Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis
David Back, Pamela Belperio, Mark Bondin, Francesco Negro, Andrew H Talal, Caroline Park, ZhenZhen Zhang, Brett Pinsky, Eric Crown, Federico J Mensa, Fiona Marra, David Back, Pamela Belperio, Mark Bondin, Francesco Negro, Andrew H Talal, Caroline Park, ZhenZhen Zhang, Brett Pinsky, Eric Crown, Federico J Mensa, Fiona Marra
Abstract
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.
Trial registration: ClinicalTrials.gov NCT02243280 NCT02243293 NCT02604017 NCT02640482 NCT02640157 NCT02636595 NCT02642432 NCT02651194 NCT02446717 NCT02738138.
Keywords: chronic hepatitis C; drug interactions; mental disorders; sustained virologic response; treatment adherence and compliance.
Conflict of interest statement
David Back: Advisory board member/speakers bureau and receives honorarium from: Gilead, Merck, AbbVie, Bristol‐Myers Squibb, Janssen; received research grant funding from: Gilead, Merck, AbbVie, Bristol‐Myers Squibb, Janssen; received travel sponsorship from: AbbVie. Pamela Belperio: Nothing to disclose. Fiona Marra: consulting or grants from AbbVie, Gilead, Merck, Janssen and Viiv. Francesco Negro: advisor to Gilead, AbbVie, Merck. Unrestricted research grant from AbbVie. Investigator initiated study supported by Gilead. Andrew Talal: Research grants: AbbVie, Merck, Gilead, Intercept, Conatus, Abbott, Genfit, Center for AIDS Research, Patient‐Centered Outcomes Research Institute (PCORI); Advisor: AbbVie, Merck, Abbott Diagnostics, Chronic Liver Disease Foundation; Speaker's Bureau: Chronic Liver Disease Foundation. Mark Bondin, Caroline Park, ZhenZhen Zhang, Brett Pinsky, Federico Mensa, Eric Crown are employees of AbbVie, Inc and may hold stock or stock options.
© 2019 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.
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