In:
Antiviral Therapy, SAGE Publications, Vol. 19, No. 6 ( 2014-08), p. 559-567
Abstract:
Response-guided therapy (RGT) for HCV treatment, whereby therapy duration is shortened according to on-treatment virological response, requires patient HCV RNA concentrations below the lower limit of quantification (LLOQ) or limit of detection (LOD) of the viral load assay at weeks 4 and 12. Concordance of two assays and impact on treatment decisions were investigated. Methods Plasma samples ( n=1,411; baseline to week 12) from HCV genotype-1-infected patients ( n=290) receiving simeprevir (TMC435) plus pegylated interferon-α2a/ ribavirin in the PILLAR study (NCT00882908) were analysed using Roche High-Pure-System/COBAS® TaqMan® v2.0 assay (HPS; LLOQ 25 IU/ml and LOD 15 IU/ml; Roche Diagnostics, Indianapolis, IN, USA) and reanalysed using Abbott RealTime assay (ART; LLOQ and LOD 12 IU/ml; Abbott Molecular Inc., Des Plaines, IL, USA). Results Overall, 217/766 (28.3%) samples from different time points with HCV RNA undetectable by HPS had HCV RNA detectable by ART. Conversely, 35/584 (6.0%) samples undetectable by ART were detectable by HPS. For both assays, most discrepant samples (96–100%) had HCV RNA 〈 25 IU/ ml. At week 4, 75.5% of samples were undetectable by HPS, whereas 49.4% were undetectable by ART, resulting in different RGT assessment in 26.1% ( P 〈 0.0001). At week 12, 95.4% and 91.9% of samples were undetectable with HPS and ART, respectively. Conclusions Lower rates of undetectable HCV RNA with ART at week 4 suggest that if RGT criteria are determined with ART, the proportion of patients qualifying for shorter treatment duration may be significantly lower (26%). Therefore, different RGT criteria may be necessary for ART to maximize numbers benefiting from shortened treatment. Further testing and validation are required.
Type of Medium:
Online Resource
ISSN:
1359-6535
,
2040-2058
Language:
English
Publisher:
SAGE Publications
Publication Date:
2014
detail.hit.zdb_id:
2118396-X
SSG:
15,3
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