Pharmacovigilance study to define the long term safety profile of etravirine in HIV-infected children and adolescents in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Perinatal HIV infection

Population studied

• Short description of the study population:
  All HIV-infected children and adolescents with current or previous use of Etravirine (ETR) treatment (excluding in utero exposure), regardless of clinical stage, and who were aged < 18 years at commencement of ETR treatment were included in the study.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The objectives are to describe:1) clinical characteristics of patients at start of ETR2) incidence of grade 3 and 4 adverse events for key laboratory markers by duration on ETR3) incidence of clinical serious and non-serious adverse events considered to be causally related to ETR 4) characterise reasons for discontinuation of ETR5) off-label use of ETR in children
• Data analysis plan:
  Standard descriptive statistics will be used to summarise the data. Demographic and baseline disease characteristics (eg sex, ethnic group,mode of infection, ever AIDS diagnosis) as well as antiretroviral therapy exposure (eg age starting any ART, age starting ETR, ART duration before ETR, viral load and CD4 at ETR start, other drug classes prescribed with ETR, and median estimated months and total patient years on ETR) of children taking ETR will be described. Laboratory toxicity data for periods on ETR will be summarised by duration of time on ETR (for example, <12 months, 12-24 months, >24 months). Rates of events for children on the licensed dose will be presented along with 95% confidence intervals, by DAIDS grade.Additional descriptive analyses will be presented on an individual patient basis for all patients with a grade ≥3 test result whilst on ETR.