An Observational, Drug Utilization Study of Viread® in Children and Adolescents with HIV-1 Infection (GS-EU-104-0433)

Study type

• Study topic:
  Human medicinal product

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  All HIV-infected children and adolescents aged <18 years treated with Viread® or TDF-FDC at or after 22 November 2012, regardless of clinical stage.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  700

Study design details

• Main study objective:
  To describe the characteristics of HIV-1 infected patients less than 18 years of age being treated with Viread in the European Union.
• Outcomes:
  The primary outcome for this study was to assess characteristics of patients treated with Viread® on or after 22 November 2012. Specifically, to assess how physicians were prescribing Viread® to adolescents, and assess the clinical management and outcome of any ≥ Grade 3 renal and bone biochemistry markers, serum phosphate values of < 3.0 mg/dl (0.96 mmol/l) and serious adverse reactions. To evaluate and describe the characteristics of HIV-1 infected patients< 18 years of age being treated with tenofovir disoproxil fumarate(TDF)-based regimens at or after the Viread® approval date and to assess the monitoring and outcome of any ≥ Grade 3 renal and bone biochemistry markers and serious adverse drug reactions in patients receiving TDF-FDC.
• Data analysis plan:
  Demographic characteristics (eg sex, ethnic group, mode of infection, ever AIDS diagnosis) of participants taking Viread were described, by licensed v unlicensed dose and age. The antiretroviral therapy profile of children on licensed and unlicensed Viread doses were also described. Grade 3 and 4 renal and bone events or confirmed serum phosphate <3.0 mg/dL whilst on Viread or within 30 days after discontinuation of Viread in patients newly starting Viread post-approval were summarized. Data were collected on resolution of the event (if relevant), other ART drug and concomitant medications (including dietary supplements) taken at the time of the event, whether an endocrinologist or nephrologist was consulted, and whether Viread was stopped or continued. The number of children who discontinued Viread-containing treatment was tabulated and the reasons for drug discontinuation summarised.