Switch studies in virologically suppressed patients

Switch to DRV/r + RPV
PROBE Study
Original article : J Acquir Immune Defic Syndr. 2016 May 1;72(1):46-51 – F Maggiolo
Last update : 18/07/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • A rilpivirine plus ritonavir-boosted DRV dual therapy was not inferior over 48 weeks to a standard boosted PI–based triple cART
  • The dual therapy did not negatively affect lipid profile and renal function and was more friendly on bone mineral density
  • This approach constitutes an alternative for patients experiencing nucleoside reverse transcriptase inhibitor–related toxicities
  • Limitations
    • Small sample size

Design

Objective

  • Primary endpoint: proportion with HIV RNA < 50 c/mL at W24 and W48 (ITT, FDA snapshot) with non inferiority of DRV/r + RPV (lower limit of the 95% CI for the difference = -12%, 80% power)
  • Protocol-defined virologic failure: 2 consecutive HIV RNA > 50 c/mL

Baseline characteristics (mean)

Virologic outcome at W24 and W48 (ITT, snapshot)


* blips at 57 and 138 c/mL
** blip at 59 c/mL

  • Virologic non inferiority at W24 and W48

Secondary endpoints at W48


* p = 0.018

Safety and Tolerability at W48

 

Back to Table of Contents

Copyright AEI 2017 | Links | Contact | Faculty and Disclosure | Terms of use aei