Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) Fixed-Dose Combination (FDC) Compared With Ritonavir-Boosted Atazanavir (ATV/r) Plus Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) in Treatment-Naive Women With Human Immunodeficiency Virus (HIV)-1 Infection (ARIA Study): Analyses by Race Subgroups

Background. Built upon an unboosted integrase-strand transfer inhibitor (INSTI), the FDC of DTG/ABC/3TC offers a complete regimen for HIV-1 infection, with good tolerability and a high barrier to resistance. 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/r + FTC/TDF (ClinicalTrials.gov: NCT01910402). Methods. Treatment-naive 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/r + 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). Additional analyses were performed to evaluate efficacy based on race subgroups. Proportion of Subjects with HIV-1 RNA <50 c/mL (Snapshot) Results. Four hundred ninety-five women were randomized and treated. Subjects were well matched for demographic and baseline characteristics. Median age was 37 years; 45% of subjects were White and 42% African heritage. DTG/ABC/3TC was superior to ATV/r + 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. Higher response rates were observed in the DTG/ABC/3TC arm compared to ATV/r + TDF/FTC across race subgroups, as well as in US subjects (table). The safety profile of DTG/ABC/3TC was favorable compared to ATV/r + TDF/FTC, with fewer drug related AEs in the DTG/ABC/3TC group. There were no treatment-emergent primary INSTI or ABC/3TC resistance mutations in the DTG/ABC/3TC group. Conclusion. DTG/ABC/3TC demonstrated superior efficacy and a favorable safety profile compared to ATV/r + FTC/TDF in treatment-naive women, after 48 weeks of treatment. Race subgroup analyses were consistent with overall results. Disclosures. D. Hagins, ViiV Healthcare: Investigator, Investigator payment clinical trial conduct (HIV); C. Dietz, ViiV Healthcare: Investigator, Investigator payment for clinical trial conduct (HIV); M. Jain, ViiV Healthcare: Investigator, Investigator payment clinical trial conduct (HIV). Merck: Investigator, Investigator payment clinical trial conduct (HIV). Gilead Sciences: Investigator, Investigator payment clinical trial conduct (HIV). Janssen: Investigator, Investigator payment clincial trial conduct (HIV); C. Van Dam, ViiV Healthcare: Investigator, Research support; I. Brar, ViiV Healthcare: Investigator, Investigator payment clinical trial conduct (HIV). Gilead: Investigator and Speaker's Bureau, Investigator payment clinical trial conduct (HIV) and Speaker honorarium. Janssen: Investigator and Speaker's Bureau, Investigator payment clinical trial conduct (HIV) and Speaker honorarium; C. Man, ViiV Healthcare: Employee and Shareholder, GSK stock as part of compensation and salary and Salary; J. Zhou, Glaxo SmithKline: Employee, GSK stock as part of compensation and salary and Salary; A. Buchanan, ViiV Healthcare: Employee and Shareholder, GSK Stock and Salary; B. Wynne, ViiV Healthcare: Employee, GSK stock as part of compensation and Salary; C. Vavro, ViiV Healthcare: Employee and Shareholder, GSK stock as part of compensation and salary and Salary; M. Aboud, ViiV Healthcare: Employee and Shareholder, GSK stock as part of compensation and salary and Salary; K. Smith, ViiV Healthcare: Employee and Shareholder, GSK stock as part of compensation and salary and Salary