Cost analysis of residual viremia detected by two real-time PCR assays for response-guided (dual or triple) therapy of HCV genotype 1 infection

Analisi Economica Associata all'utilizzo Di Due Test (Real-Time PCR-Based) per Valutare La Determinazione Dell'HCV-RNA Nei Pazienti HCV Genotipo 1 in Trattamento Con Duplice o Triplice Terapia

Abstract

Introduction The duration of interferon-based dual and triple therapies for HCV-G1 is determined by assessment of early viral kinetics. We conducted a cost analysis to determine the mean cost of dual or triple therapy treatment for a patient with HCV-G1, where the therapy duration (24 or 48 weeks) is guided by HCV-RNA assay. Methods HCV-RNA was assessed by two widely used real-time PCR-based assays, Cobas Ampliprep/Cobas TaqMan (CAP-CTM) and Real-Time HCV (ART). As far as the dual therapy (PegINFα-2b and RBV) is concerned, at week 12 of treatment 16.0% of patients (27/169) were eligible to receive a shorter duration of therapy (24 weeks) according to CAP-CTM and 8.9% (15/169) according to ART: 26 patients achieved SVR (15.4%) with CAP-CTM and 15 with ART (8.9%). With regard to triple therapy (TPV, PegINFα-2a and RBV), at week 12 of treatment 59.6% of patients (31/52) were eligible to receive a shorter duration of therapy (24 weeks) according to CAP-CTM and 28.8% (15/52) according to ART: 30 patients achieved SVR (57.7%) with CAP-CTM and 13 with ART (25.0%). The cost analysis was conducted from the perspective of the Italian National Health Service (NHS). Only drug (TPV, PegINFα-2a, PegINFα-2b and RBV) and test (CAP-CTM and ART) costs were taken into account. Ex-factory prices (included all discounts) and national tariffs were used to calculate drug consumptions and tests, respectively. Costs were assessed in Euros 2015. Results With regard to dual therapy, the overall mean treatment cost per patient with CAP-CTM (€9,572.77) was lower than with ART (€9,876.19). With regard to triple therapy, the overall mean treatment cost per patient was lower with CAP-CTM (€31,354.40) than with ART (€33,155.26). Conclusions CAP-CTM HCV-RNA assay was cost-saving from the Italian NHS perspective compared with ART HCV-RNA assay in the dual (-€303.42 per patient) and triple (-€1,800.96 per patient) HCV therapy.