Journal
CLINICAL INFECTIOUS DISEASES
Volume 62, Issue 10, Pages 1228-1234Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciw061
Keywords
hepatitis C virus; HCV RNA assay; baseline viral load; Cobas AmpliPrep/Cobas TaqMan; Abbott RealTime HCV
Categories
Funding
- Abbott
- AbbVie
- Bristol-Myers Squibb
- Covidien
- Gilead
- Janssen-Cilag
- Merck/Merck Sharp Dohme (MSD)
- Roche
- Janssen
- Merck
- Theravance
- Merck/MSD
- Boehringer
- Novartin
- Novartis
- Tibotec
- Vertex
- Qiagen
- Siemens
- Achillion
- Fujirebio
- GlaxoSmithKline
- Transgene
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Background. Interferon-free treatment of chronic hepatitis C virus (HCV) genotype 1 infection may be shortened to 8 weeks in treatment-naive, noncirrhotic patients with baseline HCV RNA levels of <4 or <6 million (M) IU/mL based on post-hoc analyses of phase 3 trial data. The applicability of these viral load thresholds in clinical practice is unknown. Methods. Pretreatment and on-treatment serum samples (n = 740) from patients with HCV genotype 1 infection were included for HCV RNA analysis with 2 widely used assays, Cobas AmpliPrep/CobasTaqMan (CAP/CTM) and Abbott RealTime HCV (ART) assays. Results. HCV RNA levels were significantly higher with CAP/CTM than with ART (overall difference, +0.11 log(10) IU/mL; P < .001). In treatment-naive, noncirrhotic patients, discordance rates around the clinical cutoffs at 4M and 6M IU/mL were 23% and 18%, respectively. The mean differences between assays in discordant samples were 0.38 (4M) and 0.41 (6M) log(10) IU/mL, respectively. Overall, 87% and 95% of treatment-naive, noncirrhotic patients, respectively, had baseline HCV RNA levels below 4M and 6M IU/mL with ART. These rates were significantly higher than those measured with CAP/CTM (64% and 78%, respectively; P < .001). Finally, discordance rates around the proposed thresholds in 2 consecutive samples of the same patient were in the range of 1%-2% for ART and 13%-17% for CAP/CTM. Conclusions. Selection of patients for 8-week regimens on the basis of a single HCV RNA determination may not be reliable because viral load levels around the proposed clinical thresholds show significant interassay and intrapatient variability.
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