949. 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-Naïve Women with HIV-1 Infection (ARIA Study): Analyses by Race Subgroups
Session: Oral Abstract Session: HIV Clinical Management
Friday, October 28, 2016: 10:45 AM
Room: 275-277
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-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/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.

Results: 495 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 1). 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.

Table 1

Proportion of Subjects with HIV-1 RNA <50 c/mL (Snapshot)

DTG/ABC/3TC

N=248

n/N (%)

ATV/r+TDF/FTC

N=247

n/N (%)

OVERALL

203/248 (82)

176/247 (71)

Race: White

99/115 (86)

86/107 (80)

Race: African heritage

75/102 (74)

72/108 (67)

Race: Other

29/31 (94)

18/32 (56)

US Subjects

46/62 (74)

46/69 (67)

Conclusion: DTG/ABC/3TC demonstrated superior efficacy and a favorable safety profile compared to ATV/r+FTC/TDF in treatment-naïve women, after 48 weeks of treatment. Race subgroup analyses were consistent with overall results.

Debbie Hagins, MD1, Craig Dietz, DO, MPH, FACOI, AAHIVS2, Mamta Jain, MD3, Cornelius Van Dam, MD4, Indira Brar, MD5, Choy Man, BSc6, Jiangxiu Zhou, PhD7, Annie Buchanan, MD, MPH6, Brian Wynne, MD8, Cindy Vavro, BA6, Michael Aboud, MD9 and Kimberly Smith, MD6, (1)Chatham County Health Department, Savannah, GA, (2)Kansas City CARE Clinic, Kansas, MO, (3)UT Southwestern Medical Center, Dallas, TX, (4)Regional Center for Infectious Disease, Greensboro, NC, (5)Infectious Diseases, Henry Ford Hospital, Detroit, MI, (6)ViiV Healthcare, Research Triangle Park, NC, (7)Glaxo SmithKline, Collegeville, PA, (8)ViiV Healthcare, Collegeville, PA, (9)ViiV Healthcare, Brentford, United Kingdom

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

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