1382. Sword 1 & 2: Subgroup Analysis of 48 Week Results by Age, Race and Gender
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Friday, October 6, 2017
Room: Poster Hall CD
Posters
  • Walmsley_IDWeek Poster_SWORD Subgroup.pdf (369.0 kB)
  • Background: Switching to the 2-drug regimen (2DR) of DTG+RPV was proven non-inferior to continuing a suppressive PI-, INI- or NNRTI- based current antiretroviral regimen (CAR) at Week 48. This analysis evaluated the efficacy and safety of switching from CAR to DTG+RPV by age, race and gender subgroups.

    Methods: Two identically designed, open-label, multicenter, global, phase III, non-inferiority studies compared the  efficacy and safety of switching from a 3 or 4-drug CAR to DTG+RPV once daily in HIV-1-infected adults, with HIV-1 RNA<50c/mL. Primary endpoint was proportion of pts with VL<50c/mL at Wk48 using FDA Snapshot. Additional analysis were performed to summarize efficacy base on age, race and gender subgroups for each individual study and pooled.

    Results: 1024 pts were randomized and exposed (DTG+RPV 513; CAR 511), across both studies.  Treatment arms were well matched for demographic and baseline characteristics.  Median age across both arms was 43.4 years, with 29% and 28% ≥ 50 years in DTG+RPV and CAR, respectively. 23% and 21% were female while 18% and 22% were non-white for DTG+RPV and CAR.  For the pooled studies and for SWORD-1 and SWORD-2 individually, switching to DTG+RPV was non-inferior to CAR at Wk48.  Similar response rates were observed in the DTG+RPV arm compared to CAR across subgroups (Table 1).  More AEs were reported in the DTG+/RPV arm across all subgroups except Asian race; no unexpected AEs were identified for either drug

    Table 1

    Proportion of pts with HIV-1 RNA <50 c/mL at Week 48 (Snapshot):
    Pooled SWORD Studies Population

     

    DTG/RPV

    N=513

    n/N (%)

    CAR

    N=511

    n/N (%)

    OVERALL

    486/513 (95)

    486/511 (95)

    Age: <50 years

    350/366 (96)

    348/369 (94)

    Age: ≥50 years

    136/147 (93)

    137/142 (96)

    Gender: Male

    375/393 (95)

    387/403 (96)

    Gender: Female

    111/120 (93)

      98/108 (91)

    Race: White

    395/421 (94)

    378/398 (95)

    Race: African heritage

    36/37 (97)

    44/47 (94)

    Race: Other

    Asian

    17/17 (100)

    38/38 (100)

    14/16 (88)

    49/50 (98)

     

    Conclusion: Switch to a novel, once daily 2DR of DTG+RPV in patients with a suppressed viral load, was an effective and well tolerated treatment option across age, race, and gender subgroups which were consistent with overall results.

    Sharon Walmsley, MD, FRCP1, Gary Richmond, MD2, Fritz Bredeek, MD, PhD, FACP3, Moti Ramgopal, MD, FACP, FIDSA4, Chien-Ching Hung, MD, MIH, PhD5, Elizabeth Blair, PharmD6, Lesley Kahl, PhD7, Mark Underwood, PhD6,8, Kostas Angelis, PhD9, Kati Vandermeulen, BSc10, Brian Wynne, MD8 and Michael Aboud, MD11, (1)University of Toronto, Toronto, ON, Canada, (2)Broward Gen. Med. Ctr, Ft. Lauderdale, FL, (3)Metropolis Medical, San Francisco, CA, (4)Midway Immunology and Research Center, Fort Pierce, FL, (5)Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan, (6)ViiV Heatlhcare, Durham, NC, (7)ViiV Heatlhcare, Brentford, United Kingdom, (8)ViiV Healthcare, Research Triangle Park, NC, (9)GlaxoSmithKline, London, United Kingdom, (10)Jansen, Brussels, Belgium, (11)ViiV Healthcare, Brentford, United Kingdom

    Disclosures:

    S. Walmsley, Merck: Board Member , Consultant , Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Grant recipient , Research grant and Speaker honorarium
    ViiV Healthcare: Board Member , Consultant , Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Grant recipient , Research grant and Speaker honorarium
    Gilead Sciences: Board Member , Consultant , Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Grant recipient , Research grant and Speaker honorarium
    GSK: Board Member , Consultant , Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Grant recipient , Research grant and Speaker honorarium
    Janssen: Board Member , Consultant , Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Grant recipient , Research grant and Speaker honorarium
    BMS: Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Grant recipient , Research grant and Speaker honorarium

    G. Richmond, Viiv Healthcare: Investigator , Research support

    F. Bredeek, ViiV Healthcare: Investigator and Scientific Advisor , Consulting fee and Research support

    M. Ramgopal, viiv: Investigator , Consulting fee

    C. C. Hung, Gilead Sciences: Board Member and Speaker's Bureau , Consulting fee and Speaker honorarium
    ViiV: Board Member and Investigator , Consulting fee and Research support
    Abbvie: Board Member and Investigator , Consulting fee and Research grant
    Bristol-Myers Squibb: Investigator , Research support
    Jassen: Board Member and Investigator , Consulting fee and Research support

    E. Blair, ViiV Healthcare: Employee and Shareholder , Salary

    L. Kahl, ViiV Healthcare: Employee and Shareholder , Salary

    M. Underwood, ViiV Healthcare: Employee , Salary

    K. Angelis, GlaxoSmithKline: Employee , Salary

    K. Vandermeulen, Jansen: Employee , Salary

    B. Wynne, ViiV Healthcare: Employee , Salary

    M. Aboud, ViiV Healthcare: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.