1 Imperial College Healthcare NHS Trust, London, UK.
2 Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt am Main, Germany.
3 Vancouver Infectious Diseases Center, Vancouver, BC, Canada.
4 Divisions of Gastroenterology and Hepatology and Clinical Pathology, Geneva University Hospital, Geneva, Switzerland.
5 James J. Peters VA Medical Center, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
6 The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
7 Department of Infectious Diseases, AO Ospedale Niguarda Ca' Granda, Milan, Italy.
8 Humanitas University and Clinical and Research Hospital, Rozzano, Italy.
9 AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany.
10 AbbVie, North Chicago, IL, USA.
11 Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.
12 Department of Hepatology, Centre de Recherche sur l'Inflammation (CRI), INSERM UMR 1149, University of Paris Diderot, AP-HP Hôpital Beaujon, Clichy, France.
BACKGROUND & AIMS:
Adequate adherence to hepatitis C virus (HCV) treatment is believed to be a key component of treatment success because non-adherence can potentially result in treatment failure and the emergence of resistant viral variants. This analysis assessed factors associated with non-adherence to glecaprevir/pibrentasvir (G/P) therapy and the impact of non-adherence on sustained virological response at post-treatment week 12 (SVR12) rates in HCV genotype (GT) 1-6-infected patients.
Adherence was calculated by pill counts at study visits during treatment, and defined as having a lowest treatment adherence of ≥80% and ≤120% at each study visit. Exploratory logistic regression modelling assessed predictors of non-adherence to G/P therapy. SVR12 rates by treatment adherence were assessed in the intent-to-treat (ITT) population and modified ITT (mITT) population, which excludes non-virological failures.
Overall, 97% (2024/2091) of patients were adherent to G/P therapy at all consecutive study visits. Alcohol use was the only baseline characteristic independently associated with non-adherence to G/P therapy (OR: 2.38; 95% CI: 1.13-5.01; P = .022). In the mITT population, overall SVR12 rates were high both in patients who were adherent to G/P therapy and those who were not (99% [1983/2008] and 95% [58/61] respectively; P = .047). Corresponding SVR12 rates in the ITT population were 98% (1983/2024) and 87% (58/67) respectively.
Most patients adhered to G/P therapy. SVR12 rates were high both in patients who were adherent to G/P treatment and those who were not. Patient education on treatment adherence should remain an important part of HCV treatment.
CLINICAL TRIALS REGISTRATION:
NCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194, NCT02243293, NCT02446717.