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High Sustained Virologic Response Rates of Glecaprevir/Pibrentasvir in Patients With Dosing Interruption or Suboptimal Adherence |
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Am J Gastroenterol. 2021 Sep 1;116(9):1896-1904. doi: 10.14309/ajg.0000000000001332.
Philippe J Zamor 1, Ashley Brown 2, Douglas E Dylla 3, John F Dillon 4, Anne F Luetkemeyer 5, Jordan J Feld 6, David Mutimer 7, Reem Ghalib 8, Eric Crown 3, Sandra S Lovell 3, Yiran Hu 3, Christophe Moreno 9, David R Nelson 10, Massimo Colombo 11, Georgios Papatheodoridis 12, Juergen K Rockstroh 13, Richard Skoien 14, Eric Lawitz 15, Ira M Jacobson 16
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Author information
- 1Atrium Health, Carolinas Medical Center, Charlotte, North Carolina, USA.
- 2Imperial College Healthcare NHS Trust, London, UK.
- 3AbbVie, North Chicago, Illinois, USA.
- 4Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, UK.
- 5Zuckerberg San Francisco General, University of California at San Francisco, San Francisco, California, USA.
- 6Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada.
- 7NIHR Liver Biomedical Research Unit, University of Birmingham, Birmingham, UK.
- 8Texas Clinical Research Institute, Arlington, Texas, USA.
- 9Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
- 10Department of Medicine, University of Florida, Gainesville, Florida, USA.
- 11Liver Center, IRCCS San Raffaele Hospital, Milan, Italy.
- 12Medical School of National and Kapodistrian University of Athens, Athens, Greece.
- 13Medizinische Klinik und Poliklinik I, Universitätsklinikum Bonn, Bonn, Germany.
- 14Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Queensland, Australia.
- 15The Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas, USA.
- 16NYU Langone Health, New York, New York, USA.
Abstract
Introduction: Pangenotypic, all-oral direct-acting antivirals, such as glecaprevir/pibrentasvir (G/P), are recommended for treatment of hepatitis C virus (HCV) infection. Concerns exist about the impact on efficacy in patients with suboptimal adherence, particularly with shorter treatment durations. These post hoc analyses evaluated adherence (based on pill count) in patients prescribed 8- or 12-week G/P, the impact of nonadherence on sustained virologic response at post-treatment week 12 (SVR12), factors associated with nonadherence, and efficacy in patients interrupting G/P treatment.
Methods: Data were pooled from 10 phase 3 clinical trials of treatment-naive patients with HCV genotype 1-6 without cirrhosis/with compensated cirrhosis (treatment adherence analysis) and 13 phase 3 clinical trials of all patients with HCV (interruption analysis).
Results: Among 2,149 patients included, overall mean adherence was 99.4%. Over the treatment duration, adherence decreased (weeks 0-4: 100%; weeks 5-8: 98.3%; and weeks 9-12: 97.1%) and the percentage of patients with ≥80% or ≥90% adherence declined. SVR12 rate in the intention-to-treat (ITT) population was 97.7% (modified ITT SVR12 99.3%) and remained high in nonadherent patients in the modified ITT population (<90%: 94.4%-100%; <80%: 83.3%-100%). Psychiatric disorders were associated with <80% adherence, and shorter treatment duration was associated with ≥80% adherence. Among 2,902 patients in the interruption analysis, 33 (1.1%) had a G/P treatment interruption of ≥1 day, with an SVR12 rate of 93.9% (31/33). No virologic failures occurred.
Discussion: These findings support the impact of treatment duration on adherence rates and further reinforce the concept of "treatment forgiveness" with direct-acting antivirals.
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