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Abstract Details
Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts
Adv Ther. 2021 Jun;38(6):3409-3426. doi: 10.1007/s12325-021-01753-3. Epub 2021 May 22.
Xavier Forns1, Jordan J Feld2, Douglas E Dylla3, Stanislas Pol4, Kazuaki Chayama5, Jinlin Hou6, Jeong Heo7, Pietro Lampertico89, Ashley Brown10, Mark Bondin3, Fernando Tatsch3, Margaret Burroughs3, John Marcinak3, Zhenzhen Zhang3, Amanda Emmett3, Stuart C Gordon11, Ira M Jacobson12
Author information
1Liver Unit, Hospital Clinic de Barcelona, IDIBAPS and CIBEREHD, University of Barcelona, Barcelona, Spain. xforns@clinic.cat.
2Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada.
3AbbVie Inc., North Chicago, IL, USA.
4Liver Unit, Cochin Hospital, APHP, Inserm U-1223, Institut Pasteur, Université de Paris, Paris, France.
5Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
6Department of Infectious Diseases, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.
7Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Busan, Republic of Korea.
8Division of Gastroenterology and Hepatology, CRC "A.M. and A. Migliavacca" Center for Liver Disease, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
9Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
10Imperial College Healthcare NHS Trust, London, UK.
11Division of Gastroenterology and Hepatology, Henry Ford Health System and Wayne State University School of Medicine, Detroit, MI, USA.
12NYU Langone Health, New York, USA.
Abstract
Introduction: More than 70 million people are estimated to be infected with hepatitis C virus (HCV) globally. If left untreated, HCV infection can lead to complications such as extensive liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Evolution of treatments has resulted in highly effective and well-tolerated all-oral direct-acting antivirals. The pangenotypic regimen of glecaprevir/pibrentasvir is approved for treating HCV for patients without cirrhosis or with compensated cirrhosis (CC). Guidelines have evolved to simplify treatment to enable non-specialists to manage and treat HCV-infected patients. Simultaneously, such treatment algorithms provide guidance on the pretreatment identification of small subsets of patients who may require specialist treatment and long-term follow-up for advanced liver disease, including those at risk of developing HCC. This study describes the safety profile of glecaprevir/pibrentasvir in patients identified using previously described noninvasive laboratory measures who may be eligible for treatment by non-liver specialists.
Methods: This post hoc analysis of glecaprevir/pibrentasvir in patients, identified by noninvasive laboratory measures, intended to exclude patients with advanced liver disease and severe renal impairment, who can be managed within non-liver specialist settings. Patients were included from clinical trials and real-world studies of glecaprevir/pibrentasvir for HCV treatment. Baseline demographics, clinical characteristics, and safety assessments, including adverse events and laboratory abnormalities, were summarized.
Results: Data across these large-scale studies confirm that glecaprevir/pibrentasvir is well tolerated across different patient populations, with fewer than 0.1% of patients experiencing a serious adverse event related to treatment drugs, and few patients developing HCC during or after treatment.
Conclusion: The safety profile of glecaprevir/pibrentasvir enhances the confidence of non-liver specialists to treat the majority of HCV-infected patients, and provides an opportunity to expand the treater pool, potentially increasing diagnosis and treatment rates for HCV, contributing to elimination of HCV.