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Report for Clinical Trial NCT02057003
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Security and Efficacy of Triple Therapy Including Direct-Acting Antivirals Against Chronic Hepatitis C Infection In HIV-Coinfected Patients In Real-Life Conditions: The Prospective HEPAVIR Cohort.
The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.
NCT02057003 Hepatitis C, Chronic Human Immunodeficiency Virus MeSH:Hepatitis A Hepatitis C Acquired Immunodeficiency Syndrome HIV Infections Hepatitis C, Chronic Hepatitis
HPO:Hepatitis
1 Interventions
Name: DAA against HCV
Primary Outcomes
Description: Achievement of SVR to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.
Measure: Number of patients who achieve SVR to DAA-based therapy as measure of efficacy Time: 18 monthsDescription: Development of severe adverse events related to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.
Measure: Number of patients who develop severe adverse events as measure of safety Time: 18 monthsSecondary Outcomes
Description: In order to compare TVR- and BOC-based therapy, the numbers of patients who achieve SVR to DAA-based therapy will be analyzed.
Measure: Number of patients who achieve SVR to a BOC-based regimen as compared to numbers of patients who achieve SVR to a TVR-based regimen. Time: 18 monthsMeasure: Number of patients who reach undetectable HCV-RNA at week 4 of PI-based therapy as a measure of on-treatment response to therapy. Time: 18 months
Description: In order to compare TVR- and BOC-based therapy, the numbers of patients who develop adverse events during either treatment will be analyzed.
Measure: Number of patients who develop adverse events during a BOC-based regimen as compared to numbers of patients who develop adverse events during a TVR-based regimen. Time: 18 monthsDescription: The numbers of patients who achieve SVR to DAA-based therapy in absence of interferon will be analyzed.
Measure: Number of patients who achieve SVR to an interferon-free regimen. Time: 36 weeksTime Perspective: Prospective
Cohort
There is one SNP
SNPs
1 rs12979860
Definition of hepatic fibrosis: - advanced fibrosis: F3 as determined by liver biopsy or 11 kilopascals as determined by transient elastometry - cirrhosis: F4 as determined by liver biopsy or 14.6 kilopascals as determined by transient elastometry Variables collected within in the cohort: - primary outcome variable: SVR (efficacy study) and % of patients who discontinued therapy due to adverse events (safety study) - epidemiological variable: age, sex, interleukin 28B rs12979860 genotype - variables related to hepatitis C virus-infection: infection route, genotype, grade of hepatic fibrosis and method used for its determination, baseline Child-Pough-Index, previous hepatic decompensations - treatment-related variables: previous response to treatment, doses and dose reductions/discontinuations of peg-IFN, RBV and the DAA(s), overall severe adverse events, adverse events that occur in more than 5% of the patients, hepatic decompensations, deaths, HCV viral load at baseline and at each visit - variables related to HIV-infection: Centers for Disease Control and Prevention (CDC) category, HIV viral load, cluster of differentiation 4 (CD4) cell count, antiretroviral regimen - analytical variables: aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelets, leucocytes, low-density lipoprotein cholesterol, bilirubin, gamma-glutamyltransferase (GGT), alkaline phosphatase, - clinical variables: alcohol intake Quality assurance and data checks: Data will be obtained from controlled databases at the participating centers.