Previous presentation: This work is not being submitted elsewhere. Intermediate analyses were presented at IAS 2011 (Rome) and final analyses at ESPID 2012 (Thessaloniki).
Post-licensing safety of fosamprenavir in HIV-infected children in Europe†
Article first published online: 25 NOV 2013
© 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, 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.
Pharmacoepidemiology and Drug Safety
Volume 23, Issue 3, pages 321–325, March 2014
How to Cite
Judd, A., Duong, T., Galli, L., Goetghebuer, T., Ene, L., Julian, A. N., Amador, J. T. R., Pimenta, J. M., Thorne, C., Giaquinto, C. and on behalf of the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord (2014), Post-licensing safety of fosamprenavir in HIV-infected children in Europe. Pharmacoepidem. Drug Safe., 23: 321–325. doi: 10.1002/pds.3543
- Issue published online: 4 MAR 2014
- Article first published online: 25 NOV 2013
- Manuscript Accepted: 17 OCT 2013
- Manuscript Revised: 28 AUG 2013
- Manuscript Received: 8 APR 2013
- European Union Seventh Framework Programme. Grant Number: 260694
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.
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.
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.
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. © 2013 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.