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No Evidence of an Association Between Efavirenz Exposure and Suicidality Among HIV Patients Initiating Antiretroviral Therapy in a Retrospective Cohort Study of Real World Data

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ABSTRACT

Recently, published studies have reported conflicting results regarding the association between efavirenz exposure and the risk of suicidality among patients with human immunodeficiency virus. The objective of this analysis was to compare the rate of suicidality among patients initiating efavirenz-containing versus efavirenz-free antiretroviral (ARV) regimens.

This retrospective cohort study used US administrative claims data for commercially and Medicaid-insured individuals for the years 2006 to 2013. ARV-naive patients aged ≥12 years initiating an efavirenz-containing or efavirenz-free ARV regimen with ≥6 months of continuous insurance enrollment prior to ARV initiation were selected. The primary outcome was suicidality, defined as the occurrence of any medical claim with a diagnosis code for suicidal ideation or an inpatient or emergency department medical claim for suicide attempt. Unadjusted incidence rates were calculated and propensity score-adjusted hazard ratios were estimated to account for differences in patient characteristics.

There were 19,983 patients (efavirenz-containing, n = 11,187; efavirenz-free, n = 8796) in the commercial database and 5154 patients (efavirenz-containing, n = 2224; efavirenz-free, n = 2930) in the Medicaid database. Unadjusted incidence rates (95% confidence interval [CI]) of suicidality per 1000 person-years were: commercial, efavirenz-containing (3.3 [2.4–4.4]), efavirenz-free (4.0 [2.7–5.8]); Medicaid, efavirenz-containing (25.7 [18.8–34.4]), efavirenz-free (40.6 [31.9–50.9]). In propensity score-adjusted analyses, efavirenz use was not associated with suicidality: adjusted hazard ratio (95% CI) of suicidality compared with efavirenz-free regimen, commercial, 1.029 (0.636–1.665); Medicaid, 0.902 (0.617–1.319).

This analysis found no conclusive evidence of an increased risk of suicidality among patients initiating an efavirenz-containing ARV regimen. However, channeling bias may exist even after adjusting for measured patient characteristics.

No MeSH data available.


Cumulative hazards of suicidality in the (A) commercial and (B) Medicaid databases. EFV = efavirenz.
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Figure 1: Cumulative hazards of suicidality in the (A) commercial and (B) Medicaid databases. EFV = efavirenz.

Mentions: Suicidality was rare in both databases during the follow-up period, though more common in the Medicaid database (commercial: efavirenz-containing regimens, n = 42, efavirenz-free regimens, n = 29; Medicaid: efavirenz-containing regimens, n = 45, efavirenz-free regimens, n = 74). In the commercial database, the unadjusted incidence rate of suicidality per 1000 person-years was 3.3 (95% confidence interval [CI] = 2.4–4.4) among patients initiating efavirenz-containing regimens and 4.0 (95% CI = 2.7–5.8) among patients initiating efavirenz-free regimens. In the Medicaid database, the unadjusted incidence rate of suicidality per 1000 person-years was 25.7 (95% CI = 18.8–34.4) among patients initiating efavirenz-containing regimens and 40.6 (95% CI = 31.9–50.9) among patients initiating efavirenz-free regimens. Unadjusted cumulative hazard functions of suicidality are presented in Figure 1.


No Evidence of an Association Between Efavirenz Exposure and Suicidality Among HIV Patients Initiating Antiretroviral Therapy in a Retrospective Cohort Study of Real World Data
Cumulative hazards of suicidality in the (A) commercial and (B) Medicaid databases. EFV = efavirenz.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4998256&req=5

Figure 1: Cumulative hazards of suicidality in the (A) commercial and (B) Medicaid databases. EFV = efavirenz.
Mentions: Suicidality was rare in both databases during the follow-up period, though more common in the Medicaid database (commercial: efavirenz-containing regimens, n = 42, efavirenz-free regimens, n = 29; Medicaid: efavirenz-containing regimens, n = 45, efavirenz-free regimens, n = 74). In the commercial database, the unadjusted incidence rate of suicidality per 1000 person-years was 3.3 (95% confidence interval [CI] = 2.4–4.4) among patients initiating efavirenz-containing regimens and 4.0 (95% CI = 2.7–5.8) among patients initiating efavirenz-free regimens. In the Medicaid database, the unadjusted incidence rate of suicidality per 1000 person-years was 25.7 (95% CI = 18.8–34.4) among patients initiating efavirenz-containing regimens and 40.6 (95% CI = 31.9–50.9) among patients initiating efavirenz-free regimens. Unadjusted cumulative hazard functions of suicidality are presented in Figure 1.

View Article: PubMed Central - PubMed

ABSTRACT

Recently, published studies have reported conflicting results regarding the association between efavirenz exposure and the risk of suicidality among patients with human immunodeficiency virus. The objective of this analysis was to compare the rate of suicidality among patients initiating efavirenz-containing versus efavirenz-free antiretroviral (ARV) regimens.

This retrospective cohort study used US administrative claims data for commercially and Medicaid-insured individuals for the years 2006 to 2013. ARV-naive patients aged ≥12 years initiating an efavirenz-containing or efavirenz-free ARV regimen with ≥6 months of continuous insurance enrollment prior to ARV initiation were selected. The primary outcome was suicidality, defined as the occurrence of any medical claim with a diagnosis code for suicidal ideation or an inpatient or emergency department medical claim for suicide attempt. Unadjusted incidence rates were calculated and propensity score-adjusted hazard ratios were estimated to account for differences in patient characteristics.

There were 19,983 patients (efavirenz-containing, n = 11,187; efavirenz-free, n = 8796) in the commercial database and 5154 patients (efavirenz-containing, n = 2224; efavirenz-free, n = 2930) in the Medicaid database. Unadjusted incidence rates (95% confidence interval [CI]) of suicidality per 1000 person-years were: commercial, efavirenz-containing (3.3 [2.4–4.4]), efavirenz-free (4.0 [2.7–5.8]); Medicaid, efavirenz-containing (25.7 [18.8–34.4]), efavirenz-free (40.6 [31.9–50.9]). In propensity score-adjusted analyses, efavirenz use was not associated with suicidality: adjusted hazard ratio (95% CI) of suicidality compared with efavirenz-free regimen, commercial, 1.029 (0.636–1.665); Medicaid, 0.902 (0.617–1.319).

This analysis found no conclusive evidence of an increased risk of suicidality among patients initiating an efavirenz-containing ARV regimen. However, channeling bias may exist even after adjusting for measured patient characteristics.

No MeSH data available.