Page 33 - The Flying Publisher Guide to Hepatitis C Treatment

Patients’ monitoring during and after treatment | 33

2.2). Therefore, a single test result serves the purpose of both
quantitative and qualitative HCV NAT with similar sensitivity
(Ogawa 2010).

Table 2.2 – Currently available HCV RNA quantification methods*
Assay Manufacturer Method Conversion Dynamic
Factor Range
(copies/mL) (IU/mL)
Cobas Taqman Roche Molecular Real time 3.4 43-69,000,000
HCV Test Systems PCR
Abbott Real-Time Abbott Diagnostics Real time 3.4 12-100,000,000
PCR PCR
LCx HCV RNA Abbott Diagnostics RT-PCR 3.8 25-2,630,000
Quantitative
SuperQuant National Genetics RT-PCR 3.4 30-1,470,000
Institute
Versant HCV RNA Siemens Health bDNA 5.2 615-7,700,000
3.0 Assay Care Diagnostics
* According to data from Vermehren 2008 and Ghany 2009

Minimal residual viremia might be predictive of post-treatment
relapse (Matsuura 2009). Rules for treatment duration and early
discontinuation were mainly established with NAT assays with a
detection limit of 50 IU/ml. Lower detection limits (undetectable
VL defined as less than 15 IU/ml) did not significantly influence
the SVR rates after shortened treatment duration, for patients
with RVR (82% for G1 infected patients treated for 24 weeks and
95% for G2/3 infected patients treated for 16 weeks) (Sarrazin
2010).
The assay’s choice should be tailored to the dominant genotype
in the study population, as some assays have been reported to
substantially underestimate HCV RNA levels in certain
genotypes. The same assay should be used for all samples from a
single patient and, whenever possible, throughout the clinical
development program.