CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. Electronic address: email@example.com.
Bergamo HCV Network, ASST Papa Giovanni XXIII, Italy.
Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Gastroenterology and Hepatology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Infectious Diseases, ASST Sacco, Milan, Italy.
Infectious Diseases, San Gerardo Hospital, ASST Monza, Monza, Italy.
Hospital Pharmacy, ASST Ovest Milanese, Legnano (MI), Italy.
Infectious Diseases, Busto Arsizio Hospital, ASST Valle Olona, Varese, Italy.
Internal Medicine and Hepatology, Humanitas Research Hospital and Humanitas University, Pieve Emanuele (MI), Italy.
Internal Medicine, ASST Ovest Milanese, Legnano (MI), Italy.
Hepatology, San Giuseppe Hospital, Università degli Studi di Milano, Milan, Italy.
Internal Medicine, ASST Ovest Milanese, Abbiategrasso (MI), Italy.
ASST Santi Paolo e Carlo, Milan, Italy.
Brescia HCV Network, ASST Brescia, Italy.
Infectious Diseases, ASST Cremona, Cremona (MI), Italy.
Internal Medicine, San Raffaele Hospital, Milan, Italy.
ASST Lariana, Como, Italy.
Gastroenterology, ASST Ovest Milanese, Legnano (MI), Italy.
Immunology and Infectious Diseases, San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.
Infectious Diseases, ASST Lecco, Italy.
Gastroenterology, Valduce Hospital, Como, Italy.
Gastroenterology, Maggiore Hospital, ASST Crema (CR), Italy.
Internal Medicine, Vizzolo Predabissi Hospital, Vizzolo Predabissi (MI), Italy.
CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
Infectious Diseases, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
Infectious Diseases, ASST Ovest Milanese, Legnano (MI), Italy.
QUOVADIS no profit Association, Italy.
Molecular Virology Unit, Microbiology and Virology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
BACKGROUND AND AIMS:
The efficacy and safety of glecaprevir/pibrentasvir (G/P) for patients infected with hepatitis C virus (HCV) have only been investigated in clinical trials, with no real-world data currently available. The aim of our study was to investigate the effectiveness and safety of G/P in a real-world setting.
All patients with HCV consecutively starting G/P between October 2017 and January 2018 within the NAVIGATORE-Lombardia Network were analyzed. G/P was administered according to drug label (8, 12 or 16 weeks). Fibrosis was staged either histologically or by liver stiffness measurement. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks after the end of treatment.
A total of 723 patients (50% males) were treated with G/P, 89% for 8 weeks. The median age of our cohort was 58 years, with a median body mass index of 23.9 kg/m2, and median liver stiffness measurement of 6.1 kPa; 84% were F0-2 and 16% were interferon-experienced. Median HCV-RNA was 1,102,600 IU/ml, and 49% of patients had HCV genotype 1 (32% 1b), 28% genotype 2, 10% genotype 3 and 13% genotype 4. The median estimated glomerular filtration rate was 90.2 ml/min, platelet count 209x103/mm3 and albumin 4.3 g/dl. The SVR rates were 94% in intention-to-treat and 99.3% in per protocol analysis (8-week vs. 12 or 16-week: 99.2% vs. 100%). Five patients failed therapy because of post-treatment relapse; a post-treatment NS5A resistance-associated substitution was detected in 1 case. SVR rates were lower in males (p = 0.002) and in HCV genotype-3 (p = 0.046) patients treated for 8 weeks, but independent of treatment duration, fibrosis stage, baseline HCV-RNA, HIV co-infection, chronic kidney disease stage and viral kinetics. Mild adverse events were reported in 8.3% of the patients, and 0.7% of them prematurely withdrew treatment. Three patients died of drug-unrelated causes.
In a large real-world cohort of Italian patients, we confirmed the excellent effectiveness and safety of G/P administered for 8, 12 or 16 weeks.
A large number of patients with hepatitis C virus have been treated with glecaprevir/pibrentasvir (G/P) within the NAVIGATORE-Lombardia Network, in Italy. This is the first real-world study evaluating effectiveness and safety of G/P in patients with hepatitis C virus treated according to international recommendations. This study demonstrated excellent effectiveness (with sustained virological response rates of 99.3%) and safety profiles.