Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

EDURANT 25 MG - FILM-COATED TABLET
REKAMBYS
REKAMBYS 600 MG - PROLONGED-RELEASE SUSPENSION FOR INJECTION
REKAMBYS 900 MG - PROLONGED-RELEASE SUSPENSION FOR INJECTION
VOCABRIA
VOCABRIA 30 MG - FILM-COATED TABLET
VOCABRIA 400 MG - PROLONGED-RELEASE SUSPENSION FOR INJECTION
VOCABRIA 600 MG - PROLONGED-RELEASE SUSPENSION FOR INJECTION

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

CABOTEGRAVIR
RILPIVIRINE
RILPIVIRINE HYDROCHLORIDE

Anatomical Therapeutic Chemical (ATC) code

(J05AG05) rilpivirine
rilpivirine
(J05AX) Other antivirals
Other antivirals

Medical condition to be studied

Human immunodeficiency virus transmission
Population studied

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)

Estimated number of subjects

0
Study design details

Main study objective

• Describe CAB LA and/or RPV LA containing regimens usage patterns
• Assess adherence, durability and discontinuation for persons starting regimen
• Assess the clinical effectiveness among PLWH who initiate regimen
• Monitor for resistance and next treatment response among individuals who switched off regimen
• Evaluate the effectiveness of routine risk minimization measures of regimen

Outcomes

• Regimen discontinuation
• Durability
• Adherence
• Clinical effectiveness
• Resistance testing

Data analysis plan

Descriptive analyses will summarize the study population exposed to CAB and/or RPV LA. Proportions and multivariable regression models will be used to assess adherence, discontinuation, virologic failure, and resistance among participants with virologic failure for whom data on resistance testing are available.