Risk of CV Events With EFV vs. EFV-free Regimens

Bristol-Myers Squibb29,612 enrolled

Overview

The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.

Study Type

OBSERVATIONAL

Enrollment

29,612

Conditions

HIV/AIDS

Interventions

EfavirenzDRUG

Eligibility

Min age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Aged 18 years or older on the index date * Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,2013. * Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim. * Have at least 6 months (180 days) of continuous enrollment prior to the index claim Exclusion Criteria: * Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period * Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period

Outcomes

Primary Outcomes

Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen

cardiovascular events specifically based on incidence rate and compare the hazard (myocardial infarction, stroke,percutaneous coronary intervention, coronary artery bypass graft, and composite of aforementioned events) between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen

Time frame: upto 1 to 5 years

Data from ClinicalTrials.gov

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