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Efavirenz associated with suicidality
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SAN FRANCISCO — Treatment with efavirenz was associated with an increased risk for suicidality among patients with HIV, according to data presented here at ID Week.
“Efavirenz is widely used to treat HIV infection, but there is uncertainty regarding a potential relationship between it and suicidal ideation, suicide attempt or suicide,” Katie Mollan, MS, of the University of North Carolina at Chapel Hill Center for AIDS Research, said during her presentation. “The package insert notes occasional reports of suicide, but a causal relationship cannot be determined from post-marketing reports.”
Mollan and colleagues estimated suicidality and compared time to suicidality among treatment-naïve patients enrolled in AIDS Clinical Trials Group studies conducted from 2001 to 2010. In the four studies, patients were assigned to a regimen that did contain efavirenz (Sustiva, Gilead) or a non-efavirenz-based regimen. In these studies, 3,241 people had received efavirenz and 2,091 people did not. Baseline characteristics, including age, pre-study psychiatric events and use of psychoactive medications were similar between the groups.
Suicidality was defined as suicidal ideation or attempted/completed suicide. Among the patients who received efavirenz, there were 8.08 incidents of suicidality per 1,000 person-years, compared with 3.66 events per 1,000 person-years among those who did not receive efavirenz-based regimens (HR=2.28; 95% CI, 1.27-4.10). The incident of attempted/completed suicide was 2.90 per 1,000 person-years in the efavirenz group and 1.22 per 1,000 person-years in the non-efavirenz group (HR=2.58; 95% CI, 0.94-7.06).
A multivariable adjusted model showed that efavirenz, younger age, injection drug use and psychiatric history were associated with a higher risk of suicidality.
“Suicidality was uncommon, but reported in each study and subgroup evaluated,” Mollan said. “Death from suicide, injury or unknown causes paralleled suicidality results. Careful attention should be paid to cause of death ascertainment in all clinical trials.”
For more information:
Mollan K. #670. Presented at: ID Week 2013; Oct. 2-6; San Francisco.
Disclosure: Mollan receives research support from Gilead. Other researchers report financial relationships with Viiv, Abbott, Gilead, Bristol-Myers Squibb, Janssen, Merck, GlaxoSmithKline and Tibotec.