Evidence map›Paper›PMID 35096668›Full record

ArticleGerms2021

Treatment initiation or switch to BIC/FTC/TAF - real-world safety and efficacy data from two HIV centers in Romania.

Oana Săndulescu, Mădălina Irimia, Otilia Elisabeta Benea, Mariana Mărdărescu, Liliana Lucia Preoțescu, Carmen Mihaela Dorobăț, Isabela Ioana Loghin, Irina Cristina Nicolau, Raluca Elena Jipa, Ramona Ștefania Popescu and 14 more

Abstract read
In one paragraph

Article in Germs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Observational
  4. Observational
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Article
  10. Observational
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

24 authors.

Oana SăndulescuMD, PhD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Mădălina IrimiaMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Otilia Elisabeta BeneaMD, PhD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Mariana MărdărescuMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No.1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Liliana Lucia PreoțescuMD, PhD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Carmen Mihaela DorobățMD, PhD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Isabela Ioana LoghinMD, University of Medicine and Pharmacy "Grigore T. Popa" Iași, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Irina Cristina NicolauMD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Raluca Elena JipaMD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Ramona Ștefania PopescuMD, PhD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Cristina Loredana BeneaMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Alina CozmaMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Ioana Andreea DărămușMD, PhDc, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Victor Daniel MironMD, PhDc, Carol Davila University of Medicine and Pharmacy Bucharest, No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Liviu Jany PrisăcariuMD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Adriana Florina BahnăMD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Irina NistorMD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Oana Manuela SecrieruMD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Silvas GeorgeMD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania.
Andreea BîrcăMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Loredana DobreaMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Alexandra-Ștefana ȘogorescuMD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Ioana ViziteuMedical student, Carol Davila University of Medicine and Pharmacy Bucharest, No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Anca Streinu-CercelMD, PhD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDevelopment of highly active antiretroviral therapy marked an important step forward in the management of people living with HIV and fixed dose combinations are now available to be used as modern antiretroviral regimens. The single-tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was recently approved in Europe and included in international guidelines and recommendations. It became available in Romania in early 2021. We present the real-world results from a retrospective analysis of patients initiating BIC/FTC/TAF in two HIV centers in Romania.

methodsThis retrospective analysis included patients treated with BIC/FTC/TAF (first-line or switch) in two HIV centers in Romania, one in Bucharest and one in Iași. We collected data on baseline patient characteristics, reasons for initiation of BIC/FTC/TAF and preliminary clinical and laboratory efficacy, safety and tolerability data. All assessments had been performed according to local practice. Statistical analyses were mostly descriptive and association analysis was performed to assess changes in laboratory parameters from baseline to data cut-off (October 2021).

resultsIn total, 122 patients were initiated on BIC/FTC/TAF in routine clinical practice from February to October 2021 in the two HIV centers, either as first-line or switch. The majority of patients were male (71%). The median age at baseline was 35.0 years (IQR 32.0-50.8 years). Overall, 91 patients (75%) were treatment-experienced and the most frequent reason for switch was treatment simplification (79%). The mean ± standard deviation follow-up duration on treatment with BIC/FTC/TAF was 101.6 ± 64.2 days until the cut-off date for this analysis. We found no significant changes in lipid values, blood glucose or liver enzymes, coupled with a significant decrease in viral load (p=0.001). A low number of adverse events occurred during the treatment period (n=4): two cases of fatigue and two gastrointestinal reactions. No patient discontinued BIC/FTC/TAF and the overall tolerability was good.

conclusionsThe insights of the first report on BIC/FTC/TAF use in routine clinical practice in Romania provide an overview of effectiveness and safety to local clinicians treating this patient population.

Indexed as

BIC/FTC/TAFPLWHreal-worldRomania

Identifiers

PMID35096668
PMCPMC8789359

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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.