dc.contributor.author | Sax, PE | en_US |
dc.contributor.author | Arribas, JR | en_US |
dc.contributor.author | Orkin, C | en_US |
dc.contributor.author | Lazzarin, A | en_US |
dc.contributor.author | Pozniak, A | en_US |
dc.contributor.author | DeJesus, E | en_US |
dc.contributor.author | Maggiolo, F | en_US |
dc.contributor.author | Stellbrink, H-J | en_US |
dc.contributor.author | Yazdanpanah, Y | en_US |
dc.contributor.author | Acosta, R | en_US |
dc.contributor.author | Huang, H | en_US |
dc.contributor.author | Hindman, JT | en_US |
dc.contributor.author | Martin, H | en_US |
dc.contributor.author | Baeten, JM | en_US |
dc.contributor.author | Wohl, D | en_US |
dc.contributor.author | GS-US-380-1489 and GS-US-380-1490 study investigators | en_US |
dc.date.accessioned | 2023-05-17T15:47:30Z | |
dc.date.available | 2023-04-17 | en_US |
dc.date.issued | 2023-05 | en_US |
dc.identifier.other | 101991 | |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/87678 | |
dc.description.abstract | BACKGROUND: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG + F/TAF). After 144 weeks of randomized follow-up, an open-label extension evaluated B/F/TAF to 240 weeks. METHODS: Of 634 participants randomized to B/F/TAF, 519 completed the double-blinded treatment, and 506/634 (80%) chose the 96-week open-label B/F/TAF extension, which was completed by 444/506 (88%) participants. Efficacy was based on the secondary outcome of the proportion of participants with HIV-1 RNA <50 copies/mL at Week 240 by missing = excluded and missing = failure methods. All 634 participants who were randomized to B/F/TAF and received at least one dose of B/F/TAF were included in efficacy and safety analyses. (Study 1489: ClinicalTrials.govNCT02607930; EudraCT 2015-004024-54. Study 1490: ClinicalTrials.govNCT02607956; EudraCT 2015-003988-10). FINDINGS: Of those with available virologic data, 98.6% (95% CI [97.0%-99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%-70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL. No treatment-emergent resistance to B/F/TAF was detected. Adverse events led to drug discontinuation in 1.6% (n = 10/634) of participants (n = 5 with events considered drug-related). No discontinuations were due to renal adverse events. Median (IQR) total cholesterol increased 21 (1,42) mg/dL from baseline; the change in total cholesterol:HDL was 0.1 (-0.5,0.6). Median (IQR) weight change from baseline was +6.1 kg (2.0, 11.7) at Week 240. In Study 1489, hip and spine bone mineral density mean percent changes from baseline were ≤0.6%. INTERPRETATION: Through 5 years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to adverse events. These results demonstrate the durability and safety of B/F/TAF in people with HIV. FUNDING: Gilead Sciences. | en_US |
dc.format.extent | 101991 - ? | en_US |
dc.language | eng | en_US |
dc.relation.ispartof | EClinicalMedicine | en_US |
dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
dc.subject | Antiretroviral therapy | en_US |
dc.subject | Bone safety | en_US |
dc.subject | Integrase strand transfer inhibitor | en_US |
dc.subject | Long-term | en_US |
dc.subject | Renal safety | en_US |
dc.title | Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. | en_US |
dc.type | Article | |
dc.identifier.doi | 10.1016/j.eclinm.2023.101991 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37200995 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published online | en_US |
pubs.volume | 59 | en_US |
dcterms.dateAccepted | 2023-04-17 | en_US |