German Hepatitis C-Registry (DHC-R)

Conditions: B18.2
Chronic viral hepatitis C

Registration Number: DRKS00009717

Lead Sponsor: eberstiftungs-GmbH Deutschland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 18940

Inclusion Criteria

Age 18 and chronic Hepatitis C Virus infection with viral replication (HCV-RNA +)

Patients which are treated with the following antiviral therapies can be documented in the registry:

elbasvir/grazoprevir (up to 3,000 patients);

glecaprevir/pibrentasvir (up to 800 patients with active drug abuse and/or alcohol abuse and/or compensated liver cirrhosis (Child-Pugh A));

sofosbuvir/velpatasvir/voxilaprevir (exclusively as rescue therapy after DAA failure, up to 300 patients)

Moreover, patients which are not treated can be documented in the registry. Patients are treated at the sole discretion of the physician.

Exclusion Criteria

Pregnancy (patient or female partner of male patient), women in nursing period or women of childbearing age without reliable contraception. Contraindications for use of antiviral treatment. Treatment of hepatitis c, which is conducted in clinial trials of phase I to IV must not be documented in the DHC-R. Patients whose hepatitis c treatment is documented in other remunerated non-interventional studies are not allowed to be documented simultaneously in the DHC-R.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients, who achieved sustained virological response 12 weeks after end of treatement (SVR12).

Secondary Outcome Measures

Name	Time	Method
Safety & tolerability: all (severe) adverse events during treatment and follow-up period).<br>virological outcome: RVR, EVR, EoTR, SVR24, on-treatment failure, viral relapse rates.<br>Baseline including: Cirrhosis, previous therapy (if applicable), IL28B GT, BMI, Race, Age, viral genotype and viral load, rel-evant laboratory parameters, concomitant diseases.<br>Adherence to therapy.<br>Impact of successful therapy on morbidity and mortality on patients.<br>Patient reported outcomes (based on patient questionnaires and clinical outcomes).<br>