Graham R Foster1, Gregory J Dore2, Stanley Wang3, Jason Grebely2, Kenneth E Sherman4, Axel Baumgarten5, Brian Conway6, Daniel Jackson7, Tarik Asselah8, Michael Gschwantler9, Krzysztof Tomasiewicz10, Humberto Aguilar11, Armen Asatryan3, Yiran Hu3, Federico J Mensa3. 1. Hepatology Unit, Queen Mary University of London, Mile End Rd., London E1 4NS, UK. Electronic address: g.r.foster@qmul.ac.uk. 2. The Kirby Institute, UNSW Sydney, Wallace Wurth Building, High St., Kensington NSW 2052, Australia. 3. AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, USA. 4. Division of Digestive Diseases, University of Cincinnati College of Medicine, CARE/Crawley Building, Suite E-870, 3230 Eden Avenue, Cincinnati, OH 45267, USA. 5. Center for Infectiology, Driesener Str. 11, 10439 Berlin, Germany. 6. Vancouver Infectious Diseases Centre, 1200 Burrard St., Vancouver, BC V6Z 2C7, Canada. 7. Digestive Health Specialists of the Southeast, 480 Honeysuckle Rd., Dothan, AL 36305, USA. 8. Université Paris Diderot, INSERM UMR1149, AP-HP Hôpital Beaujon, 100 Boulevard du Général Leclerc, 92110 Clichy, France. 9. Department of Internal Medicine IV, Wilhelminenspital, and Sigmund Freud University, Freudplatz, 1A-1020 Vienna, Austria. 10. Department of Infectious Diseases and Hepatology, Medical University of Lublin, Staszica 16, 20-081 Lublin, Poland. 11. Louisiana Research Center, 1800 E 70th St, Shreveport, LA 71105, USA.
Abstract
BACKGROUND: Injection drug use is the primary mode of transmission for hepatitis C virus (HCV), and treatment guidelines recommend treating HCV-infected people who use drugs; however, concerns about adherence, effectiveness, and reinfection have impeded treatment uptake. METHODS: Data were pooled from seven phase III trials that evaluated the efficacy and safety of 8 or 12 weeks of glecaprevir/pibrentasvir (G/P) in patients chronically infected with HCV genotypes 1-6. Patients had compensated liver disease, with or without cirrhosis, and were HCV treatment-naïve or -experienced with interferon or pegylated interferon ± ribavirin, or sofosbuvir plus ribavirin ± pegylated interferon. Patients were grouped into recent drug users (injection drug use ≤12 months before screening, positive urine drug screen [UDS], and/or drug-related adverse event), former drug users (>12 months before screening and negative UDS), or non-drug users. Assessments included sustained virologic response at 12 weeks posttreatment (SVR12), treatment adherence, and safety. RESULTS: Among 1819 patients, 5%, 34%, and 61% were recent, former, and non-drug users, respectively. Treatment adherence and completion were high (≥96%) regardless of drug use status. SVR12 was achieved by 93% (n/N = 91/98), 97% (n/N = 591/610), and >99% (n/N = 1106/1111) of recent, former, and non-drug users, respectively (intention-to-treat analysis). The overall rates of virologic failure were ≤1.5% across all three subpopulations, with no HCV reinfections among recent drug users. Drug-related serious adverse events and adverse events leading to treatment discontinuation were experienced by ≤1% of patients. CONCLUSIONS: G/P is a well-tolerated and efficacious pangenotypic regimen for chronic HCV-infected people with recent or active drug use.
BACKGROUND: Injection drug use is the primary mode of transmission for hepatitis C virus (HCV), and treatment guidelines recommend treating HCV-infectedpeople who use drugs; however, concerns about adherence, effectiveness, and reinfection have impeded treatment uptake. METHODS: Data were pooled from seven phase III trials that evaluated the efficacy and safety of 8 or 12 weeks of glecaprevir/pibrentasvir (G/P) in patients chronically infected with HCV genotypes 1-6. Patients had compensated liver disease, with or without cirrhosis, and were HCV treatment-naïve or -experienced with interferon or pegylated interferon ± ribavirin, or sofosbuvir plus ribavirin ± pegylated interferon. Patients were grouped into recent drug users (injection drug use ≤12 months before screening, positive urine drug screen [UDS], and/or drug-related adverse event), former drug users (>12 months before screening and negative UDS), or non-drug users. Assessments included sustained virologic response at 12 weeks posttreatment (SVR12), treatment adherence, and safety. RESULTS: Among 1819 patients, 5%, 34%, and 61% were recent, former, and non-drug users, respectively. Treatment adherence and completion were high (≥96%) regardless of drug use status. SVR12 was achieved by 93% (n/N = 91/98), 97% (n/N = 591/610), and >99% (n/N = 1106/1111) of recent, former, and non-drug users, respectively (intention-to-treat analysis). The overall rates of virologic failure were ≤1.5% across all three subpopulations, with no HCV reinfections among recent drug users. Drug-related serious adverse events and adverse events leading to treatment discontinuation were experienced by ≤1% of patients. CONCLUSIONS: G/P is a well-tolerated and efficacious pangenotypic regimen for chronic HCV-infectedpeople with recent or active drug use.
Authors: Kristina M Brooks; Jose R Castillo-Mancilla; Mary Morrow; Samantha MaWhinney; Sarah E Rowan; David Wyles; Joshua Blum; Ryan Huntley; Lana M Salah; Arya Tehrani; Lane R Bushman; Peter L Anderson; Jennifer J Kiser Journal: Open Forum Infect Dis Date: 2020-11-19 Impact factor: 4.423