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Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study

Lookup NU author(s): Professor Stuart McPhersonORCiD



This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


© 2019, The Author(s). 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, APRI ≤ 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 ≤ 1 and no prior evidence of cirrhosis. Trial Registration: number, NCT03212521. Funding: AbbVie. Plain Language Summary: Plain language summary available for this article.

Publication metadata

Author(s): Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S

Publication type: Article

Publication status: Published

Journal: Advances in Therapy

Year: 2019

Volume: 36

Issue: 12

Pages: 3458-3470

Print publication date: 01/12/2019

Online publication date: 23/10/2019

Acceptance date: 27/08/2019

Date deposited: 19/11/2019

ISSN (print): 0741-238X

ISSN (electronic): 1865-8652

Publisher: Springer Healthcare


DOI: 10.1007/s12325-019-01123-0

PubMed id: 31646465


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