Switch studies in virologically suppressed patients

Switch to PI/r monotherapy
MOBIDIP Study
Original article : Ciaffi L, Lancet HIV 2017; 4:e384-92
Last update : 28/09/2017

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

Design

Objective

  • 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 failures 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

Follow-up of dual therapy (PI/r + 3TC) arm at W96, N = 132

  • Confirmed virological failure (2 consecutive HIV RNA > 500 c/mL)
    • N = 8 (virological success = 94% [ HIV RNA < 50 c/mL: 79%])
    • Genotype testing in 7/8: 2 lost M184V mutation, none developed PI or new NRTI mutations
    • Reintroduction of TDF in 5/8 participants: 4/5 resuppressed, 1 data missing
    • No change in 3 participants: resuppressed without change
  • 3 discontinuations for non virological failure
  • Global treatment success rate at W96: 91.7%

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