Switch studies in virologically suppressed patients
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Switch to INSTI + NNRTI
SWORD Study: Switch to DTG + RPV
Original article : Llibre JM. CROI 2017, Abs. 44LB
Dernière mise à jour : 29/03/2017

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • A switch to a novel, once-daily 2 drug-regimen of DTG + RPV demonstrated high efficacy and was non-inferior to the continuation
    of a combined antiretroviral therapy in virologically suppressed
    HIV-1–infected adults
  • The safety profiles of both DTG and RPV were consistent with their respective labels
  • Switching to DTG + RPV had a neutral effect on lipids, while significantly improving bone turnover biomarkers

Design

Endpoint

  • Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (ITT-exposed, snapshot) ; non-inferiority if lower margin of a two-sided 95% CI for the difference = - 8% for pooled studies (- 10% for each individual study)

Baseline characteristics and patient disposition

Virologic outcome at W48 (ITT-E, snapshot)

Other virologic results at W48

  • HIV RNA < 50 c/mL (ITT-E snapshot)
    • SWORD-1
      • 95% DTG + RPV
      • 96% continuation cART
      • Adjusted ≠: - 0.6% (95% CI: - 4.3 to + 3.0)
    • SWORD-2
      • 94% DTG + RPV
      • 94% continuation cART
      • Adjusted ≠: 0.2% (95% CI: - 3.9 to + 4.2)
  • Confirmed virologic failure: HIV RNA ≥ 50 c/mL, retest ≥ 200 c/mL
  • DTG + RPV, N = 2
    • Emergence of NNRTI resistance mutation (K101K/E) ‒
  • Continued cART , N = 2
    • No mutations

HIV RNA of subject with NNRTI- resistant mutation

  • 41-year-old female
    • Pre- cART HIV RNA > 2 millions c/mL ; 1 st cART : TDF/FTC/EFV
    • Randomised to DTG + RPV
    • Documented non-adherence before W36

HIV RNA, c/mL

Adverse events , %


* (some participants have more than 1 AE) ; anxiety (N = 4), depression (N = 3), insomnia (N = 2), depressed mood (N = 1), headache (N = 1), panic attack (N = 1), suicidal ideation (N = 1), tremor (N = 1), drug-induced liver injury (N = 1), eosinophilic pneumonia, acute (N = 1), abdominal distension (N = 2), dyspepsia (N = 2), peptic ulcer (N = 1), gastrointestinal haemorrhage (N = 1), pancreatitis, acute (N = 1), Hodgkin's disease (N = 1), Kaposi sarcoma (N = 1), plasmablastic lymphoma (N = 1)

Fasting lipids at baseline and W48

 

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