Glecaprevir/Pibrentasvir is safe and effective in Italian patients with chronic hepatitis C aged 75 years or older: A multicentre study

Author:

Pugliese Nicola12ORCID,Calvaruso Vincenza3ORCID,Masarone Mario4ORCID,D'Ambrosio Roberta5ORCID,Battistella Sara67,Licata Anna8ORCID,Persico Marcello4ORCID,Anolli Maria Paola5,Distefano Marco9,Petta Salvatore3ORCID,Russo Francesco Paolo67ORCID,Di Marco Vito3ORCID,Aghemo Alessio12ORCID

Affiliation:

1. Division of Internal Medicine and Hepatology, Department of Gastroenterology IRCCS Humanitas Research Hospital Rozzano Italy

2. Department of Biomedical Sciences Humanitas University Pieve Emanuele Italy

3. Section of Gastroenterology and Hepatology, PROMISE University of Palermo Palermo Italy

4. Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, “Scuola Medica Salernitana” University of Salerno Salerno Italy

5. Division of Gastroenterology and Hepatology Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico Milan Italy

6. Department of Surgery, Oncology and Gastroenterology University of Padua Padua Italy

7. Gastroenterology and Multivisceral Transplant Unit Azienda Ospedale‐Università di Padova Padua Italy

8. Internal Medicine Unit, Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialties (PROMISE) University of Palermo Palermo Italy

9. UOC Malattie Infettive, Ospedale Umberto I di Siracusa ASP Siracusa Siracusa Italy

Abstract

AbstractBackgroundGlecaprevir and Pibrentasvir (G/P) determine high rates of sustained virological response (SVR) with optimal safety profile in patients with chronic hepatitis C virus (HCV) infection. The efficacy and safety of G/P in Caucasian patients aged 75 years and older have not been widely analysed.MethodsThis is a retrospective multicentre real‐world study enrolling all consecutive patients 75 years and older who received G/P between October 2017 and January 2022 at five referral centres in Italy. SVR was analysed by intention‐to‐treat (ITT) and per‐protocol analyses (PP).ResultsA total of 570 patients met the inclusion criteria and were analysed: mean age was 80 (75–97) years, 356 (62%) were females, 52% (298/570) had HCV‐1, 44% (252/570) had HCV‐2 and 137 (24%) patients had liver cirrhosis. Four hundred and sixty‐three (81%) patients were taking at least one concomitant drug, with 144 (25%) taking ≥5 concomitant drugs. G/P was given for 8 weeks in 488 patients (86%). During treatment, 48 patients (8%) reported side effects, with 10 (2%) patients discontinuing treatment prematurely. Two patients developed treatment‐unrelated serious adverse events. Overall, the SVR rate was 97.9% (558/570) by ITT analysis and 99.6% (558/560) by PP analysis. SVR rates remained consistently high among subgroup analysis stratified by genotype, treatment duration, fibrosis stage and concomitant medications.ConclusionsTreatment with G/P achieved 97.9% SVR rates in HCV patients older than 75 years of age. Safety was optimal with only 2% of patients discontinuing early.

Publisher

Wiley

Subject

Hepatology

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