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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatitis C patients | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple therapy | Drug |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse | Lyon | France |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| 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)) |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |