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

JULUCA | Virologic Suppression & Resistance Results

JULUCA Maintained Virologic Suppression as Effectively as Traditional 3-drug Regimens at 48 Weeks

  • Treatment difference was –0.2% (95% CI; –3.0%, 2.5%); assessed using a noninferiority margin of –8%1

Rates of virologic nonresponse

HIV-1 RNA ≥50 copies/mL: JULUCA <1% (n=3); continuing baseline ART 1% (n=6)
  • Treatment difference: –0.6% (95% CI; –1.7%, 0.6%); assessed using a noninferiority margin of –4%1

CI=confidence interval.

Durable Virologic Suppression Maintained With JULUCA at Week 1002

Rates of virologic nonresponse at Week 100

  • HIV-1 RNA ≥50 copies/mL, 3% (n=13)2

Patients Switched to JULUCA at Week 52 Maintained Virologic Suppression2

Rates of virologic nonresponse from Week 52 to Week 100

  • HIV-1 RNA ≥50 copies/mL, 2% (n=10)2

High Barrier to Resistance Through Week 1002

  • One patient receiving JULUCA (dolutegravir and rilpivirine) had a detectable decrease in susceptibility (>4-fold) to the rilpivirine component of JULUCA in the resistance analysis data set (n=8 with confirmed HIV-1 RNA ≥200 copies/mL at failure or last visit and having resistance data)*

*The confirmed virologic failure population (pooled data from SWORD 1 & 2) who had 2 consecutive viral loads of ≥50 copies/mL, with the second one ≥200 copies/mL.
Resistance testing not performed in 2 patients (1 patient in each treatment arm) because of low viral load.
INSTI resistance test failed in 2 patients (1 patient in each treatment arm).

References:

  1. Llibre JM, Hung C-C, Brinson C, Castelli F, 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.
  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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