JULUCA | Adverse Reactions
Adverse Reactions and Rates of Discontinuation Due to Adverse Events Through Week 1001*
The most common adverse reactions Grades 1 to 4 with ≥2% frequency in the JULUCA arm through 48 weeks were diarrhea (2%) and headache (2%). Withdrawals due to adverse events through 48 weeks occurred in 4% (21/513) of patients in the JULUCA arm compared to <1% (3/511) with continuing ART.
*SWORD 1 & 2 (pooled data).
†Most common AEs leading to discontinuation were psychiatric disorders: 2% of patients who continued on JULUCA through Week 100 and 1% of patients who switched to JULUCA at Week 52.
AEs = adverse events.
- 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.
For virologically suppressed adult patients with HIV-1
Adverse Reactions and Rates of Discontinuation Due to Adverse Events Through Week 1481*
- AEs leading to discontinuation were cumulative, 8% through Week 148 (4% from Day 1- Week 48 and 7% from Week 48-Week 100)1
- Low rates of Grade 2 to 4 drug-related AEs and serious AEs were reported1
- The majority of AEs were Grade 1 or 2
- There were 4 drug-related SAEs; all started before Week 48
- Safety profile of the late-switch group through Week 148 was comparable to the early-switch group at Week 1001
*Most common AEs leading to discontinuation were psychiatric disorders; 3% of patients who continued on JULUCA through Week 148 and 1% of patients who switched to JULUCA at Week 52.
AE = adverse event; SAE = serious adverse event
- van Wyk J, Orkin C, Rubio R, et al. Durable suppression and low rate of virologic failures 3 years after switch to DTG+RPV 2-drug regimen: SWORD 1 & 2 studies. Presented at: 25th Annual Conference of the British HIV Association; April 2-5, 2019; Bournemouth, UK. Poster P008.