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 1482
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 Density1,3
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
Change in lumbar spine BMD at Week 481
- 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
- In subjects who received JULUCA from study start and were continuing JULUCA at Week 148, mean BMD increases from baseline were 0.98% (total hip) and 0.53% (lumbar spine)
- The long-term clinical significance of these BMD changes is not known
- Data on file, ViiV Healthcare.
- 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
- McComsey GA, Lupo S, Parks D. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018;32(4):477-485. doi: 10.1097/QAD.0000000000001725.