Ribavirin Bioavailability After Telaprevir Exposure

Study Overview
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Brief Summary
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Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.

Official Title
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Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Triple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hepatitis C virus infection Previous non-response to pegylated-interferon/ribavirin therapy Re-treatment with pegylated-interferon/ribavirin and telaprevir Exclusion Criteria: Decompensated liver cirrhosis

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 |
| --- | --- |
| Hepatitis C patients<br>Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir | Drug: Triple therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy | Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification | before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function between baseline and week 4 of triple therapy | Renal function was assessed with the commonly used Modification of the Diet in Renal Disease (MDRD) study equation which allows to assess the estimated glomerular filtration rate (eGFR). | Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy | 
| Ribavirin plasma trough concentration at week 8 of therapy |  | at the later phase of therapy (Week 8 ± 2 weeks) | 
| Ribavirin plasma trough concentration after telaprevir withdrawal |  | after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16)) | 
| Renal function at week 8 of therapy |  | at the later phase of therapy (Week 8 ± 2 weeks) | 
| Renal function after telaprevir withdrawal |  | after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16)) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Antiviral Agents, Glomerular Filtration Rate, Hepatitis C, Ribavirin, Telaprevir