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http://hdl.handle.net/2445/173691
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DC Field | Value | Language |
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dc.contributor.author | Orkin, Chloe | - |
dc.contributor.author | Eron, Joseph J. | - |
dc.contributor.author | Rockstroh, Jürgen Kurt | - |
dc.contributor.author | Podzamczer Palter, Daniel | - |
dc.contributor.author | Esser, Stefan | - |
dc.contributor.author | Vandekerckhove, Linos | - |
dc.contributor.author | Van Landuyt, Erika | - |
dc.contributor.author | Lathouwers, Erkki | - |
dc.contributor.author | Hufkens, Veerle | - |
dc.contributor.author | Jezorwski, John | - |
dc.contributor.author | Opsomer, Magda | - |
dc.contributor.author | AMBER study group | - |
dc.date.accessioned | 2021-02-05T11:28:19Z | - |
dc.date.available | 2021-02-05T11:28:19Z | - |
dc.date.issued | 2020-04-01 | - |
dc.identifier.uri | http://hdl.handle.net/2445/173691 | - |
dc.description.abstract | Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247). Methods: Treatment-naive, HIV-1-positive adults [screening plasma viral load >= 1000 copies/ml; CD4(+) cell count >50 cells/mu l) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96. Results: At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load <50 copies/ml; FDA-Snapshot, from baseline) was 85.1% (308/362) (D/C/F/TAF) and 83.7% (304/363) (control). Week 96 virologic failure (viral load >= 50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF; <1% control post switch) and no deaths occurred on D/C/F/TAF. Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the control arm post switch. Increases in total-cholesterol/high-density-lipoprotein--cholesterol rtio at week 96 were +0.25 versus baseline (D/C/F/TAF) and +0.24 versus switch (control). Conclusion: At week 96, D/C/F/TAF resulted in high virologic response and low virologic failure rates, with no resistance development to darunavir or TAF/TDF. Bone, renal and lipid safety were consistent with known D/C/F/TAF component profiles. Control arm safety post switch was consistent with the D/C/F/TAF arm. AMBER week 96 results confirm the efficacy, high barrier to resistance and bone/renal safety benefits of D/C/F/TAF for treatment-naive patients. | - |
dc.format.extent | 12 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1097/QAD.0000000000002463 | - |
dc.relation.ispartof | Aids, 2020, vol. 34, num. 5, p. 707-718 | - |
dc.relation.uri | https://doi.org/10.1097/QAD.0000000000002463 | - |
dc.rights | cc by-nc-nd (c) Orkin et al., 2020 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | - |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Infeccions per VIH | - |
dc.subject.classification | Antiretrovirals | - |
dc.subject.other | HIV infections | - |
dc.subject.other | Antiretroviral agents | - |
dc.title | Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2021-01-25T08:13:28Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31833849 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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