Glecaprevir/pibrentasvir for 8 weeks in patients with compensated cirrhosis: Safety and effectiveness data from the German Hepatitis C-Registry.

Abstract

Glecaprevir/pibrentasvir, a pangenotypic, direct-acting antiviral combination approved for chronic hepatitis C virus treatment, has limited real-world evidence supporting 8-week therapy in compensated cirrhosis. We investigated effectiveness and safety of 187 hepatitis C virus-infected, treatment-naïve, patients with compensated cirrhosis receiving 8-week glecaprevir/pibrentasvir therapy in the German Hepatitis C-Registry between 2 August 2017 and 1 January 2020. Sustained virologic response was 98.4% (127/129) in the per-protocol analysis (excluding patients lost to follow-up or who discontinued treatment due to compliance) and was 85.8% (127/148) in patients with data available in an intention-to-treat analysis. Nineteen patients were lost to follow-up; nine genotype 3 patients, nine nongenotype 3 patients and one mixed genotype patient. One patient relapsed, and one died, unrelated to treatment. Adverse events (>5%) were fatigue and headache. Two serious adverse events occurred; no adverse events resulted in drug discontinuation. An 8-week glecaprevir/pibrentasvir therapy was effective and well-tolerated in this real-world analysis.

• Authors: Hartwig Klinker, Uwe Naumann, Martin Rössle, Thomas Berg, Mark Bondin, Kristina Lohmann, Bettina Koenig, Stefan Zeuzem, Markus Cornberg
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 41 Issue 7 Pg. 1518-1522 (07 2021) ISSN: 1478-3231 [Electronic] United States
• PMID: 33966349 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 The Authors. Liver International published by John Wiley & Sons Ltd.

Chemical References

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

Topics

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