The integrase inhibitor Tivicay (dolutegravir) is associated with a modest increased risk of insomnia compared with other antiretrovirals (ARVs).

Tivicay is included in the single-tablet ARV regimen Triumeq (dolutegravir/abacavir/lamivudine).

Publishing their findings in Current Opinion in HIV and AIDS, researchers conducted a meta-analysis of studies including 6,647 cumulative years of follow-up of people taking ARVs in nine randomized clinical trials. Eight of these were published clinical trials, and one was a study presented at a recent conference.

After comparing the rates of various adverse health events among study participants broken down by whether they received Tivicay, the researchers found that the one such negative outcome that was significantly higher among those taking this integrase inhibitor was grade 1 to 4 insomnia. A total of 6.1 percent of those receiving Tivicay experienced such insomnia compared with 4.5 percent of those taking other ARVs.

The study authors saw no difference based on whether participants took Tivicay in their rates of suicidality, cardiovascular health events or immune reconstitution inflammatory syndrome (IRIS), a potentially fatal reaction that may occur when an individual with a very compromised immune system starts HIV treatment and suddenly experiences a burst of immune activity.

The investigators advocated for further evaluations of Tivicay’s safety, including future meta-analysis and vigilant monitoring of those taking the ARV for adverse health events that may be related to its use.

To read the study abstract, click here.