A Prospective, Observational Drug Utilization Study of Cobicistat in Adults with HIV-1 Infection (GS-US-216-1230)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  HIV-1 infected adults aged ≥18 years who take COBI up to one month prior to enrollment during Q1 2015 to Q1 2017 and are seen at one of approximately 40 clinical sites in Europe (anticipated to include Austria, Germany, the UK, Denmark, Ireland, Finland, Norway, Sweden, the Netherlands, Belgium, Iceland, and Spain) and Switzerland.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 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:
  500

Study design details

• Main study objective:
  To assess the rate of off-label use of COBI to boost PIs other than ATV or DRV once-daily and to assess the rate of concurrent use of COBI with contraindicated medications
• Outcomes:
  The rate of off-label use of COBI to boost PIs other than ATV or DRV once-daily and the rate of concurrent use of COBI with contraindicated medications, Describe outcomes following off-label use of COBI.Describe rate of use of identified and potential interacting medications with COBI, the rate of suspected drug interactions during use of COBI and the rate of related AEs during use of COBI with identified and potential interacting medications.Describe the frequency of COBI utilization by patients with baseline conditions
• Data analysis plan:
  Rates and 95% CIs of both (a) off label use of COBI with protease inhibitors other than ATV or DRV once-daily, and (b) concomitant use of COBI with contraindicated medications, determined using Poisson regression models, taking into account person time of COBI exposure.