JULUCA | Sword 1 & 2 Trials: Study Overview
Two identically designed Phase 3, randomized, multicenter, open-label, parallel group, noninferiority trials
Designed to evaluate the safety and efficacy of switching to JULUCA vs continuation of stable suppressive ART (2 NRTIs plus either an INSTI, an NNRTI, or a PI)
Patients were treatment-experienced, virologically suppressed (HIV-1 RNA <50 copies/mL; on stable suppressive uninterrupted therapy for ≥6 months prior to screening) adults (≥18 years) with HIV-1
- Severe hepatic impairment, positive for hepatitis B virus (HBV) surface antigen, or with an anticipated need for hepatitis C virus (HCV) therapy during the study
- History of treatment failure
- Known substitutions associated with resistance to dolutegravir or rilpivirine
ART=antiretroviral therapy; NRTIs=nucleoside reverse transcriptase inhibitors; INSTI=integrase strand transfer inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor.
SWORD 1 & 2: Baseline Characteristics and Study Design (pooled analysis)1
*70% of patients were on a baseline regimen of an FTC/TDF NRTI combination.
CDC=Centers for Disease Control and Prevention; FTC=emtricitabine; TDF=tenofovir disoproxil fumarate.
Primary endpoint at Week 48 was the proportion of patients
with HIV-1 RNA <50 copies/mL
†At Week 52, patients in the continuing ART arm who remained virologically suppressed at Week 48 were switched to JULUCA and followed to Week 148.
- 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