Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam

Study Overview
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Brief Summary
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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

Official Title
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Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam

Conditions
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Hepatitis C Infection

Intervention / Treatment
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* Other: Clinical examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient is at least 18 years old The patient is HCV RNA positive Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with HCV infection<br> | Other: Clinical examination<br>* Blood test and patient interview as for standard patient care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient inclusion rate | Number of patients included/number of eligible patients | 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, | Day 0-1 | 
| Lost to follow-up rate |  | Month 6 | 
| Lost to follow-up rate |  | Month 12 | 
| Archival of all signed consent forms |  | End of study: Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social-demographic characteristics of patients at inclusion | age, sex, weight, height, pregnancy test, | Day 0 | 
| drug and alcohol consumption, | type and amount | Day 0 | 
| treatment at inclusion |  | Day 0 | 
| commencement of treat |  | Day 1 | 
| initial HCV viral load, | UI/ml | Day 0 | 
| HCV genotype |  | Day 0 | 
| Fibrosis stage |  | Day 0 | 
| HIV viral load | Copies/ml | Day 0 | 
| Lymphocyte T4 level | Number of CD4 lymphocytes/mm3 | Day 0 | 
| Fibrosis stage | Fibroscan result | Day 0 | 
| Hepatic ultrasound |  | Day 0 | 
| Transaminase levels | Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase | Day 0 | 
| HIV co-infection | Yes/no | Day 0 | 
| Hepititis B co-infection | Yes/no | Day 0 | 
| Methadone treatment | Yes/no | Day 0 | 
| Access to health cover | Yes/no | Day 0 | 
| Commencement of treatment | Yes/no | Day 1 | 
| Type of treatment |  | Day 0 | 
| Treatment side effects |  | ay | 
| Early viral response | Undetectable HCV RNA | Week 4 | 
| Sustained viral response | Undetectable HCV RNA | Week 12 | 
| HCV re-infection | Yes/no | Month 12 | 
| Risk factors associated with reinfection |  | 3 months after clearance |