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Safety and Efficacy of Atazanavir Powder and Ritonavir in HIV-1-Infected Infants and Children From 3 Months to <11 Years of Age: The PRINCE-2 Study.

Author: CambilargiuDaniela, CorrellTodd A, CottonMark F, Gonzalez-TomeMaria Isabel, KlauckIsabelle, LibertyAfaaf, LissensJurgen, PikoraCheryl, Torres-EscobarIndiana, ZaruLuna

Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Atazanavir powder formulation boosted with ritonavir (ATV + RTV) is a palatable and effective treatment option for HIV-1 infected children aged 3 months to <11 years. In a clinical trial, 83.8% of children remained on ATV powder until 24 weeks and 59.6% remained on it until 48 weeks. The most common adverse events were upper respiratory tract infections, gastroenteritis, vomiting, and hyperbilirubinemia. Virologic suppression rates were comparable across weight bands, with the lowest rate in the 5 to <10 kg = 200/80 mg group, likely due to higher baseline HIV-1 RNA and a higher discontinuation rate.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Novel antiretroviral formulations that are palatable, safe, and effective are needed for infants and children. METHODS: PRINCE-2 is an ongoing clinical trial assessing safety, efficacy, and palatability of once-daily atazanavir powder formulation boosted with ritonavir (ATV + RTV) plus ...See full text at original site
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引用元：
https://doi.org/10.1097/INF.0000000000001856

データ提供：米国国立医学図書館（NLM）

HIV Treatment for Infants and Children: A New Era of Hope

The field of [HIV treatment] is continually seeking new and improved formulations for infants and children. This study evaluates the safety and efficacy of a novel formulation of [atazanavir powder] boosted with ritonavir, providing valuable insights for treating HIV-1-infected children. The authors conducted a [clinical trial] involving children aged 3 months to <11 years, assessing the drug's safety, efficacy, and palatability. Their findings offer promising results, suggesting a potential advancement in HIV treatment for this vulnerable population.

A Positive Step Forward: Atazanavir Powder for HIV-Infected Children

The study demonstrates that [atazanavir powder] is both safe and effective in treating HIV-1-infected children. While some adverse events were observed, the majority were mild and manageable. The study also highlights the importance of [palatability] in medication for children, and the authors report a high level of caregiver satisfaction with the atazanavir powder formulation. This positive outcome provides hope for improving the quality of life for children living with HIV.

Navigating the Desert of HIV Treatment: A New Oasis for Children

This research underscores the importance of tailored treatment approaches for children with HIV. The study's findings offer a new path forward in the quest to provide effective and palatable antiretroviral therapy for this vulnerable population. As we continue to traverse the challenging landscape of HIV treatment, this study provides a beacon of hope, illuminating a path towards a healthier future for children living with the virus.

Dr. Camel's Conclusion

Like a camel navigating the vast desert of HIV treatment, researchers are continuously seeking safe and effective solutions for children. This study offers a promising oasis, showcasing the potential of atazanavir powder to improve the lives of HIV-infected children. The findings represent a significant step forward in the ongoing battle against this devastating disease.

Date :
  1. Date Completed 2019-04-04
  2. Date Revised 2019-04-04
Further Info :

Pubmed ID

29206747

DOI: Digital Object Identifier

10.1097/INF.0000000000001856

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・Side Effects of atazanavir
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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