Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRIa¤1 in a Single-Arm, Open-Label, Multicenter Study.

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From: Advances in Therapy(Vol. 36, Issue 12)
Publisher: Springer
Document Type: Clinical report
Length: 467 words

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Keywords: Chronic hepatitis C; Direct acting antiviral; Glecaprevir/pibrentasvir; Infectious diseases; Simplification Abstract: Introduction The presence or absence of cirrhosis in patients with chronic hepatitis C virus (HCV) infection influences the type and duration of antiviral therapy. Non-invasive markers, like serum aspartate aminotransferase (AST) to platelet ratio index (APRI), may help identify appropriate HCV treatment-naive patients for 8-week treatment with the pangenotypic regimen of glecaprevir/pibrentasvir. Methods This single-arm, open-label, international, prospective study (NCT03212521) evaluated the efficacy and safety of 8-week glecaprevir/pibrentasvir regimen in HCV treatment-naïve adults with chronic HCV genotypes 1--6 infection, APRIâ¤1, and no prior evidence of cirrhosis. The primary and secondary outcomes were sustained virologic response at 12 weeks post-treatment (SVR12) by modified intent-to-treat (mITT) and intent-to-treat (ITT) analyses, respectively. Additional endpoints included virologic failures, treatment adherence, and genotype-specific SVR12 rates. Results Among the 230 patients enrolled, most were less than 65 years old (90%) 37% and 43% had a history of injection drug use or psychiatric disorders, respectively. SVR12 rates were 100% (222/222 95% CI 98.3--100%) and 96.5% (222/230 95% CI 94.2--98.9%) by mITT and ITT analyses, respectively. There were no virologic failures. ITT SVR12 rates were greater than 94% for all HCV genotypes. In patients with available data, treatment adherence was 99% (202/204). There were no grade 3 or higher laboratory abnormalities in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, and low rates of serious adverse events (2%). Conclusions Glecaprevir/pibrentasvir was highly efficacious and well tolerated in HCV treatment-naïve patients with APRI â¤1 and no prior evidence of cirrhosis. Trial Registration ClinicalTrials.gov number, NCT03212521. Funding AbbVie. Plain Language Summary Plain language summary available for this article. Author Affiliation: (1) grid.214458.e, 0000000086837370, Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA (2) grid.5841.8, 0000 0004 1937 0247, Liver Unit, Hospital Clinic, IDIBAPS and CIBERehd, University of Barcelona, Barcelona, Spain (3) grid.420004.2, 0000 0004 0444 2244, Liver Unit, The Newcastle upon Tyne Hospitals NHS Foundation and Trust and Newcastle University, Newcastle upon Tyne, UK (4) Toronto Liver Centre, Toronto, Canada (5) grid.63368.38, 0000 0004 0445 0041, Division of Gastroenterology, Sherri and Alan Conover Center for Liver Disease and Transplantation, Houston Methodist, Houston, TX, USA (6) grid.431072.3, 0000 0004 0572 4227, AbbVie, Inc., North Chicago, IL, USA (7) grid.7839.5, 0000 0004 1936 9721, J.W. Goethe University, Frankfurt, Germany Article History: Registration Date: 09/10/2019 Received Date: 27/08/2019 Online Date: 23/10/2019 Article note: Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.9924842. Electronic supplementary material The online version of this article ( https://doi.org/10.1007/s12325-019-01123-0) contains supplementary material, which is available to authorized users. Byline: Robert J. Fontana (1), Sabela Lens (2), Stuart McPherson (3), Magdy Elkhashab (4), Victor Ankoma-Sey (5), Mark Bondin (6), Ana Gabriela Pires Santos (6), Zhenyi Xue (6), Roger Trinh (6), Ariel Porcalla (6), Stefan Zeuzem (7)

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Gale Document Number: GALE|A605520910