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Volume 14
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10.3390/pathogens14111177
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Article

Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study

by
Nicola Pugliese
1,2,
Fabio Conti
3,
Valerio Rosato
4,
Paolo Gallo
5,
Stefano Gitto
6,
Marco Riglietta
7,
Francesca Frigerio
8,
Valentina Perrone
9,*,
Chiara Veronesi
9,
Maria Cappuccilli
9,
Luca Degli Esposti
9,
Alessandra Mangia
10,† and
Loreta A. Kondili
11,12,†
1
Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, MI, Italy
2
Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, 20089 Rozzano, MI, Italy
3
Dipartimento di Medicina Interna, Ospedale degli Infermi di Faenza, 48018 Faenza, FC, Italy
4
Unità di Medicina Interna ed Epatologia, Ospedale Evangelico Villa Betania, 80147 Napoli, NA, Italy
5
UOS Medicina Clinica ed Epatologia, Policlinico Universitario Campus Bio-Medico, 00128 Roma, RM, Italy
6
Department of Experimental and Clinical Medicine, University of Florence, 50141 Firenze, FI, Italy
7
UOC Dipendenze, ASST Papa Giovanni XXIII, 24127 Bergamo, BG, Italy
8
Gilead Sciences, 20146 Milano, MI, Italy
9
CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, BO, Italy
10
UOS Epatologia, Istituto di Ricovero e Cura (IRCCS) “Casa Sollievo della Sofferenza”, 71013 San Giovanni Rotondo, FG, Italy
11
Center for Global Health, Istituto Superiore di Sanità, 00161 Rome, RM, Italy
12
Internal Medicine, UniCamillus International Medical Universityof Health Sciences, 00131 Rome, RM, Italy
 
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*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Pathogens 2025, 14(11), 1177; https://doi.org/10.3390/pathogens14111177
Submission received: 23 June 2025 / Revised: 22 July 2025 / Accepted: 24 July 2025 / Published: 18 November 2025
(This article belongs to the Section Epidemiology of Infectious Diseases)
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Abstract

Pangenotypic direct-acting antivirals (pDAAs) have transformed hepatitis C virus (HCV) treatment. In Italy, sofosbuvir/velpatasvir (SOF/VEL) and glecaprevir/pibrentasvir (GLE/PIB) are available. While both show similar efficacy, differences in patient profiles and potential drug–drug interactions (DDIs) may influence treatment choice. This study examined factors affecting pDAA selection and potential prescribing gaps. Using administrative databases (2018–2023) covering 3.7 million citizens, HCV patients were divided into SOF/VEL and GLE/PIB cohorts and compared by demographic, clinical, and therapeutic data. Among 5565 patients, 2837 (51%) received SOF/VEL and 2728 (49%) received GLE/PIB. SOF/VEL patients were older (60.8 vs. 57.6 years, p < 0.001) and had more comorbidities: diabetes (24% vs. 17%), mental disorders (22% vs. 14%), cancer (14% vs. 9%), and cardiovascular disease (31% vs. 22%). Hospitalization rates were higher (19% vs. 13%), as were exemption codes for chronic hepatitis (58% vs. 50%) and hypertension (32% vs. 23%). Polypharmacy was more common with SOF/VEL; 25% used ≥10 non-pDAA drugs (vs. 17%), and mean medications per patient were higher (6.3 ± 5.6 vs. 4.9 ± 5.2). SOF/VEL was often used for older, frailer patients, likely due to a more favourable DDI profile. These prescribing trends highlight the importance of tailoring pDAA choice to patient comorbidity profiles, ensuring appropriate and individualized HCV treatment.
Keywords: drug–drug interactions (DDIs); glecaprevir/pibrentasvir; hepatitis C virus (HCV); pangenotypic direct-acting antivirals; sofosbuvir/velpatasvir drug–drug interactions (DDIs); glecaprevir/pibrentasvir; hepatitis C virus (HCV); pangenotypic direct-acting antivirals; sofosbuvir/velpatasvir

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MDPI and ACS Style

Pugliese, N.; Conti, F.; Rosato, V.; Gallo, P.; Gitto, S.; Riglietta, M.; Frigerio, F.; Perrone, V.; Veronesi, C.; Cappuccilli, M.; et al. Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study. Pathogens 2025, 14, 1177. https://doi.org/10.3390/pathogens14111177

AMA Style

Pugliese N, Conti F, Rosato V, Gallo P, Gitto S, Riglietta M, Frigerio F, Perrone V, Veronesi C, Cappuccilli M, et al. Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study. Pathogens. 2025; 14(11):1177. https://doi.org/10.3390/pathogens14111177

Chicago/Turabian Style

Pugliese, Nicola, Fabio Conti, Valerio Rosato, Paolo Gallo, Stefano Gitto, Marco Riglietta, Francesca Frigerio, Valentina Perrone, Chiara Veronesi, Maria Cappuccilli, and et al. 2025. "Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study" Pathogens 14, no. 11: 1177. https://doi.org/10.3390/pathogens14111177

APA Style

Pugliese, N., Conti, F., Rosato, V., Gallo, P., Gitto, S., Riglietta, M., Frigerio, F., Perrone, V., Veronesi, C., Cappuccilli, M., Degli Esposti, L., Mangia, A., & Kondili, L. A. (2025). Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study. Pathogens, 14(11), 1177. https://doi.org/10.3390/pathogens14111177

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