Multi-vector analysis of the market for drugs used to treat hepatitis C

Наркевич, И. А.; Анатольевич, Наркевич Игорь; Nemyatykh, O. D.; Дмитриевна, Немятых Оксана; Сиукаева, Д. Д.; Динорьевна, Сиукаева Дина; Tsitlionok, Evgenia A.; Алексеевна, Цитлионок Евгения; Lisacenco, Valeria O.; Олеговна, Лисаченко Валерия; Grinyuk, Anastassiya S.; Сергеевна, Гринюк Анастасия

doi:10.17816/phf49892

Pharmacy Formulas

2020

DOI: 10.17816/phf49892

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Multi-vector analysis of the market for drugs used to treat hepatitis C

И. А. Наркевич

Наркевич Игорь Анатольевич²,

O. D. Nemyatykh

et al.

Abstract: The article presents a study on the structural assessment of the range of drugs for the treatment of hepatitis C. Methods of content analysis, data aggregation, grouping, comparative and marketing analysis have been used. The information base of the study was the State Register of Medicines and National Register of Medicines of April 24, 2020, as well as instructions for the medical use of drugs. It was revealed that 52 trade names of medicinal products (23 INN) and 17 substances had been registered in the Rus… Show more

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Development of approaches to the evaluation of pharmacotherapy effectiveness for chronic hepatitis C

Narkevich,

Tsitlionok

2023

Farmakoèkonomika

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Objective: to analyse the consumption pattern of antiviral therapy (AVT) for chronic hepatitis C on the example of an infectious hospital.Material and methods. The study was based on data from 380 discharge summaries of an infectious diseases hospital for 2011–2019. The criterion of sampling was the established diagnosis of chronic hepatitis C. The first line therapy regimens were analyzed and compared; the calculations were based on direct treatment costs of the study sample. The pharmacoeconomic effectiveness of therapy was assessed by calculating the cost-effectiveness ratio (CER).Results. A retrospective analysis of patients’ sampling allowed to establish a general profile: a 40-year-old man with hepatitis C virus genotype 1 and a mild degree of liver fibrosis. A total of 18 international nonproprietary names (17 trade names) were used for AVT. The pattern of drugs prescribed correlated with the clinical guidelines for the studied period and allowed to distinguish the beginning of the transition from interferon-based regimens to direct-acting antivirals (DAAs). The change in the treatment paradigm was associated not only with increased efficacy in achieving a sustained virological response, but also with minimization of side effects. The high frequency of prescribing interferon regimens as AVT was accompanied by low rates of achieving virus elimination (63.69%), high frequency of relapses (12.88%), as well as the lack of response to pharmacological correction (21.32%) and premature discontinuation of therapy due to adverse events (2.11%). A total of 142,450,414.91 rubles was spent on the first line pharmacotherapy in the study cohort during the study period. Costs per 1 patient with the diagnosis “chronic hepatitis C” and F0–F3 fibroses according to METAVIR were 372,847.07 rubles with achieving sustained virologic response without relapse in 66% of cases, costs per patient with F4 liver lesion were 398,464.73 rubles (45,16%, respectively).Conclusion. The findings allow us to note the transition from interferon-, nucleoside- and nucleotide-based drugs to DAAs, which can be associated with an increase in therapy effectiveness and proportion of cases with sustained virologic response achieved along with a decrease in the number of adverse events. The results of the study have practical implications for building a strategy for hepatitis C virus elimination in terms of choosing effective pharmacotherapy while reducing the economic burden.

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Development of approaches to the evaluation of pharmacotherapy effectiveness for chronic hepatitis C

Narkevich,

Tsitlionok

2023

Farmakoèkonomika

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A structural analysis of sales of drugs for the treatment of chronic hepatitis C in the Russian market

Tsitlionok

Наркевич

Немятых

et al. 2021

jour

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The World Health Organization reports that 3-4 mil. people are newly infected with hepatitis C virus per year, of which 70% will develop chronic HCV disease. Viral hepatitis is a significant burden on the state budget due to its prevalence among the working-age population. Increase of antiviral therapy coverage for patients diagnosed with chronic hepatitis C is one of the priorities of healthcare system. The paper presents the results of the analysis of trends in the sales pattern over 2016–2020. The objects of the study were State Register of Medicinal Products (as of February 24, 2020), clinical guidelines of the Ministry of Health of Russia on the pharmacotherapy of chronic hepatitis C, information database of the DSM Group analytical company.It has been established that the sales of drugs used for the treatment of chronic hepatitis C in the Russian pharmaceutical market tend to grow by 17.60% in value terms and 106.16% in physical terms during the period under consideration. At the same time, the composition of dasabuvir + ombitasvir + paritaprevir + ritonavir (in value terms) and ritonavir (in physical terms) accounts for the greatest share among international non-proprietary names. It was revealed that the products of foreign manufacturers prevail in the sales pattern. Abbvie, Johnson & Johnson and AstraZeneca are the leaders among the companies – manufacturers of drugs for the therapy of chronic hepatitis C in terms of sales. It was found that 84.62% of drugs used for the treatment of chronic hepatitis C are included into the VED list.

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Generic drugs of direct antiviral action for the treatment of hepatitis C: features of bioequivalence studies

Eremenko

Уварова²,

Serebrova

et al. 2023

Medicinskij sovet

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Introduction. In the last decade, approaches to the treatment of chronic viral hepatitis C (HCV) have undergone significant changes. The new WHO strategy aims to eliminate HCV by 2030 by reducing the number of new infections and deaths by simplifying hepatitis C therapy. The development of drugs for the treatment of patients with chronic HCV has a number of features, which requires compliance with special recommendations for conducting clinical bioequivalence studies.Aim. The study was to analyze the guidelines and protocols of bioequivalence studies of drugs for HCV therapy. Materials and methods. An information and analytical method was used to evaluate recommendations for conducting bioequivalence studies of HCV drugs according to the US Food and Drug Administration, the European Medicines Agency, and WHO. Separately, an analysis of permitted clinical trials was carried out according to the data of the GRLS of the Ministry of Health of the Russian Federation. Results and discussions. According to the results of the study, it was noted that for the WHO guidelines on the bioequivalence of drugs for HCV therapy, it is common to develop common principles for planning and conducting research. Special attention is paid to the preferred design of the study. It is also necessary to analyze data on the variability of the pharmacokinetic parameters of the substance under study, which are used to calculate the required number of volunteers to be included in the study. Conclusions. Direct antiviral drugs under development for HCV therapy, for which clinical bioequivalence studies are currently being conducted in the Russian Federation, cover a large list of INN. The entry of new reproduced drugs into the pharmaceutical market will improve patients’ access to effective treatment of hepatitis C. In order to conduct a high-quality bioequivalence study, it is necessary to thoroughly familiarize yourself with nosology manuals, critical assessment and analysis of information, which will allow you to choose the appropriate design of the study and correctly plan its conduct.

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Multi-vector analysis of the market for drugs used to treat hepatitis C

Cited by 3 publications

References 1 publication

Development of approaches to the evaluation of pharmacotherapy effectiveness for chronic hepatitis C

Development of approaches to the evaluation of pharmacotherapy effectiveness for chronic hepatitis C

A structural analysis of sales of drugs for the treatment of chronic hepatitis C in the Russian market

Generic drugs of direct antiviral action for the treatment of hepatitis C: features of bioequivalence studies

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