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646
Using Real World Data to Assess the Risk of Suicidality among Patients Initiating an Efavirenz-containing Regimen versus an Efavirenz-free Antiretroviral Regimen

Session: Oral Abstract Session: HIV Related Inflammation, Complications and Comorbidities
Friday, October 10, 2014: 11:45 AM
Room: The Pennsylvania Convention Center: 107-AB

Background:

The aim of this study was to compare the incidence rate of suicidality and suicide attempt among patients initiating efavirenz (EFV)-containing versus EFV-free antiretroviral (ARV) regimens, adjusting for confounding factors.

 Methods:

This was a cohort analysis using administrative claims data from a US commercial and a public insurance database (Medicaid) spanning 2006-2013. We identified ARV-naive patients age ≥12 years initiating an EFV-containing or EFV-free regimen with ≥6 months of continuous enrollment prior to ARV initiation.  Suicidality was defined as ICD-9-CM diagnosis (Dx) codes for suicidal ideation or attempt.  Suicide attempt was defined as 1) an inpatient or emergency department claim with a Dx code for suicide attempt and 2) an expanded definition that also included Dx codes for injuries consistent with suicide attempt + a psychiatric Dx during the same encounter. The outcomes were identified from ARV initiation until the earliest of the end of exposure, enrollment or the study period. Outcomes were compared using hazard ratios (HRs) from a propensity score (PS) adjusted Cox model accounting for baseline demographics, comorbidities and comedications.

Results:

There were 19,983 patients (EFV: 11,187, EFV-free: 8,796) in the commercial database; 83% male and mean age 40.  In the Medicaid database, there were 5,154 patients (EFV: 2,224, EFV-free: 2,930); 53% male and mean age 41. In both databases, patients initiating an EFV-free regimen had a higher prevalence of depression and other psychiatric conditions. Incidence rates for all outcomes were higher in the Medicaid population. In adjusted analyses, EFV use was not associated with suicidality or the expanded definition of suicide attempt (figures). For the restrictive definition, the point estimate was in the opposite direction in the commercial vs. the Medicaid database, which may be reflective of the patient populations and the small number of events.

Conclusion:

In this analysis of two large real world databases, HIV patients with depression and psychiatric conditions were less likely to be prescribed EFV. Despite PS-adjustment, we did not find conclusive evidence of an increased risk of suicidality or suicide attempt among patients initiating an EFV-containing regimen.  

Ella Nkhoma, PhD1, John Coumbis, MD2, Amanda Farr, MPH3, Stephen Johnston, MA4, Bong-Chul Chu, PhD5, Lisa Rosenblatt, MD6, Daniel W. Seekins, MD7 and Angelina Villasis, MD7, (1)Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Wallingford, CT, (2)Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Pennington, NJ, (3)Truven Health Analytics, Cambridge, MA, (4)Truven Health Analytics, Bethesda, MD, (5)Truven Health Analytics, Santa Barbara, CA, (6)Health Economics and Outcomes Research, Bristol-Myers Squibb, Plainsboro, NJ, (7)R&D, Bristol-Myers Squibb, Plainsboro, NJ

Disclosures:

E. Nkhoma, Bristol-Myers Squibb: Employee, Salary

J. Coumbis, Bristol-Myers Squibb: Employee, Salary

A. Farr, Bristol-Myers Squibb: Consultant, Consulting fee

S. Johnston, Bristol-Myers Squibb: Consultant, Consulting fee

B. C. Chu, Bristol-Myers Squibb: Consultant, Consulting fee

L. Rosenblatt, Bristol-Myers Squibb: Employee, Salary

D. W. Seekins, Bristol-Myers Squibb: Employee, Salary

A. Villasis, Bristol-Myers Squibb: Employee, Salary

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