نبذة مختصرة : The protease inhibitors (PI) actively using for the treatment of chronic hepatitis C (CHC).The aim of this analysis was to evaluate the cost-effectiveness of narlaprevir and simeprevir in the CHC (genotype 1) therapy in treatment-naïve patients and relapses.Material and methods. Analysis of the cost-effectiveness of simeprevir and narlaprevir was conducted from the perspective of the health care system and base on QUEST-1, QUEST-2, ASPIRE and PIONEER clinical trials. The relative risk of achieving SVR 24 compared to the peg-INF + RBV therapy was used in the model. Treatment discontinuation in patients receiving narlaprevir assumed in the absence of a SVR after 12 weeks and in patients receiving simeprevir in the SVR absence after 4 weeks. The cost of narlaprevir was calculate based on estimated registration price in case of EDL (essential pharmaceutical list approved by MOH) inclusion, including VAT (10%) and 10% as trade margin. Costs of other antiviral products were in line with the results of 2015 average auctions prices.Results. In the base case costs on antiviral products with narlaprevir as first-line therapy are lower compared with simeprevir by 12,2% (950,6 and 1083,0 thousand RUR, respectively), and the cost per patient with SVR 24 by 7,8%. In patients group after relapse costs on antiviral products with narlaprevir as first-line therapy will decrease compared with simeprevir by 4,3% (971,3 and 1014,7 thousand RUR, respectively), and the cost per patient with SVR 24 by 25,0%. The sensitivity analysis demonstrated a high reliability of obtained results. Thus, assuming equal clinical effectiveness of narlaprevir and simeprevir, costs of treatment naive patients will be 10.6% lower for narlaprevir group compared to simeprevir group (953,0 and 1066,0 thousand rur, respectively), and by 12,9% for the treatment of relapses (957,9 and 1100,0 thousand RUR, respectively).Conclusions. With comparable clinical efficacy and tolerability of narlaprevir and simeprevir both in treatmentnaïve patients and patients with ...
Relation: https://journal.niidi.ru/jofin/article/view/466/445; EASL Recommendations on Treatment of Hepatitis C 2015 // Journal of Hepatology 2015; 63: 199–236.; Wendt A., Bourlière M. An update on the treatment of genotype-1 chronic hepatitis C infection: lessons from recent clinical trials // Ther. Adv. Infect. Dis. 2013; 1(6): 191-208.; Manns M., Marcellin P., Poordad F., et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial // Lancet 2014; 384 (9941): 414-26.; Jacobson I.M., Dore G.J., Foster G.R., et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatmentnaïve patients with chronic hepatitis c virus genotype 1 infection (QUEST-1): a phase 3, randomized, double-blind, placebocontrolled trial // Lancet 2014; 384: 403-13.; Levin J. Simeprevir (TMC435) in combination with peginterferon and ribavirin for treatment of HCV genotype 1 infection in treatment-naïve and -experienced patients (PILLAR and ASPIRE Trials) // IDSA Oct 17-21 2012 San Diego.; Бакулин, И.Г. Предварительные результаты исследования 3 фазы нового отечественного ингибитора протеазы нарлапревира у первичных и ранее леченных больных хроническим гепатитом С 1 генотипа (исследование PIONEER) / И.Г. Бакулин, Д.Т. Абдурахманов, П.О. Богомолов // Сборник тезисов 42-ой научной сессии ЦНИИГ «Принципы доказательной медицины в клиническую практику», 02–03.03.2016. – С. 20.; https://journal.niidi.ru/jofin/article/view/466; undefined
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