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
Study drug and medical condition

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

DOLUTEGRAVIR

Medical condition to be studied

Human immunodeficiency virus transmission
Population studied

Short description of the study population

A total of four distinct study populations were identified from the OPERA Observational Database for analysis per the inclusion criteria defined below:
Population 1 (Primary objective 1)
Inclusions:
1) A diagnosis of HIV, a positive HIV Western Blot, or a positive HIV enzymelinked immunosorbent assay (ELISA); and a detectable HIV viral load test.
2) At least 13 years of age at the index date.
3) Male, female, or transgender
4) Never diagnosed with type 1 or juvenile DM
5) Initiating DTG, RAL, EVG/c or DRV(/r/c) for the first time between 01AUG2013 and 31MAR2018
6) Not Exposed to >1 core agent of interest concurrently
7) Viral load measured within 120 days prior to baseline
Population 2 (Primary objectives 2 & 3, Secondary objective 1, exploratory objectives 1 & 2)
Inclusions:
1) A diagnosis of HIV, a positive HIV Western Blot, or a positive HIV enzymelinked immunosorbent assay (ELISA); and a detectable HIV viral load test.
2) At least 13 years of age at the index date.
3) Male, female, or transgender
4) Never diagnosed with type 1 or juvenile DM
5) Initiating DTG, RAL, EVG/c or DRV(/r/c) for the first time between 01AUG2013 and 31MAR2018
6) Not Exposed to >1 core agent of interest concurrently
7) Viral load measured within 120 days prior to baseline
8) No diagnosis of T2DM at or before core agent initiation
Population 3 (Secondary objective 2)
Inclusions:
1) A diagnosis of HIV, a positive HIV Western Blot, or a positive HIV enzymelinked immunosorbent assay (ELISA); and a detectable HIV viral load test.
2) At least 13 years of age at the index date.
3) Male, female, or transgender
4) Never diagnosed with type 1 or juvenile DM
5) Initiating DTG, RAL, EVG/c or DRV(/r/c) for the first time between 01AUG2013 and 31MAR2018
6) Not Exposed to >1 core agent of interest concurrently
7) Viral load measured within 120 days prior to baseline
8) Diagnosis of T2DM at or before core agent initiation
Population 4 (Secondary objective 3)
Inclusions:
1) A diagnosis of HIV, a positive

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

Estimated number of subjects

15000
Study design details

Main study objective

To assess the baseline prevalence of and the incidence rate over follow-up of prediabetes and T2DM among new users of DTG, RAL, EVG/c and DRV (/r/c), and to estimate the association between core agent initiation (DTG vs. to RAL, EVG/c or DRV(/r/c)) and development of T2DM

Data analysis plan

Descriptive analyses will be conducted for patients prescribed a core agent of interest between 01AUG2013 and 31MAR2018. Pairwise comparisons between DTG and each of the other core agent groups will be evaluated by p-values calculated from Pearson Chi-Square test for categorical variables. Fisher’s exact test will be used to compare frequencies with few events. Wilcoxon Rank Sum test will be used to calculate p-values for continuous variables. All descriptive analyses will be stratified by ART-naïve, ART-experienced, suppressed, and ART-experienced, not suppressed.