July 08, 2014
1 min read

Efavirenz increased risk for suicidality

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Efavirenz-based antiretroviral therapy was associated with a twofold increase in suicidality compared with regimens not containing efavirenz, researchers from Harvard School of Public Health and University of North Carolina at Chapel Hill have found.

“Care should be taken to avoid stigmatization of persons living with HIV and psychiatric comorbid conditions,” the researchers wrote in Annals of Internal Medicine. “When efavirenz is used as a component of antiretroviral therapy, patients should be monitored carefully for exacerbation of depression or evidence of suicidal thoughts or behavior.”

For this retrospective study, the researchers evaluated data from ART-naive participants in four AIDS Clinical Trials Group studies conducted from 2001 to 2010. The studies involved randomization to regimens with efavirenz (Sustiva, Bristol-Myers Squibb) or without efavirenz. The researchers measured suicidality, defined as suicidal ideation or attempted or completed suicide, and compared the suicidality incidence between the regimens.

The study included 5,332 ART-naive patients: 3,241 received an efavirenz-containing regimen and 2,091 received an efavirenz-free regimen. Participants in the efavirenz group experienced more suicidality (HR=2.28; 95% CI, 1.27-4.01). There were 47 suicidality events in the efavirenz group, for an incidence of 8.08 per 1,000 person-years. In the efavirenz-free group, there were 15 events, for an incidence rate of 3.66 per 1,000 person-years.

The efavirenz group also had a higher incidence of attempted or completed suicide (HR=2.58; 95% CI, 0.94-7.06). There were 17 events in the efavirenz group, which resulted in an incidence of 2.90 per 1,000 person-years. There were five events in the efavirenz-free group, for an incidence of 1.22 per 1,000 person-years. There were eight suicides in the efavirenz group and one suicide in the efavirenz-free group.

“The random assignment to efavirenz or nonefavirenz therapy increases the likelihood that these results represent a causal relationship between efavirenz and suicidality,” the researchers wrote. “Given the widespread use of efavirenz and severity of these adverse events, the observed increased risk is clinically relevant.”

Disclosure: See study for list of disclosures.