title: Post-licensing safety of fosamprenavir in HIV-infected children in Europe.
abstract: OBJECTIVE
  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
authors.forename: Ali
authors.initials: A
authors.lastname: Judd
authors.forename: Trinh
authors.initials: T
authors.lastname: Duong
authors.forename: Luisa
authors.initials: L
authors.lastname: Galli
authors.forename: Tessa
authors.initials: T
authors.lastname: Goetghebuer
authors.forename: Luminita
authors.initials: L
authors.lastname: Ene
authors.forename: Antoni
authors.initials: A
authors.lastname: Noguera Julian
authors.forename: Jose Tomas
authors.initials: JT
authors.lastname: Ramos Amador
authors.forename: Jeanne Marie
authors.initials: JM
authors.lastname: Pimenta
authors.forename: Claire
authors.initials: C
authors.lastname: Thorne
authors.forename: Carlo
authors.initials: C
authors.lastname: Giaquinto
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002219:Carbamates / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D015331:Cohort Studies; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D005663:Furans; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced / Q000175:diagnosis; D008297:Male; D010755:Organophosphates / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012189:Retrospective Studies; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D002219:Carbamates; D005663:Furans; D010755:Organophosphates; D013449:Sulfonamides; C426859:fosamprenavir
references.citation: HIV Med. 2009 Nov;10(10):591-613
references.pmid: 19878352
references.citation: Expert Rev Anti Infect Ther. 2007 Jun;5(3):349-63
references.pmid: 17547501
references.citation: Infection. 2010 Aug;38(4):301-19
references.pmid: 20514509
references.citation: Pediatr Infect Dis J. 2010 Jun;29(6):563-6
references.pmid: 20160659
references.citation: Lancet. 2007 Jul 7;370(9581):12-4
references.pmid: 17617255