Hepatitis C
Conditions
Keywords
Anemia, Antiviral Agents, Glomerular Filtration Rate, Hepatitis C, Ribavirin, Telaprevir
Brief summary
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.
Interventions
DRUGTriple therapy
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in renal function between baseline and week 4 of triple therapy | Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of 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). |
| 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)) | — |
Countries
France
Outcome results
None listed