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Significance of detectable HCV RNA below the limit of quantification in patients treated with DAAs using standard and ultrasensitive protocols
Author(s) -
ViscoComandini Ubaldo,
Lapa Daniele,
Lionetti Raffaella,
Taibi Chiara,
Loiacono Laura,
Montalbano Marzia,
Capobianchi Maria R.,
D'Offizi Gianpiero,
Garbuglia Anna R.
Publication year - 2018
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.25084
Subject(s) - discontinuation , medicine , viral load , antiviral therapy , regimen , univariate analysis , virology , algorithm , virus , chronic hepatitis , multivariate analysis , mathematics
Predictive factors of HCV relapse after treatment with DAAs are poorly understood. In this study, we aimed to assess whether the residual viral load positivity observed during or at the end of treatment (EOT) has an impact on viral outcome. Blood samples were collected from 337 patients with genotypes (GT) 1a, 1b, 2, 3, and 4 HCV chronic infection, treated with DAAs to determine HCV RNA load by the Abbott RealTime HCV (ART) assay at treatment week (W) 4, at EOT, and 4, 12, 24 weeks after discontinuation. EOT and other samples with “detected <12/mL” (DNQ) were retested by an ultrasensitive protocol (USP) to confirm the result. Frequency of DNQ was analyzed in subgroups of patients and clinical conditions to assess potential correlations. At W4, 22% and 30.9% of the samples were undetectable and DNQ by ART assay, respectively, but no correlation for achieving SVR was found. In contrast, an HCV RNA cut‐off of ≥50/mL at W4 was a significant predictor of therapy failure ( P = 0.036, univariate analysis). At EOT, DNQ was associated to 12W treatment duration ( P < 0.001) and GT1a infection ( P = 0.036). Overall, 20/41 (48.8%) of DNQ samples at EOT or post‐treatment W4, were confirmed by USP but only in a single case the patient experienced viral relapse. HCV RNA at W4 can predict SVR, irrespective to genotype or DAA regimen. HCV RNA DNQ at EOT is associated to shorter treatment duration and to GT1a, but is not a predictor of therapy failure.