The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies
Study Type
OBSERVATIONAL
Enrollment
300
Blood test and patient interview as for standard patient care
CHU Nimes
Nîmes, France
Hospital Viet Tiep
Haiphong, Vietnam
Patient inclusion rate
Number of patients included/number of eligible patients
Time frame: End of study: 12 months
Rate of missing data of patient variables
Current treatment, introduction of treatment, viral load, HCV genotype, fibrosis stage, HIV co-infection, drug consumption, alcohol consumption, methadone treatment,
Time frame: Day 0-1
Lost to follow-up rate
Time frame: Month 6
Lost to follow-up rate
Time frame: Month 12
Archival of all signed consent forms
Time frame: End of study: Month 12
Social-demographic characteristics of patients at inclusion
age, sex, weight, height, pregnancy test,
Time frame: Day 0
drug and alcohol consumption,
type and amount
Time frame: Day 0
treatment at inclusion
Time frame: Day 0
commencement of treat
Time frame: Day 1
initial HCV viral load,
UI/ml
Time frame: Day 0
HCV genotype
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Time frame: Day 0
Fibrosis stage
Time frame: Day 0
HIV viral load
Copies/ml
Time frame: Day 0
Lymphocyte T4 level
Number of CD4 lymphocytes/mm3
Time frame: Day 0
Fibrosis stage
Fibroscan result
Time frame: Day 0
Hepatic ultrasound
Time frame: Day 0
Transaminase levels
Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase
Time frame: Day 0
HIV co-infection
Yes/no
Time frame: Day 0
Hepititis B co-infection
Yes/no
Time frame: Day 0
Methadone treatment
Yes/no
Time frame: Day 0
Access to health cover
Yes/no
Time frame: Day 0
Commencement of treatment
Yes/no
Time frame: Day 1
Type of treatment
Time frame: Day 0
Treatment side effects
Time frame: ay
Early viral response
Undetectable HCV RNA
Time frame: Week 4
Sustained viral response
Undetectable HCV RNA
Time frame: Week 12
HCV re-infection
Yes/no
Time frame: Month 12
Risk factors associated with reinfection
Time frame: 3 months after clearance