Evidence map›Paper›PMID 39772928›Full record

Observational studyInternational journal of STD & AIDS2025

Effectiveness, safety, and patient-reported outcomes of bictegravir/emtricitabine/tenofovir alafenamide in routine clinical care in Italy: 12-Month results from the BICSTaR cohort.

Andrea Antinori, Giulia Marchetti, Vincenzo Esposito, Stefano Rusconi, Diana Canetti, Eugenia Quiros-Roldan, Bianca Candelaresi, Annalisa Saracino, Massimo Andreoni, Andrea Marongiu and 6 more

Erratum issuedAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in International journal of STD & AIDS, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Andrea AntinoriHIV/AIDS Department, National Institute of Infectious Diseases, L. Spallanzani, IRCCS, Rome, Italy.
Giulia MarchettiClinic of Infectious Diseases, Department of Health Sciences, University of Milan, "ASST Santi Paolo e Carlo", Milan, Italy.
Vincenzo EspositoInfectious Diseases and Gender Medicine Unit D, Cotugno Hospital-A.O. dei Colli, Naples, Italy.
Stefano RusconiInfectious Diseases Unit, ASST Ovest Milanese - University of Milan, Milan, Italy.
Diana CanettiClinic of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Eugenia Quiros-RoldanDivision of Infectious and Tropical Medicine, ASST Spedali Civili, Brescia, Italy.
Bianca CandelaresiInfectious Diseases Clinic, Department of Biological Sciences and Public Health, Marche Polytechnic University, Ancona, Italy.
Annalisa SaracinoDivision of Infectious Diseases, Bari University Hospital, University of Bari, Bari, Italy.
Massimo AndreoniInfectious Diseases Clinic, University Hospital "Tor Vergata", Rome, Italy.
Andrea MarongiuGilead Sciences Europe Ltd, Uxbridge, UK.
Tali CassidyGilead Sciences Europe Ltd, Uxbridge, UK.
David ThorpeGilead Sciences Europe Ltd, Uxbridge, UK.
Laura AlbiniGilead Sciences Srl, Milan, Italy.
Roberto CalderaGilead Sciences Srl, Milan, Italy.
Gabriele ForcinaGilead Sciences Srl, Milan, Italy.
Giovanni Di PerriDepartment of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBICSTaR is a multi-national, observational cohort evaluating the effectiveness, safety, and patient-reported outcomes (PROs) in treatment-naïve (TN) and -experienced (TE) people with HIV-1 receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical care. We present the 12-month (M12) outcomes of the Italian BICSTaR cohort.

methodsParticipants initiating B/F/TAF in routine care were prospectively followed. Outcomes included virological and immunologic effectiveness, drug-related adverse events (DRAEs), treatment persistence, and PROs using the HIV Symptom Index (HIV-SI) and the HIV Treatment Satisfaction Questionnaires (HIVTSQ).

results

conclusionsIn this real-world Italian cohort of mostly treatment-experienced people switching for simplification, B/F/TAF demonstrated high effectiveness and persistence over 12 months and confirmed the favourable safety profile shown in clinical trials.

trial registrationEuropean cohort: EUPAS22185.

Indexed as

AdenineAnti-HIV AgentsEmtricitabineHeterocyclic Compounds, 4 or More RingsHIV InfectionsPatient Reported Outcome MeasuresTenofovirAdultAlanineAmidesCD4 Lymphocyte CountDrug CombinationsFemaleHeterocyclic Compounds, 3-RingHIV-1HumansAdenineAlanineAmidesAnti-HIV AgentsbictegravirDrug CombinationsEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsPiperazinesPyridonesRNA, ViralTenofovirtenofovir alafenamideantiretroviral therapybictegravirHIV-Infectionreal-world datatenofovir alafenamide

Identifiers

PMID39772928
PMCPMC11877974

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.