The Clinical and Economic Benefits of a New Paradigm of HCV Diagnosis and Treatment


  • Stefano Fagiuoli Gastroenterology, Hepatology and Transplantation Unit, Department of Medicine, Papa Giovanni XXIII Hospital, Bergamo - Italy
  • Matteo Ruggeri National Center for HTA, Istituto Superiore di Sanità, Rome and St. Camillus International University of Health and Medical Sciences, Rome - Italy
  • Filipa Aragao Maple Health Group, LLC, New York - US and NOVA National School of Public Health, Public Health Research Centre, Universidade NOVA de Lisboa, Lisbon - Portugal
  • Rob Blissett Maple Health Group, LLC, New York - USA



Cost, Hepatitis C virus, Liver disease, Retention, Simplification


Introduction: The current paradigm (CP) of hepatitis C virus (HCV) diagnosis and treatment in Italy’s National Health Service system has numerous steps. The European Association for the Study of the Liver recommends initiation of a pan-genotypic direct-acting antiviral regimen after a simple diagnostic process. The present study estimated the efficiency gains resulting from two simplified pathways from diagnosis to treatment of chronic hepatitis C patients in Italy over the next 5 years from a societal perspective.

Methods: The CP, a New Paradigm 1 (NP1), and a New Paradigm 2 (NP2) were evaluated in a Markov model. The NP1 model simplifies monitoring and laboratory test requirements in the diagnosis and treatment phases. The NP2 model also eliminates the primary care referral requirement.

Results: Treatment process time for non-cirrhotic patients was 48, 43, and 25 weeks in the CP, NP1, and NP2, respectively, and in cirrhotic patients was 49, 46, and 37 weeks. Under the CP, 19% of patients/year would be lost to follow-up, which decreases by 11% in NP1 and 100% in NP2. Compared with the CP, implementation of NP1 at 5 years would reduce compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liverrelated deaths by 12.6%, 12.4%, 8.1%, and 8.8%, respectively; these cases would be reduced by 94.0%, 93.8%, 61.0%, and 58.4% in NP2. Total 5-year costs with the CP, NP1, and NP2 are estimated at 135.6€ million, 110.5€ million, and 80.5€ million, respectively.

Conclusions: Simplification of HCV diagnosis and monitoring requirements would allow Italy to move closer to international guidelines with significant health benefits and economic gains.


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How to Cite

Fagiuoli, S., Ruggeri, M., Aragao, F., & Blissett, R. (2021). The Clinical and Economic Benefits of a New Paradigm of HCV Diagnosis and Treatment. Global and Regional Health Technology Assessment, 8(1), 58–66.



Original Research Articles


Received 2020-09-14
Accepted 2021-02-15
Published 2021-04-15


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