High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis

Edward Gane, Fred Poordad, Stanley Wang, Armen Asatryan, Paul Y. Kwo, Jacob Lalezari, David L. Wyles, Tarek Hassanein, Humberto Aguilar, Benedict Maliakkal, Ran Liu, Chih Wei Lin, Teresa I. Ng, Jens Kort, Federico J. Mensa

Research output: Contribution to journalArticle

65 Scopus citations

Abstract

Background & Aims The combination of ABT-493 (NS3/4A protease inhibitor) plus ABT-530 (NS5A inhibitor) has shown high rates of sustained virologic response at post-treatment week 12 (SVR12) in noncirrhotic patients infected with hepatitis C virus (HCV) genotypes (GTs) 1–6. We describe 2 open-label phase 2 studies investigating the efficacy and safety of ABT-493 plus ABT-530 with or without ribavirin (RBV) in GT1- or GT3-infected patients with compensated cirrhosis. Methods Patients with GT1 infection received 200 mg ABT-493 plus 120 mg ABT-530 for 12 weeks. Patients with GT3 infection were randomized 1:1 to receive 300 mg ABT-493 plus 120 mg ABT-530 with or without once-daily 800 mg RBV for 12 weeks; treatment-experienced patients who were not treated with RBV received 16 weeks of therapy. Efficacy was measured by SVR12, defined as an HCV-RNA level less than 25 IU/mL. Adverse events and laboratory parameters were evaluated throughout the study. Results Twenty-seven patients with GT1 infection and 55 patients with GT3 infection were enrolled. The majority were treatment-naive (84%) and male (65%). In patients with GT1 infection, SVR12 was achieved by 96% (26 of 27; 95% confidence interval [CI], 82–99) of patients, with 1 relapse. Among GT3-infected patients, SVR12 was achieved in 96% (27 of 28; 95% CI, 82–99) of patients in the RBV-free arm (1 relapse), and in 100% (27 of 27; 95% CI, 88–100) in the RBV-containing arm. The most common adverse events were headache, fatigue, and nausea. Laboratory abnormalities were rare; no patient discontinued treatment. Conclusions In cirrhotic HCV GT1- or GT3-infected patients, ABT-493 plus ABT-530 with or without RBV achieved SVR12 rates of 96%–100% and was well tolerated. ClinicalTrials.gov identifiers NCT02243280 and NCT02243293.

Original languageEnglish (US)
Pages (from-to)651-659.e1
JournalGastroenterology
Volume151
Issue number4
DOIs
StatePublished - Oct 1 2016

Keywords

  • Glecaprevir
  • Hepatitis C
  • Pibrentasvir
  • SURVEYOR

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Gane, E., Poordad, F., Wang, S., Asatryan, A., Kwo, P. Y., Lalezari, J., Wyles, D. L., Hassanein, T., Aguilar, H., Maliakkal, B., Liu, R., Lin, C. W., Ng, T. I., Kort, J., & Mensa, F. J. (2016). High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology, 151(4), 651-659.e1. https://doi.org/10.1053/j.gastro.2016.07.020