Premium
Detection of low HCV viraemia by repeated HCV RNA testing predicts treatment failure to triple therapy with telaprevir
Author(s) -
Maasoumy B.,
Cobb B.,
Bremer B.,
Luk K.,
Halfon P.,
Aslam S.,
Manns M. P.,
Cornberg M.,
Wedemeyer H.
Publication year - 2014
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12544
Subject(s) - medicine , telaprevir , concordance , hepatitis c virus , virology , gastroenterology , taqman , viral load , real time polymerase chain reaction , virus , ribavirin , biology , biochemistry , gene
Summary Background Early on‐treatment virological response is one of the most important predictors for sustained virological response ( SVR ) to treatment of chronic hepatitis C virus ( HCV ) genotype 1 infection with triple therapy including HCV protease inhibitors ( PI ). Treatment duration (24 vs. 48 weeks) is based on HCV RNA results at weeks 4 and 12 of PI therapy when HCV RNA must be ‘undetectable’ to allow shorter therapy. Aim To analyse the reliability of HCV RNA measurements at key decision time points (weeks 4 and 12) and the predictive value of concordant or discordant assay results for SVR . Methods Weeks 4 and 12 samples of patients receiving telaprevir‐containing triple therapy were initially tested with the AmpliPrep/ COBAS ‐TaqMan_ HCV ‐Test‐v1.0 (limit of detection; LOD = 15 IU /mL) and retested with the AmpliPrep/ COBAS ‐TaqMan_ HCV ‐Test‐v2.0 ( LOD = 15 IU /mL) and the High_Pure/ COBAS ‐TaqMan_ HCV ‐Test‐v2.0 ( LOD = 20 IU /mL). Results Concordance among the three test results in classifying samples as HCV RNA ‘undetectable’ or ‘detectable’ was only 55% at week 4, but 85% at week 12. Retesting of ‘undetectable’ week 4 samples with the respective other assays revealed positive HCV RNA results in 32–50%. In 30%, HCV RNA was ‘undetectable’ by all three tests at week 4 and all of these patients achieved SVR . In contrast, treatment failure occurred in 62% of patients with at least one ‘detectable’ result, including cases with one or two other ‘undetectable’ tests at week 4. Conclusions A single ‘undetectable’ HCV RNA result at week 4 is not always associated with achieving SVR . Repeated testing in difficult‐to‐treat patients may identify those at risk for treatment failure.