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

Author(s):  
Evgeniya A. Tsitlionok ◽  
Igor A. Narkevich ◽  
Oksana D. Nemyatykh ◽  
Dina D. Siukaeva ◽  
Anastasiya S. Grinyuk ◽  
...  

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.

2011 ◽  
Vol 152 (22) ◽  
pp. 876-881
Author(s):  
Alajos Pár

The review discusses the genetic polymorphisms involved in the pathogenesis of hepatitis C virus (HCV) infection, that may determine the outcome of disease. In this field earlier both certain major histocompatibility complex (MHC) alleles and some cytokine gene variants have also been studied. Recently, the genome-wide association study (GWAS) and targeted single nucleotide polymorphism (SNP) analysis have revealed that a variant in the promoter region of interleukin-28B (IL-28B) gene is strongly linked to viral clearance and it may be the strongest pretreatment predictor of treatment response in chronic hepatitis C. Last year it was shown that two genetic variants leading to inosine triphosphatase deficiency protect against haemolytic anemia in patients receiving ribavirin during antiviral treatment for chronic HCV infection. Orv. Hetil., 2011, 152, 876–881.


Medicina ◽  
2021 ◽  
Vol 57 (6) ◽  
pp. 597
Author(s):  
Bianca Cerbu ◽  
Stelian Pantea ◽  
Felix Bratosin ◽  
Iulia Vidican ◽  
Mirela Turaiche ◽  
...  

Background and Objectives: The COVID-19 pandemic is an ongoing public health emergency. Patients with chronic diseases are at greater risk for complications and poor outcomes. The objective of this study was to investigate the liver function abnormalities and clinical outcomes in patients with COVID-19 and chronic hepatitis C. Materials and Methods: This retrospective, single-center study was conducted on a cohort of 126 patients with a history of hepatitis C, confirmed with COVID-19 between 01 April 2020 and 30 December 2020. Several clinical outcomes were compared between patients with active and non-active HCV infection, and the risks of liver impairment and all-cause mortality in active HCV patients were analyzed using a multivariate logistic regression model. Results: Among 1057 patients under follow-up for chronic HCV infection, 126 (11.9%) were confirmed with COVID-19; of these, 95 (75.4%) were under treatment or achieved SVR, while in the other 31 (24.6%), we found active HCV replication. There was a significantly higher proportion of severe COVID-19 cases in the active HCV group as compared to the non-active HCV group (32.2 vs. 7.3%, p < 0.001). Multivariate analysis showed that age, sex, alanine aminotransferase, C-reactive protein, procalcitonin, and HCV viral load were significant independent risk factors for liver impairment and all-cause mortality. The length of stay in hospital and intensive care unit for COVID-19 was significantly higher in patients with active HCV infection (p-value < 0.001), and a higher proportion of these patients required mechanical ventilation. Conclusions: Active HCV infection is an independent risk factor for all-cause mortality in COVID-19 patients.


Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1103
Author(s):  
Keyla Santos Guedes de Sá ◽  
Ednelza da Silva Graça Amoras ◽  
Simone Regina Souza da Silva Conde ◽  
Maria Alice Freitas Queiroz ◽  
Izaura Maria Vieira Cayres-Vallinoto ◽  
...  

An inefficient immune response against the hepatitis C virus (HCV), combined with viral evasion mechanisms, is responsible for the chronicity of infection. The need to evaluate the innate mechanisms of the immune response, such as TLR3 and IFN-λ3, and their relationship with the virus–host interaction is important for understanding the pathogenesis of chronic hepatitis C. The present study aimed to investigate the gene expressions of TRL3 and IFNL3 in liver tissue, seeking to evaluate whether these could be potential biomarkers of HCV infection. A total of 23 liver biopsy samples were collected from patients with chronic HCV, and 8 biopsies were collected from healthy control patients. RNA extraction, reverse transcription and qPCR were performed to quantify the relative gene expressions of TLR3 and IFNL3. Data on the viral load; AST, ALT, GGT and AFP levels; and the viral genotype were collected from the patients′ medical records. The intrahepatic expression of TLR3 (p = 0.0326) was higher in chronic HCV carriers than in the control group, and the expression of IFNL3 (p = 0.0037) was lower in chronic HCV carriers than in the healthy control group. The expression levels of TLR3 (p = 0.0030) and IFNL3 (p = 0.0036) were higher in the early stages of fibrosis and of necroinflammatory activity in the liver; in contrast, TLR3 and IFNL3 expressions were lower in the more advanced stages of fibrosis and inflammation. There was no correlation between the gene expression and the serum viral load. Regarding the initial METAVIR scale scores, liver transaminase levels were lower in patients with advanced fibrosis when correlated with TLR3 and IFNL3 gene expressions. The results suggest that in the early stages of the development of hepatic fibrosis, TLR3 and IFN-λ3 play important roles in the antiviral response and in the modulation of the tolerogenic liver environment because there is a decrease in the intrahepatic expressions of TLR3 and IFNL3 in the advanced stages of fibrosis, probably due to viral evasion mechanisms.


2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Ossama Ashraf Ahmed ◽  
Eslam Safwat ◽  
Mohamed Omar Khalifa ◽  
Ahmed I. Elshafie ◽  
Mohamed Hassan Ahmed Fouad ◽  
...  

Background and Aims. As indicated by the World Health Organization (WHO), Egypt is positioned as the country with the world’s highest prevalence of Hepatitis C virus (HCV). HCV is transmitted through unexamined blood transfusions, different employments of syringes, and poor cleansing, as per the WHO. Our study aimed at screening and management of chronic hepatitis C genotype 4 infected patients in Bardeen village, Sharkeya Governorate, Egypt, with Sofosbuvir plus Daclatasvir, as well as estimating the safety and efficacy of that regimen. Methods. Screening of adult patients in Bardeen village was done from March 2016 till November 2016 using hepatitis C virus antibodies by third-generation ELISA testing. Positive results were confirmed by PCR. Patients eligible for treatment received Sofosbuvir 400 mg and Daclatasvir 60 mg daily for 12 weeks and were assessed for sustained virologic response at 12 weeks following the end of treatment (SVR 12). Results. Out of 2047 subjects screened for hepatitis C virus, 249 (12.2%) showed positive results. 221 out of those 249 subjects (88.7%) had detectable RNA by PCR. Treatment of eligible patients (183 patients) with Sofosbuvir plus Daclatasvir for 12 weeks resulted in 96% achievement of sustained virologic response at week 12. Adverse events were tolerable. Conclusion. Sofosbuvir plus Daclatasvir regimen is safe and effective for treatment of chronic hepatitis C Genotype 4 infected patients with minimal adverse events. HCV eradication program implemented in Egypt can be a model for other countries with HCV and limited resources. The availability of generic drugs in Egypt will help much in eradication of the virus.


2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Mostafa M. Sira ◽  
Behairy E. Behairy ◽  
Azza M. Abd-Elaziz ◽  
Sameh A. Abd Elnaby ◽  
Ehab E. Eltahan

Liver fibrosis and viremia are determinant factors for the treatment policy and its outcome in chronic hepatitis C virus (HCV) infection. We aimed to investigate serum level of inter-alpha-trypsin inhibitor heavy chain 4 (ITIH4) and its relation to liver fibrosis and viremia in children with chronic HCV. ITIH4 was measured by ELISA in 33 treatment-naive children with proved chronic HCV and compared according to different clinical, laboratory and histopathological parameters. Liver histopathological changes were assessed using Ishak score and compared with aspartate transaminase-to-platelet ratio (APRI) and FIB-4 indices as simple noninvasive markers of fibrosis. ITIH4 was measured in a group of 30 age- and sex-matched healthy controls. ITIH4 was significantly higher in patients than in controls (54.2±30.78 pg/mL versus 37.21±5.39 pg/mL; P=0.021). ITIH4, but not APRI or FIB-4, had a significant direct correlation with fibrosis stage (P=0.015, 0.961, and 0.389, resp.), whereas, the negative correlation of ITIH4 with HCV viremia was of marginal significance (P=0.071). In conclusion, ITIH4 significantly correlated with higher stages of fibrosis indicating a possible relation to liver fibrogenesis. The trend of higher ITIH4 with lower viremia points out a potential antiviral properties and further studies in this regard are worthwhile.


2019 ◽  
Vol 2 (1) ◽  
pp. 23-30
Author(s):  
Mark Collister ◽  
Julia Rempel ◽  
Jiaqi Yang ◽  
Kelly Kaita ◽  
Zach Raizman ◽  
...  

Background: Interleukin 32 (IL-32) is a recently described pro-inflammatory cytokine implicated in chronic hepatitis C virus (HCV)-related inflammation and fibrosis. IL-32α is the most abundant IL-32 isoform. Methods: Circulating IL-32α levels were documented in patients with chronic HCV infections ( n = 31) and compared with individuals who spontaneously resolved HCV infection ( n = 14) and HCV-naive controls ( n = 20). In addition, peripheral blood mononuclear cells (PBMC) from the chronic HCV ( n = 12) and HCV-naive ( n = 9) cohorts were investigated for responses to HCV core and non-structural (NS)3 protein induced IL-32α production. Finally, correlations between IL-32α levels, hepatic fibrosis and subsequent responses to interferon-based therapy were documented in patients with chronic HCV. Results: Circulating IL-32α levels in patients with chronic HCV were similar to those of spontaneously resolved and HCV-naive controls. HCV protein induced IL-32α responses were similar in chronic HCV patients and HCV-naive controls. In patients with chronic HCV, serum IL-32α levels correlated with worsening METAVIR fibrosis (F) scores from F0 to F3 ( r = 0.596, P < 0.001) as did NS3 induced IL-32α responses ( r = 0.837, P < 0.05). However, these correlations were not sustained with the inclusion of IL-32α levels at F4 scores, suggesting events at F4 interfere with IL-32α synthesis or release. In chronic HCV patients who underwent treatment ( n = 28), baseline in vivo and in vitro induced IL-32α concentrations were not predictive of therapeutic outcomes. Conclusions: IL-32α activity is associated with worsening fibrosis scores in non-cirrhotic, chronic HCV patients.


Cells ◽  
2018 ◽  
Vol 7 (11) ◽  
pp. 185
Author(s):  
Salwa Abo El-khair ◽  
Mona Arafa ◽  
Tarek Besheer ◽  
Ahmed El-Eraky ◽  
Ayman Elsamanoudy

Chronic hepatitis C is implicated in insulin resistance (IR) susceptibility. An X-ray repair cross-complementing group 1 gene (XRCC1) is proposed to be a candidate gene for a study of IR susceptibility. So, this study aims to investigate the possible association of the XRCC1 gene polymorphisms with the risk of IR related to chronic hepatitis C virus (HCV) infection in Egyptian patients. In a case-control study, a total of 210 subjects, including 140 chronic HCV patients (87 patients with IR and 53 without IR) and 70 healthy controls, were included. Two genetic polymorphisms (c.1254C > T and c.1517G > C) of the XRCC1 gene were genotyped via the PCR-restriction fragment length polymorphism (PCR-RFLP) technique. The result of the current study revealed that these two single nucleotide polymorphisms (SNPs) have statistically significant influences on susceptibility to IR in chronic HCV infected Egyptian patients. It could be concluded that c.1254C > T, the TT genotype, CT/CC carriers as well as c.1517G > C, the CC genotype and GC/GG carriers might be associated with increased IR susceptibility. Moreover, T-allele of c.1254C > T and the C-allele of c.1517G > C genetic variants might influence the susceptibility.


JMS SKIMS ◽  
2010 ◽  
Vol 13 (2) ◽  
pp. 39-40
Author(s):  
Showkat Ali Zargar

Chronic hepatitis C is highly prevalent with prevalence rate of around 3% involving about 180 million people worldwide, despite major advances in its understanding of viral 1 pathogenesis and significant evolution in antiviral therapies. Most of the patients develop chronic infection because the virus evades the host immune response in majority of patients. Chronic HCV infection can lead to cirrhosis and hepatocellular carcinoma. Complications of HCV-related cirrhosis are the leading indication for liver transplantation in United States and Europe...... J Med Sci 2010;13(2): 39-40.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Mohammed Abd Elfattah Elmalatawy ◽  
Khaled Zakaria Elqarmoty ◽  
Hany Samir Rasmy ◽  
Ebrahim Youssef Abdelwarth

Abstract Background Hepatitis c virus is global health burden and major health hazard in Egypt, since the virus is the etiological factor of chronic hepatitis that frequently progress to a cirrhosis and hepatocellular carcinoma (HCC). In addition to cirrhosis and hepatocellular carcinoma, HCV is thought to cause metabolic alterations, including steatosis, dyslipidemia, insulin resistance (IR), diabetes, obesity, and cardiovascular events. Objective To determine the value of RPB4 in the prediction of response to new DAAS treatment in chronic HCV infected patients and to correlate its level with the metabolic profile and fibrosis degree among chronic HCV Patients and Methods This study was Prospective cohort clinical study that was conducted at hepatology and virology outpatient clinic at Ain Shams University Hospital &Hepatology and virology outpatient clinic at Kafr –El Sheikh liver institute from January 2019 to October 2019 after informed consent. Results The present study showed that the best level of RBP4 in prediction of hepatic fibrosis stage 4 was ≤ 46 pg/ml and had sensitivity of 100% while the specificity was 66.67%.The positive predictive value was 50%while the negative predictive value was 100% and test accuracy was 80.5%. Conclusion Serum RBP4 was found to be higher in chronic hepatitis C naïve patients than normal person; there was significant reduction of RBP4 post treatment. Fibroscan showed marked reduction of fibrosis degree after treatment with Directly acting antiviral in both cirrhotic and noncirrhotic patients regardless the treatment regimen used with improved overall liver function tests, liver enzymes and platelet count in patients who reached SVR and maintained negative PCR after treatment.


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