The role of etravirine in the management of treatment-experienced pediatric patients with HIV

Danielle Osterholzer Ryan White Center for Pediatric Infectious Diseases, Riley Hospital for Children at Indiana University Health, Division of Adult Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA Abstract: Pediatric patients infected with human immunodeficiency vi...

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Main Author: Osterholzer D
Format: Article
Language:English
Published: Dove Medical Press 2013-04-01
Series:HIV/AIDS : Research and Palliative Care
Online Access:http://www.dovepress.com/the-role-of-etravirine-in-the-management-of-treatment-experienced-pedi-a12716
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spelling doaj-fdf3669eb1f14b8e83a185d48012b31d2020-11-25T01:41:41ZengDove Medical PressHIV/AIDS : Research and Palliative Care1179-13732013-04-012013default6773The role of etravirine in the management of treatment-experienced pediatric patients with HIVOsterholzer DDanielle Osterholzer Ryan White Center for Pediatric Infectious Diseases, Riley Hospital for Children at Indiana University Health, Division of Adult Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA Abstract: Pediatric patients infected with human immunodeficiency virus (HIV) are now living longer, healthier lives due to the advent of combined antiretroviral (ARV) therapy, including regimens that often contain non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, first-generation NNRTIs such as nevirapine (NVP) and efavirenz (EFV) have a low genetic barrier to resistance, and both drugs can become ineffective with a single viral point mutation. New agents with activity against resistant viral strains must be available to salvage children and adolescents with virologic failure after NNRTI use. One such drug, etravirine, an oral second-generation NNRTI approved for use in the US in heavily treatment-experienced HIV-1-infected adults in 2008, is accumulating data in this younger population. Etravirine became approved by the US Food and Drug Administration in early 2012 to be used in combination with other ARV medications in HIV-1-infected children aged 6 years to <18 years who are failing their regimens with HIV-1 strains resistant to NNRTIs and other ARVs. This approval was largely based on data from a prospective, open-label, phase II clinical trial in this age group prescribed etravirine at 5.2 mg/kg twice daily (up to the adult dose of 200 mg twice daily) in combination with an investigator-selected optimized background regimen. Currently available 48-week follow-up data show complete viral suppression (<50 copies/mL) in 56% of the patients, with relatively few serious adverse events attributed to the drug. Additional studies and case reports from the field suggest its utility in clinical practice. This review is designed to increase the background understanding of this drug in pediatric HIV providers, to lay out the current pediatric data to support its use, and to define its practical role in the treatment of HIV-infected children now and in the future. Keywords: salvage, resistance, children, adolescents, NNRTI, perinatalhttp://www.dovepress.com/the-role-of-etravirine-in-the-management-of-treatment-experienced-pedi-a12716
collection DOAJ
language English
format Article
sources DOAJ
author Osterholzer D
spellingShingle Osterholzer D
The role of etravirine in the management of treatment-experienced pediatric patients with HIV
HIV/AIDS : Research and Palliative Care
author_facet Osterholzer D
author_sort Osterholzer D
title The role of etravirine in the management of treatment-experienced pediatric patients with HIV
title_short The role of etravirine in the management of treatment-experienced pediatric patients with HIV
title_full The role of etravirine in the management of treatment-experienced pediatric patients with HIV
title_fullStr The role of etravirine in the management of treatment-experienced pediatric patients with HIV
title_full_unstemmed The role of etravirine in the management of treatment-experienced pediatric patients with HIV
title_sort role of etravirine in the management of treatment-experienced pediatric patients with hiv
publisher Dove Medical Press
series HIV/AIDS : Research and Palliative Care
issn 1179-1373
publishDate 2013-04-01
description Danielle Osterholzer Ryan White Center for Pediatric Infectious Diseases, Riley Hospital for Children at Indiana University Health, Division of Adult Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA Abstract: Pediatric patients infected with human immunodeficiency virus (HIV) are now living longer, healthier lives due to the advent of combined antiretroviral (ARV) therapy, including regimens that often contain non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, first-generation NNRTIs such as nevirapine (NVP) and efavirenz (EFV) have a low genetic barrier to resistance, and both drugs can become ineffective with a single viral point mutation. New agents with activity against resistant viral strains must be available to salvage children and adolescents with virologic failure after NNRTI use. One such drug, etravirine, an oral second-generation NNRTI approved for use in the US in heavily treatment-experienced HIV-1-infected adults in 2008, is accumulating data in this younger population. Etravirine became approved by the US Food and Drug Administration in early 2012 to be used in combination with other ARV medications in HIV-1-infected children aged 6 years to <18 years who are failing their regimens with HIV-1 strains resistant to NNRTIs and other ARVs. This approval was largely based on data from a prospective, open-label, phase II clinical trial in this age group prescribed etravirine at 5.2 mg/kg twice daily (up to the adult dose of 200 mg twice daily) in combination with an investigator-selected optimized background regimen. Currently available 48-week follow-up data show complete viral suppression (<50 copies/mL) in 56% of the patients, with relatively few serious adverse events attributed to the drug. Additional studies and case reports from the field suggest its utility in clinical practice. This review is designed to increase the background understanding of this drug in pediatric HIV providers, to lay out the current pediatric data to support its use, and to define its practical role in the treatment of HIV-infected children now and in the future. Keywords: salvage, resistance, children, adolescents, NNRTI, perinatal
url http://www.dovepress.com/the-role-of-etravirine-in-the-management-of-treatment-experienced-pedi-a12716
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