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.
Study Type
OBSERVATIONAL
Enrollment
37
Hôpital de la Croix Rousse
Lyon, France
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
Time frame: 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
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).
Time frame: 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
Time frame: at the later phase of therapy (Week 8 ± 2 weeks)
Ribavirin plasma trough concentration after telaprevir withdrawal
Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Renal function at week 8 of therapy
Time frame: at the later phase of therapy (Week 8 ± 2 weeks)
Renal function after telaprevir withdrawal
Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
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