Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Observational cohort analysis

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective analysis
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

ABACAVIR

Medical condition to be studied

Human immunodeficiency virus transmission
Population studied

Short description of the study population

Patients aged 16 years or older living with HIV and HIV/Hepatitis C co-infection receiving combination antiretroviral therapy (cART) identified from the EuroSIDA cohort.
Inclusion criteria:
• Individuals from the EuroSIDA cohort over the age of 16 at enrolment receiving cART (at least 3 drugs from any class, excluding ritonavir) at some point after 1/1/2009 will be eligible for inclusion (Objective 1). Objective 2 will further require all individuals to have initiated ABC after 1/1/2009.
• Drug exposure prior to EuroSIDA enrolment cannot be assessed, and will not be considered for the inclusion criteria.

Age groups

Adolescents (12 to < 18 years)
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
Other

Special population of interest, other

Patients with HIV transmission

Estimated number of subjects

20000
Study design details

Main study objective

To describe treatment utilization patterns of abacavir (ABC) and to describe the cumulative frequency, incidence and factors associated with ABC discontinuation due to any reason and due to hypersensitivity reactions (HSR) among persons initiating ABC as part of a cART regimen after 1/1/2009

Outcomes

Receipt of ABC and ABC discontinuation

Data analysis plan

• Descriptive statistics will be used to summarize outcomes of interest and risk factors as appropriate• Baseline characteristics will be compared among patients who remain on ABC, discontinue due to any reason, and discontinue due to HSR using chi-squared tests/Fisher’s exact test and Kruskal-Wallis tests as appropriate • Factors associated with ABC initiation and HSR-related discontinuation will be investigated using Poisson models with generalized estimating equations to control for inclusion of repeated events• Cumulative frequencies of time to discontinuation for any reason and due to HSR will be calculated using survival methods and displayed in KM plots• Sensitivity analyses will be conducted for all discontinuations of ABC occurring within the first 6 weeks and reported to be due to any toxicity