Cohort on Hepatitis C Micro-elimination in MSM
- Conditions
- B18.2Chronic viral hepatitis C
- Registration Number
- DRKS00015330
- Lead Sponsor
- Zibp GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the changes in incidence of acute HCV infection in HIV-Infected MSM in the DAA era
- Secondary Outcome Measures
Name Time Method To determine the prevalence of replicative HCV infection in HIV-infected MSM between 2018 and 2021