Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1 : subgroup analyses of the phase 3 AMBER study
Background: The once-daily, single-tablet regimen darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is approved for the treatment of HIV-1 infection. The 48-week efficacy and safety of D/C/F/TAF versus darunavir/cobicistat + emtricitabine/tenofovir disoproxil fumarate (control) in treatment-naïve adults were demonstrated in the phase 3 AMBER study. Objective: To describe AMBER outcomes across patient subgroups based on demographic and clinical characteristics at baseline. Methods: AMBER patients had viral load (VL) ≥1000 copies/mL, CD4+ cell count >50 cells/µL, and genotypic susceptibility to darunavir, emtricitabine, and tenofovir. Primary endpoint was the proportion of patients with virologic response (VL <50 copies/mL; FDA snapshot). Safety was assessed by adverse events, estimated glomerular filtration rate (cystatin C; eGFRcystC), and bone mineral density. Outcomes were assessed by age (≤/>50 years), gender, race (black/non-black), baseline VL (≤/>100,000 copies/mL), baseline CD4+ cell count (</≥200 cells/µL), and baseline WHO clinical stage of HIV infection (1/2). Results: For the 725 AMBER patients (D/C/F/TAF: 362; control: 363), virologic response rates at week 48 were similar with D/C/F/TAF (91%) and control (88%), and this was consistent across all subgroups. Adverse event rates were similar in both arms, although numerically higher among patients >50 years and women, relative to their comparator groups, regardless of treatment arm (notably, sample sizes were small for patients >50 years and women). Improvements in eGFRcystC and stable bone mineral density were observed with D/C/F/TAF overall, and results were generally consistent across subgroups. Conclusions: For treatment-naïve patients in AMBER, initiating therapy with the D/C/F/TAF single-tablet regimen was an effective and well-tolerated option, regardless of demographic or clinical characteristics.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
HIV research & clinical practice - 20(2019), 1 vom: 16. Feb., Seite 24-33 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rashbaum, Bruce [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 28.05.2020 Date Revised 04.12.2021 published: Print-Electronic ClinicalTrials.gov: NCT02431247 Citation Status MEDLINE |
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| doi: |
10.1080/15284336.2019.1608714 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM299161781 |
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| 041 | |a eng | ||
| 100 | 1 | |a Rashbaum, Bruce |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1 |b subgroup analyses of the phase 3 AMBER study |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 28.05.2020 | ||
| 500 | |a Date Revised 04.12.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02431247 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background: The once-daily, single-tablet regimen darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is approved for the treatment of HIV-1 infection. The 48-week efficacy and safety of D/C/F/TAF versus darunavir/cobicistat + emtricitabine/tenofovir disoproxil fumarate (control) in treatment-naïve adults were demonstrated in the phase 3 AMBER study. Objective: To describe AMBER outcomes across patient subgroups based on demographic and clinical characteristics at baseline. Methods: AMBER patients had viral load (VL) ≥1000 copies/mL, CD4+ cell count >50 cells/µL, and genotypic susceptibility to darunavir, emtricitabine, and tenofovir. Primary endpoint was the proportion of patients with virologic response (VL <50 copies/mL; FDA snapshot). Safety was assessed by adverse events, estimated glomerular filtration rate (cystatin C; eGFRcystC), and bone mineral density. Outcomes were assessed by age (≤/>50 years), gender, race (black/non-black), baseline VL (≤/>100,000 copies/mL), baseline CD4+ cell count (</≥200 cells/µL), and baseline WHO clinical stage of HIV infection (1/2). Results: For the 725 AMBER patients (D/C/F/TAF: 362; control: 363), virologic response rates at week 48 were similar with D/C/F/TAF (91%) and control (88%), and this was consistent across all subgroups. Adverse event rates were similar in both arms, although numerically higher among patients >50 years and women, relative to their comparator groups, regardless of treatment arm (notably, sample sizes were small for patients >50 years and women). Improvements in eGFRcystC and stable bone mineral density were observed with D/C/F/TAF overall, and results were generally consistent across subgroups. Conclusions: For treatment-naïve patients in AMBER, initiating therapy with the D/C/F/TAF single-tablet regimen was an effective and well-tolerated option, regardless of demographic or clinical characteristics | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a HIV-1 | |
| 650 | 4 | |a antiretroviral | |
| 650 | 4 | |a darunavir | |
| 650 | 4 | |a protease inhibitor | |
| 650 | 4 | |a single-tablet regimen | |
| 650 | 4 | |a tenofovir alafenamide | |
| 650 | 4 | |a treatment initiation | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
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| 650 | 7 | |a Tenofovir |2 NLM | |
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| 650 | 7 | |a Adenine |2 NLM | |
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| 650 | 7 | |a Cobicistat |2 NLM | |
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| 650 | 7 | |a Darunavir |2 NLM | |
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| 700 | 1 | |a Spinner, Christoph D |e verfasserin |4 aut | |
| 700 | 1 | |a McDonald, Cheryl |e verfasserin |4 aut | |
| 700 | 1 | |a Mussini, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Jezorwski, John |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Donghan |e verfasserin |4 aut | |
| 700 | 1 | |a Van Landuyt, Erika |e verfasserin |4 aut | |
| 700 | 1 | |a Brown, Kimberley |e verfasserin |4 aut | |
| 700 | 1 | |a Wong, Eric Y |e verfasserin |4 aut | |
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