Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 22
Filter
1.
Arch Med Sci ; 18(6): 1460-1466, 2022.
Article in English | MEDLINE | ID: mdl-36457986

ABSTRACT

Introduction: Non-cirrhotic treatment-naive hepatitis C patients infected with genotype 1 can be treated with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks, but in practice this regimen is frequently extended up to 12 weeks at least in part due to insufficient real-world data supporting shortening of treatment. The aim of our study was to compare 8- and 12-week regimens' efficacy in patients eligible for 8-week therapy in a real-world setting. Material and methods: Data of HCV genotype 1 infected patients treated with LDV/SOF between 2015 and 2018 included in the EpiTer-2 database were analyzed with respect to patients' characteristics and length of treatment. Results: Among a total of 1718 patients treated with LDV/SOF, 679 were included in the analysis, 238 (35%) received 8-week regimen, whereas 441 were treated for 12 weeks although they fulfilled the criteria for a shorter course. The majority of patients were infected with genotype 1b (89%) and demonstrated minimal fibrosis (55%). The 12-week regimen was assigned significantly more frequently to patients with comorbidities, concomitant medications and advanced liver fibrosis. The sustained virologic response rate was similar after 8 (98%) and 12 (97%) weeks of therapy according to intent-to-treat analysis and reached 99% in both groups after exclusion of patients lost to follow-up. Conclusions: We confirmed high effectiveness regardless of treatment duration with LDV/SOF in non-cirrhotics infected with HCV genotype 1 eligible for the 8-week regimen according to the current label. This real-world study also demonstrated no need for addition of ribavirin (RBV) in this population and showed that shortening of treatment significantly improves the safety profile of LDV/SOF medication.

2.
J Clin Med ; 11(17)2022 Sep 01.
Article in English | MEDLINE | ID: mdl-36079122

ABSTRACT

Hepatitis C infection is one of the main reasons for liver cirrhosis and hepatocellular carcinoma. In recent years, more and more is being heard about extrahepatic manifestations of the hepatitis C infection including its possible influence on the development of hypertension and cardiovascular diseases. In the given work, the frequency analysis of the incidence of hypertension and cardiovascular diseases among 2898 HCV-infected patients treated in Poland and the assessment of their relevance to the HCV genotype and the progression of liver fibrosis can be found. The prevalence of hypertension in the group of analyzed patients was 39% and was significantly associated with old age (OR = 1.08 (1.07-1.08)) and female sex, as well as the progression of liver fibrosis (OR = 1.54 (1.29-1.85)). Hypertension was found in 47.6% of patients with F4 fibrosis, 42.1% of patients with F3 fibrosis, and 25% of patients with F1 fibrosis. The incidence of cardiovascular disease in the studied group of patients was as follows: all incidents, 131 (4.52%); including ischemic heart disease 104, (3.95%); stroke, 2 (0.07%); atherosclerosis, 21 (0.72%); and aneurysms, 4 (0.14%). The obtained results prove that the prevalence of cardiovascular diseases is significantly associated with the advanced age of patients and the progression of liver fibrosis. The relevance of sex and the HCV genotype to the prevalence frequency of cardiovascular diseases in the study group has not been proven. This being the case, no differences in the frequency of their incidence depending on the HCV genotype, including genotype 3, was found. Hepatitis C infection as a non-classical risk factor for cardiovascular disease and hypertension does require further studying.

3.
J Clin Med ; 11(2)2022 Jan 13.
Article in English | MEDLINE | ID: mdl-35054072

ABSTRACT

HCV infection is one of the main reasons for liver cirrhosis and hepatocellular carcinoma. In recent years, one finds more and more extrahepatic manifestations of HCV infection, including its possible influence on the development of diabetes. In the presented work, one finds the frequency analysis of the incidence of diabetes among 2898 HCV infected patients treated in Poland, and the assessment of their relevance to the HCV genotype and the progression of fibrosis. The results indicate that the hepatitis C infection seems to be a risk factor for diabetes in persons with more advanced liver fibrosis, for older people, and for the male gender. Thus, one found no differences regarding the frequency of its incidence depending on HCV genotype, including genotype 3.

4.
J Clin Med ; 10(15)2021 Jul 25.
Article in English | MEDLINE | ID: mdl-34362064

ABSTRACT

There is still limited data available from real-world experience studies on the pangenotypic regimens in patients with genotype (GT) 3 hepatitis C virus (HCV) infection and liver cirrhosis. The current study aimed to evaluate the efficacy and safety of pangenotypic regimens in this difficult-to-treat population. A total of 236 patients with mean age 52.3 ± 11.3 years and male predominance (72%) selected from EpiTer-2 database were included in the analysis; 72% of them were treatment-naïve. The majority of patients (55%) received the combination of sofosbuvir/velpatasvir (SOF/VEL), 71 without and 58 with ribavirin (RBV), whereas the remaining 107 individuals were assigned to glecaprevir/pibrentasvir (GLE/PIB). The effectiveness of the treatment following GLE/PIB and SOF/VEL regimens (96% and 93%) was higher compared to SOF/VEL + RBV option (79%). The univariate analysis demonstrated the significantly lower sustained virologic response in males, in patients with baseline HCV RNA ≥ 1,000,000 IU/mL, and among those who failed previous DAA-based therapy. The multivariate logistic regression analysis recognized only the male gender and presence of ascites at baseline as the independent factors of non-response to treatment. It should be emphasized that despite the availability of pangenotypic, strong therapeutic options, GT3 infected patients with cirrhosis still remain difficult-to-treat, especially those with hepatic impairment and DAA-experienced.

5.
World J Gastroenterol ; 27(18): 2177-2192, 2021 May 14.
Article in English | MEDLINE | ID: mdl-34025072

ABSTRACT

BACKGROUND: The introduction of direct-acting antiviral drugs into clinical practice has revolutionized the treatment of chronic hepatitis C, making it highly effective and safe for patients. However, few researchers have analyzed the factors causing therapy failure in some patients. AIM: To analyze factors influencing the failure of direct antiviral drugs in the large, multicenter EpiTer-2 cohort in a real-world setting. METHODS: The study cohort consisted of patients with chronic hepatitis C treated at 22 Polish centers from 2016-2020. Data collected from the online EpiTer-2 database included the following: hepatitis C virus (HCV) genotype, stage of fibrosis, hematology and liver function parameters, Child-Turcotte-Pugh and Model for End-stage Liver Disease scores, prior antiviral therapy, concomitant diseases, and drugs used in relation to hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV) coinfections. Adverse events observed during the treatment and follow-up period were reported. Both standard and machine learning methods were used for statistical analysis. RESULTS: During analysis, 12614 patients with chronic hepatitis C were registered, of which 11938 (mean age: 52 years) had available sustained virologic response (SVR) data [11629 (97%) achieved SVR and 309 (3%) did not]. Most patients (78.1%) were infected with HCV genotype 1b. Liver cirrhosis was diagnosed in 2974 patients, while advanced fibrosis (F3) was diagnosed in 1717 patients. We included patients with features of hepatic failure at baseline [ascites in 142 (1.2%) and encephalopathy in 68 (0.6%) patients]. The most important host factors negatively influencing treatment efficacy were liver cirrhosis, clinical and laboratory features of liver failure, history of hepatocellular carcinoma, and higher body mass index. Among viral factors, genotype 3 and viral load also exerted an influence on treatment efficacy. Classical statistical analysis revealed that treatment ineffectiveness seemed to be influenced by the male sex, which was not confirmed by the multivariate analysis using the machine learning algorithm (random forest). Coinfection with HBV (including patients with on-treatment reactivation of HBV infection) or HIV, extrahepatic manifestations, and renal failure did not significantly affect the treatment efficacy. CONCLUSION: In patients with advanced liver disease, individualized therapy (testing for resistance-associated variants and response-guided treatment) should be considered to maximize the chance of achieving SVR.


Subject(s)
End Stage Liver Disease , Hepatitis C, Chronic , Liver Neoplasms , Antiviral Agents/adverse effects , Child , Cohort Studies , Drug Therapy, Combination , End Stage Liver Disease/drug therapy , Genotype , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Humans , Liver Cirrhosis/drug therapy , Liver Neoplasms/drug therapy , Male , Middle Aged , Poland , Severity of Illness Index , Sustained Virologic Response , Treatment Outcome
6.
Liver Int ; 41(8): 1789-1801, 2021 08.
Article in English | MEDLINE | ID: mdl-33655628

ABSTRACT

BACKGROUND AND AIMS: The aim of this study was to assess the real-life effectiveness and safety of direct acting antivirals (DAAs) in patients with cirrhosis and history of hepatic decompensation compared to those with compensated cirrhosis. METHOD: Data of patients treated with DAAs and included in the EpiTer-2 database (N = 10 152) were collected retrospectively. The primary endpoint was sustained viral response (SVR) at 12 weeks posttreatment. Patients were also evaluated in terms of liver-related adverse events and treatment modification/discontinuation. RESULTS: The overall SVR rate was 91.4% in the intent to treat (ITT) analysis and 95.2% in the per-protocol (PP) analysis (P < .001). Patients with decompensated cirrhosis had lower SVR rates compared to those with compensated cirrhosis in ITT analysis (86.4% vs 92.0%, P < .001), while not in PP analysis (92.9% vs 95.5%, P > .05). Adverse events (AE) occurred 45.6% and 29.3% of patients with decompensated and compensated cirrhosis (P < .001). Patients with decompensated cirrhosis were at higher risk of death (5.4% vs 0.9%; P < .0001) or liver decompensation (21.5% vs 1.3%; P < .0001). Treatment with protease inhibitors was not associated with hepatic decompensation (P = .3). Only 82.6% of patients with decompensated cirrhosis completed DAA treatment (vs 92.8% in compensated cirrhotics; P < .0001). CONCLUSION: Despite higher frequency of AE and treatment modifications, once completed, DAAs yield comparable results for patients with decompensated and compensated cirrhosis. High rate of serious adverse events in patients with advanced liver disease treated with PI may not be related to the detrimental effect of the medications, but rather to the disease itself.


Subject(s)
Antiviral Agents , Hepatitis C, Chronic , Antiviral Agents/adverse effects , Hepacivirus , Hepatitis C, Chronic/drug therapy , Humans , Liver Cirrhosis/complications , Liver Cirrhosis/drug therapy , Retrospective Studies , Sustained Virologic Response
7.
J Clin Med ; 10(4)2021 Feb 09.
Article in English | MEDLINE | ID: mdl-33572429

ABSTRACT

Liver injury-expressed as elevated liver enzymes-is common in patients with COVID-19. Little is known about the potential mechanisms of liver damage by SARS-CoV-2. A direct cytopathic effect on hepatocytes as well as injury related to hypoxia or hepatotoxicity are being considered. The aim of the study was to compare the clinical characteristic of COVID-19 disease in patients with normal and abnormal liver enzymes activity. A group of 150 patients with COVID-19, hospitalized in our center, was analyzed. Patients with the known liver comorbidities were excluded (n = 15). Clinical features and laboratory parameters were compared between patients with normal and abnormal aminotransferase values. Liver injury expressed as any alanine aminotransferase (ALT) elevation was noted in 45.6% of patients hospitalized due to COVID-19. The frequencies of aspartate aminotransferase (AST) elevation were lower. It was noted that elevated ALT/AST unfavorably affected other parameters related to liver function such as albumin level; gamma-glutamyl transpeptidase (GGTP); and partly, ALP activity and influenced inflammation-related parameters. The most probable cause of mild hepatitis during COVID-19 was anoxia and immune-mediated damage due to the inflammatory response following SARS-CoV-2 infection. A direct cytopathic effect of SARS-CoV-2 on hepatocytes, albeit less probable, can be considered as well. The use of potentially hepatotoxic drugs may contribute to liver damage.

8.
J Gastroenterol Hepatol ; 36(7): 1944-1952, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33171526

ABSTRACT

BACKGROUND AND AIMS: The revolution of the antiviral treatment of hepatitis C virus (HCV) infection resulting in higher effectiveness came with the introduction of direct-acting antivirals with pangenotypic regimens as a final touch. Among them, the combination of glecaprevir (GLE) and pibrentasvir (PIB) provides the opportunity for shortening therapy to 8 weeks in the majority of patients. Because of still insufficient evaluation of this regimen in the real-world experience, our study aimed to assess the efficacy and safety of 8-week GLE/PIB in chronic hepatitis C patients depending on liver fibrosis and genotype (GT). METHODS: The analysis included patients who received GLE/PIB for 8 weeks selected from the EpiTer-2 database, large retrospective national real-world study evaluating antiviral treatment in 12 584 individuals in 22 Polish hepatology centers. RESULTS: A total of 1034 patients with female predominance (52%) were enrolled in the analysis. The majority of them were treatment naïve (94%), presented liver fibrosis (F) of F0-F3 (92%), with the most common GT1b, followed by GT3. The overall sustained virologic response after exclusion of nonvirologic failures was achieved in 95.8% and 98%, respectively (P = 0.19). In multivariate logistic regression HCV GT-3 (beta = 0.07, P = 0.02) and HIV infection (beta = -0.14, P < 0.001) were independent predictors of nonresponse. CONCLUSIONS: We demonstrated high effectiveness of 8-week GLE/PIB treatment in a non-GT3 population irrespective of liver fibrosis stage. Comparable efficacy was achieved in non-cirrhotic patients regardless of the genotype, including GT3 HCV.


Subject(s)
HIV Infections , Hepatitis C , Aminoisobutyric Acids , Antiviral Agents/adverse effects , Benzimidazoles , Cyclopropanes , HIV Infections/drug therapy , Hepacivirus/genetics , Hepatitis C/drug therapy , Hepatitis C, Chronic/drug therapy , Humans , Lactams, Macrocyclic , Leucine/analogs & derivatives , Liver Cirrhosis/drug therapy , Proline/analogs & derivatives , Pyrrolidines , Quinoxalines , Retrospective Studies , Sulfonamides
9.
Am J Case Rep ; 21: e927452, 2020 Sep 25.
Article in English | MEDLINE | ID: mdl-32973125

ABSTRACT

BACKGROUND COVID-19 is an infectious disease caused by SARS-CoV-2. It has spread rapidly through the world, endangering human life. The main target of COVID-19 is the lungs; however, it can involve other organs, including the liver. Patients with severe COVID-19 have an increased incidence of abnormal liver function, and patients with liver disorders are considered to be at a higher risk of severe COVID-19 infection. The mechanism of liver injury reported in 14% to 53% of COVID-19 patients is poorly recognized and several possibilities need to be considered (cytokine storm, direct viral action, hypoxia). The incidence of underlying liver comorbidities in patients with a COVID-19 infection ranges from 1% to 11%. CASE REPORT This is a report of 2 nosocomial COVID-19 infections and severe COVID-19 pneumonia in 2 patients who were hospitalized during treatment for alcoholic liver disease (ALD). Case 1 and case 2 were a 31-year-old woman and a 40-year-old woman, respectively, with decompensated ALD and symptoms of the COVID-19 infection. Both patients were transferred from another hospital to our hospital after confirmation of COVID-19 during their hospitalization. The course of the infection progressed rapidly in both patients with the development of multiple-organ failure and death over a short period. CONCLUSIONS There are no clear recommendations on the management of ALD in the COVID-19 pandemic. Alcoholic hepatitis may be a risk factor for severe COVID-19 and a poor outcome. A high percentage of nosocomial COVID-19 infections are observed; therefore, special precautions should be taken to minimize the risk of COVID-19 exposure.


Subject(s)
Coronavirus Infections/diagnosis , Cross Infection/diagnosis , Liver Diseases, Alcoholic/therapy , Pneumonia, Viral/diagnosis , Severe Acute Respiratory Syndrome/diagnostic imaging , Tomography, X-Ray Computed/methods , Adult , COVID-19 , Combined Modality Therapy , Coronavirus Infections/complications , Cross Infection/therapy , Disease Progression , Fatal Outcome , Female , Hospitalization , Humans , Liver Diseases, Alcoholic/diagnosis , Multiple Organ Failure , Pandemics , Pneumonia, Viral/complications , Radiography, Thoracic/methods , Respiration, Artificial , Risk Assessment
10.
Expert Rev Anti Infect Ther ; 18(10): 1045-1054, 2020 10.
Article in English | MEDLINE | ID: mdl-32538232

ABSTRACT

OBJECTIVES: The aim of the study was to analyze the prevalence and clinical characteristics of HCV/HBV coinfection and to evaluate the rate of HBV-reactivation during anti-HCV therapy in a large real-world study. METHODS: Analyzed population consisted of 10,152 chronic hepatitis C patients treated with DAA between 2015 and 2019 in a nationwide study. Prior to the DAA all subjects had HBsAg and 60% anti-HBc testing. RESULTS: 111 of 10,152 patients (1.1%) had detectable HBsAg and 1239 of 6139 (20.2%) anti-HBcAb. The prevalence of occult hepatitis B was 0.48%. HCV/HBV patients were younger with a higher proportion of males, HIV-coinfected, and advanced fibrosis. They were less often diagnosed with diabetes but more often with chronic kidney disease. In HBsAg(+) subjects with baseline HBV-DNA available 6/102 (5.9%) HBV-reactivations during or after DAA therapy were observed, and in two (1.9%) significant hepatic flares were noted. In HBsAg(-)/anti-HBc(+) group 2 (0.16%) reactivations were observed only in patients undergoing immunosuppressive therapy. DISCUSSION: Data from a large European cohort suggest a relatively low risk of HBV-reactivation during DAA-therapy for HCV infection in HBsAg(+) patients. In HBsAg(-)/anti-HBc(+) HBV-reactivation seems to be limited to subjects with immunodeficiency. Importantly, previous exposure to HBV and occult hepatitis B is present in a significant proportion of HCV-infected.


Subject(s)
Antiviral Agents/administration & dosage , Hepatitis B/epidemiology , Hepatitis C, Chronic/drug therapy , Adult , Aged , Aged, 80 and over , Antiviral Agents/pharmacology , Cohort Studies , Coinfection , DNA, Viral/blood , Europe , Female , Hepatitis B/virology , Hepatitis B Antibodies/blood , Hepatitis B Surface Antigens/blood , Hepatitis C, Chronic/virology , Humans , Immunosuppressive Agents/administration & dosage , Male , Middle Aged , Prevalence , Virus Activation
12.
Adv Med Sci ; 65(1): 12-17, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31841821

ABSTRACT

PURPOSE: Since 2017 treatment-naïve patients infected with genotype 1b of hepatitis C virus and minimal or moderate fibrosis can be treated with Ombitasvir/Paritaprevir/ritonavir + Dasabuvir (OPrD) for 8 weeks according to updated Summary of Product Characteristics. The aim of our study was to assess the comparative efficacy of 8 and 12-weeks therapy with OPrD in large cohort of patients eligible for 8 weeks regimen treated in real-world setting. MATERIALS AND METHODS: We analysed data of 3067 HCV genotype 1b infected patients treated with OPrD between 2015 and 2017. Final analysis included patients with none, minimal or moderate fibrosis (F0-F2). RESULTS: A total of 771 patients were enrolled in the study, including 197 (26%) treated for 8-weeks and 574 patients fulfilling criteria for 8-weeks but assigned to 12-weeks regimen. Majority of patients had no or minimal fibrosis (F0-F1). Longer treatment duration was more often administered in patients with moderate fibrosis, comorbidities, concomitant medications. SVR was achieved in 186 (94%) patients treated for 8 weeks and 558 (97%) for 12 weeks (p = 0.07). After exclusion of lost to follow-up patients, sustained virological response (SVR) rate reached 95% and 99%, respectively (p = 0.01). We were not able to identify factors associated with non-response. CONCLUSIONS: This real-word experience study confirmed similar, high effectiveness of 8 and 12-weeks regimens of OPrD in genotype 1b HCV infected patients with non-advanced fibrosis. Despite of reduced SVR rate after 8-weeks regimen, there is no need to extend therapy to 12-weeks in vast majority of such patients and no need to add ribavirin.


Subject(s)
Anilides/therapeutic use , Antiviral Agents/therapeutic use , Carbamates/therapeutic use , Cyclopropanes/therapeutic use , Hepacivirus/genetics , Lactams, Macrocyclic/therapeutic use , Liver Cirrhosis/drug therapy , Proline/analogs & derivatives , Ritonavir/therapeutic use , Sulfonamides/therapeutic use , Uracil/analogs & derivatives , 2-Naphthylamine , Adolescent , Adult , Aged , Aged, 80 and over , Drug Therapy, Combination , Female , Follow-Up Studies , Genotype , Hepatitis C/complications , Hepatitis C/virology , Humans , Liver Cirrhosis/epidemiology , Liver Cirrhosis/virology , Male , Middle Aged , Prognosis , Proline/therapeutic use , Retrospective Studies , Sustained Virologic Response , Uracil/therapeutic use , Valine , Young Adult
13.
J Gastroenterol Hepatol ; 35(7): 1238-1246, 2020 Jul.
Article in English | MEDLINE | ID: mdl-31734959

ABSTRACT

BACKGROUND AND AIM: Grazoprevir/elbasvir (GZR/EBR) was approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infected patients with or without compensated liver cirrhosis. The aim of this study was to assess GZR/EBR regimen in the real-world experience, particularly in previously "difficult-to-treat" patients with chronic kidney diseases, human immunodeficiency virus-coinfected, cirrhotics, and treatment-experienced. METHODS: The analysis included patients treated with GZR/EBR selected from 10 152 individuals from the EpiTer-2 database, large national real-world study evaluating antiviral treatment in 22 Polish hepatology centers between 2015 and 2018. Data were completed retrospectively and submitted online. RESULTS: A total of 1615 patients who started GZR/EBR therapy in 2017 and 2018 with a female predominance (54%) and median age of 54 years were analyzed. The majority were infected with GT1b (89%) and treatment naïve (81%). Liver cirrhosis was diagnosed in 19%, and 70% of patients had comorbidities, of which chronic renal disease was present in 7% and HIV-coinfection in 4%. Overall, a sustained virologic response (SVR) was achieved by 95% according to intent-to-treat (ITT) and 98% after exclusion of lost to follow up (modified ITT). No differences were found in cure rate between all included patients and subpopulations previously considered as difficult-to-treat. Majority of patients completed the treatment course as scheduled, adverse events were mostly mild and did not lead to therapy discontinuation. CONCLUSIONS: GZR/EBR treatment carried-out in patients infected with HCV genotype 1 and 4 demonstrated good tolerability and an excellent SVR rate with no effectiveness reduction in so called difficult-to-treat populations.


Subject(s)
Benzofurans/administration & dosage , Genotype , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/virology , Imidazoles/administration & dosage , Quinoxalines/administration & dosage , Adolescent , Adult , Aged , Aged, 80 and over , Amides , Antiviral Agents/administration & dosage , Carbamates , Comorbidity , Cyclopropanes , Data Analysis , Drug Therapy, Combination , Female , HIV Infections/epidemiology , Hepatitis C, Chronic/epidemiology , Humans , Liver Cirrhosis/epidemiology , Male , Middle Aged , Renal Insufficiency, Chronic/epidemiology , Retrospective Studies , Sex Factors , Sulfonamides , Sustained Virologic Response , Treatment Outcome , Young Adult
14.
Can J Gastroenterol Hepatol ; 2019: 4029541, 2019.
Article in English | MEDLINE | ID: mdl-30941326

ABSTRACT

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.


Subject(s)
Antiviral Agents/therapeutic use , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Liver Cirrhosis/drug therapy , Adult , Aged , Drug Resistance, Viral/genetics , Female , Genotype , Hepatitis C, Chronic/pathology , Hepatitis C, Chronic/virology , Humans , Liver Cirrhosis/pathology , Liver Cirrhosis/virology , Male , Middle Aged , Retreatment , Retrospective Studies , Sustained Virologic Response , Treatment Failure , Viral Nonstructural Proteins/genetics , Young Adult
15.
BMC Infect Dis ; 18(1): 580, 2018 Nov 16.
Article in English | MEDLINE | ID: mdl-30445916

ABSTRACT

BACKGROUND: According to the EASL and AASLD guidelines, the recommended treatment for patients who failed to achieve a sustained virologic response (SVR) on prior interferon-based triple therapy with protease inhibitors (PI), is a combination of sofosbuvir and NS5A inhibitors. Polish national recommendations also allow the use of paritaprevir/ritonavir/ombitasvir+dasasbuvir±ribavirin (PrODR) in this group of patients. The aim of the study was to evaluate the efficacy and safety of PrODR vs. ledipasvir/sofosbuvir±RBV (LSR) in PI-experienced patients in real-life setting. METHODS: Our analysis included patients registered in the nationwide, investigators initiated, multicentre EpiTer-2 database. Among 4530 patients registered, 335 with genotype 1 (93% 1b) were previously treated with IFN-based regimens with PIs: 127 with boceprevir (BOC), 208 with telaprevir (TVR). Patients with advanced fibrosis (F3/F4) were significantly predominant (BOC 28.4%/61.4%, TVR 18.8%/64.4%, respectively). Subjects were assigned to IFN-free retreatment as follows: BOC - 64 (50.4%) PrODR and 63 (49.6%) LSR; TVR- 103 (49.5%) PrODR and 105 (50.5%) LSR. RESULTS: SVR rates were comparable for particular groups: BOC → PrODR- 100%; BOC → LSR - 98%; TVR → PrODR - 97%; TVR → LSR - 96% (intent-to treat analysis-ITT) and BOC → PrODR→100%; BOC → LSR - 99%; TVR → PrODR - 99%; TVR → LSR - 98% (modified intent-to treat analysis-mITT). Both treatment regimens had a favourable safety profile. Adverse events (AEs) were generally mild or moderate in severity. Three deaths were reported. The treatment was stopped due to AEs in five patients (three treated with PrODR and two with LSR). CONCLUSION: Efficacy and safety of treatment with PrODR and LSR is comparable in BOC or TVR-experienced patients.


Subject(s)
Anilides/administration & dosage , Benzimidazoles/therapeutic use , Carbamates/administration & dosage , Drug Resistance, Multiple, Viral/drug effects , Fluorenes/therapeutic use , Hepatitis C, Chronic/drug therapy , Macrocyclic Compounds/administration & dosage , Ritonavir/administration & dosage , Sulfonamides/administration & dosage , Uracil/analogs & derivatives , Uridine Monophosphate/analogs & derivatives , 2-Naphthylamine , Adult , Aged , Anilides/adverse effects , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Carbamates/adverse effects , Cohort Studies , Cyclopropanes , Drug Therapy, Combination , Female , Hepacivirus/drug effects , Hepacivirus/genetics , Hepatitis C, Chronic/epidemiology , Humans , Interferons/administration & dosage , Interferons/adverse effects , Lactams, Macrocyclic , Macrocyclic Compounds/adverse effects , Male , Middle Aged , Poland/epidemiology , Proline/analogs & derivatives , Protease Inhibitors/administration & dosage , Protease Inhibitors/adverse effects , Ritonavir/adverse effects , Sofosbuvir , Sulfonamides/adverse effects , Treatment Outcome , Uracil/administration & dosage , Uracil/adverse effects , Uridine Monophosphate/therapeutic use , Valine , Young Adult
16.
J Interferon Cytokine Res ; 38(2): 93-100, 2018 02.
Article in English | MEDLINE | ID: mdl-29443655

ABSTRACT

The aim of the study is to analyze treatments available for patients infected with genotype (G) 3 hepatitis C virus (HCV) in Poland at the beginning of the interferon (IFN)-free era and evaluate the efficacy and safety of different therapeutic options administered in a real-world setting. We analyzed data of 198 patients who started antiviral therapy after July 1, 2015, and completed it before December 31, 2016; 57.6% of them had liver cirrhosis and 46% were treatment experienced. Fifty percent of patients were assigned to sofosbuvir (SOF)+pegylated IFN alfa (PegIFNa)+ribavirin (RBV), 9% to PegIFNa+RBV, 36% received SOF+RBV, and 5% SOF+daclatasvir (DCV)±RBV. Cirrhotic patients were assigned more frequently to IFN-free regimens. Overall, a sustained virological response was achieved by 84.3% of patients in intent-to-treat (ITT) analysis and 87% in modified ITT analysis. For SOF+PegIFNa+RBV and SOF+DCV±RBV regimens, the sustained virologic response (SVR) rate reached at least 90%, whereas the two other therapeutic options demonstrated efficacy <80%. The SVR rate in noncirrhotics was higher than in cirrhotics, irrespective of regimen. Adverse events were documented in 52.5%, with the most common being weakness/fatigue and anemia. We confirmed effectiveness and safety of the SOF-based treatment in a real-world cohort of patients with chronic HCV G3 infection. Most notably, we demonstrated good tolerability and high efficacy of the SOF+PegIFNa+RBV regimen.


Subject(s)
Antiviral Agents/pharmacology , Hepacivirus/drug effects , Hepatitis C, Chronic/drug therapy , Interferon-alpha/pharmacology , Sofosbuvir/pharmacology , Adult , Aged , Aged, 80 and over , Female , Hepacivirus/genetics , Hepatitis C, Chronic/genetics , Humans , Male , Microbial Sensitivity Tests , Middle Aged , Poland
17.
Ann Parasitol ; 63(1): 27-32, 2017.
Article in English | MEDLINE | ID: mdl-28574237

ABSTRACT

Ruminants often live in environments where the natural balance has been disturbed by humans. As a result, there is a transfer of parasitosis to domestic animals and sometimes humans. The aim of the study was to determine the annual species composition and level of gastrointestinal nematode infection of mouflon (Ovis aries musimon) from the half-open breeding colonizing areas of the Goleniowska Forest, and to assess the effectiveness of deworming. The course of the parasitic infection of mouflon depends largely on geoclimatic and breeding factors. These diseases are caused by more than 17 species of nematodes with varying degrees of pathogenicity. Due to the high degree of parasitic infections in deer, both in Poland and abroad, it is necessary to develop specific preventive programs using preparations with a broad spectrum of action.


Subject(s)
Gastrointestinal Diseases/parasitology , Nematode Infections/veterinary , Sheep Diseases/parasitology , Animals , Animals, Wild , Antinematodal Agents/administration & dosage , Female , Gastrointestinal Diseases/drug therapy , Gastrointestinal Diseases/epidemiology , Male , Nematoda , Nematode Infections/drug therapy , Nematode Infections/epidemiology , Nematode Infections/parasitology , Poland/epidemiology , Sheep , Sheep Diseases/drug therapy , Sheep Diseases/epidemiology
18.
Ann Transplant ; 19: 367-72, 2014 Jul 30.
Article in English | MEDLINE | ID: mdl-25073736

ABSTRACT

BACKGROUND: Sequels of chronic HCV infection are currently one of the most common indications for liver transplantation (LTx). Because HCV reinfection and allograft injury are inevitable, it may influence survival. Earlier studies have not reported higher mortality among HCV-infected patients, but cumulative data seem to contradict these findings. The aim of the study was to analyze post-LTx survival in HCV-positive patients in comparison with non-HCV-positive recipients and impact of antiviral treatment on survival in patients with recurrent HCV hepatitis. MATERIAL AND METHODS: Using data from the Polish national transplant registry, a retrospective cohort study of 327 patients who underwent LTx between 2000 and 2012 was performed. Cumulative 5-year mortality for HCV-positive patients vs. HCV-negative recipients and HCV-positive recipients treated with pegylated interferon/ribavirin vs. non-treated subjects was calculated using Kaplan-Meyer methodology. Mortality hazard rates were estimated using univariate proportional Cox models. RESULTS: Liver transplantation in HCV-positive vs. HCV-negative recipients was associated with significantly lower survival rate (cumulative 5-year survival 89.8 vs. 80.26%, respectively, p=0.04276) with a 5-year mortality HR of 1.99. Antiviral treatment improved survival irrespective of virological response (84.06% treated vs. 51.22% non-treated, p=0.00003). Univariate Cox HR for HCV treated vs. untreated patients is 0.18. Further improvement of survival was significantly associated with sustained virological response (100% vs. 77.67%, p=0.042). CONCLUSIONS: Our study confirms higher mortality risk among HCV-infected transplant recipients, improved survival related to the HCV treatment following graft reinfection, and positive association between the HCV treatment success and better survival.


Subject(s)
Antiviral Agents/therapeutic use , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/surgery , Liver Transplantation/mortality , Adolescent , Adult , Aged , Cohort Studies , End Stage Liver Disease/etiology , End Stage Liver Disease/mortality , End Stage Liver Disease/surgery , Female , Hepatitis C, Chronic/complications , Humans , Interferon alpha-2 , Interferon-alpha/therapeutic use , Kaplan-Meier Estimate , Male , Middle Aged , Poland/epidemiology , Polyethylene Glycols/therapeutic use , Proportional Hazards Models , Recombinant Proteins/therapeutic use , Retrospective Studies , Ribavirin/therapeutic use , Young Adult
19.
Ann Transplant ; 19: 161-4, 2014 Apr 08.
Article in English | MEDLINE | ID: mdl-24714452

ABSTRACT

BACKGROUND: Recurrence of hepatitis C virus (HCV) infection after liver transplantation is inevitable and decreases survival. Graft loss due to recurrent HCV occurs in 25% to 30% of patients. The recommended AASLD treatment is PEG-IFN, with or without ribavirin, but some patients might be not eligible for this treatment. An alternative antiviral agent is silibinin (SIL). In vitro silibinin stops replication, probably by inhibiting HCV RNA polymerase. CASE REPORT: We present the cases of 2 patients with severe recurrent HCV infection who received intravenous silibinin (IV SIL) as a "rescue therapy". In the first patient with cholestatic fibrosing hepatitis, HCV RNA became undetectable. We also noted significant viremia reduction, and improvement in laboratory results and clinical presentation in the second patient. CONCLUSIONS: Administration of IV SIL resulted in a rapid decrease of HCV viremia. In post-transplant patients with HCV recurrence who are not eligible for standard antiviral treatment, IV SIL can be considered as an alternative, but further investigations are necessary to establish treatment protocols.


Subject(s)
Antiviral Agents/administration & dosage , Carcinoma, Hepatocellular/surgery , Hepatitis C, Chronic/drug therapy , Liver Neoplasms/surgery , Liver Transplantation/adverse effects , Silymarin/administration & dosage , Administration, Intravenous , Carcinoma, Hepatocellular/complications , Hepatitis C, Chronic/complications , Humans , Liver Neoplasms/complications , Male , Middle Aged , Recurrence , Salvage Therapy , Silybin
20.
Ann Transplant ; 14(3): 45-50, 2009.
Article in English | MEDLINE | ID: mdl-19644159

ABSTRACT

BACKGROUND: Weight gain is commonly observed after OLTx. It is still debatable whether increasing weight is due to the regain of weight lost before transplantation or it is a complex metabolic disorder. MATERIAL/METHODS: Body mass index and weight gain were sought at 6 months, one, two and four years after liver transplantation (OLTx) in relation to sex, weight at the time of transplantation, aetiology of liver disease, type of immunosuppression, glucose metabolism and lipid parameters as well as cardiovascular episodes. A group of 75 patients has been studied. RESULTS: Mean weight gain and BMI change were the highest within the first six months after OLTx (6.1 kg and 2.0 kg/m(2), respectively); since than gaining weight decreased. Men gained more weight than women, especially in the first half-year after OLTx. The only clear predictive factor of overweight and obesity was the baseline weight (the higher the baseline weight the most dynamic the weight gain after OLTx). CONCLUSIONS: Dietary mistakes and lack of physical activity may play a major role in the weight increase after OLTx. Despite striking proportion of overweight and obese patients in the studied group, the number of cardiovascular episodes seem to match the general population.


Subject(s)
Liver Transplantation/adverse effects , Liver Transplantation/pathology , Weight Gain , Adult , Body Mass Index , Female , Humans , Male , Middle Aged , Obesity/etiology , Obesity/pathology , Overweight/etiology , Overweight/pathology , Risk Factors , Sex Characteristics , Time Factors
SELECTION OF CITATIONS
SEARCH DETAIL
...