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Background: The FDC of DTG/ABC/3TC is built upon an unboosted integrase-strand transfer inhibitor (INSTI), and may offer a simplified regimen for the treatment of HIV-1 infection. To gain additional data for women on this regimen, we conducted ARIA, an international, randomized, open-label study to evaluate the safety and efficacy of DTG/ABC/3TC versus ATV+RTV+FTC/TDF (ClinicalTrials.gov: NCT01910402).
Methods: Treatment-naïve adult women, with HIV-1 RNA ≥500 copies(c)/mL were randomized (1:1, stratified by plasma HIV-1 RNA and CD4+ count) to 48 weeks of treatment with DTG/ABC/3TC or ATV+RTV+FTC/TDF once daily. The primary endpoint was the proportion of women achieving an HIV‑1 RNA < 50 c/mL at Week 48 (Snapshot algorithm). Women who became pregnant were withdrawn, and where possible offered an option to enter a DTG/ABC/3TC pregnancy study.
Results: 495 women were randomized and treated. Median age was 37 years. Subjects were well matched for demographic and baseline (BL) characteristics. DTG/ABC/3TC was superior to ATV+RTV+FTC/TDF, with 82% and 71%, respectively, achieving HIV-1 RNA < 50 c/mL at Week 48 (adjusted difference 10.5%, 95% CI: 3.1% to 17.8%, p=0.005). Differences were driven by lower rates of both discontinuations due to adverse events (AEs) and Snapshot virologic failures in the DTG/ABC/3TC group. Increases in CD4+ count were similar between treatment groups. The safety profile of DTG/ABC/3TC was favorable compared to ATV+RTV+TDF/FTC, with fewer drug-related AEs reported in the DTG/ABC/3TC group. Of six DTG/ABC/3TC subjects who met protocol-defined virologic withdrawal criteria, none had treatment-emergent primary INSTI or ABC/3TC resistance mutations, compared with four ATV+RTV+TDF/FTC subjects who met virologic withdrawal criteria of which one had an emergent NRTI mutation, M184M/I/V.


 DTG/ABC/3TC, N=248ATV+RTV+TDF/FTC, N=247
Race: White (%), African heritage (%)46, 4143, 44
Median BL CD4+ (cells/mm3)340350
Median BL HIV-1 RNA (log10 c/mL)4.414.43
Week 48 HIV-1 RNA <50 c/mL (Snapshot, %)8271
Median change in CD4+ at Week 48 (cells/mm3)234200
Virologic failure (Snapshot, %)614
Discontinuations due to AEs (%)47
Pregnancies (%)23
Drug-related AEs (%)3349
[Table 1]


Conclusions: DTG/ABC/3TC demonstrated superior efficacy and a favorable safety profile compared with ATV+RTV+FTC/TDF in treatment-naïve women after 48 weeks of treatment. The study provides important information to help guide treatment decisions for women.