Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis

Abstract

Introduction: More than 70 million people are estimated to be infected with hepatitis C virus globally. Glecaprevir/pibrentasvir is a widely used treatment and has recently been approved for an 8-week regimen for treatment-naïve patients with compensated cirrhosis in Europe and the USA, who would previously have received glecaprevir/pibrentasvir for 12 weeks. This label update was based on the EXPEDITION-8 study, which included 343 treatment-naïve patients with compensated cirrhosis. However, there is currently a lack of similarly large-scale real-world studies of the 8-week glecaprevir/pibrentasvir regimen in this population.

Methods: This summary of seven separate smaller real-world studies aims to validate the results seen in EXPEDITION-8 and provide an up-to-date real-world reference for clinicians making treatment decisions for patients with compensated cirrhosis (Child-Pugh A) who may benefit from a shorter-duration therapy with glecaprevir/pibrentasvir. The newly emerging real-world effectiveness data on treatment-naïve patients with compensated cirrhosis treated with 8 weeks of glecaprevir/pibrentasvir help to understand where further research is needed to support patients with hepatitis C virus.

Results: Across all seven studies, glecaprevir/pibrentasvir showed high effectiveness with an average sustained virologic response rate of 98.1%, similar to that found in a clinical trial setting (99.7%). Only one patient (0.5%) experienced virologic failure and treatment was well tolerated.

Conclusion: Expanding the number of patients eligible for the shortened treatment duration will potentially increase treatment initiation and completion, particularly in underserved populations, contributing to the elimination of hepatitis C virus.

Keywords: Fibrosis; Hepatitis C; Infectious disease; Review; Therapeutics.

Fig. 1

SVR12 rates in TN patients with CC, GT1–6^a treated with 8 weeks of G/P. ^aScottish HCV study included GT1,2,4–6, US VA study included GT1–3. ^bFour patients were lost to follow-up in the ITT population. ^cOne confirmed reinfection with subsequent spontaneous clearance, no virologic failure. ^dOne virologic failure. ^eOne patient died after completing treatment but before SVR12 testing, one patient was lost to follow-up. ^fPatients missing SVR12 data were excluded from SVR12 analysis. CC compensated cirrhosis, DHC-R German Hepatitis C-Registry, G/P glecaprevir/pibrentasvir, GT genotype, HCV hepatitis C virus, ITT intention-to-treat, PMOS post-marketing observational studies, SVR12 sustained virologic response at week 12, TN treatment-naïve, VA Veterans Association