Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

EDURANT
REKAMBYS
REKAMBYS
REKAMBYS
VOCABRIA
VOCABRIA
VOCABRIA
VOCABRIA

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

CABOTEGRAVIR
RILPIVIRINE

Anatomical Therapeutic Chemical (ATC) code

(J05AG05) rilpivirine
rilpivirine
(J05AJ04) cabotegravir
cabotegravir
(J05AX) Other antivirals
Other antivirals

Medical condition to be studied

Human immunodeficiency virus transmission
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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 study population initiating CAB+RPV LA regimen
• Assess adherence, durability and discontinuation for individuals starting the regimen
• Assess the clinical effectiveness among individuals who initiate the regimen and had suppressed viral load at regimen initiation
• Monitor for resistance in case of virologic failure while on the regimen or after switching over the follow-up period

Outcomes

• Clinical effectiveness
• Regimen discontinuation
• Adherence
• Resistance testing at virologic failure and next treatment response

Data analysis plan

Descriptive analyses will summarize the study population exposed to CAB+RPV LA. Proportions and multivariable regression models will be used to assess the factors associated with virologic failure, non-adherence, discontinuation of CAB+RPV LA regimen and resistance among participants with virologic failure.