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Sword-1 &-2 Phase III Studies.

SWORD-1 & SWORD-2 are the first Phase III studies of a 2-drug regimen out to 148 weeks. 2,3

Two Large Studies with Over 1,000 Adults

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SWORD Study Design
Snapshot virological outcomes at Week 48 and Week 100

The Benefits of Juluca

  • Non-inferior to traditional 3- to 4-drug regimens at maintaining virological suppression 2
  • Powered by DTG at the core 1
  • Tenofovir-Free (No TDF or TAF) 2,4
Rationale for dolutegravir-based 2DR:
  • High efficacy with dolutegravir-based regimens 3,6,8,15,18,24,27
  • Mode of action at 2 different viral targets 11,19,28
  • High Barrier to resistance 8,11
  • Favourable pharmacokinetic profile 11-14
  • Convenient once-daily dosing regimen 11

References:

  1. Juluca Summary of Product Characteristics available at www.medicines.ie. Last accessed January 2021.
  2. van Wyk J, Orkin C, Rubio R, et al. Durable suppression and low rate of virologic failures 3 years after switch to DTG+RPV 2-drug regimen: SWORD 1&2 studies. Presented at: 25th Annual Conference of the British HIV Association; April 2-5, 2019; Bournemouth, UK. Poster P008.
  3. Llibre JM et al. Lancet. 2018; 391:839-849.
  4. McComsey GA et al. AIDS. 2018;32:477-485.
  5. Orkin C, et al. HIV Medicine 2018;19:18-32.
  6. Aboud M et al. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands.
  7. Min S et al. AIDS 2011;25:1737-1745.
  8. Cahn P et al. Lancet 2013;382:700-708.
  9. Kobayashi M et al. Antimicrob Agents Chemother 2011;55:813-821.
  10. Hightower KE et al. Antimicrob Agents Chemother 2011;5:4552-4559.
  11. Tivicay Summary of Product Characteristics. Available from www.medicines.ie. Last Accessed: January 2021
  12. Liverpool Interaction Charts. https://www.hiv-druginteractions.org/printable_charts Last Accessed: January 2021.
  13. van Lunzen J et al. Lancet Infect Dis 2012;12:111-118.
  14. Elliot E et al. IWCPHIV 2015; Abstract 13.
  15. Walmsley S et al. N Engl J Med 2013;369:1807-1818.
  16. Clotet B et al. Lancet 2014;383:2222-2231.
  17. Orrell C et al. Lancet HIV. doi: 10.1016/S2352-3018(17)30095-4.
  18. Raffi F, et al. Lancet 2013;381:735-743.
  19. Hill A et al. Open Infect Dis J. 2010;4:85-91.
  20. Kelly SG et al. Drugs. 2016;76:523-531.
  21. McKinnon JE et al. Antivir Ther. 2009;14:1-12.
  22. Orkin C.Integrating new antiretroviral therapy. Presented at: Conference on Retroviruses and OpportunisticInfections; March 4-7, 2018; Boston, MA.
  23. Cahn P et al. Lancet 2018. Published online November 9,2018 http://dx.doi.org/10.1016/S0140-6736(18)32462-0.
  24. Aboud M et al. Presented at: InternationalAIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. Poster THPEB040.
  25. Molina J-M et al.Lancet HIV. 2015;2(4):e127-e136.
  26. Walmsley S et al. J Acquir Immune Defic Syndr. 2015;70(5):515-519.
  27. Epivir Summary of Product Characteristics. Available at www.medicines.ie. Last Accessed January 2021

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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