B18.2
Conditions
Interventions
Group 1: Study arm 1 reflects the conventional pathway of hepatitis C diagnosis and treatment within the routine healthcare system. Individuals from at-risk populations are screened in cooperating fac
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects with the following characteristics: - Positive test for HCV RNA in PCR - Capable of written informed consent for study participation. The inclusion into the study is possible without current access to health care insurance coverage, as the study population usually has either limited or no access to health insurance coverage and would (following standard-of-care) otherwise not be able to receive treatment for HCV.
Exclusion criteria
Exclusion criteria: Subjects with the following characteristics: - Younger than 18 years of age - Incapable of written informed consent - In a legal guardianship relationship (according to §1814 BGB) - With (high-grade) evidence of decompensated cirrhosis as assessed by the health care professional - Pregnancy - Currently on medication that is contraindicated for coadministration with GLE/PIB as per German drug label The exclusion criteria do not consider a participant’s insurance status. A previously diagnosed and successfully treated hepatitis C virus infection is likewise not an exclusion criterion. Ongoing intravenous drug use and opioid substitution therapy are also not grounds for exclusion. Participants who, at screening, show evidence of decompensated liver cirrhosis - such as hepatic encephalopathy, active infection, ascites or hydropic decompensation, markedly reduced urine output indicative of severe renal dysfunction, or recent variceal or non-variceal bleeding - should be referred to a hepatology-specialized healthcare facility for further management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to determine the effectiveness of new microelimination strategies for hepatitis C (HCV): Proportion of participants achieving sustained virologic response at week 4 (HCV-RNA negative in PCR) after completion of Glecaprevir/Pibrentasvir (GLE/PIB) therapy (SVR4) in patients receiving treatment at a low-threshold drug support facility (test-and-treat) compared to patients receiving treatment through referral to general practitioners or specialists (refer-out). Due to the high local fluctuations and the mobile population within this cohort, blood sampling for the measurement of the viral load for SVR is defined as a blood draw within the period of 4–6 weeks after the end of therapy. The primary outcome will be measured as the rate of patients achieving SVR4 in both study arms (Intention-to-Treat population). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: - Comparison of SVR4 rates between the two study cohorts. - Comparison of rapid virologic response (RVR), defined as detectable versus undetectable HCV RNA at week 4 after treatment initiation. - Comparison of sustained virologic response 12 weeks after completion of therapy (SVR12). - Assessment of medication adherence/compliance, including re-presentation for medication dispensing, attendance at the final visit, self-reported adherence, pill count, and quantification of loss to follow-up in both cohorts. Exploratory and descriptive endpoints include: - Determination of the prevalence of HCV infection among people who inject drugs (PWID) and other individuals at risk. - Construction of HCV care cascades for low-threshold drug-support facilities, including: • patients screened • participants recruited • valid test results • HCV RNA-positive individuals • treatment initiation • achieved RVR • achieved SVR4 • Characterization of demographic and clinical characteristics, including nationality, comorbidities, co-infections, drug use, previous treatments, and additional relevant variables. - Determination of hepatitis B virus infection status. - Determination of the prevalence of past hepatitis A virus infection. - Reinfection after completion of GLE/PIB therapy: HCV genotyping from the screening visit and study visit 4 (V4) using dried blood spots, if feasible and depending on loss to follow-up. - Number needed to test and number needed to diagnose HCV infection. - Probability of achieving SVR while accounting for covariates (e.g., age, drug use, comorbidities). | — |
Countries
Germany
Contacts
Public ContactFrank Tacke
Charité Universitätsmedizin Berlin
Outcome results
None listed