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10.3390/microorganisms13122697
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Article

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

by
Sotirios Roussos
1,
Konstantinos Protopapas
2,
Elpida Mastrogianni
3,
Charisis Totsikas
4,
Charalampos D. Moschopoulos
2,
Stylianos Bourmpoutelis
3,
Panagiota Resta
5,6,
Kassandra Procter
5,6,
Evangelos Kokolesis
7,
Anastasia Antoniadou
2,
Antonios Papadopoulos
2,
Vasileios Papastamopoulos
4,
Apostolos Beloukas
5,6,
Ioannis Katsarolis
8,
Vana Sypsa
1,
Angelos Hatzakis
1,7 and
Mina Psichogiou
3,*
1
Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece
2
4th Department of Internal Medicine, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Chaidari, Greece
3
1st Department of Internal Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, 11527 Athens, Greece
4
5th Department of Internal Medicine-Infectious Diseases Unit, Evangelismos General Hospital, 10676 Athens, Greece
5
Department of Biomedical Sciences, University of West Attica, 12243 Athens, Greece
6
National AIDS Reference Centre of Southern Greece, School of Public Health, University of West Attica, 12243 Athens, Greece
7
Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases, 11475 Athens, Greece
8
Medical Affairs, Gilead Sciences Hellas, 17564 Paleo Faliro, Greece
*
Author to whom correspondence should be addressed.
Microorganisms 2025, 13(12), 2697; https://doi.org/10.3390/microorganisms13122697
Submission received: 7 November 2025 / Revised: 22 November 2025 / Accepted: 24 November 2025 / Published: 26 November 2025
(This article belongs to the Section Public Health Microbiology)
Versions Notes

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 >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 < 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 < 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: rapid ART initiation; people who inject drugs; bictegravir/emtricitabine/tenofovir alafenamide; peer navigation; integrated care model; retention in care; patient-reported outcomes; opioid agonist therapy rapid ART initiation; people who inject drugs; bictegravir/emtricitabine/tenofovir alafenamide; peer navigation; integrated care model; retention in care; patient-reported outcomes; opioid agonist therapy

Share and Cite

MDPI and ACS Style

Roussos, S.; Protopapas, K.; Mastrogianni, E.; Totsikas, C.; Moschopoulos, C.D.; Bourmpoutelis, S.; Resta, P.; Procter, K.; Kokolesis, E.; Antoniadou, A.; et al. 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. Microorganisms 2025, 13, 2697. https://doi.org/10.3390/microorganisms13122697

AMA Style

Roussos S, Protopapas K, Mastrogianni E, Totsikas C, Moschopoulos CD, Bourmpoutelis S, Resta P, Procter K, Kokolesis E, Antoniadou A, et al. 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. Microorganisms. 2025; 13(12):2697. https://doi.org/10.3390/microorganisms13122697

Chicago/Turabian Style

Roussos, Sotirios, Konstantinos Protopapas, Elpida Mastrogianni, Charisis Totsikas, Charalampos D. Moschopoulos, Stylianos Bourmpoutelis, Panagiota Resta, Kassandra Procter, Evangelos Kokolesis, Anastasia Antoniadou, and et al. 2025. "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" Microorganisms 13, no. 12: 2697. https://doi.org/10.3390/microorganisms13122697

APA Style

Roussos, S., Protopapas, K., Mastrogianni, E., Totsikas, C., Moschopoulos, C. D., Bourmpoutelis, S., Resta, P., Procter, K., Kokolesis, E., Antoniadou, A., Papadopoulos, A., Papastamopoulos, V., Beloukas, A., Katsarolis, I., Sypsa, V., Hatzakis, A., & Psichogiou, M. (2025). 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. Microorganisms, 13(12), 2697. https://doi.org/10.3390/microorganisms13122697

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