@article{ref1,
title="Association between Efavirenz as initial therapy for HIV-1 infection and increased risk for suicidal ideation or attempted or completed suicide: an analysis of trial data",
journal="Annals of internal medicine",
year="2014",
author="Mollan, Katie R. and Smurzynski, Marlene and Eron, Joseph J. and Daar, Eric S. and Campbell, Thomas B. and Sax, Paul E. and Gulick, Roy M. and Na, Lumine and O'Keefe, Lauren and Robertson, Kevin R. and Tierney, Camlin",
volume="161",
number="1",
pages="1-10",
abstract="BACKGROUND: The relationship between efavirenz use and suicidality is not well-defined. <br><br>OBJECTIVE: To compare time to suicidality with efavirenz-containing versus efavirenz-free antiretroviral regimens for initial treatment of HIV. <br><br>DESIGN: Participant-level data were analyzed from 4 AIDS Clinical Trials Group, antiretroviral-naive studies conducted from 2001 to 2010. Within each study, participants were randomly assigned to an efavirenz-containing (n = 3241) or efavirenz-free (n = 2091) regimen. (ClinicalTrials.gov: NCT00013520 [A5095], NCT00050895 [A5142], NCT00084136 [A5175], and NCT00118898 [A5202]). SETTING: AIDS Clinical Trials Group sites; 74% of participants enrolled in the United States. PATIENTS: Antiretroviral-naive participants. INTERVENTION: Efavirenz versus efavirenz-free regimens. MEASUREMENTS: Suicidality was defined as suicidal ideation or attempted or completed suicide. Groups were compared with a hazard ratio and 95% CI estimated from a Cox model, stratified by study. <br><br>RESULTS: Seventy-three percent of participants were men, the median age was 37 years, and 32% had documented psychiatric history or received psychoactive medication within 30 days before entering the study. Median follow-up was 96 weeks. Suicidality incidence per 1000 person-years was 8.08 (47 events) in the efavirenz group and 3.66 (15 events) in the efavirenz-free group (hazard ratio, 2.28 [95% CI, 1.27 to 4.10]; P = 0.006). Incidence of attempted or completed suicide was 2.90 (17 events) and 1.22 (5 events) in the efavirenz and efavirenz-free groups, respectively (hazard ratio, 2.58 [CI, 0.94 to 7.06]; P = 0.065). Eight suicides in the efavirenz group and 1 in the efavirenz-free group were reported. LIMITATION: There was not a standardized questionnaire about suicidal ideation or attempt. Efavirenz was open-label in 3 of 4 studies. <br><br>CONCLUSION: Initial treatment with an efavirenz-containing antiretroviral regimen was associated with a 2-fold increased hazard of suicidality compared with a regimen without efavirenz. PRIMARY FUNDING SOURCE: National Institutes of Health.<p /> <p>Language: en</p>",
language="en",
issn="0003-4819",
doi="10.7326/M14-0293",
url="http://dx.doi.org/10.7326/M14-0293"
}