B18.2
Conditions
Interventions
Group 1: In this cohort study we will include men who have sex with men with recently acquired HCV infection.
At study entry EDTA plasma will be taken for a phylogenetic analysis of the HC virus. Furt
Sponsors
Zibp GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: MSM with or without HIV with documented current or spontaneously cleared hepatitis C infection as defined below: a. Documented HCV antibody seroconversion OR b. HCV RNA positive AND c. Prior negative anti-HCV antibody or HCV RNA test within 12 months OR d. rise of any liver transaminases above ULN within the past 12 months with prior normal transaminases during the year before OR e. any ALT elevation and suspected infectious event AND f. exclusion of other causes of acute hepatitis or HCV reinfection after cured or cleared prior HCV infection, defined by a. HCV RNA detectable after SVR12 or spontaneous clearance (two negative HCV RNA measures with an interval of 24 weeks) or b. HCV genotype switch within these timeframes (s.above) and/or c. HCV RNA detectable with phylogenetic proof of reinfection
Exclusion criteria
Exclusion criteria: 1. Patients in whom a time-point of HCV infection cannot be estimated (midpoint between first positive and last negative HCV antibody or RNA (whichever more recent), midpoint between last normal and first raised ALT) 2. Inability to provide written informed consent 3. Younger than 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the changes in incidence of acute HCV infection in HIV-Infected MSM in the DAA era | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the prevalence of replicative HCV infection in HIV-infected MSM between 2018 and 2021 | — |
Countries
Germany
Contacts
Public ContactStephan Grunwald
Zibp GmbH
Outcome results
None listed