Effect of ASV and DCV therapy on the quality of immune status in chronic HCV patients;Investigator initiated research proposal nr. AI447-108

Completed

Conditions: hepatitis C
10019654
10047438

Registration Number: NL-OMON40207

Lead Sponsor: Stichting Maag-, Darm en Leveronderzoek (SLO)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

• Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1b infection;• Patients are non-responders to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy;• High viral load (>400,000 IU/ml);• Indication for antiviral therapy of hepatitis C according to current clinical guidelines;• Written informed consent

Exclusion Criteria

• Decompensated cirrhosis (Child-Pugh Grade B or C);• Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma within the last 3 months.;• Females who are pregnant or breast-feeding;• History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study;• Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV);• Presence of contra-indications for antiviral therapy with ASV and DCV: ;• Interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week);• Any exposure to NS3 protease inhibitors or NS5A polymerase inhibitors;• Treatment with peginterferon/ ribavirin within 6 months before start of therapy;• Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate in detail the functionality of immune cells in blood in chronic HCV<br /><br>patients before, during and after treatment with ASV and DCV, in an IFN-free<br /><br>regimen.<br /><br><br /><br>The following questions will be addressed in this study:<br /><br>1. Does the reduction in viral load due to dual therapy with ASV and DCV affect<br /><br>the immune status of patients chronically infected with HCV?<br /><br>2. Does the reduction in viral load due to dual therapy with ASV and DCV<br /><br>restore impaired immune responses to HCV?</p><br>

Secondary Outcome Measures