Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03090035
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2017-02-27
Brief Title:
Impact of Interleukin 28B rs12979860 Genotype on Virological Responses Chronic Hepatitis C Treatment
Sponsor:
Sheikh Zayed Medical College
Organization:
Sheikh Zayed Medical College
Study Overview
Official Title:
Impact of Interleukin 28B rs12979860 Genotype on Virological Responses in Chronic Hepatitis C Treatment
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective
Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection This study was conducted to find out the frequency of different IL-28B rs12979860 genotypes in patients with chronic hepatitis C HCV genotype type 2 3 infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response SVR
Methods
In this non-randomized observational study ninety eight 98 patients with diagnosis of chronic hepatitis C were included In all patients Peg-IFN plus Ribavirin were given in standard doses for 24 weeks End treatment response sustained virological response and relapse rate were the primary endpoints of this study Analysis of IL28B rs12979860 polymorphism CC CT and TT was performed by PCR-RFLP protocol
Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection This study was conducted to find out the frequency of different IL-28B rs12979860 genotypes in patients with chronic hepatitis C HCV genotype type 2 3 infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response SVR
Methods
In this non-randomized observational study ninety eight 98 patients with diagnosis of chronic hepatitis C were included In all patients Peg-IFN plus Ribavirin were given in standard doses for 24 weeks End treatment response sustained virological response and relapse rate were the primary endpoints of this study Analysis of IL28B rs12979860 polymorphism CC CT and TT was performed by PCR-RFLP protocol
Detailed Description:
INTRODUCTION
Hepatitis C virus HCV is a major health problem that effects nearly 170 million people worldwide 1 2 According to a report about 64-103 million people are suffering from chronic HCV infection 3 and this chronic infection results in liver scarring hepatocellular carcinoma or end-stage liver disease in about forty thousand 40000 patients every year 4 5 According to WHO liver disease initiated by chronic hepatitis C infection is responsible for more than 35 thousand deaths and 3 to 4 million people are infected every year3 6 Hepatitis C Virus has been classified into seven genotypes and several subtypes which are associated with distinct forms of geographic dispersal 7 8 The success of HCV treatment is affected by many viral treatment or host factors
Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection Sustained virological response SVR rate with this treatment in HCV-2 3 has been reported to be 58-84 in previously untreated patients 9 SVR can be affected by liver cirrhosis hepatocellular carcinoma ethnicity age gender and obesity 10 11 It has been clarified by some studies that interleukin-28B has an important role in the treatment success of HCV infection and IL-28B CC genotype is associated with 2 folds higher sustained virological response SVR as compared to CT and TT genotype 12-14 The aim of present study was to find out the frequency of different IL28B rs12979860 genotypes in patients with chronic hepatitis C genotype type 2 or 3 infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response SVR
METHODS
This non-randomized observational study was conducted in Sheikh Zayed Medical CollegeHospital Rahim Yaar Khan A total of ninety eight 98 patients with diagnosis of chronic hepatitis C genotype 2 or 3 were involved in this study The duration of study was from January 2015 to January 2016 People living in Rahim Yaar Khan City belongs to different ethinic backgrounds because this city is located at the junction of three provinces of Pakistan total provinces are four so people residing here represent the whole Pakistani population living in different provinces Institutional ethical approval was taken before starting this research work A written informed consent was taken from every patient before including himher in this study
The diagnosis of chronic hepatitis C was made through liver enzyme levels HCV-RNA positivity and anti-HCV antibody test Patients with other chronic liver disorders with positive hepatitis B virus HBV and human immunodeficiency virus HIV infection were excluded from this study
Treatment Protocol and Detection of IL28B Polymorphism
In all patients Pegulated Interferon α2 pegIFN plus Ribavirin were given in standard doses PegINF was given in a dose of 180 μgweek and ribavirin 1200 mgday to every patient for the period of 24 weeks for HCV genotype 2 3
PCR analysis was done in every patient before starting the treatment after 24 weeks of treatment to see end treatment response and 48 weeks to evaluate SVR and relapse rate of treatment Analysis of IL28B rs12979860 polymorphism CC CT and TT was performed by PCR restriction fragment length polymorphism RFLP assay protocol Pyrosequencing method was used to determine HCV genotypes
Data analysis was done using SPSS V17 software Mean and standard deviation were used for the presentation of quantitative variables Frequency and percentages were used to present qualitative data Chi-square testFisher Exact test was used to compare qualitative data P-value 005 was taken as significant
Hepatitis C virus HCV is a major health problem that effects nearly 170 million people worldwide 1 2 According to a report about 64-103 million people are suffering from chronic HCV infection 3 and this chronic infection results in liver scarring hepatocellular carcinoma or end-stage liver disease in about forty thousand 40000 patients every year 4 5 According to WHO liver disease initiated by chronic hepatitis C infection is responsible for more than 35 thousand deaths and 3 to 4 million people are infected every year3 6 Hepatitis C Virus has been classified into seven genotypes and several subtypes which are associated with distinct forms of geographic dispersal 7 8 The success of HCV treatment is affected by many viral treatment or host factors
Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection Sustained virological response SVR rate with this treatment in HCV-2 3 has been reported to be 58-84 in previously untreated patients 9 SVR can be affected by liver cirrhosis hepatocellular carcinoma ethnicity age gender and obesity 10 11 It has been clarified by some studies that interleukin-28B has an important role in the treatment success of HCV infection and IL-28B CC genotype is associated with 2 folds higher sustained virological response SVR as compared to CT and TT genotype 12-14 The aim of present study was to find out the frequency of different IL28B rs12979860 genotypes in patients with chronic hepatitis C genotype type 2 or 3 infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response SVR
METHODS
This non-randomized observational study was conducted in Sheikh Zayed Medical CollegeHospital Rahim Yaar Khan A total of ninety eight 98 patients with diagnosis of chronic hepatitis C genotype 2 or 3 were involved in this study The duration of study was from January 2015 to January 2016 People living in Rahim Yaar Khan City belongs to different ethinic backgrounds because this city is located at the junction of three provinces of Pakistan total provinces are four so people residing here represent the whole Pakistani population living in different provinces Institutional ethical approval was taken before starting this research work A written informed consent was taken from every patient before including himher in this study
The diagnosis of chronic hepatitis C was made through liver enzyme levels HCV-RNA positivity and anti-HCV antibody test Patients with other chronic liver disorders with positive hepatitis B virus HBV and human immunodeficiency virus HIV infection were excluded from this study
Treatment Protocol and Detection of IL28B Polymorphism
In all patients Pegulated Interferon α2 pegIFN plus Ribavirin were given in standard doses PegINF was given in a dose of 180 μgweek and ribavirin 1200 mgday to every patient for the period of 24 weeks for HCV genotype 2 3
PCR analysis was done in every patient before starting the treatment after 24 weeks of treatment to see end treatment response and 48 weeks to evaluate SVR and relapse rate of treatment Analysis of IL28B rs12979860 polymorphism CC CT and TT was performed by PCR restriction fragment length polymorphism RFLP assay protocol Pyrosequencing method was used to determine HCV genotypes
Data analysis was done using SPSS V17 software Mean and standard deviation were used for the presentation of quantitative variables Frequency and percentages were used to present qualitative data Chi-square testFisher Exact test was used to compare qualitative data P-value 005 was taken as significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None