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

JULUCA | Sword 1 & 2 Trials: Study Overview

Trial Designs

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

Exclusion criteria1

  • 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.

Study Design2

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 100.

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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