541. Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Treatment Naïve Patients: Week 48 Results in Subgroups Based on Baseline Viral Load, CD4+ Count, and WHO Clinical Staging
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Thursday, October 4, 2018
Room: S Poster Hall
  • IDWeek 2018 AMBER Subgroups Poster_JUV-64095_FINAL.pdf (203.5 kB)
  • Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is a once-daily, single-tablet regimen approved in Europe and under regulatory review in the US for the treatment of HIV-1 infection. In the pivotal AMBER trial in antiretroviral treatment (ART)-naïve, HIV-1–infected adults, D/C/F/TAF achieved a high virologic response rate at Week 48 that was non-inferior to control (D/C+F/tenofovir disoproxil fumarate); favorable renal/bone outcomes were seen with D/C/F/TAF versus control. These results were consistent across age, gender, and race subgroups. Here we report Week 48 results in subgroups based on viral load (VL), CD4+ count, and WHO clinical staging of HIV/AIDS at baseline.

    Methods: The phase 3, randomized (1:1), blinded, non-inferiority AMBER trial enrolled ART-naïve, HIV-1–infected adults. The primary endpoint was the proportion of patients with virologic response (VL <50 copies/mL; FDA snapshot) at Week 48. Adverse events (AEs) and laboratory parameters were monitored throughout the study. Results were evaluated in subgroups based on VL (≤ vs >100,000 copies/mL), CD4+ count (< vs ≥350 cells/µL), and WHO clinical stage (1 vs 2 vs 3 vs 4) at baseline.

    Results: Of the 725 patients randomized and treated, the majority had VL ≤100,000 copies/mL (82% of patients), CD4+ count ≥350 cells/µL (72%), and WHO clinical stage 1 (84%) at baseline. Overall virologic response rates were 91.4% with D/C/F/TAF and 88.4% with control; results were similar across baseline VL, CD4+ count, and WHO clinical stage subgroups (Figure). Overall rates of serious AEs, grade 3-4 AEs, and AE-related discontinuations were similar for D/C/F/TAF (n=17 [4.7%], n=19 [5.2%], and n=7 [1.9%], respectively) and control (n=21 [5.8%], n=22 [6.1%], and n=16 [4.4%]), as well as across subgroups (Table).

    Conclusion: D/C/F/TAF achieved high (91.4%), non-inferior virologic response rates versus control (88.4%) in ART-naïve, HIV-1–infected adults. Consistent and robust efficacy and safety results were found with D/C/F/TAF versus control based on VL, CD4+ count, and WHO clinical stage at baseline.

    Christoph D. Spinner, MD1, Bruce Rashbaum, MD2, Cheryl Mcdonald, MD3, Cristina Mussini, MD4, Donghan Luo, PhD5, John Jezorwski, MS6, Kimberley Brown, PharmD, AAHIVE7 and Eric Y. Wong, PhD7, (1)Technische Universität München, Munich, Germany, (2)Capital Medical Associates, Washington DC, DC, (3)Tarrant County Infectious Disease Associates, Fort Worth, TX, (4)University of Modena and Reggio Emilia, Modena, Italy, (5)Janssen Research & Development, LLC, Titusville, NJ, (6)Janssen Research & Development, LLC, Pennington, NJ, (7)Janssen Scientific Affairs, LLC, Titusville, NJ


    C. D. Spinner, None

    B. Rashbaum, Gilead: Shareholder and Speaker's Bureau , : Any financial benefit related to being a shareholder and Speaker honorarium .

    C. Mcdonald, Gilead: Various , Personal fees . Merck: Various , Personal fees . ViiV: Various , Personal fees . Janssen: Various , Personal fees .

    C. Mussini, None

    D. Luo, Janssen: Employee , Salary .

    J. Jezorwski, Janssen: Employee , Salary .

    K. Brown, Janssen: Employee , Salary .

    E. Y. Wong, Janssen: Employee , Salary .

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.