1350. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF (Quad) Demonstrates Comparable Efficacy and Favorable Tolerability to Efavirenz/Emtricitabine /Tenofovir DF in Patients with Adherence <95%
Session: Poster Abstract Session: Antiretroviral Treatment
Saturday, October 20, 2012
Room: SDCC Poster Hall F-H
Posters
  • DeJesus 102 Adherence Subanalysis IDSA 2012 Po1350.pdf (170.0 kB)
  • Background: Elvitegravir/cobicistat/emtricitabine/tenofovir DF (“QUAD”) was well tolerated and demonstrated non-inferior efficacy to EFV/FTC/TDF [ATR] (88% vs. 84% respectively) with HIV-1 RNA < 50 copies/mL (c/mL) by snapshot analysis at Week (Wk) 48 in a randomized, controlled trial of HIV-infected treatment naïve patients. ATR has previously shown efficacy even in those with adherence <95%, the standard generally utilized to avoid virologic failure and resistance for antiretroviral therapy.1,2

    Methods: Post hoc analysis of efficacy and safety in patients with adherence <95%, measured by pill count through Week 48.

    Results: Median adherence in Study 102 was 98% for both Quad and Atripla by pill count. 86/348 patients (25%) had adherence <95% for Quad (23 [7%] of those <90%) and 89/352 (25%) had adherence <95% for ATR (36 [10%] of those <90%). The rates of virologic suppression (HIV-1 RNA < 50 c/mL) were high in Quad and ATR and comparable between adherence groups with 91% vs. 88% for adherence ≥95% and 79% vs. 75% for those with adherence <95%.

    Eight patients (2%) in each arm developed resistance. Resistance developed in Quad and ATR in 4 v 5 patients with adherence ≥95%, 2 v 1 patients with adherence 90-<95%, and 2 patients in each arm with adherence < 90%.

    Conclusion: Adherence with Quad and ATR was high overall. In patients with adherence <95%, the efficacy of Quad was high and comparable to ATR, which has previously been shown to have better efficacy compared to other antiretroviral regimens at lower adherence. Quad may become an effective antiretroviral regimen with comparable efficacy to ATR even in those with incomplete adherence.

    Reference:  1Paterson, DL, et al. Ann Int Med, 2000, 133:21-30, 2Bangsberg, D, et al. CID, 2006; 43:939-941

    Edwin DeJesus, MD, FACP1, William Robbins, MD2, Fritz Bredeek, MD, PhD, FACP3, Peter Shalit, MD4, Kirsten White, PhD5, Hiu Liu, PhD6, Lauren Dau, PharmD7, Erin Quirk, MD8 and David Piontkowsky, JD, MD9, (1)Orlando Immunology Center, Orlando, FL, (2)Value Health MD, LLC, Orlando, FL, (3)Metropolis Medical, San Francisco, CA, (4)Tribal Medicine, Seattle, WA, (5)Virology, Gilead Sciences, Foster City, CA, (6)Biostatics, Gilead Sciences, Foster City, CA, (7)Medical Affairs, Gilead Sciences, Foster City, CA, (8)Clinical Research, Gilead Sciences, Foster City, CA, (9)Medical Affairs, Gilead Sciences, Foster City, CA

    Disclosures:

    E. DeJesus, Gilead Sciences: Consultant, Investigator, Research Contractor and Speaker's Bureau, Research grant and Research support
    GSK: Consultant, Investigator and Speaker's Bureau, Research grant and Research support
    Merck: Consultant, Investigator and Speaker's Bureau, Research grant and Research support
    BMS: Consultant, Investigator and Speaker's Bureau, Research grant and Research support
    Tibotec: Consultant, Investigator and Speaker's Bureau, Research grant and Research support

    W. Robbins, Gilead Sciences: Investigator, Research grant and Research support

    F. Bredeek, Gilead Sciences: Grant Investigator, Investigator, Research Contractor and Speaker's Bureau, Research grant, Research support and Speaker honorarium
    Merck: Grant Investigator, Investigator, Scientific Advisor and Speaker's Bureau, Research grant, Research support and Speaker honorarium
    Viiv: Grant Investigator, Investigator, Scientific Advisor and Speaker's Bureau, Research grant, Research support and Speaker honorarium

    P. Shalit, Gilead Sciences: Consultant, Investigator and Speaker's Bureau, Research grant and Research support
    BMS: Speaker's Bureau, Consulting fee
    Merck: Grant Investigator, Investigator and Speaker's Bureau, Research grant and Research support
    GSK: Grant Investigator, Investigator and Speaker's Bureau, Research grant and Research support

    K. White, Gilead Sciences: Employee, Salary

    H. Liu, Gilead Sciences: Employee, Salary

    L. Dau, Gilead Sciences: Employee, Salary

    E. Quirk, Gilead Sciences: Employee, Salary

    D. Piontkowsky, Gilead Sciences: Employee, Salary

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