For virologically suppressed adult patients with HIV-1. See Full Indication.

JULUCA | Lipid and Fracture Data and a DEXA Substudy

Neutral Effect on Lipids

In pooled data from SWORD 1 & 2, a secondary endpoint evaluated lipids at 48 weeks1

  • No discernible pattern of changes from baseline in mean serum concentrations of lipids at Week 1002

HDL=high-density lipoprotein; LDL=low-density lipoprotein; ART=antiretroviral therapy.

Fractures Reported in SWORD 1 & 2 (Pooled Data) at 48 Weeks

A DEXA Substudy of SWORD 1 & 2 Evaluating Bone Mineral Density1

A DEXA substudy evaluated the change in BMD at 48 weeks following a switch from an ART regimen containing TDF to JULUCA once daily compared with continued therapy with the TDF-containing regimen

102 patients were included; median age was 43 years for JULUCA, 46 years for continuing ART; percentage of females was 51% for JULUCA, 53% for continuing ART

Primary endpoint was percentage change from baseline at Week 48 in total hip BMD; percentage change in lumbar spine BMD was a secondary endpoint

DEXA=dual-energy X-ray absorptiometry; BMD=bone mineral density.

Change in hip BMD at Week 481

(Primary endpoint)

Change in lumbar spine BMD at Week 481

(Secondary endpoint)

CI=confidence interval.

  • BMD declines of ≥5% at the lumbar spine were experienced by 2% of patients receiving JULUCA and 5% of patients who continued their TDF-containing regimen
  • The long-term clinical significance of these BMD changes is not known

References:

  1. Data on file, ViiV Healthcare.
  2. Aboud M, Orkin C, Podzamczer D, et al. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019, Epub ahead of print. http://dx.doi.org/10.1016/S2352-3018(19)30149-3.

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