Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

Markus Cornberg, Adriana Ahumada, Alessio Aghemo, Massimo Andreoni, Abhi Bhagat, Isabel Butrymowicz, Michal Carmiel, Gabriel Chodick, Brian Conway, Yanna Song, Antonio Gasbarrini, Dietrich Hüppe, Francisco Jorquera Plaza, Pietro Lampertico, Maria Luisa Manzano Alonso, Lindsay Myles, Marcello Persico, Alnoor Ramji, Christoph Sarrazin, Erica VillaClara Weil, Juan Isidro Uriz Otano

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

Introduction In clinical trials with hepatitis C virus-infected treatment-naive (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest. Methods The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed. Results A total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan(R) >= 12.5 kPa: 98.9% (89.3%); platelet count < 100 x 10(9)/l: 100% (88.2%); both platelets < 150 x 10(9)/l and FibroScan(R) > 20 kPa: 100% (88.9%); aspartate aminotransferase-to-platelet ratio index > 1.09: 98.7% (83.1%); fibrosis-4 index > 3.25: 98.6% (84.0%); albumin < 3 g/dl: 100% (91.7%); people who use drugs: 97.7% (84.3%); psychiatric disorders: 96.6% (84.8%); and human immunodeficiency virus coinfection: 100% (95.0%). Overall, 26.9% (104/386) of patients experienced an adverse event, none of which were classed as serious. Conclusion In this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.
Lingua originaleEnglish
pagine (da-a)3146-3158
Numero di pagine13
RivistaAdvances in Therapy
Volume39
DOI
Stato di pubblicazionePubblicato - 2022

Keywords

  • Compensated cirrhosis
  • Direct-acting antivirals
  • Treatment-naïve
  • Real world
  • Hepatitis C virus

Fingerprint

Entra nei temi di ricerca di 'Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study'. Insieme formano una fingerprint unica.

Cita questo