Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C.
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D'Ambrosio Roberta, Pasulo Luisa, Puoti Massimo, Vinci Maria, Schiavini Monica, Lazzaroni Sergio, Soria Alessandro, Gatti Federico, Menzaghi Barbara, Aghemo Alessio, Capelli Francesca, Rumi Maria Grazia, Morini Lorenzo, Giorgini Alessia, Pigozzi Marie Graciella, Rossini Angelo, Maggiolo Franco, Pan Angelo, Memoli Massimo, Spinelli Ombretta, Del Poggio Paolo, Saladino Valeria, Spinetti Angiola, De Bona Anna, Capretti Andrea, Uberti-Foppa Caterina, Bonfanti Paolo, Terreni Natalia, Menozzi Fernanda, Colombo Alberto Eraldo, Giglio Omar, Centenaro Riccardo, Borghi Marta, Baiguera Chiara, Picciotto Viviana, Landonio Simona, Gori Andrea, Magnani Carlo, Noventa Franco, Paolucci Stefania, Lampertico Pietro, Fagiuoli Stefano, NAVIGATORE-Lombardia Study Group
Аннотация
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
LAY SUMMARY: 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.