Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir

Sevinsky, Heather; Zaru, Luna; Wang, Reena; Xu, Xiaohui; Pikora, Cheryl; Correll, Todd; Eley, Timothy

doi:10.1097/inf.0000000000001855

Cited by 3 publications

(4 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The PRINCE I and PRINCE II trials showed that ATV powder formulation in combination with RTV liquid in children 3 months to <11 years and weighing 5 to <35 kg dosed in weight bands reached the target drug exposure levels. 61,65,66 Results from the PRINCE I and II trials together with IMPAACT P1020 and the modeling study by Hong et al supported the FDA approval of ATV/r doses in children (see Table 3 , Supplemental Digital Content 2 , http://links.lww.com/TDM/A324).…”

Section: Methodsmentioning

confidence: 82%

“…58–60 Safety data from a large cohort study on ATV/r in children also show increasing incidence and severity of hyperbilirubinemia with increasing C trough . 61 Because in this case the increase in bilirubin is not a product of liver damage but rather because ATV interacts with bilirubin conjugation, this effect is benign. Advantages of therapy should be weighed against potential stigmatizing side effect of icteric eyes from an increase in unconjugated bilirubin.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Optimizing Pediatric Dosing Recommendations and Treatment Management of Antiretroviral Drugs Using Therapeutic Drug Monitoring Data in Children Living With HIV

Waalewijn

Turkova

Rakhmanina

et al. 2019

Therapeutic Drug Monitoring

View full text Add to dashboard Cite

show abstract

Section: Methodsmentioning

confidence: 82%

Section: Methodsmentioning

confidence: 99%

Optimizing Pediatric Dosing Recommendations and Treatment Management of Antiretroviral Drugs Using Therapeutic Drug Monitoring Data in Children Living With HIV

Waalewijn

Turkova

Rakhmanina

et al. 2019

Therapeutic Drug Monitoring

View full text Add to dashboard Cite

show abstract

“…Dosage forms used with children must be palatable and must permit flexible dosing to accommodate reasonable precision over the large range of doses that are required. Use of dosing bands, by assigning children over a range of weights to the same dose, allows use of capsules or tablets that may be more stable to be used in cases in which some flexibility in dosing is permissable …”

Section: Dosage Formsmentioning

confidence: 99%

“…Use of dosing bands, by assigning children over a range of weights to the same dose, allows use of capsules or tablets that may be more stable to be used in cases in which some flexibility in dosing is permissable. 35,40 The relative bioavailability between the different dosage forms must be known so that as children are switched, the required dosing is maintained. Stability information is also required for all dosage forms and understanding of the impact of excursions in temperature, such as when doses are not refrigerated.…”

Section: Dosage Formsmentioning

confidence: 99%

The Path to Perfect Pediatric Posology — Drug Development in Pediatrics

Korth‐Bradley

2018

The Journal of Clinical Pharma

View full text Add to dashboard Cite

Reluctance to enroll pediatric subjects in clinical trials has left gaps in information about dosing, safety, and efficacy of medications. Pharmacotherapeutic information for pediatric patients may be available for only a small range of ages and may be deficient, as children respond differently as they grow and mature from prematurity to adolescence. Current regulations, however, require early planning for the participation of children in drug development, as pediatric plans must be submitted at the end of phase 1 (European Union) or the end of phase 2 (United States). These plans are extensive, outlining planned studies, subjects to be enrolled, dose and dosage form justification, planned observations, and statistical analysis as well as planned modeling, simulation, and extrapolation analyses. The extent to which efficacy information in adults can be extrapolated to children depends on how similar the disease is in adults and each of the 5 pediatric age groups. Extrapolation may not be possible for conditions that do not occur in adults, requiring a complete development plan in adults, or extrapolation may be complete because of similar pathology and response to treatment. Pharmacokinetic and safety information cannot be extrapolated and must be collected in children of all ages, unless a waiver is granted. Physiologically based pharmacokinetic modeling, optimal design, population pharmacokinetics, and scavenged samples are all examples of new methodologies being used to study pediatric therapeutics. Clinicaltrials.gov and EU Clinical Trials registry are good sources of results of pediatric trials, although sponsors are also working toward prompt publication of study results in peer‐reviewed journals.

show abstract

Pharmacokinetic Drug-Drug Interactions Involving Antiretroviral Agents: An Update

Zhao

Yuan

et al. 2023

CDM

View full text Add to dashboard Cite

Antiretroviral therapy is the recognized treatment for human immunodeficiency virus (HIV) infection involving several antiviral agents. Even though highly active antiretroviral therapy has been proven to be very effective in suppressing HIV replication, the antiretroviral drugs, belonging to different pharmacological classes, present quite complex pharmacokinetic properties such as extensive drug metabolism and transport by membrane-associated drug carriers. Moreover, due to uncomplications or complications in HIV-infected populations, an antiretroviral-based multiple-drug coadministration therapy strategy is usually applied for treatment effect, thus raising the possibility of drugdrug interactions between antiretroviral drugs and common drugs such as opioids, stains, and hormonal contraceptives. Herein, thirteen classical antiretroviral drugs approved by US Food and Drug Administration were summarized. Besides, relative drug metabolism enzymes and transporters known to interact with those antiretroviral drugs were detailed and described. Furthermore, one after the summarized antiretroviral drugs, the drug-drug interactions between two antiretroviral drugs or antiretroviral drug - conventional medical drugs of the past decade were discussed and summarized. This review is intended to deepen the pharmacological understanding of antiretroviral drugs and promote more secure clinical applications for antiretroviral drugs to treat HIV.

show abstract

Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir

Cited by 3 publications

References 17 publications

Optimizing Pediatric Dosing Recommendations and Treatment Management of Antiretroviral Drugs Using Therapeutic Drug Monitoring Data in Children Living With HIV

Optimizing Pediatric Dosing Recommendations and Treatment Management of Antiretroviral Drugs Using Therapeutic Drug Monitoring Data in Children Living With HIV

The Path to Perfect Pediatric Posology — Drug Development in Pediatrics

Pharmacokinetic Drug-Drug Interactions Involving Antiretroviral Agents: An Update

Contact Info

Product

Resources

About