New therapeutic options became available in 2015 in the European Union. We present the availability of interferon-free regimens with direct acting antivirals (DAA) in four Central European countries – the Czech Republic, Hungary, Poland and Slovakia – which despite similar historical, geographical and economic situations demonstrate different systems for access to anti-HCV (hepatitis C virus) medication. Treatment of patients in the Czech Republic was based in 2015 on an exceptional individual reimbursement procedure, but regular reimbursement procedures are expected in 2016. In Hungary the decision for treatment is balanced against budget limitations and the national Priority Index system reflecting stage of liver disease, activity of the disease and predictive factors. A reimbursed interferon (IFN)-free therapeutic program for all genotypes, without restrictions related to hepatic fibrosis and treatment history, is already available in Poland. In Slovakia patients with advanced fibrosis are currently selected for possible IFN-free therapy in 2016.
The clinical trials of the COVID-19 vaccines that are authorized in the European Union have revealed high efficacy in preventing symptomatic infections. However, during vaccination campaigns, some vaccine recipients, including those partially and fully vaccinated, will experience severe COVID-19, requiring hospitalization. This may particularly concern patients with a diminished immune response to the vaccine, as well as non-responders. This work has retrospectively analyzed the 92 cases of patients who were hospitalized between 27 December 2020 and 31 May 2021 in four Polish healthcare units due to COVID-19, and who have previously received the COVID-19 vaccine (54.3% ≤ 14 days after the first dose, 26.1% > 14 days after the first dose, 7.6% ≤ 14 days after the second dose, and 12% > 14 days after the second dose). These patients represented a minute fraction (1.2%) of all the COVID-19 patients who were hospitalized during the same period in the same healthcare institutions. No significant differences in white blood count, absolute lymphocyte count nadir, C-reactive protein, interleukin-6, procalcitonin, oxygen saturation, lung involvement, and fever frequency were found between the recipients of the first and second vaccine dose. A total of 15 deaths were noted (1.1% of all fatal COVID-19 cases in the considered period and healthcare units), including six in patients who received the second dose (five > 14 days after the second dose)—three of these subjects were using immunosuppressive medicines, and two were confirmed to be vaccine non-responders. The study reassures that severe COVID-19 and deaths are not common in vaccinated individuals, highlights that the clinical course in such patients may not reveal any distinctive features, and advocates for close monitoring of those at a higher risk of vaccine failure.
AIM OF THE STUDY: To collect and analyse data obtained from HCV opinion leaders/experts from central European countries, on factors which can affect the WHO target of HCV elimination by 2030. MATERIAL AND METHODS: Data were collected from opinion leaders/experts involved in management of HCV infections in Central European countries which participated in 9(th) Conference of the Central European Hepatologic Collaboration (Warsaw, 10-11 October 2019). A dedicated questionnaire collected current information related to HCV elimination in Bulgaria, Croatia, the Czech Republic, Hungary, Latvia, Lithuania, Poland and Slovakia. RESULTS: The HCV prevalence rate in particular countries varied from 0.2% to 1.7%. In most central European countries all the HCV infected population is eligible for reimbursement of treatment. However, in some countries there are still some limitations related to the stage of the disease and people who inject drugs. All countries have access to at least one pangenotypic regimen. The most common barrier to HCV elimination in all countries is insufficient political will to establish priority for HCV. None of the reporting countries has established a national screening programme. CONCLUSIONS: Access to therapy for HCV is similar and the majority of patients in Central Europe can be treated according to the current guidelines. Unfortunately there are still some limitations and a lack of political will to implement national screening programmes. According to collected data HCV elimination will not be possible in the region by 2030.
Aim of the study: To collect and analyse data obtained from HCV opinion leaders/experts from central European countries, on factors which can affect the WHO target of HCV elimination by 2030. Material and methods: Data were collected from opinion leaders/experts involved in management of HCV infections in Central European countries which participated in 9th Conference of the Central European Hepatologic Collaboration (Warsaw, 10-11 October 2019). A dedicated questionnaire collected current information related to HCV elimination in Bulgaria, Croatia, the Czech Republic, Hungary, Latvia, Lithuania, Poland and Slovakia. Results: The HCV prevalence rate in particular countries varied from 0.2% to 1.7%. In most central European countries all the HCV infected population is eligible for reimbursement of treatment. However, in some countries there are still some limitations related to the stage of the disease and people who inject drugs. All countries have access to at least one pangenotypic regimen. The most common barrier to HCV elimination in all countries is insufficient political will to establish priority for HCV. None of the reporting countries has established a national screening programme. Conclusions: Access to therapy for HCV is similar and the majority of patients in Central Europe can be treated according to the current guidelines. Unfortunately there are still some limitations and a lack of political will to implement national screening programmes. According to collected data HCV elimination will not be possible in the region by 2030.
Aim of the study: To collect and analyse data obtained from HCV opinion leaders/experts from central European countries, on factors which can affect the WHO target of HCV elimination by 2030. Material and methods: Data were collected from opinion leaders/experts involved in management of HCV infections in Central European countries which participated in 9th Conference of the Central European Hepatologic Collaboration (Warsaw, 10-11 October 2019). A dedicated questionnaire collected current information related to HCV elimination in Bulgaria, Croatia, the Czech Republic, Hungary, Latvia, Lithuania, Poland and Slovakia. Results: The HCV prevalence rate in particular countries varied from 0.2% to 1.7%. In most central European countries all the HCV infected population is eligible for reimbursement of treatment. However, in some countries there are still some limitations related to the stage of the disease and people who inject drugs. All countries have access to at least one pangenotypic regimen. The most common barrier to HCV elimination in all countries is insufficient political will to establish priority for HCV. None of the reporting countries has established a national screening programme. Conclusions: Access to therapy for HCV is similar and the majority of patients in Central Europe can be treated according to the current guidelines. Unfortunately there are still some limitations and a lack of political will to implement national screening programmes. According to collected data HCV elimination will not be possible in the region by 2030.
In: Ecotoxicology and environmental safety: EES ; official journal of the International Society of Ecotoxicology and Environmental safety, Band 239, S. 113651
COVID-19 vaccinations are about to begin in various countries or are already ongoing. This is an unprecedented operation that is also met with a loud response from anti-vaccine communities—currently using all available channels to manipulate public opinion. At the same time, the strategy to educate on vaccinations, explain their mechanism of action, and build trust in science is subdued in different world parts. Such actions should go much beyond campaigns promoting the COVID-19 vaccines solely on the information provided by the health institutions and national authorities. In this paper, actions provided by independent expert groups needed to counteract the anti-vaccine propaganda and provide scientific-based information to the general public are offered. These actions encompass organizing groups continuously communicating science on COVID-19 vaccines to the general public; tracking and tackling emerging and circulating fake news; and equipping celebrities and politicians with scientific information to ensure the quality of messages they communicate, as well as public letters, and statements of support for vaccination by healthcare workers, recognized scientists, VIPs, and scientific societies; and no tolerance to false and manipulated claims on vaccination spread via traditional and social media as well as by health professionals, scientists, and academics. These activities should be promptly implemented worldwide, regardless of the current status and availability of the COVID-19 vaccine in a particular region. If we are about to control the pandemic for the sake of public benefit, it is high time to collectively speak out as academic and medical societies with support from decision-makers. Otherwise, the battle will be lost to those who stand against scientific evidence while offering no feasible solution to the problem.
Dorota Zarębska-Michaluk,1 Jerzy Jaroszewicz,2 Magdalena Rogalska,3 Diana Martonik,3 Paweł Pabjan,1 Aleksandra Berkan-Kawińska,4 Beata Bolewska,5 Barbara Oczko-Grzesik,2 Dorota Kozielewicz,6 Magdalena Tudrujek-Zdunek,7 Justyna Kowalska,8 Anna Moniuszko-Malinowska,9 Krzysztof Kłos,10 Marta Rorat,11,12 Piotr Leszczyński,13,14 Anna Piekarska,4 Joanna Polańska,15 Robert Flisiak3 1Department of Infectious Diseases, Jan Kochanowski University, Kielce, 25-369, Poland; 2Department of Infectious Diseases and Hepatology, Medical University of Silesia, Katowice, 40-055, Poland; 3Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, 15-089, Poland; 4Department of Infectious Diseases and Hepatology, Medical University of ŁÃ³dź, ŁÃ³dź, 90-549, Poland; 5Department of Infectious Diseases, University of Medical Sciences, Poznań, 61-701, Poland; 6Department of Infectious Diseases and Hepatology, Faculty of Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń, 87-100, Poland; 7Department of Infectious Diseases and Hepatology, Medical University of Lublin, Lublin, 20-059, Poland; 8Department of Adults' Infectious Diseases, Medical University of Warsaw, Warsaw, 02-091, Poland; 9Department of Infectious Diseases and Neuroinfections, Medical University of Białystok, Białystok, 15-089, Poland; 10Department of Infectious Diseases and Allergology, Military Institute of Medicine, Warsaw, 04-141, Poland; 11Department of Forensic Medicine, Wrocław Medical University, Wrocław, 50-367, Poland; 12First Infectious Diseases Ward, Gromkowski Regional Specialist Hospital in Wrocław, Wrocław, 51-149, Poland; 13Department of Rheumatology, Rehabilitation and Internal Medicine, Poznan University of Medical Sciences, Poznań, 61-701, Poland; 14Department of Rheumatology and Osteoporosis, Szpital im. J. Strusia w Poznaniu, Poznań, 61-285, Poland; 15Silesian University of Technology, Gliwice, 44-100, PolandCorrespondence: Dorota Zarębska-MichalukDepartment of Infectious Diseases, Jan Kochanowski University in Kielce, Ul. Radiowa 7, Kielce, 25-317, PolandTel +48 662441465Fax +48 41 3682262Email dorota1010@tlen.plPurpose: The pathogenesis of coronavirus disease 2019 (COVID-19) is complicated, and in addition to antiviral therapy and combating coagulopathy, treatment should also include inhibition of the proinflammatory cytokines overproduction. The purpose of this study is to compare the effectiveness of tocilizumab (TCZ) and dexamethasone (DEX) administered alone or in combination in patients with severe COVID-19.Patients and Methods: Patients were selected from the SARSTer database, containing 3330 individuals with COVID-19 treated between 1 March 2020 and 10 March 2021. The current study included adult patients with baseline oxygen saturation (SpO2) ≤ 90%, requiring regular or non-invasive high-flow oxygen supplementation.Results: Among included 460 patients, 59 were treated with TCZ, 125 with TCZ and DEX, 169 with DEX, and 107 did not receive TCZ nor DEX. The groups were balanced regarding demographics, coexisting diseases, baseline SpO2, and comedications with remdesivir or low-molecular-weight heparin. The death rate of 6.8% was significantly lower in patients receiving TCZ alone than each arm (19.6%– 23.1%), particularly in patients with interleukin-6 concentration exceeding 100pg/mL (5% vs 22.9%– 51.7%, respectively). Analysis of clinical improvement demonstrated doubled, significantly higher rate after 21 and 28 days in patients treated with TCZ alone (60% and 75%, respectively) compared to DEX (27.6% and 37.9%, respectively). The need for mechanical ventilation was similar in all arms.Conclusion: In patients with severe course of COVID-19, particularly those developing cytokine storm, administration of TCZ provides a significantly better effect than DEX regarding survival, clinical improvement, and hospital discharge rate. The combination of TCZ and DEX does not improve therapy effectiveness in patients with severe COVID-19 compared to the administration of TCZ alone.Keywords: SARS-CoV-2, COVID-19, tocilizumab, dexamethasone, cytokine storm
In: Marshall , A D , Cunningham , E B , Nielsen , S , Aghemo , A , Alho , H , Backmund , M , Bruggmann , P , Dalgard , O , Seguin-Devaux , C , Flisiak , R , Foster , G R , Gheorghe , L , Goldberg , D , Goulis , I , Hickman , M , Hoffmann , P , Jancoriene , L , Jarcuska , P , Kåberg , M , Kostrikis , L G , Makara , M , Maimets , M , Marinho , R T , Maticic , M , Norris , S , Ólafsson , S , Øvrehus , A , Pawlotsky , J-M , Pocock , J , Robaeys , G , Roncero , C , Simonova , M , Sperl , J , Tait , M , Tolmane , I , Tomaselli , S , van der Valk , M , Vince , A , Dore , G J , Lazarus , J V & Grebely , J 2018 , ' Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe ' , The Lancet Gastroenterology & Hepatology , vol. 3 , no. 2 , pp. 125–133 . https://doi.org/10.1016/S2468-1253(17)30284-4
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.
In: Marshall , A D , Cunningham , E B , Nielsen , S , Aghemo , A , Alho , H , Backmund , M , Bruggmann , P , Dalgard , O , Seguin-Devaux , C , Flisiak , R , Foster , G R , Gheorghe , L , Goldberg , D , Goulis , I , Hickman , M , Hoffmann , P , Jancorienė , L , Jarcuska , P , Kåberg , M , Kostrikis , L G , Makara , M , Maimets , M , Marinho , R T , Matičič , M , Norris , S , Ólafsson , S , Øvrehus , A , Pawlotsky , J-M , Pocock , J , Robaeys , G , Roncero , C , Simonova , M , Sperl , J , Tait , M , Tolmane , I , Tomaselli , S , van der Valk , M , Vince , A , Dore , G J , Lazarus , J V , Grebely , J 2018 , ' Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe ' , Lancet Gastroenterology and Hepatology , vol. 3 , no. 2 , pp. 125–133 . https://doi.org/10.1016/S2468-1253(17)30284-4
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.
In: Marshall , A D , Cunningham , E B , Nielsen , S , Aghemo , A , Alho , H , Backmund , M , Bruggmann , P , Dalgard , O , Seguin-Devaux , C , Flisiak , R , Foster , G R , Gheorghe , L , Goldberg , D , Goulis , I , Hickman , M , Hoffmann , P , Jancorienė , L , Jarcuska , P , Kåberg , M , Kostrikis , L G , Makara , M , Maimets , M , Marinho , R T , Matičič , M , Norris , S , Ólafsson , S , Øvrehus , A , Pawlotsky , J-M , Pocock , J , Robaeys , G , Roncero , C , Simonova , M , Sperl , J , Tait , M , Tolmane , I , Tomaselli , S , van der Valk , M , Vince , A , Dore , G J , Lazarus , J V , Grebely , J & International Network on Hepatitis in Substance Users (INHSU) 2018 , ' Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe ' , The Lancet Gastroenterology & Hepatology , vol. 3 , no. 2 , pp. 125-133 . https://doi.org/10.1016/S2468-1253(17)30284-4
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.