JULUCA | Virologic Suppression & Resistance Results
JULUCA Maintained Virologic Suppression as Effectively as 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
- Treatment difference: –0.6% (95% CI; –1.7%, 0.6%); assessed using a noninferiority margin of –4%1
Durable Virologic Suppression Maintained With JULUCA at Week 1482
Rates of virologic nonresponse at Week 148
- HIV-1 RNA ≥50 copies/mL, 3% (n=13)2
Patients Who Switched to JULUCA at Week 52 Maintained Virologic Suppression Through Week 1482
Rates of virologic nonresponse from Week 52 to Week 148
- HIV-1 RNA ≥50 copies/mL, 2% (n=10)2
Resistance Data Through 148 Weeks2
- In the pooled SWORD-1 and SWORD-2 trials, 12 subjects (7 in SWORD-1 and 5 in SWORD-2) had confirmed virologic failure (HIV-1 RNA greater than 200 copies/mL) while receiving JULUCA (dolutegravir and rilpivirine) at any time through Week 148. Ten of the confirmed virologic failures had post-baseline resistance data, with 6 isolates showing evidence of rilpivirine resistance, and 2 with evidence of dolutegravir resistance substitutions*
- Genotypic and/or phenotypic resistance substitutions to rilpivirine included: E138E/A, L100L/I, K101Q and E138A, K101K/E, and L100L/V/M†
*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.
†INSTI resistance test failed in 2 patients (1 patient in each treatment arm). One V151V/I substitution was present post baseline; no integrase phenotypic data were at virologic failure. One other subject had the dolutegravir-resistance substitution G193E at baseline and virologic failure, but no detectable phenotypic resistance at Week 24.
- 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.
- van Wyk J, Orkin C, Rubio R, et al. Durable suppression and low rate of virologic failure 3 years after switch to dolutegravir + rilpivirine 2-drug regimen: 148-week results from SWORD-1 and SWORD-2 randomized clinical trials. J Acquir Immune Defic Syndr. 2020;85:325-330. doi: 10.1097/QAI.0000000000002449