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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

Type: Drug

DAA-based therapy 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 months

Description: 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 months

Secondary 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 months

Measure: 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 months

Description: 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 weeks

Time 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.



HPO Nodes


HPO:
Hepatitis
Genes 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3