Treatment adherence in patients treated with telaprevir for a chronic hepatitis C genotype 1 infection: an observational study

Completed

• Conditions: hepatitis C; 10019654; 10047438

• Registration Number: NL-OMON39839
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Age 18 to 70 years
- BMI 18-38 kg/m2
- Treatment-naïve for HCV, virological relapse or partial virological response (> 2log10 decline at week 12) after previous treatment with peg/RBV
- HCV genotype 1a or 1b
- Clinical and laboratory findings consistent with a clinical diagnosis of chronic hepatitis C
- Serum HCV RNA >10.000 IU/mL at baseline

Exclusion Criteria

History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding or other signs of hepatic insufficiency or portal hypertension ;Positive results on the following screening laboratory tests: urine or serum pregnancy test (for women of childbearing potential), hepatitis B surface antigen and human immunodeficiency virus (HIV) antibody.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>treatment adherence measured by MEMScaps and questionaire </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>virological outcome (ie RVR/SVR)<br /><br>plasma concentrations telaprevir/ ribavirine<br /><br>outcome Hospital Anxiety and Depression scale questionnaire </p><br>