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Fortsett

Tilbake

First single-pill 2DR

Fewer ARVs vs a 3-drug regimen: TDF, TAF and ABC free 

Treatment non-inferior to traditional 3-drug regimens at maintaining virological suppression…2

Is now available with just 2 well-established agents3-5

All in 1 pill1

JULUCA (dolutegravir/rilpivirine) is indicated for the treatment of HIV-1 infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any NNRTI or INI.1

EXPLORE THE CLINICAL DATA

JULUCA – 95% of Patients Maintained Virological Suppression2

Snapshot virological outcomes at Week 48 (pooled)2

Virological outcomes

Graph adapted from reference 2 by ViiV Healthcare

JULUCA was non-inferior to continued 3-drug regimens2

  • Adjusted treatment difference -0.2% (95% CI; -3.0, 2.5)2

DTG 50 mg + RPV 25 mg (bioequivalent to JULUCA) used in SWORD studies.1

JULUCA – High Barrier to Resistance up to 48 Weeks2

For patients switched to JULUCA, there was no increased risk of virological failure vs continued 3-drug regimen: <1% (3/513) vs 1% (6/511), respectively (diff. -0.5%, 95% CI: -1.4 to 0.5)2

Zero failures
  • One NNRTI mutation was identified (K101K/E) in a subject with documented poor/non-adherence; however, the virus remained susceptible to RPV2

One Subject with an Identified NNRTI Mutation After Poor/Non-Adherence Resuppressed on DTG + RPV at Week 452

  • Participant randomised to DTG + RPV2
  • Documented poor/non-adherence leading up to Week 362
Non-adherence

Graph adapted from reference 2 by ViiV Healthcare

JULUCA – Significant Increase in Bone Mineral Density (Dexa Sub-Study)6

Bone mineral density

Graphs developed by ViiV Healthcare based on reference 6

  • 1.29% (95% CI: 0.27 to 2.31) and 1.32% (95% CI: 0.07 to 2.57) improvement in hip and lumbar spine bone mineral density (BMD), respectively, compared with those continuing on TDF-based regimens6

Switching to JULUCA provides a robust option for maintaining virological suppression while preserving bone health.6

JULUCA – Maintains Lipid Levels2

Although the majority of patients switching away from TDF-based regimens, lipid values remained stable at Week 482

Lipid values

Graph adapted from reference 2 by ViiV Healthcare
(Statistical analysis not performed)

Increases in lipid parameters are known from the individual component RPV: Total cholesterol (fasted, very common) and LDL cholesterol (fasted, common)1,7

JULUCA – Tolerability

Patients switched to JULUCA had a median time on ART of 4.25 years2

Adverse events by week 48 in SWORD-1 and SWORD-2 (pooled)2

Adverse events

Table adapted from reference 2 by ViiV Healthcare
(Statistical analysis not performed)

*Two deaths, one in JULUCA group and one in continued 3-drug regimen group, in the study, both considered unrelated to study drug.2 
‡Reported by ≥2% of participants in either group.2

Any adverse events reported by ≥2% of participants in either group in SWORD-1 and SWORD-2 studies by week 482

Adverse events

Table adapted from reference 2 by ViiV Healthcare
(Statistical analysis not performed)

Referanser

  1. JULUCA▼ preparatomtale 
  2. Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet 2018;391(10123):839–849.
  3. TIVICAY preparatomtale 
  4. Edurant preparatomtale 
  5. TRIUMEQ preparatomtale
  6. McComsey GA, Lupo S, Parks D, et al. Switch from tenofovir disoproxil fumarate combination to dolutegravir plus rilpivirine improves parameters of bone health. AIDS 2018;32(4):477–485.
  7. European Medicines Agency Juluca Assessment report, EMEA/H/C/004427/0000, 22 March 2018 (accessed 05 June 2018)