ArticlePloS one2023
Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir.
Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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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.
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.
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Who cites it
9 citing papers in PubMed, 9 citations in OpenAlex.
- Bictegravir/Tenofovir Alafenamide/Emtricitabine in Real-Life: A Multi-Year Experience.Journal of clinical medicine · 2026Article
- Long-term persistence, effectiveness, safety, and metabolic impact of bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination in people living with HIV in the BICTARG cohort.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026Observational
- Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis.Virology journal · 2026Article
- Trends in Serum Amylase Levels in People Living with HIV: A Comparison Between INSTI and NNRTI/PI-Based Regimens.Viruses · 2025Observational
- Experience of a Nationwide implementation of single-tablet second-generation integrase inhibitors-based treatment in Mexico.IJID regions · 2025Article
- Effectiveness, safety, and patient-reported outcomes of treatment with bictegravir/emtricitabine/tenofovir alafenamide fixed dose combination in people living with HIV in Argentina: the BICTARG cohort.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025Observational
- Enhanced metabolic health and immune response with bictegravir/emtricitabine/TAF: Insights from a 96‑week retrospective study.Biomedical reports · 2024Article
- Article
- Considerations for the Use of AAV-based Gene Therapy in HIV-Positive Individuals With Haemophilia.Haemophilia : the official journal of the World Federation of HemophiliaReview
Corrections and comments
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Authors and funding
23 authors at 15 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIntegrase strand transfer inhibitors (INSTI) are one of the most prescribed drug classes for the treatment of HIV infection worldwide. Emtricitabine/Tenofovir Alafenamide/ Bictegravir (FTC/TAF/BIC) has been evaluated in randomized clinical trials; few studies have verified tolerability and safety in clinical practice. Our aim was to investigate the metabolic and hepatic safety in a real-life setting of FTC/TAF/BIC. MATERIALS AND
methodsConsecutive people living with HIV infection (PLWH) enrolled in the SCOLTA project, switching to or initiating their first antiretroviral treatment with FTC/TAF/BIC were included. PLWH with HBV co-infection were excluded. Metabolic and hepatic variables were collected at T0 and T1, were defined as baseline and 6-month follow-up respectively, and their modifications were analysed using the paired t-test and the analysis of variance.
resultsFive hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (±12.1), 74% were male, 16.1% were naïve to antiretrovirals (ART). At T1, ART-experienced PLWH showed a significant reduction of total cholesterol (TC) and triglycerides, and a slight increase in blood glucose (BG) and ALT. On the contrary, in ART-naïve PLWH blood lipids significantly increased, although with an unaffected TC/high density lipoprotein (HDL)-c ratio, while alanine aminotransferase (ALT) decreased significantly, mainly in those with altered baseline level. The treatment interruptions were 45 (8.4%) over the whole observation period, 13 (2.4%) due to AEs. The most frequent AEs were related to the central nervous system (6 events of depression, insomnia, headache, agitation) and 3 PLWH discontinued the regimen because of grade 1-2 weight gain.
conclusionsIn ART-experienced PLWH switching to FTC/TAF/BIC a significant improvement of lipid profile occurred but with significant BG and ALT variation without clinical relevance. In ART-naïve PLWH, blood lipids increased even though lipid profile did not worsen, and a trend towards normalization of liver enzymes was suggested. FTC/TAF/BIC is well tolerated in the real life setting.
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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.