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

Autor: Francesco Negro, Pamela S. Belperio, Andrew H. Talal, Mark Bondin, Federico J. Mensa, Caroline Park, David Back, Brett Pinsky, Eric Crown, Fiona Marra, Zhenzhen Zhang
Rok vydání: 2019
Předmět:
Cyclopropanes
Liver Cirrhosis
Male
Aminoisobutyric Acids
Pyrrolidines
Sustained Virologic Response
Hepacivirus
ddc:616.07
0302 clinical medicine
Medicine
030212 general & internal medicine
Depression (differential diagnoses)
Aged
80 and over
Sulfonamides
Mental Disorders
Middle Aged
Antidepressive Agents
Pibrentasvir
Infectious Diseases
Anxiety
Original Article
Female
030211 gastroenterology & hepatology
medicine.symptom
Adult
medicine.medical_specialty
Genotype
Proline
Lactams
Macrocyclic
Antiviral Agents
Young Adult
03 medical and health sciences
Leucine
Quinoxalines
Virology
chronic hepatitis C
Humans
Medical history
Psychiatry
Adverse effect
Aged
Hepatology
business.industry
Original Articles
drug interactions
Glecaprevir
Hepatitis C
Chronic
Discontinuation
Treatment Adherence and Compliance
Regimen
Benzimidazoles
business
Zdroj: Journal of Viral Hepatitis
JOURNAL OF VIRAL HEPATITIS
Journal of Viral Hepatitis, Vol. 26, No 8 (2019) pp. 951-960
ISSN: 1365-2893
1352-0504
Popis: 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.
Databáze: OpenAIRE
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