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.