1 Internal Medicine and Hepatology Unit, University of Salerno, Italy.
2 Clinic of Infectious Diseases, University of Bari, Italy.
3 Internal Medicine and Hepatology Unit, Hospital of Gragnano, Italy.
4 Infectious Diseases Unit, AORN Caserta, Italy.
5 Hepatology Unit, "Villa Betania" Evangelical Hospital, Naples, Italy.
6 Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, Italy.
7 Internal Medicine Unit, "S.S. Annunziata" Hospital, Taranto, Italy.
8 Infectious Diseases and Hepatology Unit, Cotugno Hospital, Naples, Italy.
9 Traveler and Migration Medicine Center, ASP Catanzaro, Italy.
10 Department of Clinical Medicine and Surgery, Gastroenterology and Hepatology Unit, Federico II University, Naples, Italy.
11 S. Caterina Novella Hospital, Galatina, Lecce, Italy.
12 Infectious Diseases Unit, University of Campania "Luigi Vanvitelli", Italy.
13 CURE Center, University of Foggia, Italy.
14 Internal Medicine Unit, Ostuni, Bari, Italy.
15 Internal Medicine Unit, Hospital of Castellaneta, Taranto, Italy.
16 Hepatology Unit, AORN Cardarelli, Naples, Italy.
17 Geriatrics Unit, "Mater Domini" University, Catanzaro, Italy.
18 S. de Bellis Hospital - IRCCS, Castellana Grotte, Italy.
19 Infectious Diseases Unit, University of Campania "Luigi Vanvitelli", Naples, Italy.
20 Infectious Disease Unit, Perrino Hospital, Brindisi, Italy.
21 Liver Diseases Unit, Fatebenefratelli Hospital, Naples, Italy.
22 Department of Precision Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
23 Biostatistics-Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
BACKGROUND AND AIMS:
It is paramount to identify predictors of treatment failure with direct antiviral agents in 'field-practice' patients, including people who inject drugs (PWID). Data on the efficacy of glecaprevir/pibrentasvir (GLE/PIB) in a field-practice scenario are scant. The multicenter MISTRAL study enrolled 1,177 patients, including PWID, to assess real-life efficacy and safety of GLE/PIB and to identify the predictive factors for this treatment.
This was a prospective, longitudinal study. The outcome variable was the rate of SVR at week 12.
A total of 123 patients (10%) were infected from hepatitis C virus (HCV) 3. METAVIR fibrosis score was F4 in 104 subjects (9%); 118 patients (10%) were PWID. Overall, 1,163/1,177 (99%) patients achieved SVR. The baseline clinical factors discriminating between treatment success and treatment failure were age at treatment (P=0.031) and creatinine level (P=0.034). SVR rates were not influenced by gender, substance abuse, previous treatment, treatment duration, fibrosis or chronic kidney disease stage. Compared with non-substance users, the 118 PWID exhibited a significantly different genotype pattern distribution (χ2 <0.001). A total of 40/118 (33.9%) of substance users were HCV3 compared to 83/1,056 (7.9%) non-substance users. Only six patients (0.5%) reported a serious adverse event.
The MISTRAL study provides evidence of GLE/PIB efficacy in a field-practice scenario in a highly epidemic HCV area in southern Italy; it unveiled significant differences in genotype distribution among the most underserved and difficult-to-treat patient subgroups including PWID.