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

J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antidepressive Agents / therapeutic use
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / therapeutic use*
  • Female
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / complications
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Liver Cirrhosis / complications
  • Liver Cirrhosis / drug therapy
  • Male
  • Mental Disorders / complications
  • Mental Disorders / drug therapy*
  • Middle Aged
  • Quinoxalines / therapeutic use*
  • Sulfonamides / therapeutic use*
  • Sustained Virologic Response
  • Treatment Adherence and Compliance
  • Young Adult

Substances

  • Antidepressive Agents
  • Antiviral Agents
  • Benzimidazoles
  • Quinoxalines
  • Sulfonamides
  • pibrentasvir
  • glecaprevir

Associated data

  • ClinicalTrials.gov/NCT02243280
  • ClinicalTrials.gov/NCT02243293
  • ClinicalTrials.gov/NCT02604017
  • ClinicalTrials.gov/NCT02640482
  • ClinicalTrials.gov/NCT02640157
  • ClinicalTrials.gov/NCT02636595
  • ClinicalTrials.gov/NCT02642432
  • ClinicalTrials.gov/NCT02651194
  • ClinicalTrials.gov/NCT02446717
  • ClinicalTrials.gov/NCT02738138