English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

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 United States 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 noninferior to control (D/C+F/tenofovir disoproxil fumarate); favorable renal/bone outcomes were seen with D/C/F/TAF vs. 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, noninferiority 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%), noninferior virologic response rates vs. control (88.4%) in ART-naïve, HIV-1–infected adults. Consistent and robust efficacy and safety results were found with D/C/F/TAF vs. control based on VL, CD4+ count, and WHO clinical stage at baseline. Disclosures 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. D. Luo, Janssen: Employee, Salary. J. Jezorwski, Janssen: Employee, Salary. K. Brown, Janssen: Employee, Salary. E. Y. Wong, Janssen: Employee, Salary.

open forum infectious diseases

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