title: Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy.
abstract: The WHO estimates that more than 185 million people are infected with hepatitis C virus (HCV) worldwide. The aim of the study is to assess the incremental cost-effectiveness ratio (ICER) of the use of daclatasvir (DCV) + sofosbuvir (SOF) + ribavirin (RBV) for 12 and 16 weeks vs SOF + RBV for 16 and 24 weeks for the treatment of genotype 3 HCV infected cirrhotic patients from the Italian National Health Service (NHS) perspective. A published cohort-based Markov model was used to perform the analysis estimating the lifetime direct medical costs associated with the management of the pathology and the quality adjusted life years gained by patients. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. SOF + RBV for 16 weeks was excluded from the analysis due to the significant lower effectiveness, compared with SOF + RBV for 24 weeks (51% vs 79%). DCV + SOF + RBV would increase QALYs and costs in all the comparisons: the ICERs obtained comparing DCV + SOF + RBV for 12 and 16 weeks with SOF + RBV for 24 weeks (reference scenario) are 38,572 €/QALY and 16,436 €/QALY, respectively, both below the 40,000 €/QALY threshold identified by the Italian Health Economics Association. Sensitivity analyses confirmed the robustness of the results. The use of DCV + SOF + RBV is likely to be cost-effective compared with SOF + RBV (for 24 weeks) for the treatment of cirrhotic patients infected with genotype 3 HCV considering a threshold value of 40,000 €/QALY.
authors.affiliation: School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. urestelli@gmail.com.|Centre for Research on Health Economics, Social and Health Care Management (CREMS)-LIUC-Carlo Cattaneo Univerity, Castellanza, VA, Italy. urestelli@gmail.com.
authors.forename: Umberto
authors.initials: U
authors.lastname: Restelli
authors.affiliation: Department of Molecular Medicine, University of Padua, Padua, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Alberti
authors.affiliation: Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.affiliation: Centre for Research on Health Economics, Social and Health Care Management (CREMS)-LIUC-Carlo Cattaneo Univerity, Castellanza, VA, Italy.
authors.forename: Marzia
authors.initials: M
authors.lastname: Bonfanti
authors.affiliation: Health Economic and Outcome Research Bristol Myers Squibb S.r.l., Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Nappi
authors.affiliation: School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.|Centre for Research on Health Economics, Social and Health Care Management (CREMS)-LIUC-Carlo Cattaneo Univerity, Castellanza, VA, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Croce
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D002219:Carbamates; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005838:Genotype; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000191:economics / Q000627:therapeutic use; D007558:Italy; D008103:Liver Cirrhosis; D011759:Pyrrolidines; D012254:Ribavirin / Q000191:economics / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000191:economics / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D012254:Ribavirin; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: Cost-effectiveness analysis; Daclatasvir; Hepatitis C virus; Italy