Evidence map›Paper›PMID 41439027›Full record

ArticleHIV/AIDS (Auckland, N.Z.)2025

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People with HIV: A Real-World Data from the Spanish BICSTaR Cohort.

Alexy Inciarte, Celia Miralles, Ana Silva-Klug, Boris Revollo, Miguel García Deltoro, Joaquín Portilla, Antonio Antela, Manuel Ángel Castaño Carracedo, Cristina De Álvaro, Johanna Ramroth and 2 more

Abstract read
In one paragraph

Article in HIV/AIDS (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Alexy InciarteHIV Unit, Clínic Hospital, Barcelona, Spain.ORCID 0000-0003-1896-3457
Celia MirallesInternal Medicine Department, Álvaro Cunqueiro Hospital, Vigo, Spain.
Ana Silva-KlugHIV Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Spain.ORCID 0000-0003-4660-534X
Boris RevolloInfectious Diseases Department, Germans Trias I Pujol University Hospital, Badalona, Spain.ORCID 0000-0001-9245-2183
Miguel García DeltoroInfectious Diseases Department, Consorcio General University Hospital, Valencia, Spain.ORCID 0000-0002-5969-1059
Joaquín PortillaInternal Medicine Department, Dr Balmis General University Hospital, Alicante, Spain.ORCID 0000-0002-3676-9511
Antonio AntelaInfectious Diseases Unit, Clinic University Hospital (CHUS), Santiago de Compostela, Spain.ORCID 0000-0002-4819-0953
Manuel Ángel Castaño CarracedoInfectious Diseases Department, Regional University Hospital, Málaga, Spain.ORCID 0000-0002-4322-7681
Cristina De ÁlvaroMedical Department, Gilead Sciences SLU, Madrid, Spain.ORCID 0009-0007-0350-9282
Johanna RamrothReal-World Evidence, Gilead Sciences Ltd, Uxbridge, UK.ORCID 0000-0002-5534-0921
Ana González-CordónHIV Unit, Clínic Hospital, Barcelona, Spain.ORCID 0000-0002-0894-3711
Josep MallolasHIV Unit, Clínic Hospital, Barcelona, Spain.ORCID 0000-0002-8365-141X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended as first-line HIV treatment in international guidelines. This analysis aimed to assess the effectiveness and safety of B/F/TAF in real-world Spanish clinical practice. Methods: This was an analysis of the Spanish subset from the BICSTaR study in treatment-naïve (TN) and treatment-experienced (TE) people with HIV who started treatment between November 2019 and July 2021 (European study registration: EUPAS22185). The primary endpoint was virologic suppression (HIV-1 RNA <50 copies/mL); additional endpoints included CD4 cell count changes, treatment persistence, adverse events, weight changes, and the 36-Item Short Form Survey mental and physical component summary (MCS/PCS) scores at 12 months. Results: In total, 249 people with HIV initiated B/F/TAF treatment (62 TN, 187 TE). At 12 months, virologic suppression was achieved by 86% of TN and 98% of TE participants, with 91% of those TE participants with baseline HIV-1 RNA ≥50 copies/µL achieving suppression. Median CD4 count increased by 296 cells/µL in TN (p<0.001) and 12 cells/µL in TE (p=0.302) participants. Persistence at 12 months was high in all participants, with 95% still on treatment. Overall, none of TN and less than 3% of TE participants discontinued B/F/TAF due to drug-related adverse events, all of which were mild or moderate. Median weight increase was 2.9 kg in TN (p<0.001) and 1.0 kg in TE (p<0.001) participants. Median MCS scores improved in the TN group (8.4-point increase, p<0.001) but not in the TE group (0.4-point increase, p=0.767), while PCS scores remained stable both among TN and TE. Conclusion: These real-world findings strongly support B/F/TAF use in TN and TE people with HIV in Spain, demonstrating high 12-month persistence and effectiveness, and mental health benefits in TN participants, with minimal adverse events.

Indexed as

B/F/TAFhealth-related quality of lifeHIV-1prospective non-interventional cohort studyreal-world evidencevirologic suppression

Identifiers

PMID41439027
PMCPMC12719640

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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 OpenQuestion graph.