Efficacy of HCV treatment in Poland at the turn of the interferon era – the EpiTer study

Canadian Journal of Gastroenterology and Hepatology

Buczyńska

Simon

et al. 2019

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Background and Aim. The development of interferon- (IFN-) free regimens substantially improved efficacy of treatment for HCV, but despite excellent effectiveness the failures still occur. The aim of our study was to evaluate the efficacy of retreatment with genotype specific direct acting antivirals- (DAA-) based regimens in nonresponders to previous IFN-free therapy. Materials and Methods. Analysed population consisted of 31 nonresponders to IFN-free regimen, which received second IFN-free rescue therapy, selected from 6228 patients included in a national database EpiTer-2. Results. Age and gender distribution were similar, whereas proportion of genotype 1b was slightly higher and genotype 4 lower in the whole population compared to studied one. Patients included in the study demonstrated much more advanced fibrosis. Primary therapy was discontinued in 12 patients, which were recognized as failures due to nonvirologic reason, whereas virologic reason of therapeutic failure was recognized in 19 patients which completed therapy. Overall sustained virologic response (SVR) rate was 81% and 86% in intent-to-treat (ITT) and modified ITT analysis, respectively (74% and 78% in virologic failures, 92% and 100% in nonvirologic failures). Resistance-associated substitutions (RAS) testing was carried out in 8 patients from the group of completed primary therapy and three of them had potential risk for failure of rescue therapy due to NS5A association, while two of them achieved SVR. Conclusions. We demonstrated moderate effectiveness of genotype specific rescue therapy in failures due to virologic reason and high in those who discontinued primary therapy. Therefore rescue therapy with genotype specific regimens should be considered always if more potent regimens are not available.

Section: Introductionmentioning

confidence: 99%

Real World Experience of Chronic Hepatitis C Retreatment with Genotype Specific Regimens in Nonresponders to Previous Interferon-Free Therapy

Canadian Journal of Gastroenterology and Hepatology

Buczyńska

Simon

et al. 2019

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“…Analysis covered by the recently published EpiTer‐1 study clarified distribution of HCV genotypes and efficacy of HCV treatment in Poland at the end of the interferon era between 2013 and 2015 . The EpiTer‐2 study was initiated to follow epidemiologic changes of HCV infection in Poland and its therapeutic implications related to the availability of new, mostly interferon‐free treatment options.…”

Section: Introductionmentioning

confidence: 99%

Treatment of HCV infection in Poland at the beginning of the interferon‐free era—the EpiTer‐2 study

Flisiak

Journal of Viral Hepatitis

Janczewska³

et al. 2018

The aim of the EpiTer-2 study was to analyse patient characteristics and their medication for HCV infection in Poland at the beginning of the interferon-free era. Analysis of data of HCV infected patients treated during the initial period of availability of interferon-free regimens in Poland, who started therapy after 1 July 2015 and had available an efficacy evaluation report before 30 June 2017 was undertaken. A total of 2879 patients with chronic hepatitis C were entered, including 46% with liver cirrhosis. The most common was genotype 1b (86.8%). The study population was gender balanced, the majority of patients were overweight or obese and 69% presented comorbidities, with the highest prevalence that for hypertension. More than half of patients were retreated due to failure of previous therapy with pegylated interferon and ribavirin. Almost two-third of patients received current therapy with ombitasvir/paritaprevir/ritonavir±dasabuvir (OPrD) ±ribavirin. Other patients received mostly sofosbuvir-based regimens including combination with ledipasvir and pegylated interferon and ribavirin for genotype 3-infected patients. Efficacy of treatment in the whole study population measured as intent-to-treat analysis was 95%. The most frequent regimen, administered for patients infected with genotype 1b, was 12 weeks of OPrD, resulting in an SVR rate of 98%. At least one adverse event was reported in 38% of patients, and the death rate was 0.8%. In conclusion, data from the EpiTer-2 study confirmed the excellent efficacy and safety profile of the real-world experience with recently introduced therapeutic options for genotype 1 HCV infection, but demonstrated weakness of the current therapeutic programme regarding genotype 3 infections.

“…The Polish population was established according to the most recent data from the Statistics Poland (SP; Główny Urząd Statystyczny) database for the year 2017. Treatment efficacy was estimated based on publications in time-frames depending on the availability of therapeutic options in Poland [7-13].…”

Section: Methodsmentioning

confidence: 99%

Perspectives of hepatitis C virus (HCV) elimination in Poland

Flisiak

2019

ceh

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Aim of the studyAccording to the World Health Organization (WHO) strategy, elimination of hepatitis C virus (HCV) as a major public health threat by 2030 includes diagnosis and cure of 90% of those infected between 2015 and 2030. The aim of this study is to estimate the realistic possibility to achieve the WHO elimination targets in Poland.Material and methodsThe Polish population was established according to data from Statistics Poland for the year 2017. Treatment efficacy was estimated based on publications in time-frames depending on the availability of therapeutic options in Poland. The mortality of HCV-infected patients was assumed on the basis of Statistics Poland and the EpiTer-2 database The number of annual antiviral treatments was estimated based on data from the National Health Fund. Two scenarios were considered, without and with intervention dependent on the national screening program.ResultsThe current diagnosis rate in Poland was calculated as 31%. The scenario without intervention resulted in gradual reduction of annual treatments accompanied by a decrease in the number of infected patients in 2030 to 118 000 (0.31% of the current Polish population), which is only 38% compared with 2015 established as a baseline by WHO. Introduction of the HCV screening program, which includes 3 million people annually, would increase treatment uptake to 12 000 per year and reduce the number of HCV-infected persons in Poland by 90%.ConclusionsThe urgent implementation of the national screening program for HCV in Poland is essential to achieve the WHO goal by 2030. The screening strategy should include up to 3 million persons annually to achieve treatment uptake of 12 thousand patients per year.