Clinical trial simulation to evaluate tenofovir disoproxil fumarate/emtricitabine HIV pre-exposure prophylaxis dosing during pregnancy

Clinical trial simulation to evaluate tenofovir disoproxil fumarate/emtricitabine HIV pre-exposure prophylaxis dosing during pregnancy

ObjectiveTo evaluate upward-adjustment of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) pre-exposure prophylaxis (PrEP) dosing during pregnancy in order to maintain target plasma concentrations associated with HIV protection.DesignPopulation pharmacokinetic (PK) modeling and clinical trial...

Full description

Bibliographic Details
Main Authors:	Rachel K. Scott, Yifan Yu, Mark A. Marzinke, Jenell S. Coleman, Craig W. Hendrix, Robert Bies
Format:	Article
Language:	English
Published:	Frontiers Media S.A. 2023-09-01
Series:	Frontiers in Reproductive Health
Subjects:	pregnancy pre-exposure prophylaxis HIV infection tenofovir emtricitabine clinical trial simulation
Online Access:	https://www.frontiersin.org/articles/10.3389/frph.2023.1224580/full

Similar Items

New simple spectrophotometric method for determination of the antiviral mixture of emtricitabine and tenofovir disoproxil fumarate
by: Heba K. Ashour, et al.
Published: (2017-05-01)

Pharmacogenetics of tenofovir and emtricitabine penetration into cerebrospinal fluid
by: Eric H. Decloedt, et al.
Published: (2021-04-01)

Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate
by: Tim R. Cressey, et al.
Published: (2020-08-01)

Development and validation of analytical method for quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC
by: Arun Ramaswamy, et al.
Published: (2018-02-01)

Evaluation of Rapidly Disintegrating Vaginal Tablets of Tenofovir, Emtricitabine and Their Combination for HIV-1 Prevention
by: Meredith R. Clark, et al.
Published: (2014-12-01)

Increase in bone turnover markers in HIV patients treated with tenofovir disoproxil fumarate combined with raltegravir or efavirenz
by: Yonatan Oster, et al.
Published: (2020-12-01)

Prophylaxis by doravirine-lamivudine-tenofovir disoproxil fumarate or elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide after sexual exposure to HIV
by: Inès Devred, et al.
Published: (2023-09-01)

Estimating the budget impact of adopting tenofovir/emtricitabine for pre-exposure prophylaxis of HIV in the public health sector in Namibia (2021 – 2023)
by: Enos Moyo, et al.
Published: (2022-10-01)

Preclinical Evaluation of Long-Acting Emtricitabine Semi-Solid Prodrug Nanoparticle Formulations
by: Paul Curley, et al.
Published: (2023-06-01)

A novel simultaneous high performance liquid chromatography-PDA method for the determination of Tenofovir AF, Darunavir, Emtricitabine and Cobicistat in bulk and its application to marketed formulation
by: Challamalla Pavani, et al.
Published: (2022-01-01)

Short-term oral pre-exposure prophylaxis against HIV-1 modulates the transcriptome of foreskin tissue in young men in Africa
by: Stefan Petkov, et al.
Published: (2022-11-01)

Darunavir–cobicistat–emtricitabine–tenofovir alafenamide: safety and efficacy of a protease inhibitor in the modern era
by: Squillace N, et al.
Published: (2018-10-01)

Multispecies Evaluation of a Long-Acting Tenofovir Alafenamide Subdermal Implant for HIV Prophylaxis
by: Manjula Gunawardana, et al.
Published: (2020-11-01)

Long-term efficacy and safety of once-daily nevirapine in combination with tenofovir and emtricitabine in the treatment of HIV-infected patients: a 72-week prospective multicenter study (TENOR-Trial)
by: Weberschock T, et al.
Published: (2009-12-01)

Limited SHIV <it>env</it> diversification in macaques failing oral antiretroviral pre-exposure prophylaxis
by: Zheng Qi, et al.
Published: (2012-05-01)

Raltegravir, tenofovir, and emtricitabine in an HIV-Infected patient with HCV chronic hepatitis, NNRTI intolerance and protease inhibitors-induced severe liver Toxicity
by: Ortu F, et al.
Published: (2010-02-01)

Switch from a ZDV/3TC-based regimen to a completely once daily (QD) regimen of emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT)
by: Arasteh K, et al.
Published: (2009-05-01)

Switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate in a cohort of patients with HBV infection: A retrospective study
by: Giacomo Stroffolini, et al.
Published: (2024-02-01)

Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women
by: Maria Pyra, et al.
Published: (2019-04-01)

RP-HPLC method development and validation for the estimation of Emtricitabine, Bictegravir and Tenofovir alafenamide in bulk and pharmaceutical dosage form
by: Tej Kumar Kokkirala, et al.
Published: (2019-12-01)

A Comparison between the Efficiency of Vonavir (Tenofovir-Emtricitabine- Efavirenz) and Cobavir (Lamivudine-Zidovudine) with Efavirenz used for HIV Patients in Fasa, Iran
by: Saeideh Honarmand, et al.
Published: (2022-07-01)

Adverse effects of daily oral pre-exposure prophylaxis in men who have sex with men and transgender women: a systematic review and meta-analysis
by: Marcos Pereira, et al.
Published: (2023-12-01)

Phase 1 randomized pharmacokinetic and safety study of a 90‐day tenofovir vaginal ring in the United States
by: Albert Y. Liu, et al.
Published: (2024-03-01)

Statutory health insurance-covered pre-exposure prophylaxis in Germany: changing trends in nationwide tenofovir disoproxil/emtricitabine prescriptions during the COVID-19 pandemic
by: Henrieke Prins, et al.
Published: (2023-11-01)

Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide
by: Nicholas T. Funderburg, et al.
Published: (2016-11-01)

The genotoxicity of Tenofovir disoproxil fumarate in HBV-infected patients
by: Selcen Korkmaz, et al.
Published: (2018-09-01)

Tenofovir Activating Kinases May Impact the Outcome of HIV Treatment and Prevention
by: Dimitri Topalis, et al.
Published: (2015-09-01)

Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women
by: Deborah Donnell, et al.
Published: (2023-06-01)

Failure of pre-exposure prophylaxis with daily tenofovir/emtricitabine and the scenario of delayed HIV seroconversion
by: Shui-Shan Lee, et al.
Published: (2020-05-01)

Real-world impact of switching from tenofovir disoproxil fumarate to tenofovir alafenamide
by: Sarah M Michienzi, et al.
Published: (2021-07-01)

Switching to Dolutegravir/lamivudine or Bictegravir/Emtricitabine/Tenofovir alafenamide. A comparative real-world study
by: Hernando Knobel, et al.
Published: (2023-07-01)

Pharmacokinetics and efficacy of topical inserts containing tenofovir alafenamide fumarate and elvitegravir administered rectally in macaquesResearch in context
by: Natalia Makarova, et al.
Published: (2022-12-01)

Frequency of Hepatitis B Virus Resistance Mutations in Women Using Tenofovir Gel as Pre-Exposure Prophylaxis
by: Cheryl Baxter, et al.
Published: (2019-06-01)

Pre-exposure prophylaxis (PrEP) efficacy to reduce HIV/AIDS incidence rate among male sex to male (MSM) in Asia
by: Prayogi Miura-Susanto
Published: (2023-01-01)

Effects of Hydrochlorothiazide on Tenofovir Disoproxil Fumarate-Induced Nephrotoxicity in Rats
by: Iman G.Al-Rakhat, et al.
Published: (2019-12-01)

Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide
by: Hyeyeon Hong, et al.
Published: (2024-01-01)

A randomized clinical pharmacokinetic trial of Tenofovir in blood, plasma and urine in adults with perfect, moderate and low PrEP adherence: the TARGET study
by: Tim R. Cressey, et al.
Published: (2017-07-01)

Letter: Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide fumarate in patients with chronic hepatitis B: More questions than an answer – author’s reply
by: Hyeyeon Hong, et al.
Published: (2024-04-01)

Cost–effectiveness of switching from tenofovir disoproxil fumarate to tenofovir alafenamide versus entecavir for chronic hepatitis B patients in Greece
by: Emmanouil Sinakos, et al.
Published: (2024-02-01)

Monitoring the Effects of Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide Switch for Tubulotoxicity in Highly Treatment-Experienced or in Very Sick Individuals Infected with HIV
by: Nicole Marie Lioufas, et al.
Published: (2018-06-01)