Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis

Back, David, Belperio, Pamela, Bondin, Mark, Negro, Francesco, Talal, Andrew H, Park, Caroline, Zhang, ZhenZhen, Pinsky, Brett, Crown, Eric, Mensa, Federico J
et al (show 1 more authors) (2019) Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. JOURNAL OF VIRAL HEPATITIS, 26 (8). pp. 951-960.

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Although direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection are highly efficacious and safe, treatment initiation is often limited in patients with neuropsychiatric disorders due to concerns over reduced treatment adherence and drug-drug interactions. Here, we report adherence, efficacy, safety and patient-reported outcomes (PROs) from an integrated analysis of registrational studies using the pangenotypic DAA regimen of glecaprevir and pibrentasvir (G/P). Patients with chronic HCV genotypes 1-6 infection with compensated liver disease (with or without cirrhosis) receiving G/P for 8, 12 or 16 weeks were included in this analysis. Patients were classified as having a psychiatric disorder based on medical history and/or co-medications. Primary analyses assessed treatment adherence, efficacy (sustained virologic response at post-treatment week 12; SVR12), safety and PROs. Among 2522 patients receiving G/P, 789 (31%) had a psychiatric disorder with the most common diagnoses being depression (64%; 506/789) and anxiety disorders (27%; 216/789). Treatment adherence was comparably high (>95%) in patients with and without psychiatric disorders. SVR12 rates were 97.3% (768/789; 95% CI = 96.2-98.5) and 97.5% (1689/1733; 95% CI = 96.7-98.2) in patients with and without psychiatric disorders, respectively. Among patients with psychiatric disorders, SVR12 rates remained >96% by individual psychiatric diagnoses and co-medication classes. Overall, most adverse events (AEs) were mild-to-moderate in severity with serious AEs and AEs leading to G/P discontinuation occurring at similarly low rates in both patient populations. In conclusion, G/P treatment was highly efficacious, well-tolerated and demonstrated high adherence rates in patients with chronic HCV infection and psychiatric disorders.

Item Type: Article
Uncontrolled Keywords: chronic hepatitis C, drug interactions, mental disorders, sustained virologic response, treatment adherence and compliance
Depositing User: Symplectic Admin
Date Deposited: 08 Aug 2019 10:09
Last Modified: 19 Jan 2023 00:35
DOI: 10.1111/jvh.13110
Open Access URL: https://doi.org/10.1111/jvh.13110
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3051268