Glecaprevir/pibrentasvir is safe and effective in hepatitis C patients with cirrhosis: Real-world data from the German Hepatitis C-Registry

Liver Int. 2021 May;41(5):949-955. doi: 10.1111/liv.14829. Epub 2021 Mar 1.

Abstract

Glecaprevir/pibrentasvir is a pangenotypic direct-acting antiviral regimen approved for treating chronic hepatitis C virus. Real-world use of protease-inhibitor-containing regimens requires further evaluation in patients with cirrhosis. We evaluated the real-world safety and effectiveness of glecaprevir/pibrentasvir in patients with cirrhosis from the German Hepatitis C-Registry who initiated treatment between 2 August 2017 and 30 June 2019. Overall, 131 patients received 12-week (on-label) treatment and 51 received 8-week (off-label) treatment. No patient discontinued treatment due to adverse events. Four patients had serious adverse events; none were considered related to glecaprevir/pibrentasvir. Two patients had total bilirubin > 5 × upper limit of normal (ULN) during treatment. Three patients had alanine aminotransferase and three patients had aspartate aminotransferase > 3 × ULN. Rates of sustained virologic response were 100% (86/86) for 86 patients with available data. Glecaprevir/pibrentasvir treatment was well-tolerated and highly effective in patients with chronic hepatitis C and cirrhosis in real-world practice.

Keywords: antiviral agents/adverse effects; hepatitis C; liver cirrhosis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aminoisobutyric Acids
  • Antiviral Agents / adverse effects
  • Benzimidazoles
  • Cyclopropanes
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C* / drug therapy
  • Hepatitis C, Chronic* / complications
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Lactams, Macrocyclic
  • Leucine / analogs & derivatives
  • Liver Cirrhosis / drug therapy
  • Proline / analogs & derivatives
  • Pyrrolidines
  • Quinoxalines / adverse effects
  • Registries
  • Sulfonamides
  • Sustained Virologic Response

Substances

  • Aminoisobutyric Acids
  • Antiviral Agents
  • Benzimidazoles
  • Cyclopropanes
  • Lactams, Macrocyclic
  • Pyrrolidines
  • Quinoxalines
  • Sulfonamides
  • pibrentasvir
  • Proline
  • Leucine
  • glecaprevir