@article {44763,
	title = {Rapid ART Initiation with BIC/FTC/TAF in People Who Inject Drugs in Greece: Results from a Pilot Single-Arm Study of an Integrated Care Model},
	journal = {Microorganism},
	volume = {13},
	number = {12},
	year = {2025},
	note = {2076-2607Roussos, SotiriosOrcid: 0000-0003-2347-0817Protopapas, KonstantinosOrcid: 0000-0001-5404-746xMastrogianni, ElpidaOrcid: 0000-0003-3081-9415Totsikas, CharisisOrcid: 0009-0008-7179-2742Moschopoulos, Charalampos DOrcid: 0000-0001-9954-7409Bourmpoutelis, StylianosResta, PanagiotaProcter, KassandraOrcid: 0009-0004-5413-3287Kokolesis, EvangelosAntoniadou, AnastasiaOrcid: 0000-0003-0991-9198Papadopoulos, AntoniosOrcid: 0000-0003-4735-2620Papastamopoulos, VasileiosOrcid: 0000-0001-6293-0017Beloukas, ApostolosOrcid: 0000-0001-5639-0528Katsarolis, IoannisOrcid: 0000-0002-5710-1545Sypsa, VanaOrcid: 0000-0002-9430-7614Hatzakis, AngelosOrcid: 0000-0001-8420-3830Psichogiou, MinaOrcid: 0000-0002-3000-8447Not available now/Gilead/Journal ArticleSwitzerlandMicroorganisms. 2025 Nov 26;13(12):2697. doi: 10.3390/microorganisms13122697.},
	month = {Nov 26},
	edition = {2025/12/31},
	abstract = {People who inject drugs (PWIDs) remain underserved in HIV care. Evidence on rapid antiretroviral therapy (ART) for PWID is limited. We evaluated feasibility, effectiveness, safety, and patient-reported outcomes (PROs) for rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) supported by a peer navigation in Greece. This is a single-arm, multicenter pilot study including PWIDs (>=18 years) newly diagnosed or relinking after \&gt;3 months off ART. Participants started BIC/FTC/TAF on the same day or within 7 days and received peer navigation for 48 weeks. Co-primary endpoints were Week-24 virologic suppression (HIV-1 RNA \&lt; 50 copies/mL; FDA Snapshot) and grade 3-4 adverse events (AEs). Secondary endpoints included complete-case suppression at Weeks 24/48, CD4 recovery, retention, and PROs. Outcomes were compared with historical controls from the same centers. Thirty-seven participants were enrolled (83.8\% male; median age 33.3 years). Median time to ART was 0 days (vs 78 in controls, p \&lt; 0.001). Retention was 67.6\% at Week 24 and 54.1\% at Week 48. In the primary (FDA Snapshot) analysis, suppression was 62.2\% and 54.1\% at Weeks 24 and 48; in complete-case analyses, results were 92.0\% and 100\%, respectively. Mean CD4 count increased by 208 cells/μL (95\% CI 141-275) at Week 48. Quality of life improved and symptom burden decreased. No grade 3-4 AEs occurred. Rapid BIC/FTC/TAF with peer navigation eliminated delays to ART and achieved favorable virologic, immunologic, and PROs among those retained, with good tolerability. Despite retention challenges, this model appears feasible for PWID and may help close HIV care gaps toward UNAIDS 95-95-95 targets.},
	keywords = {and a research grant from Gilead Sciences for this, and advisory boards, and support for participation in congresses from Gilead, and Biotest. V.P. has received honoraria and consultation fees from Gilead, and consulting fees from Gilead, and equipment, materials, drugs, or services from, attending meetings and/or travel from Gilead Sciences and GSK (paid to the, authors declare that the research was conducted in the absence of any commercial, bictegravir/emtricitabine/tenofovir alafenamide, Cepheid, including free-of-charge reagents for a research project, all outside, company Gilead Sciences Hellas (Medical Affairs Department). The remaining, Department). V.S. has received grants from Gilead Sciences and Roche, fees from Gilead Sciences, GSK, and MSD, for lectures from Gilead Sciences and Roche, from Gilead Sciences. A.A. has received a research grant, honoraria for lectures, Gilead Sciences and GSK (paid to the University of West Attica), grant and sponsorship to the University of West Attica) and GSK (research, honoraria, honoraria (speaker fees) and travel support for medical and scientific events, honoraria for lectures,, integrated care model, interest. The authors declare that this study received funding from Gilead, involved in the collection, analysis and interpretation of data or the decision, opioid agonist therapy, or financial relationships that could be construed as a potential conflict of, patient-reported outcomes, peer navigation, people who inject drugs, presentations, speakers{\textquoteright} bureaus, manuscript writing, or educational events from, rapid ART initiation, representative of the study sponsor. M.P. has received honoraria and consultation, retention in care, Sciences (collaborative study CO-GR-380-6083). The funder contributed to the, Sciences and honoraria for lectures and advisory boards from Pfizer, AstraZeneca,, Sciences, with payments made to an affiliated institution. A.H. has served as a, Sciences. A.B. has received grants and contracts from Gilead Sciences (research, sponsorship to the University of West Attica), study design and the drafting/review of the manuscript. The funder was not, support for, support for attending meetings and/or, the submitted work. I.K. is an employee of Gilead Sciences (Medical Affairs, to submit it for publication., travel from Gilead Sciences, University of West Attica), work as principal investigator. Author Ioannis Katsarolis is employed by the},
	isbn = {2076-2607 (Print)2076-2607},
	author = {Roussos, S. and Protopapas, K and Mastrogianni, E. and Totsikas, C. and Moschopoulos, C. D. and Bourmpoutelis, S. and Resta, P. and Procter, K. and Kokolesis, E. and Antoniadou, A and Papadopoulos, A. and Papastamopoulos, V and Beloukas, A. and Katsarolis, I and Sypsa, V and Hatzakis, A and Psichogiou, M}
}
