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AIDS Conference 2018 - Durable Suppression 2 Years After Switch to DTG + RPV 2-Drug Regimen: SWORD Studies 1
 

Download the Sword 100 Week Slide Set     Access the SWORD Clinical Paper


Two Large Studies with Over 1,000 Adults

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Study design: Two identical, open-label Phase III studies 2

SWORD Study Design

JULUCA – Durable Virological Suppression Up To Week 100

Snapshot virological outcomes at Week 48 and Week 100 (SWORD-1 & SWORD-2 pooled) 12

Snapshot virological outcomes at Week 48 and Week 100

* Out to week 100, 5% discontinued due to adverse events (snapshot analysis). 1

JULUCA – High Barrier to Resistance Up to Week 100

Juluca 0 Failures
  • Through Week 100, there was a low number of confirmed virological withdrawals (CVWs) across study populations (1%; 10/990) 1
  • CVWs with resistance-associated treatment-emergent mutations were low across both groups and detected in 3 participants, all receiving DTG + RPV (0.3%; 3/990) 1
  • Three participants on DTG + RPV were identified as having ≥1 NNRTI resistance-associated mutation (1 [E138E/A]; 2 [K101K/E]; 3 [K101E, E138A and M230M/L]) 1


JULUCA – 2 Agents with the Tolerability You Expect

SWORD 100 Week Data Results
  • At Week 48, most common drug-related AEs were headache (JULUCA: 2% vs continued 3-drug regimen: 0%) and diarrhoea (JULUCA: 2% vs continued 3-drug regimen: <1%) 2 
  • At Week 100, most common drug-related AEs occurring in ≥ 2% participants were headache (2%) and nausea (2%), all being Grade 1 1
  • Cumulative adverse events in the early switch arm up to Week 100: 7% (3% from Day 1 to Week 48) 1
  • Cumulative AEs reported in the early-switch group were consistent with the respective labels 1

JULUCA is indicated for HIV-1 virologically suppressed adults on a stable regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any NNRTI or INI.

 

DTG 50 mg + RPV 25 mg (bioequivalent to JULUCA) used in SWORD studies.
Reported by 2% or more of participants in either group. 2

References:

  1. Aboud M et al. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. Poster THPEB047
  2. Llibre JM et al. Lancet. 2018;391:839-849.
  3. Mills A et al. Lancet Infect Dis. 2016;16:43-52.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@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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