Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)

Study Overview
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Brief Summary
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Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)

Detailed Description
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From end of 2013 303 HCV-monoinfected patients with advanced liver disease (F3/4) were treated with interferon (IFN)-free and RBV-free SOF-based regimens. During this period only 7 patients received additional RBV. These patients were not included in this analysis. Only patients who completed 12 weeks of treatment-free follow up until July 2015 were included in this analysis. In Austria, prescription of DAAs is restricted to specialized treatment centers. Data are obtained by 6 participating centers and submitted to the central database forming for of the Austrian Ribavirin- and Interferon-free cohort (AURIC). Incoming data are reviewed by the staff of the hepatitis study group of the Dept. of Medicine III, Medical university of Vienna.The treatment regimens consisted of SOF/DCV, SOF/SMV, and SOF/LDV. The duration of treatment was based on a response guided approach at the discretion of the treating physician (12 or 24 weeks). Sixty six patients who had started therapy before August 2014 received SMV or DCV as part of a named patient program, SOF was prescribed. For the remaining patients all drugs were prescribed and paid for by the Austrian social insurance. This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C: Sustained virologic response (SVR) defined as undetectable HCV-RNA after 12 weeks of treatment free follow up Virological breakthrough/relapse defined as reappearance of HCV on treatment/during follow up Impact of viral kinetics on prediction of treatment efficacy: Viral load measured repeatedly (at baseline, on days 2,7,14,21,28,and than every 4 weeks until end of treatment) allows to study the rapidity of viral clearance. This parameter was used to assess whether length of treatment can be modified. Plasma HCV RNA levels were quantified by One Signal Amplification (Versant HCV RNA 3.0), Adverse Event Recording (using standard GCP criteria) Longterm outcome after SVR based on examining patients with SVR in six monh intervals. Examination will include liver sonography, elastography, routine blood chemistry including alpha1-fetoprotein

Official Title
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Interferon/Ribavirin-Free Sofosbuvir Based Treatment Regimens In Patients With Advanced Liver Disease - Results Of A Real-Life Austrian Ribavirin-/Interferon Free Cohort (AURIC)

Conditions
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Chronic Hepatitis C, Cirrhosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens Exclusion Criteria: other disease with poor prognosis (ie. metastatic cancer, heart failure) participation in a clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SOF/SMV<br>SOF/SMV 400mg/150mg QD 12-24 weeks | |
| SOF/DCV<br>SOF/DCV 400mg/60mg QD 12-24 weeks | |
| SOF/LDV<br>SOF/LDV 400mg/90mg QD 12-24 weeks | |
| treatment duration<br>12 - 24 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained virologic response (SVR) | SVR is defined by the undetectability of HCV-RNA after 12 weeks of treatment free follow up | 12 weeks treatment free follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On treatment predictability of SVR | Virus testing at baseline, day 2,7,14,21,28, than every 4 weeks until SVR. Rapidity of viral clearance may be a useful parameter to determine the duration of treatment | 12/24 weeks of treatment + 12 weeks of follow up | 
| Number of patients with liver events (Mortality, Hepatic decompensation, Variceal Bleeding,Hepatocellular Carcinoma, Need for Liver Transplantation) on longterm clinical outcome | regular clinical visits including laboratory test, fibroscan and sonography will be performed every six months after achieving SVR | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, sofosbuvir, ledipasvir, daclatasvir, simeprevir