(055) Psychological and Neurological Adverse Drug Events Associated with Direct Acting Antivirals Agents Used for Hepatitis C Virus: Analysis and Comparison of the FDA Adverse Event Reporting System (FAERS) and Lexicomp

Publication Number: 1051

Background: Hepatitis C Virus (HCV) is now effectively treated using Direct Acting Antivirals (DAAs) medications, which have been deemed safe and efficacious. Nonetheless, evaluating their safety profiles through post-market surveillance remains inadequate.

Objectives: We evaluated and characterized the differences between the reported Adverse Drug Events (ADEs) of six DAAs medications using real-world reported data from the FDA Adverse Event Reporting System (FAERS) database and the published database Lexicomp.

Methods: A retrospective, descriptive analysis of specific psychological and neurological ADEs using the FAERS database from 2013 to 2020. The study DAAs included Sofosbuvir, Ledipasvir/Sofosbuvir, Elbasvir/Grazoprevir, Sofosbuvir/Velpatasvir, Sofosbuvir/Velpatasvir/Voxilaprevir, and Glecaprevir/Pibrentasvir. The most frequently reported ADEs were calculated and categorized annually for each of the DAAs. The psychological and neurological ADEs included chills, fatigue, malaise, headache, insomnia, irritability, nervousness, dizziness, asthenia, emotional lability, memory impairment, depression, mood changes, or suicidal ideation. The major adverse event outcome, such as death, life-threatening, hospitalization, disability, congenital anomaly, required intervention, and others, were also assessed annually.

Results: There were 219,643 reported psychological and neurological ADE, including fatigue 14,144 (36%), headache 11,780 (30%), insomnia 3,330 (9%), dizziness 2,204 (6%), asthenia 2,290 (6%), depression 1,500 (4%), chills 632 (2%), malaise 891 (2%), irritability 723 (2%), memory impairment 734 (2%), mood changes 233 (1%), suicidal ideation 399 (1%), nervousness 133 (0.3%), and emotional lability 127 (0.3%). The adverse event outcomes were 170,135, included death 15,499 (9.1%), life-threatening 5,989 (3.5%), hospitalization 48,405 (28.5%), disability 4,049 (2.4%), congenital anomaly 378 (0.2%), required intervention 256 (0.2%), and other 95,559 (56.2%). Most of the ADEs reported in FAERS matched the Lexicomp database. However, some ADEs were highly reported but not in the Lexicomp database, such as dizziness 726 (6%) for Sofosbuvir, insomnia 239 (9%), dizziness 146 (6%), depression 88 (3%) for Elbasvir/Grazoprevir, dizziness 312 (4%) for Sofosbuvir/Velpatasvir, insomnia 30 (7%), malaise 11 (3%) for Sofosbuvir/Velpatasvir/Voxilaprevir, and dizziness 202 (4%), insomnia 181 (3%) for Glecaprevir/Pibrentasvir.

Conclusions: The analysis of the FAERS database and Lexicomp demonstrated some consistency in ADEs reporting. It is crucial to provide a comprehensive list of ADEs to manage the potential DAAs medications ADEs better and take appropriate caution in their use.