Trial reportAIDS (London, England)2021
Tenofovir-diphosphate in peripheral blood mononuclear cells during low, medium and high adherence to emtricitabine/ tenofovir alafenamide vs. emtricitabine/ tenofovir disoproxil fumarate.
Trial report in AIDS (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Adherence and HIV Protection Thresholds for Emtricitabine and Tenofovir Disoproxil Fumarate Preexposure Prophylaxis among Cisgender Women: A Systematic Review.Current HIV/AIDS reports · 2024Pooled it
- Trial
- HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo.The Journal of infectious diseases · 2024Trial
- Short-term oral pre-exposure prophylaxis against HIV-1 modulates the transcriptome of foreskin tissue in young men in Africa.Frontiers in immunology · 2022Trial
- Predicting Oral HIV Pre-Exposure Prophylaxis Efficacy in Cisgender Women Across Pregnancy and Postpartum.Journal of clinical pharmacology · 2026Article
- Evaluation of the Safety and Efficacy of SOF/VEL Treatment and Pre-treatment of TAF in Patients with Chronic Hepatitis B Virus/Hepatitis C Virus Coinfection: A Multicenter Study.Journal of clinical and translational hepatology · 2026Article
- Pharmacological markers of HIV prevention for oral pre-exposure prophylaxis in men who have sex with men.Nature communications · 2026Article
- Pharmacokinetics of Twice-daily Tenofovir Alafenamide in Adults With HIV-associated Tuberculosis on Bictegravir/Emtricitabine/Tenofovir Alafenamide and Rifampicin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- An FDA-Approved Tenofovir Alafenamide-Based Antiretroviral Therapy Reduces Biological Age in Healthy Adults: First Human Proof-of-Concept for Retrotransposon-Targeted Gerotherapeutics.medRxiv : the preprint server for health sciences · 2026Article
- Development of a Semi-Mechanistic Population Pharmacokinetic Model for Predicting Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide Exposure in Plasma and Cellular Matrices During Pregnancy and Postpartum.Clinical pharmacokinetics · 2026Article
- Recommendations for Interpreting Intraerythrocytic Tenofovir Diphosphate and Emtricitabine Triphosphate for HIV-1 Preexposure Prophylaxis Adherence Assessment.Journal of acquired immune deficiency syndromes (1999) · 2025Review
- An Anti-HIV Drug Is Highly Effective Against SARS-CoV-2 In Vitro and Has Potential Benefit for Long COVID Treatment.Viruses · 2025Article
- Modelling the impact of initiation delay, duration and prior PrEP on the efficacy of post-exposure prophylaxis containing a tenofovir/emtricitabine backbone.Journal of the International AIDS Society · 2025Article
- Cellular pharmacology of tenofovir alafenamide and emtricitabine in neutrophils and platelets in people with and without HIV.The Journal of antimicrobial chemotherapy · 2025Article
- Pharmacokinetics of Tenofovir Diphosphate, Lamivudine Triphosphate and Emtricitabine Triphosphate in Adolescents With HIV Infection With and Without Tuberculosis Coinfection.The Pediatric infectious disease journal · 2025Article
- A Cross-Biomeasure Study to Optimize Antiretroviral Adherence Estimation.Journal of acquired immune deficiency syndromes (1999) · 2025Article
- Hepatitis B virus (HBV) viremia despite tenofovir disoproxil fumarate-containing antiretroviral therapy in persons with HBV/HIV coinfection.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2024Article
- B/F/TAF forgiveness to non-adherence.Sexually transmitted infections · 2024Article
- Pharmacogenetic determinants of tenofovir diphosphate and lamivudine triphosphate concentrations in people with HIV/HBV coinfection.Antimicrobial agents and chemotherapy · 2024Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTenofovir alafenamide (TAF) preferentially loads peripheral blood mononuclear cells (PBMCs), resulting in higher PBMC tenofovir-diphosphate (TFV-DP) vs. tenofovir disoproxil fumarate (TDF). No studies have yet compared TFV-DP in PBMC from lower than daily dosing between prodrugs, which has potential implications for event-driven preexposure prophylaxis and pharmacologic forgiveness.
designTwo separate randomized, directly observed therapy (DOT) crossover studies (DOT-DBS and TAF-DBS) were conducted to mimic low, medium and high adherence.
methodsHIV-negative adults were randomized to two 12-week DOT regimens of 33, 67 or 100% of daily dosing with emtricitabine (F)/TAF 200 mg/25 mg (TAF-DBS) or F/TDF 200 mg/300 mg (DOT-DBS), separated by a 12-week washout. PBMC steady-state concentrations (Css) of TFV-DP and FTC-TP were estimated using nonlinear mixed models and compared between F/TAF and F/TDF.
resultsThirty-five participants contributed to 33% (n = 23), 67% (n = 23) and 100% (n = 23) of daily F/TAF regimens. Forty-four contributed to 33% (n = 15), 67% (n = 16) and 100% (n = 32) of daily F/TDF regimens. PBMC TFV-DP Css were 7.3 [95% confidence interval (95% CI): 6.4-8.2], 7.1 (5.9-8.2) and 6.7- (4.4-8.9) fold higher (P < 0.0001) following F/TAF vs. F/TDF; 593 vs. 81.7, 407 vs. 57.4, and 215 vs. 32.3 fmol/106 cells, respectively. TFV-DP was 2.6 (2.1-3.1) fold higher with 33% F/TAF vs. 100% F/TDF. Estimated half-lives (95% CI) of TFV-DP in PBMC were 2.9 (1.5-5.5) days for F/TAF and 2.1 (1.5-2.9) days for F/TDF. FTC-TP was similar in both studies (P = 0.119).
conclusionF/TAF produced 6.7 to 7.3-fold higher TFV-DP in PBMC vs. F/TDF across adherence levels, supporting increased potency and pharmacologic forgiveness with F/TAF in the PBMC compartment.
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