1. Treatment with efavirenz in HIV patients was associated with an increased risk of suicidality.
Evidence Rating Level: 2 (Good)
Study Rundown: Efavirenz is a common non-nucleoside reverse transcriptase inhibitor (NNRT-I) used in the treatment of human immunodeficiency virus (HIV). The drug has been associated with rare neurologic and psychiatric side effects including risk of suicide. However, a causal link is yet to be established. Therefore, this study analyzed data from four AIDS randomized clinical trials of efavirenz as initial therapy and assessed suicidality as the primary outcome. Suicidality was defined as suicidal ideation, attempt, or success. In those patients who received efavirenz, the rate of attempted or completed suicides was approximately twice that of the control group, reaching statistical significance. This study is limited by the source studies included in this analysis, as none included a standard questionnaire regarding suicidality. Furthermore, three of the four trials were not blinded because of the initial efficacy of efavirenz, and therefore, the contribution due to reporting bias is unknown. However, these data suggest those taking efavirenz should monitored for suicidality, and in particular if they have a history of other suicide risk factors.
In-Depth [trial analysis]: All four trials included in this analysis were randomized, but only three were open-label. From these, 5332 participants were assigned to efavirenz (n=3241) or efavirenz-free (n=2091) treatment. In total, 32% of the study participants had a history of psychiatric illness, with a median follow-up of 96 weeks. The incidence of suicidality in the efavirenz group was 8.08 per 1000 person-years (47 events) and 3.66 (15 events) in the control group, with a hazard ratio (HR) of 2.28 [CI, 1.27-4.10] and p=0.006. For attempted or completed suicides, the incidence was 2.90 (17 events) in the efavirenz group and 1.22 (5 events) in the control, HR=2.58 [CI, 0.94-7.06] and p=0.065. Covariates also significantly associated with increased suicidality included history of psychiatric illness (HR=4.07) and low weight (HR=2.69). Despite the limitations of these studies, the suicide incidence may have been underreported, as deaths due to injury or unknown cause were also increased in the efavirenz group.
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