Toward the elimination of Hepatitis C: an integrated, patient-centered frameworkfor monitoring and improving care pathways in Tuscany

Introduction: Hepatitis C virus (HCV) remains a pressing global health issue despite the availability of highly effective and well-tolerated direct-acting antiviral (DAA) therapies. In Tuscany (Italy), efforts toward HCV eradication have intensified, aligning with World Health Organization (WHO) targets. Three related studies were conducted to (a) characterize HCV epidemiology and patient profiles, (b) explore how patient-reported measures influence access to care, and (c) design a region-specific pathway for monitoring HCV eradication progress. Aim: This body of research aimed to: I. Examine changes in HCV infection trends and treatment outcomes in Tuscany from 2015 to 2022; II. Investigate the role of patient- reported experience and outcome measures (PREMs and PROMs) in facilitating or hindering HCV treatment uptake; III. Develop an integrated care pathway, supported by performance indicators, that systematically tracks prevention, screening, and linkage to care for HCV in Tuscany, ultimately contributing to the goal of HCV elimination. Methods: All three studies were observational and focused on adult populations receiving care within the Tuscan Regional Health Service. In the first study, a retrospective multicenter analysis (2015–2022) employed administrative and clinical data to assess epidemiological trends and DAAs’ impact on sustained virological response (SVR). The second study deployed a longitudinal survey design to capture PREMs and PROMs from HCV patients at different stages of their treatment journey, examining their experiences and self-reported health status. The third study used administrative data linkage and patient-reported measures to develop and validate a set of performance indicators aligned with WHO guidance. These indicators were then applied in a pilot program to construct a robust, patient-centered HCV care pathway. Findings: Paper 1 Epidemiological trends: DAAs significantly improved SVR rates (exceeding 95% across most subgroups), even during the COVID-19 pandemic. Younger individuals and those with genotype 3 became increasingly represented among new HCV diagnoses, underscoring shifting demographics. Treatment uptake slowed in specific high-risk populations (e.g., people who use drugs), suggesting a need for more targeted strategies to reduce lost-to-follow-up cases; Paper 2 Patient’s reported measures: Patients emphasized the importance of streamlined pathways and effective communication with specialists and primary care providers. Positive care experiences correlated with better treatment adherence, whereas gaps in follow-up and administrative delays led to unmet clinical needs. Patient feedback revealed barriers at both the diagnostic and treatment phases, such as stigma, logistical challenges, and fragmented service coordination; Paper 3 Care pathway and performance indicators: A pilot framework of 15 key performance indicators (KPIs) was successfully designed to evaluate four dimensions: prevention, linkage to care, treatment, and outcomes. Implementing this framework in clinical settings highlighted performance strengths (e.g., efficient treatment initiation) and weaknesses (e.g., delays in specific screening programs). The use of longitudinal PREMs/PROMs proved instrumental in capturing patient-centred insights and guiding data-driven interventions to improve retention in care. Conclusions: These three investigations underscore Tuscany’s notable progress toward HCV control. High cure rates with DAAs reflect a successful therapeutic approach, yet real challenges persist—most notably, identifying asymptomatic infections and engaging vulnerable or marginalized groups in sustained care. Embedding patient-reported measures and standardized performance indicators into routine practice can strengthen existing strategies by illuminating quality gaps and ensuring that interventions are both evidence-based and patient-centred. This integrated model, which combines epidemiological surveillance with comprehensive patient feedback, offers a scalable blueprint for regions aiming to achieve the WHO’s 2030 elimination targets.