AIV - FISABIO Impact and risk of Herpes Zoster in immunosuppressed subjects in Valencia Region, Spain

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Impact and risk
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Population based, retrospective cohort study

Study drug and medical condition

• Medical condition to be studied:
  Immunodeficiency common variable

Population studied

• Short description of the study population:
  Immunosuppressed subjects ≥ 18 years in the Valencian Community, between 2009 and 2014.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  4382590

Study design details

• Main study objective:
  To estimate the incidence of HZ in IS subjects 18 years and older in Valencia Region, from 2009 to 2014, both globally and stratified by age groups, sex and immunodeficiency type (HIV, malignancies, organ transplantation, immunodeficiency disorders and autoimmune diseases)
• Outcomes:
  An incident case of HZ will be considered the first appearance of a HZ-related ICD-9-CM code (053.xx), in either SIA or CMBD (in any position). Any outpatient medical contact or visit, or hospital admission related to HZ will be considered as a medical encounter. Recurrence of HZ will be examined in all HZ incident cases. - Health care resources consumption due to HZ:Outpatient visit.Hospitalizations.Length of hospitalization.Medication.Periods off work.- Health care resources consumption due to IS:Outpatient visits.Hospitalizations.Length of hospitalization.- HZ complications - Post-herpetic Neuralgia- Comorbidities
• Data analysis plan:
  We might expect approx. 4 million subjects to fulfil the inclusion criteria. Internal data from a previous study from our team, using the same health databases from Valencia Region and the same ICD-9 codes showed a prevalence of IS of 11.8% in subjects ≥ 50 years old. These data correlate with a published work with a large study population of 51 million subjects and a prevalence of IS of 11.9% for subjects ≥ 50 years old 9. According to this and the published data, the observed prevalence of IS for subjects aged 18 years and older was approx. 7% so, we will expect around 280.000 IS subjects in the present study.