학술논문
Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.
Document Type
Academic Journal
Author
Brown A; Imperial College Healthcare NHS Trust, London, UK.; Welzel TM; Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt am Main, Germany.; Conway B; Vancouver Infectious Diseases Center, Vancouver, BC, Canada.; Negro F; Divisions of Gastroenterology and Hepatology and Clinical Pathology, Geneva University Hospital, Geneva, Switzerland.; Bräu N; James J. Peters VA Medical Center, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.; Grebely J; The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.; Puoti M; Department of Infectious Diseases, AO Ospedale Niguarda Ca' Granda, Milan, Italy.; Aghemo A; Humanitas University and Clinical and Research Hospital, Rozzano, Italy.; Kleine H; AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany.; Pugatch D; AbbVie, North Chicago, IL, USA.; Mensa FJ; AbbVie, North Chicago, IL, USA.; Chen YJ; AbbVie, North Chicago, IL, USA.; Lei Y; AbbVie, North Chicago, IL, USA.; Lawitz E; Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.; Asselah T; Department of Hepatology, Centre de Recherche sur l'Inflammation (CRI), INSERM UMR 1149, University of Paris Diderot, AP-HP Hôpital Beaujon, Clichy, France.
Source
Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 101160857 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1478-3231 (Electronic) Linking ISSN: 14783223 NLM ISO Abbreviation: Liver Int Subsets: MEDLINE
Subject
Language
English
Abstract
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.
Methods: 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.
Results: 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.
Conclusions: 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.
(© 2019 The Authors. Liver International published by John Wiley & Sons Ltd.)
Methods: 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.
Results: 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.
Conclusions: 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.
(© 2019 The Authors. Liver International published by John Wiley & Sons Ltd.)