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Clinical Pharmacology of the Single Tablet Regimen Bictegravir/Emtricitabine/Tenofovir Alafenamide in the evolving era of antiretroviral therapies.
New Microbiol
November 2024
Infectious Diseases Unit, Department of Medical Sciences, University of Turin, Italy.
In this fast-evolving era of antiretroviral chemotherapy, the single-tablet regimen (STR) BIC/FTC/TAF, an oral regimen including a potent INSTI (strand-transfer integrase inhibitors) like Bictegravir plus two different NRTIs (Nucleoside Reverse Transcriptase Inhibitors), is increasingly challenged by new oral combinations. Furthermore, long-acting injectable drugs have also been developed and others are being under development. Notably, no new STR consisting of two NRTIs plus a 3rd drug like an INSTI are in the industrial pipeline.
View Article and Find Full Text PDFPharmacokinetic evaluation of bictegravir + emtricitabine + tenofovir alafenamide in HIV treatment.
Expert Opin Drug Metab Toxicol
November 2024
Department of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Introduction: The combination of bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) represents a valid option of antiretroviral therapy (ART) as first line regimen both in ART-naïve and -experienced people with HIV (PWH). This review evaluates the pharmacokinetic profiles of these drugs and their clinical implications.
Areas Covered: This article discusses the pharmacokinetics and pharmacodynamics of BIC/FTC/TAF.
Current opinion: antiretrovirals during pregnancy and breastfeeding.
Curr Opin HIV AIDS
November 2024
Department of Pharmacy, Radboud Institute for Medical Innovations (RIMI), Radboud University Medical Center, Nijmegen, The Netherlands.
Article Synopsis
- - The review focuses on recent findings over the last two years regarding how antiretroviral drugs behave in pregnant women, including their effects on placental transfer and exposure through breastmilk.
- - It highlights key developments like the FDA's label change for Bictegravir due to its decreased yet adequate concentration during pregnancy, as well as findings from studies on long-acting formulations like cabotegravir and rilpivirine.
- - The overall conclusion emphasizes the need for better drug data during pregnancy and lactation, suggesting that more research and incentives are necessary to ensure women receive accurate information about their medications early in the drug development process.
Ideal Time to Conduct a Pharmacokinetic Investigation After Delivery to Fully Capture the Effect of Pregnancy on Drug Exposure.
Open Forum Infect Dis
October 2024
Division of Infectious Diseases and Hospital Epidemiology, Departments of Medicine and Clinical Research, University Hospital Basel, Basel, Switzerland.
Background: The World Health Organization is pushing to accelerate the study of new human immunodeficiency virus drugs in pregnant women. However, regulatory guidelines do not specify when to conduct pharmacokinetic studies in postpartum women. This knowledge gap carries the potential to jeopardize the outcomes and conclusions of clinical trials aiming to study the effect of pregnancy on drug exposure.
View Article and Find Full Text PDFBictegravir/emtricitabine/tenofovir alafenamide in adults with HIV-1 and end-stage kidney disease on chronic haemodialysis.
HIV Med
October 2024
Wake Forest University, Winston-Salem, North Carolina, USA.
Introduction: Treatment for people with HIV-1 and end-stage kidney disease (ESKD) on haemodialysis (HD) has previously required complex dose-adjusted regimens, with limited data on the use of a single-tablet regimen in this population. Our aim was to assess the efficacy and safety of once-daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and to evaluate the pharmacokinetics of bictegravir (BIC) in adults with HIV-1 and ESKD on HD.
Methods: We performed an open-label extension (OLE) of an open-label, multicentre, single-group phase 3b study (NCT02600819) of adults with ESKD on HD and HIV-1 with virological suppression.
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