Comparative neuropsychiatric toxicity profile of dolutegravir versus efavirenz versus other antiretroviral third drugs used either in first-line or switching antiretroviral therapies (ART): data from ICONA Foundation Study Cohort

• Concerns about an increased risk of neuropsychiatric adverse events (NPAEs) during exposure to Dolutegravir (DTG) have been recently raised in observational studies[1-5] • Historically, Efavirenz (EFV) was largely associated to a higher risk of NPAEs with an increased rate of discontinuations for toxicity compared with other antiretrovirals[6] • Despite this common toxicity profile, comparisons of NPAEs’ risk between DTG and EFV-based regimens are limited. A large comparative randomized trial showed a lower rate of NPAEs with fewer discontinuations in ART-naïve patients starting DTG compared to those starting EFV[7,8] . However, direct comparisonsin real-life setting are lacking.