SWORD-1 AND SWORD-2 STUDIES 

SWORD-1 and SWORD-2 are two identically designed Phase 3, open-label, parallel-group, multicentre, randomised, non-inferiority studies for patients on first or second ART with a stable plasma HIV-1 RNA for ≥6 months (N=1024).

These studies were designed to evaluate the efficacy and safety of DTG+RPV compared with the continuation of current ART regimen in patients with HIV-1 with suppressed viral load. Patients were randomly assigned either DTG+RPV once daily or continued with their current ART regimen for 52 weeks, with primary analysis occurring at Week 48. A late-switch phase took place from Weeks 52 to 148, where participants on their current ART regimen with a viral load <50 copies/mL at Week 48 were able to switch to DTG+RPV at Week 52.1,2

Study design:1
SWORD-1 and SWORD-2 study design illustration
Primary endpoint:1

Proportion of participants in the intention-to-treat population with plasma HIV-1 RNA <50 copies/mL at Week 48, using the FDA snapshot algorithm (4% non-inferiority margin).

 

Results/outcomes:1,2
  • Switching to DTG+RPV is non-inferior to current ART regiments in both studies
    • In SWORD-1: 95% vs 96% maintained viral suppression at 48 weeks (adjusted treatment difference -0.6%; 95% CI: -4.3 to 3.0)
    • In SWORD-2: 94% vs 94% maintained viral suppression at 48 weeks (adjusted treatment difference 0.2%; 95% CI: -3.9 to 4.2)
    • Pooled SWORD-1 and SWORD-2 data showed 95% maintained viral suppression in both treatment arms at 48 weeks (adjusted treatment difference -0.2%; 95% CI: -3.0 to 2.5)
       
  • DTG+RPV was non-inferior to current ART regimens in the proportion of participants defined as virological failures at 48 weeks (-0.5%; 95% CI: -1.4 to 0.5)
    • Through Week 148, there was a low number of confirmed virologic withdrawals across the study populations who received DTG+RPV (1%; 11/990)
    • For participants with available resistance testing data, no integrase resistance was observed at the CVW time point, whereas NNRTI-associated or RPV-associated resistance mutations were identified in 6 participants (<1%), with baseline RPV RAMs detected in one of these participants.
       
  • DTG+RPV showed similar tolerability to current ART regimens in SWORD pooled data
  • At Week 48, the most common AEs were nasopharyngitis (10% vs 10%), headache (8% vs 5%) and upper respiratory tract infection (5% vs 7%)
  • 1% vs <1% reported drug-related serious AEs at Week 48
  • 3% vs <1% discontinued due to AEs at Week 48
  • Through 148 weeks, DTG+RPV showed a good safety profile with few serious AEs or drug-related grade 2-4 AEs

References:

  1. Llibre JM, et al. The Lancet. 2018;391:839–849.
  2. Van Wyk J, et al. J Acquir Immune Defic. 2020;85(3):325-330.
DOVATO (Dolutegravir/lamivudine)

Dolutegravir (DTG)

Dolutegravir (DTG) has been studied across diverse patient populations as part of both 3-drug and 2-drug regimens, including patients who are virologically suppressed, treatment-experienced or treatment-naïve.

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PM-GB-DLL-WCNT-210002 | April 2021

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