Safety, efficacy, and pharmaco*kinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed, HIV-infected children: a single-arm, open-label trial. | Semantic Scholar (2024)

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@article{Natukunda2017SafetyEA, title={Safety, efficacy, and pharmaco*kinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed, HIV-infected children: a single-arm, open-label trial.}, author={Eva Natukunda and Aditya H. Gaur and Pope Kosalaraksa and Jagmohan S Batra and Natella Y. Rakhmanina and Danielle P. Porter and Yongwu Shao and Heather Zhang and Cheryl A. Pikora and Martin S. Rhee}, journal={The Lancet. Child \& adolescent health}, year={2017}, volume={1 1}, pages={ 27-34 }, url={https://api.semanticscholar.org/CorpusID:52140630}}
  • E. Natukunda, A. Gaur, M. Rhee
  • Published in 1 September 2017
  • Medicine

17 Citations

Background Citations

3

Results Citations

1

17 Citations

Pharmaco*kinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with virologically suppressed HIV: a phase 2/3, open-label, single-arm study.
    Carina A RodriguezE. Natukunda Aditya H Gaur

    Medicine

    The lancet. HIV

  • 2024
  • 1
An evaluation of elvitegravir plus cobicistat plus tenofovir alafenamide plus emtricitabine as a single-tablet regimen for the treatment of HIV in children and adolescents
    V. GiacometM. CossuA. CapettiG. ZuccottiG. Rizzardini

    Medicine

    Expert opinion on pharmacotherapy

  • 2019

E/C/FTC/TAF was well tolerated, and the antiretroviral activity and tolerability data of this combination support the use in children and adolescents, but additional studies investigating its safety and efficacy in children are paramount.

First Pharmaco*kinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial
    Hylke WaalewijnA. Szubert A. Colbers

    Medicine

    Clinical infectious diseases : an official…

  • 2023

In children with human immunodeficiency virus infection failing first-line antiretroviral therapy, TAF combined with boosted PIs or dolutegravir and dosed according to WHO-recommended weight bands provides TAF and tenofovir concentrations previously demonstrated to be well tolerated and effective in adults.

  • PDF
Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised
    F. MaggioloG. Rizzardini R. Haubrich

    Medicine

    The lancet. HIV

  • 2019
  • 19
Integrase inhibitors in children and adolescents: clinical use and resistance.
    David Torres-FernandezS. Jiménez de Ory L. Prieto

    Medicine

    The Journal of antimicrobial chemotherapy

  • 2022

INI-based regimens were effective and safe for HIV treatment in children and adolescents and presented an excellent profile, and most patients achieved and maintained viral suppression.

  • 4
Outcomes of Integrase Inhibitor–based Antiretroviral Therapy in a Clinical Cohort of Treatment-experienced Children, Adolescents and Young Adults With HIV Infection
    M. LevyCaleb GriffithNicole EllenbergerA. MonroeA. CastelN. Rakhmanina

    Medicine

    The Pediatric infectious disease journal

  • 2020

More than half of treatment-experienced children, adolescents and young adults with detectable viremia at INSTI initiation did not achieve viral suppression, while half of those with prior VS experienced transient viresmia.

  • 6
  • PDF
Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmaco*kinetic and safety substudies of the multicentre, randomised ODYSSEY trial
    P. BollenCecilia L. Moore D. Burger

    Medicine

    The lancet. HIV

  • 2020
  • 26
  • PDF
Tenofovir alafenamide revisited.
    G. di Perri

    Medicine

    Le infezioni in medicina

  • 2020

All things considered, avoidance of TDF, particularly when aging patients are concerned, appears the preferable approach, as the permanent dysfunctional pressure exerted by TDF on the proximal renal tubule could cause irreversible damage to both kidneys and bones.

  • 2
  • PDF
Noncommunicable diseases in adolescents with perinatally acquired HIV-1 infection in high-income and low-income settings
    S. InnesK. Patel

    Medicine

    Current opinion in HIV and AIDS

  • 2018

It is necessary to continue to evaluate perinatally HIV-infected children age into adolescence and adulthood with effective long-term ART, understand mechanisms underlying their risks, and identify and evaluate interventions specifically in this population.

  • 15
  • PDF
Effectiveness and safety of tenofovir alafenamide in children and adolescents living with HIV: a systematic review
    J. O’RourkeC. Townsend F. Renaud

    Medicine

    Journal of the International AIDS Society

  • 2023

Tenofovir alafenamide (TAF) is approved for paediatric use in fixed‐dose combination tablets, but efficacy and safety data in children are limited. We conducted a systematic review on the

  • 3
  • PDF

...

...

21 References

Safety, efficacy, and pharmaco*kinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial.
    A. GaurH. Kizito M. Rhee

    Medicine

    The lancet. HIV

  • 2016
  • 31
Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study
    A. PozniakJ. Arribas M. Fordyce

    Medicine

    Journal of acquired immune deficiency syndromes

  • 2016

These data support the efficacy and safety of once daily E/C/F/TAF in HIV+ patients with mild or moderate renal impairment without dose adjustment and Proteinuria, albuminuria and bone mineral density significantly improved.

  • 194
  • PDF
Efficacy, Safety and Pharmaco*kinetics of Tenofovir Disoproxil Fumarate in Virologic-Suppressed HIV-infected Children Using Weight-Band Dosing
    L. AurpibulT. Cressey K. Chokephaibulkit

    Medicine

    The Pediatric infectious disease journal

  • 2015

TDF substitution in children and adolescents who were otherwise stable while receiving a first-line nonnucleoside reverse transcriptase inhibitor–based regimen achieved adequate exposure without clinically significant renal or bone adverse events over 96 weeks; preliminary safety findings may not exclude delayed effects on renal function and bone density.

  • 27
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    A. MillsJ. Arribas S. McCallister

    Medicine

    The Lancet. Infectious diseases

  • 2016
  • 270
  • PDF
Antiviral Activity, Safety, and Pharmaco*kinetics/Pharmacodynamics of Tenofovir Alafenamide as 10-Day Monotherapy in HIV-1–Positive Adults
    P. RuaneE. Dejesus M. Rhee

    Medicine

    Journal of acquired immune deficiency syndromes

  • 2013

Compared with 300 mg TDF, TAF demonstrated more potent antiviral activity, higher peripheral blood mononuclear cell intracellular tenofovir diphosphate levels, and lower plasma TFV exposures, at approximately 1/10th of the dose.

  • 264
  • PDF
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    P. SaxE. Dejesus E. Quirk

    Medicine

    The lancet. HIV

  • 2017
  • 76
  • PDF
The long-term effectiveness of generic adult fixed-dose combination antiretroviral therapy for HIV-infected Ugandan children.
    Linda Barlow-MoshaD. Bagenda P. Musoke

    Medicine

    African health sciences

  • 2012

Treatment with generic adult FDC for HIV-infected Ugandan children led to sustained clinical, immunologic and virologic response during 96 weeks of ART, indicating early initiation of ART is key to achieving virological success.

Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials
    P. SaxD. Wohl S. McCallister

    Medicine

    The Lancet

  • 2015
  • 545
  • PDF
Tenofovir alafenamide for HIV infection: is less more?
    C. WyattJ. Baeten

    Medicine

    The Lancet

  • 2015
  • 12
Antiretroviral Drugs in Pediatric HIV-Infected Patients
    Benjamin R PhelpsN. Rakhmanina

    Medicine

    Paediatric drugs

  • 2011

A practical discussion regarding the pharmaco*kinetics of ARV agents in pediatric HIV-infected patients, as well as the practical challenges of currently available formulations, such as palatability of liquid formulations, challenges of crushing tablets, and using adult and pediatric fixed-dose combinations.

  • 28

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    Safety, efficacy, and pharmaco*kinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed, HIV-infected children: a single-arm, open-label trial. | Semantic Scholar (2024)

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