Hepatitis C Infections and Infestations
Conditions
Interventions
There are two main components to this study. The first is a questionnaire. We ask participants to complete a questionnaire that aims to understand what factors may have put them at risk for HCV infect
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged >=18 years) with acute hepatitis C (HCV) infection 2. Evidence of acute hepatits C infection or re-infection defined: I. A positive HCV RNA test in the presence of a negative anti-HCV test (antibody and/or antigen and/or HCV RNA) within the past 12 months II. A positive HCV RNA test with an acute clincial hepatitis (jaundice or ALT rise >5x ULN) and no other identifiable cause; III. A positive HCV RNA test in patients who had previously achieved spontaneous clearance (anti-HCV positive individuals with two consecutive negative HCV RNA results 24 weeks apart and did not receive treatment), sustained virological response following treatment (negative HCV RNA result 24 (for IFN-based) or 12 weeks (DAA), after stopping treatment or later IV. Evidence of HCV genotype and/or sub-type switch
Exclusion criteria
Exclusion criteria: Evidence of HCV infection not consistent with the case definition for acute hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive statistics (n[%]) of participant characteristics (demographics and risk factors) measured using a bespoke questionnaire and review of medical notes and virus characteristics (genotype) at baseline and during follow up as measured by routine Sanger sequencing and Whole Genome Sequencing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Descriptive statistics of risk factors collectively and by individual acquisition risk sub-groups, including but not limited to MSM, PWID, primary infection and re-infection. Analysis will be performed at baseline and at timepoints 12, 24 and 36 months of follow-up, using a bespoke questionnaire and review of medical notes 2. Proportion on patients with acute infection with an undetectable viral load at 3 years post enrolment by; SVR at 12 weeks post completion of DAA treatment; SVR at 24 weeks post completion of DAA treatment by review of medical notes 3. Descriptive statistics of treatment regimens and source (NHSE, clinical trial, self-sourced via internet). Analysis will be performed overall and by acquisition risk sub-group (including but not limited to MSM, PWID, primary infection and re-infection), by review of medical notes and a bespoke questionnaire 4. Descriptive network analysis including clustering and geographic analysis based upon epidemiological data by combing geographic data from questionnaire and whole genome sequence data 5. Proportion of individuals meeting criteria for re-infection at month 12, 24 and 36 of follow up, collectively and by individual subgroup, using a bespoke questionnaire and review of medical notes 6. Proportion of cases under ongoing secondary care follow up defined as attending annual follow up visits in secondary care; Proportion of cases discharged from routine follow up owing to successful treatment; Proportion lost to follow up. Data summarised at timepoints 12, 24 and 36 months of follow-up, using a bespoke questionnaire and review of medical notes 7. Phylogenetic analysis of HCV using whole genome sequencing of HCV isolates presented as maximum likelihood phylogenetic trees; Clustering analysis; Time to most recent common ancestor | — |
Countries
England, United Kingdom
Contacts
Public ContactMalick Gibani
Outcome results
None listed