Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies

Betty B. Yao, Linda M. Fredrick, Gretja Schnell, Kris V. Kowdley, Paul Y. Kwo, Fred Poordad, Kinh Nguyen, Samuel S. Lee, Christophe George, Florence Wong, Edward Gane, Armand Abergel, Catherine W. Spearman, Tuan Nguyen, Manh Hung Le, Thuy T.T. Pham, Federico Mensa, Tarik Asselah

Research output: Contribution to journalArticle

Abstract

Background & Aims: Hepatitis C virus (HCV) has high genetic diversity with six major genotypes (GT) GT1-6 and global distribution. HCV GT5 and 6 are rare with < 10 million people infected worldwide. Data on direct-acting antiviral use in these rare HCV genotypes are limited. The study aimed to evaluate the efficacy and safety of glecaprevir/pibrentasvir (G/P) in a pooled analysis of phase 2/3 trials in HCV GT5 or 6-infected patients without cirrhosis or with compensated cirrhosis. Methods: Patients with chronic HCV GT5 or 6 infection received oral G/P (300 mg/120 mg) once daily for 8 or 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (SVR12) in the intention-to-treat population. Results: One hundred eighty-one patients were evaluated; 56 with HCV GT5 and 125 with HCV GT6. The majority were treatment-naïve (88%) and non-cirrhotic (85%). Overall SVR12 rate with 8- or 12-week G/P treatment was 98% (178/181). Eight-week treatment with G/P yielded SVR12 rates of 95% (21/22) in HCV GT5- and 99% (69/70) in HCV GT6-infected non-cirrhotic patients. Eight- and 12-week treatment of patients with compensated cirrhosis achieved SVR12 rates of 100% (10/10) and 94% (17/18) respectively. The G/P regimen was well-tolerated; 3% (6/181) Grade 3 or higher adverse events, and no serious adverse events were attributed to G/P or led to study drug discontinuation. Conclusions: This integrated dataset demonstrates a high SVR12 rate following 8-week G/P treatment in patients with HCV GT5 (96%) or GT6 (99%) infection without cirrhosis or with compensated cirrhosis.

Original languageEnglish (US)
Pages (from-to)2385-2393
Number of pages9
JournalLiver International
Volume40
Issue number10
DOIs
StatePublished - Oct 1 2020

Keywords

  • genotype 5
  • genotype 6
  • glecaprevir and pibrentasvir
  • hepatitis C
  • integrated analysis
  • phase 2 and 3

ASJC Scopus subject areas

  • Hepatology

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    Yao, B. B., Fredrick, L. M., Schnell, G., Kowdley, K. V., Kwo, P. Y., Poordad, F., Nguyen, K., Lee, S. S., George, C., Wong, F., Gane, E., Abergel, A., Spearman, C. W., Nguyen, T., Hung Le, M., Pham, T. T. T., Mensa, F., & Asselah, T. (2020). Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies. Liver International, 40(10), 2385-2393. https://doi.org/10.1111/liv.14535