) reintroduction of the NRTI backbone or 3) interruption of the PI
  • March 2016: Monotherapy arm discontinued following DSMB meeting

Baseline characteristics and primary outcome at W48

* All failure resuppressed to HIV RNA < 200 c/mL a median of 10 weeks after NRTI reintroduction

Other results

  • Failure not associated with
    • Adherence
    • Nadir CD4 count
    • PI
  • CD4 gain similar in both groups at W48
  • No differences in safety (PI/r monotherapy vs PI/r + 3TC)
    • Severe adverse events = 11% (13% vs 10%)
    • AIDS-defining events = 3% (5% vs 2%)
    • No treatment interruptions for intolerance
    • Laboratory parameters : no differences
      • Changes in eGFR similar
      • Minimal changes in lipid parameters

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