Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

EFAVIRENZ
EVIPLERA

Name of medicine, other

Edurant

Medical condition to be studied

HIV infection
Population studied

Short description of the study population

Adults living with HIV who initiated therapy with Rilpivirine (RPV) or Efavirenz (EFV)-containing regimens during the study period.

Patients were included in the study if they meet all of the following criteria:
1. Have documented enrollment in the HIV cohort database prior to the start of RPV or EFV-treatment regimens;
2. Have received at least one prescription for RPV-containing regimens or EFVcontaining regimens

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

1600
Study design details

Main study objective

To assess RPV utilization according to the European SmPC.

Outcomes

To describe the proportion of patients treated with RPV-containing products in accordance with their SmPCs. To describe treatment emergent RAMs in patients treated with RPV or EFV-containing regimens.To describe virologic failure in patients treated with RPV or EFV-containing regimens. To describe the demographic characteristics, comorbidities, and medical condition of patients initiating RPV or EFV treatment.To describe ARV treatment status and prior ARV treatment, if any, of patients prior to initiating RPV or EFV treatment.To describe frequency of pre-treatment RAMs for RPV and EFV patients.To describe viral load at start and over the course of RPV or EFV treatment.

Data analysis plan

An evaluation of appropriate use will be conducted through an analysis describing and summarizing the treatment patterns and use of RPV-containing regimens. The analysis will ascertain the number of patients initiating treatment with RPV-containing regimens and the proportion of patients treated in accordance with the SmPCs of RPV-containing regimens. Incidence rates of virologic failure, pre-treatment resistance, and treatment-emergent resistance will be calculated for the RPV- and EFV-treated patients, separately, by dividing the number of events by the total person-exposure time. Relative risks comparing the RPV-containing regimens with EFV-containing regimens and 95% confidence intervals will be calculated and appropriate stratified analyses will be conducted for virologic failure and emergence of treatment resistance. Risk factors associated with virologic failure among those treated with RPV-containing regimens will be assessed using a multivariable Poisson regression model.