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Truvada not associated with added depression
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Data published in AIDS and Behavior suggest that men who have sex with men and transgender women who have sex with men experience no additional risk for depression when receiving Truvada for pre-exposure prophylaxis.
“Depression is a highly prevalent condition that presents with psychological, behavioral, and physical symptoms that can be debilitating,” Robert M. Grant, MD, MPH, professor at the University of California, San Francisco Medical School, and colleagues wrote. “Studies conducted in the United States suggest that the prevalence of depression is substantially higher among men and transgender women who have sex with men (MSM/TGW) compared to men in the general population.”
Participants were recruited as part of the iPrEx study, a 72-week randomized, placebo-controlled trial that began in 2006-2007. Either a daily dose of Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences) or placebo was given to 2,499 eligible participants from nine worldwide cities. All were aged 18 or older, male at birth, HIV seronegative, and exhibited high-risk sexual behavior.
Robert Grant
Of these participants, 2,131 completed at least one Center for Epidemiological Studies Depression Scale (CES-D) questionnaire for baseline screening or during follow-up visits. The CES-D and a short suicide ideation screening were added to the protocol after several depression-related adverse events (46 among 41 participants) and two suicide attempts occurred, Grant and colleagues wrote. Of those filling out a CES-D, 1,076 were in the placebo arm, and 1,055 received emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). Most of those who did not complete a CES-D dropped out of the study before the questionnaire was implemented.
Participants who reported depression-related adverse events of grade 2 or higher during follow-up was similar for the placebo (n = 127) and FTC/TDF (n=105) study arms (OR = 0.81; 95% CI, 0.62-1.06), as was the number of adverse events (152 vs. 144; OR = 0.66; 95% CI, 0.35-1.25). The number of participants who screened positive for suicide ideation also was similar between those assigned placebo and FTC/TDF (250 vs. 230; OR = 0.9; 95% CI, 0.67-1.21).
“During the iPrEx trial, daily oral FTC/TDF PrEP was not associated with depression; there were no significant differences in the total number of depression related AEs, CES-D scores, or suicidal ideation scores between study arms,” Grant and colleagues wrote. “Though not related to oral FTC/TDF PrEP use, depression was one of the major AEs reported in iPrEx. Half of iPrEx participants who completed at least one CES-D had scores greater than or equal to 16 at some point over the course of the study, which is the cut-off considered to reflect clinically significant depression symptoms in some settings.”
The researchers also wrote that participants who were forced to have sex the first time they had anal sex tended to have higher CES-D scores. – by David Jwanier
Disclosure: Grant reports receiving honoraria from Clinical Care Options and has served as a consultant for Siemens Healthcare on their guidelines panel. Please see the full study for a list of all other authors’ relevant financial disclosures.
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