dc.contributor.author | Orkin, C | |
dc.contributor.author | Antinori, A | |
dc.contributor.author | Rockstroh, JK | |
dc.contributor.author | Moreno-Guillén, S | |
dc.contributor.author | Martorell, CT | |
dc.contributor.author | Molina, J-M | |
dc.contributor.author | Lazzarin, A | |
dc.contributor.author | Maggiolo, F | |
dc.contributor.author | Yazdanpanah, Y | |
dc.contributor.author | Andreatta, K | |
dc.contributor.author | Huang, H | |
dc.contributor.author | Hindman, JT | |
dc.contributor.author | Martin, H | |
dc.contributor.author | Pozniak, A | |
dc.date.accessioned | 2024-02-20T13:00:14Z | |
dc.date.available | 2024-02-20T13:00:14Z | |
dc.date.issued | 2024-02-12 | |
dc.identifier.citation | Orkin, Chloea; Antinori, Andreab; Rockstroh, Jürgen K.c; Moreno-Guillén, Santiagod; Martorell, Claudia T.e; Molina, Jean-Michelf; Lazzarin, Adrianog; Maggiolo, Francoh; Yazdanpanah, Yazdani; Andreatta, Kristenj; Huang, Hailinj; Hindman, Jason T.j; Martin, Halj; Pozniak, Antonk. Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy: 96-week pooled analysis. AIDS ():10.1097/QAD.0000000000003865, February 12, 2024. | DOI: 10.1097/QAD.0000000000003865 | |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/94746 | |
dc.description.abstract | OBJECTIVE: To evaluate the efficacy and safety of 96 weeks of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy. DESIGN: Studies 1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials in people with HIV-1. After 144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week open-label extension (OLE) of B/F/TAF. METHODS: A pooled analysis evaluated viral suppression (HIV-1 RNA <50 copies/mL) and changes in CD4+ cell count at OLE Weeks 48 and 96, treatment-emergent resistance, safety and tolerability after switch from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized using descriptive statistics and compared by two-sided Wilcoxon rank sum test. RESULTS: At OLE Week 96, participants who switched to B/F/TAF (N=519) maintained high levels of virologic suppression (99.5% and 99.1% in those switching from DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4+ cell count, with no treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced drug-related adverse events (AEs) after switching, with diarrhea, weight gain and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 AEs or serious AEs. Two participants discontinued B/F/TAF due to treatment-related AEs. Participants who switched from DTG/abacavir/lamivudine experienced statistically significant greater weight gain than those who switched from DTG+F/TAF; however, median weight change from the blinded phase baseline to OLE Week 96 was numerically similar across treatment groups. CONCLUSIONS: This medium-term analysis demonstrates the safety and efficacy of switching to B/F/TAF from a DTG-containing regimen in people with HIV-1. | en_US |
dc.language | eng | |
dc.publisher | Lippincott, Williams & Wilkins | en_US |
dc.relation.ispartof | AIDS | |
dc.title | Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy: 96-week pooled analysis. | en_US |
dc.type | Article | en_US |
dc.rights.holder | © 2024 Wolters Kluwer Health, Inc. All rights reserved | |
dc.identifier.doi | 10.1097/QAD.0000000000003865 | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/38349226 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published online | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |