1380. A Randomized Trial of Bictegravir or Dolutegravir with Emtricitabine and Tenofovir Alafenamide (F/TAF) Followed by Open Label Switch to Bictegravir/F/TAF Fixed Dose Combination
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Friday, October 6, 2017
Room: Poster Hall CD
Posters
  • Sax IDWeek 2017 88x43@100%-output.pdf (132.8 kB)
  • Background: Integrase strand transfer inhibitors (INSTIs) are widely recommended for initial HIV-1 treatment. Bictegravir (BIC, B) is a novel, once-daily INSTI with potent antiviral activity being developed in coformulation with emtricitabine and tenofovir alafenamide (F/TAF).

    Methods: In this Phase 2 study, treatment naïve, HIV-infected adults were randomized 2:1 to receive blinded treatment with BIC or dolutegravir (DTG) coadministered with open label F/TAF (200/25 mg). After all participants completed 48 weeks, they were unblinded and switched to a single fixed-dose combination tablet of B/F/TAF 50/200/25 mg. The proportion of participants with HIV-1 RNA <50 copies/mL (c/mL) was assessed at Week (W) 24 and W48 of the blinded phase and 12 weeks after switching to open label B/F/TAF (W72).

    Results: Of 98 participants enrolled in the blinded treatment phase, 65 were randomized to BIC+F/TAF and 33 to DTG+F/TAF. Most were male, had asymptomatic HIV infection, with median HIV-1 RNA 4.4-4.5 log10 c/mL. The proportion of subjects with HIV-1 RNA <50 c/mL at W24 was 97% for the BIC arm and 94% for the DTG arm, and at W48 was 97% and 91%, respectively (Table). All 92 participants who completed the blinded phase were switched to B/F/TAF at W60. At W72 or 12 weeks after switching to open-label B/F/TAF, 99% (91/92) maintained HIV-1 RNA <50 c/mL (98% prior BIC arm [N=62]; 100% prior DTG arm [N=30]) and one individual withdrew prior to the analysis. No viral resistance was detected in participants treated with BIC. No participants discontinued open label B/F/TAF due to an adverse event, there were no treatment-related serious adverse events and no deaths. One individual on BIC previously discontinued due to an adverse event of urticaria following the W24 visit.

    Conclusion: All participants switched from DTG+F/TAF to open-label B/F/TAF maintained virologic suppression, with none discontinuing due to adverse events. During 72 weeks of follow-up, no treatment-emergent resistance to any components was detected in participants taking B/F/TAF.  B/F/TAF demonstrated durable virologic suppression in naïve patients through W72 and was safe and effective after switching from DTG + F/TAF, further study in treatment naïve and experienced populations is warranted.

    Paul Sax, MD1, Edwin Dejesus, MD2, Gordon Crofoot, MD3, Douglas Ward, MD4, Paul Benson, MD5, Lilian Wei, PhD6, Kirsten White, PhD6, Sean Collins, MD6, Hal Martin, MD, MPH6, Andrew Cheng, MD PhD6 and Erin Quirk, MD6, (1)Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, (2)Orlando Immunology Center, Orlando, FL, (3)The Crofoot Research Center, Houston, TX, (4)Dupont Circle Physicians Group, Washington, DC, (5)Be Well Medical, Berkley, MI, (6)Gilead Sciences, Foster City, CA

    Disclosures:

    P. Sax, Gilead: Consultant and Investigator , Consulting fee , Research grant and Research support
    BMS: Consultant and Investigator , Consulting fee , Research grant and Research support
    GlaxoSmithKline/ViiV: Consultant and Investigator , Consulting fee , Research grant and Research support
    AbbVie: Consultant , Consulting fee
    Janssen: Consultant , Consulting fee
    Merck: Consultant , Consulting fee

    E. Dejesus, Gilead Sciences: Consultant , Investigator and Speaker's Bureau , Consulting fee and Speaker honorarium
    Janssen: Consultant , Investigator and Speaker's Bureau , Consulting fee and Speaker honorarium

    G. Crofoot, Gilead: Investigator and Scientific Advisor , Advisory honorarium and Research grant
    ViiV: Investigator and Scientific Advisor , Advisory honorarium , Research grant and Research support

    D. Ward, Gilead: Investigator , Research support

    P. Benson, Gilead Sciences: Investigator , Shareholder and Speaker's Bureau , Research support and Speaker honorarium
    ViiV Healthcare: Investigator , Research support

    L. Wei, Gilead: Employee and Shareholder , Salary

    K. White, Gilead Sciences, Inc.: Employee and Shareholder , Salary

    S. Collins, Gilead: Employee and Shareholder , Salary

    H. Martin, Gilead Sciences: Employee , Salary

    A. Cheng, Gilead: Employee and Shareholder , Salary

    E. Quirk, Gilead: Employee and Shareholder , Salary

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