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.
Mollan KR, Smurzynski M, Eron JJ, Daar ES, Campbell TB, Sax PE, Gulick RM, Na L, O’Keefe L, Robertson KR, and Tierney C.
Ann Intern Med. 2014;161:1-10
18 Novembre 2014, by Pr François Raffi
This study is a retrospective cross-study analysis of individual level data from 4 ACTG antiretroviral naïve studies conducted from 2001 to 2010. Within in each study, participants were randomly assigned to an efavirenz containing (n = 3241) or efavirenz-free (n = 2191) regimen. Efavirenz assignment was open-label in 3 studies and was blinded and placebo controlled in one. The median age of the participants in the 4 studies was 37 years with 73% men and 32% with documented psychiatric history or psycho-active medication within 30 days before entering the study. After a median follow up of 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. The hazard ratio of suicidality incidence was 2.28 for the efavirenz group (p = 0.006). Incidence of attempted or completed suicide was also doubled (hazard ratio 2.58, p = 0.065).
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