ARIA STUDY
The ARIA study is a randomised, open-label, multicentre, active-controlled, parallel-group, non-inferiority Phase 3b study in treatment-naïve women (N=495).
The objective of the study was to investigate the efficacy and safety of the fixed-dose combination of DTG/ABC/3TC OD in treatment-naïve women with HIV-1. Study visits were planned for baseline, Week 4 and every 12 weeks thereafter in order for primary analysis to occur at Week 48.1
Study design:1
Primary endpoint:1
Proportion with HIV-1 RNA <50 c/mL at Week 48 as determined with the FDA snapshot analysis algorithm (-12% non-inferiority margin).
Results/outcomes:1
- In treatment-naïve women, DTG/ABC/3TC FDC was superior to ATV/r + TDF/FTC at 48 weeks of treatment
- The treatment difference in the ITT-E snapshot analysis was estimated to be 10.5% (95% CI: 3.1–17.8%; P=0.005)
- Difference driven by lower rate of virologic non-response (snapshot) and fewer discontinuations due to AEs in the DTG arm
- DTG/ABC/3TC had a favourable safety profile compared with ATV/r + TDF/FTC
- Similar to the overall safety profile for DTG from previous studies
- There were no treatment-emergent primary INSTI or ABC/3TC resistance mutations in the DTG/ABC/3TC FDC group
- The study provides important information to help guide treatment decisions in women. The non-inferior efficacy and similar safety profile of the DTG combined regimen compared with the ATV/r regimen support the use of DTG for HIV-1 infection in treatment-naïve women.
References:
- Orrell C, et al. Lancet HIV. 2017;4(12):e536–e546.
PM-GB-DLL-WCNT-210002 | April 2021
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