Background: Tenofovir/emtricitabine (TDF/FTC) used as pre-exposure prophylaxis (PrEP) has proven benefits in preventing HIV infection. Widespread use of TDF/FTC can only be justified if the preventative benefits outweigh potential risks of adverse events. A previous meta-analysis of TDF/FTC compared to alternative tenofovir alafenamide (TAF)/FTC for treatment found no significant difference in safety endpoints when used without ritonavir or cobicistat, but more evidence around the safety of TDF/FTC is needed to address concerns and inform widespread use.
Methods: A systematic review identified 13 randomised trials of PrEP, using either TDF/FTC or TDF, versus placebo or no treatment: VOICE, PROUD, IPERGAY, FEM-PrEP, TDF-2, iPrEX, IAVI Kenya, IAVI Uganda, PrEPare, PARTNERS, US Safety study, Bangkok TDF study, W African TDF study. The number of participants with grade 3/4 adverse events or serious adverse events (SAEs) was compared between treatment and control in the meta-analysis. Further analyses of specific renal and bone markers were also undertaken, with fractures as a marker of bone effects and creatinine elevations as a surrogate marker for renal impairment. Analyses were stratified by study duration (1 year of follow up).
Results: The 13 randomised trials included 15,678 participants in relevant treatment and control arms. Three studies assessed TDF use only. The number of participants with grade 3/4 adverse events was 1306/7504 (17.4%) on treatment versus 1259/7502 (16.8%) on control (difference=0%, 95% confidence interval [CI] -1% to +2%). The number of participants with SAEs was 740/7843 (9.4%) on treatment versus 795/7835 (10.1%) on no treatment (difference=0%, 95% CI -1% to +1%). The number of participants with creatinine elevations was 8/7843 on treatment versus 4/7835 on control (difference=0%, 95% CI 0%-0%). The number of participants with bone fractures was 217/5789 on treatment versus 189/5795 on control (difference=0%, 95% CI 0% to 1%). There was no difference in outcome between studies with <1 versus >1 year of randomised treatment.
Conclusions: In this meta-analysis of 13 randomised clinical trials of PrEP in 15,678 participants, there was no significant difference in risk of grade 3/4 clinical adverse events or SAEs between TDF/FTC (or TDF) and control. Furthermore, there was no significant difference in risk of specific renal or bone adverse outcomes. The favourable safety profile of TDF/FTC would support more widespread use PrEP in populations with a lower risk of HIV infection.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6248833 | PMC |
| http://dx.doi.org/10.1016/S2055-6640(20)30312-5 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Locoregional anesthesia in patients with Brugada syndrome. A retrospective database analysis.
Acta Anaesthesiol Scand
February 2025
Department of Anesthesiology and perioperative medicine, University Hospital of Brussels, Free University of Brussels, Brussels, Belgium.
Background: The use of local anesthetics (LA) in individuals with Brugada syndrome (BrS) remains a subject of debate due to the lack of large-scale studies confirming their potential risks. This study primarily aimed to evaluate the incidence of new malignant arrhythmias or defibrillation events in patients diagnosed with BrS during the perioperative period, following the administration of local anesthetics, and within 30 days postoperatively. The secondary objective was to analyze the occurrence of adverse effects during hospitalization, as well as 30-day readmission and mortality rates.
View Article and Find Full Text PDFPosaconazole for Prevention of COVID-19-Associated Pulmonary Aspergillosis in Mechanically Ventilated Patients: A European Multicentre Case-Control Study (POSACOVID).
Mycoses
January 2025
Division of Infectious Diseases, Department of Internal Medicine, Excellence Center for Medical Mycology (ECMM), Medical University of Graz, Graz, Austria.
Background: This study investigated the impact of posaconazole (POSA) prophylaxis in COVID-19 patients with acute respiratory failure receiving systemic corticosteroids on the risk for the development of COVID-19-associated pulmonary aspergillosis (CAPA).
Methods: The primary aim of this prospective, multicentre, case-control study was to assess whether application of POSA prophylaxis in mechanically ventilated COVID-19 patients reduces the risk for CAPA development. All consecutive patients from centre 1 (cases) who received POSA prophylaxis as standard-of-care were matched to one subject from centre 2 and centre 3 who did not receive any antifungal prophylaxis, using propensity score matching for the following variables: (i) age, (ii) sex, (iii) treatment with tocilizumab and (iv) time at risk.
A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer.
Signal Transduct Target Ther
January 2025
Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. Adults who were histologically diagnosed and never treated for extensive-stage small cell lung cancer (ES-SCLC) were enrolled.
View Article and Find Full Text PDFKlebsiella pneumoniae-derived extracellular vesicles impair endothelial function by inhibiting SIRT1.
Cell Commun Signal
January 2025
Beijing An Zhen Hospital, Capital Medical University, The Key Laboratory of Remodeling Cardiovascular Diseases, Ministry of Education; Collaborative Innovation Center for Cardiovascular Disorders, Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing, 100029, China.
Background: The potential role of Klebsiella pneumoniae (K.pn) in hypertension development has been emphasized, although the specific mechanisms have not been well understood. Bacterial extracellular vesicles (BEVs) released by Gram-negative bacteria modulate host cell functions by delivering bacterial components to host cells.
View Article and Find Full Text PDFCannabis use and atherosclerotic cardiovascular disease outcomes: A meta-analysis of multinational cohort data.
Dis Mon
January 2025
Department of Internal Medicine, Trinity Health Oakland/ Wayne State University, Pontiac, Michigan, USA.
Background: While an association between cannabis use and the risk of atherosclerotic cardiovascular diseases (ASCVD) has been reported numerous times, it remains inconclusive as to whether this link is causal in nature. We sought to consolidate data from observational studies to explore the association between ever use of cannabis and ASCVD outcomes, including myocardial infarction, stroke, and a combined measure of any adverse cardiovascular events in comparison to non-users or controls.
Methods: We performed a systematic literature search on PubMed, Scopus, ScienceDirect, and Cochrane Library for relevant studies from inception until April 2024.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!