(A-268) Disproportionality analysis of sexual dysfunction reports related to integrase strand-transfer inhibitors: data from the FDA Adverse Reporting System - FAERS

Background: Integrase strand-transfer inhibitors (INSTI) are widely used for the treatment and prevention of HIV due to their efficacy and favorable safety profile. However, concerns have been raised regarding sexual adverse effects associated with these drugs.

Objectives: To evaluate the association between INSTI use and sexual dysfunction using data from the FDA Adverse Reporting System (FAERS).

Methods: A disproportionality analysis was conducted using the FAERS database to identify reports of sexual dysfunction related to bictegravir (BIC), cabotegravir (CAB), dolutegravir (DTG), elvitegravir (ELV) and raltegravir (RAL). The Medical Dictionary for Regulatory Activities - MedDRA preferred terms "erectile dysfunction", "decreased libido", "sexual dysfunction", "male sexual dysfunction", "female sexual dysfunction", "priapism" and "dyspareunia" were used to identify case reports of sexual dysfunction from 2013 to 2023. Signals of disproportionate reporting of sexual dysfunction for individual INSTI agents, compared to other INSTI and antiretroviral drugs, were calculated through reporting odds ratios (ROR) with 95% confidence intervals (CI). Age and sex of case reports were also described.

Results: A total of 7,262 cases were reported for INSTI. Of these, 6,302, 734, 124, 80 and 22 were exposed to DTG, RAL, CAB, ELV and BIC, respectively. Among 172 cases of sexual dysfunction, 18 were reported for CAB, 94 for DTG and 60 for RAL. No cases of sexual dysfunction were observed for BIC or ELV. Most cases occurred in males (80%), with median age of 47 years. Disproportionate signals for sexual dysfunction were found for all the INSTI compared to other antiretrovirals, with the strongest signal observed for CAB (ROR = 3.6; CI 95% 2.8 - 4.5), followed by DTG (ROR = 2.9; CI 95% 2.5 - 3.3) and RAL (ROR = 1.7; CI 95% 1.4 - 2.1). When compared to other INSTI, higher ROR were shown for CAB (ROR = 1.8; CI 95% 1.4 - 2.3) and DTG (ROR = 1.3; CI 95% 1.1 - 1.6) while RAL had a lower ROR (ROR = 0.7; CI 95% 0.6 - 0.9).

Conclusions: Sexual dysfunction was differentially reported for CAB, DTG, and RAL compared to other antiretroviral drugs. The higher ROR observed for CAB and DTG highlight the need for increased awareness and monitoring of sexual health in individuals using INSTIs for treatment and prevention of HIV (pre-exposure prophylaxis and post-exposure prophylaxis).