JULUCA – Durable Virological Suppression Up To Week 100
* Out to week 100, 5% discontinued due to adverse events (snapshot analysis). 1
JULUCA – High Barrier to Resistance Up to Week 100
- Through Week 100, there was a low number of confirmed virological withdrawals (CVWs) across study populations (1%; 10/990) 1
- CVWs with resistance-associated treatment-emergent mutations were low across both groups and detected in 3 participants, all receiving DTG + RPV (0.3%; 3/990) 1
- Three participants on DTG + RPV were identified as having ≥1 NNRTI resistance-associated mutation (1 [E138E/A]; 2 [K101K/E]; 3 [K101E, E138A and M230M/L]) 1
JULUCA – 2 Agents with the Tolerability You Expect
- At Week 48, most common drug-related AEs were headache (JULUCA: 2% vs continued 3-drug regimen: 0%) and diarrhoea (JULUCA: 2% vs continued 3-drug regimen: <1%) 2 †
- At Week 100, most common drug-related AEs occurring in ≥ 2% participants were headache (2%) and nausea (2%), all being Grade 1 1
- Cumulative adverse events in the early switch arm up to Week 100: 7% (3% from Day 1 to Week 48) 1
- Cumulative AEs reported in the early-switch group were consistent with the respective labels 1
JULUCA is indicated for HIV-1 virologically suppressed adults on a stable regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any NNRTI or INI.
DTG 50 mg + RPV 25 mg (bioequivalent to JULUCA) used in SWORD studies.
†Reported by 2% or more of participants in either group. 2