Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)

Cirrhosis Clinical Trial

— AURIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628717
• Other study ID #: I3MHCV
• Status: Completed
• Phase: N/A
• First received: December 3, 2015
• Last updated: September 2, 2017
• Start date: July 2013
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: September 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Cirrhosis
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	adverse events will be recorded and graded	treatment (12 to 24 weeks) +12weeks treatment free follow up
Primary	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	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
Secondary	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