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Post-licensing safety of fosamprenavir in HIV-infected children in Europe

Judd, A; Duong, T; Galli, L; Goetghebuer, T; Ene, L; Noguera Julian, A; Ramos Amador, JT; ... EuroCoord; + view all (2014) Post-licensing safety of fosamprenavir in HIV-infected children in Europe. Pharmacoepidemiology and Drug Safety , 23 (3) 321 - 325. 10.1002/pds.3543. Green open access

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Abstract

Purpose: Fosamprenavir, combined with low-dose ritonavir (FPV/r), is indicated for treatment of HIV-infected children aged ≥6 years in Europe. Our purpose was to assess the safety of licensed use of FPV/r in HIV-infected children reported to six cohorts in the European Pregnancy and Paediatric HIV Cohort Collaboration. Methods: Retrospective analysis of individual patient data for all children aged 6–18 years taking the licensed dose of FPV up to 31/12/10. Adverse events (clinical events and absolute neutrophil counts, total cholesterol and triglycerides, and alanine transaminase) were summarised and DAIDS gradings characterised severity. Results: Ninety-two HIV-infected children aged 6–18 years took the licensed dose, comprising 3% of the total number of children in follow-up in participating cohorts. Median age at antiretroviral therapy initiation was 6 years (interquartile range 1–11 years), and median age at start of FPV/r was 15 years (12–17 years). Estimated median time on an FPV-containing regimen was 52 months, with a total of 266.9 patient years of exposure overall. Half (54%) were on an FPV-containing regimen at last follow-up. Rates of grade 3/4 events were generally low for all biochemical toxicity markers, and no serious adverse events considered to be causally related to FPV/r were reported. Conclusions: Results suggest that long-term licensed dose FPV-containing regimens appear to be generally well tolerated with few reported toxicities in HIV-infected children in Europe, although relatively infrequently prescribed. No serious events were reported.

Type: Article
Title: Post-licensing safety of fosamprenavir in HIV-infected children in Europe
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/pds.3543
Publisher version: http://dx.doi.org/10.1002/pds.3543
Language: English
Additional information: Copyright © 2013 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Keywords: pharmacovigilance, epidemiology, fosamprenavir, safety, HIV, children, pharmacoepidemiology
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Population, Policy and Practice Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1417993
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