Cobas taqman hcv hps assay

The primary efficacy endpoint was SVR12, defined as plasma HCV RNA level <25 IU.mL^-1 12 weeks after end of treatment. SVR4 was a secondary endpoint. Plasma HCV RNA level was measured using the quantitative Roche COBAS® Taqman HCV/HPS assay (Version 2), with a limit of detection between 10 and 20 IU/mL and a linear range of 25 IU/mL to 3.91 x 10⁸ IU/mL. Safety was assessed by monitoring adverse events (AEs, reported using the MedDRA coding dictionary version 17.1 and the NIH NIAID Division of AIDS [DAIDS] grading system), AEs leading to treatment discontinuation, serious AEs (SAEs), laboratory test abnormalities, and changes in laboratory test values. Pre-dose plasma trough concentrations for deleobuvir and faldaprevir were measured at Week 1 through Week 4. A validated high-performance liquid chromatography–tandem mass spectrometry (HPLC-MS/MS) assay was used to analyze the plasma samples (Tandem Labs, Salt Lake City, UT, USA). The faldaprevir and deleobuvir methods were validated for a range of 10.0 to 10,000 ng/ml and 23.0 to 23,000 nmol/L respectively; analyte quantitation in both methods was performed using a weighted (1/x²) linear least squares regression analysis generated from calibration standards.

Plasma HCV RNA levels were measured using the COBAS TaqMan HCV/HPS assay (Roche Molecular Diagnostics) at a central laboratory (Covance Central Laboratory Services). The LLOQ was 25 IU/ml. Viral genotyping included population sequencing of the NS3/NS4A region. Genotyping was performed for all patients at baseline, for patients who discontinued study treatment, and on samples from patients whose HCV RNA levels reached a plateau above the LLOQ or rebounded during the study period.