Impact of HCV kinetics on treatment outcome differs by the type of real-time HCV assay in NS3/4A protease inhibitor-based triple therapy

Ogawa, Eiichi; Furusyo, Norihiro; Murata, Masayuki; Hattori, Takeo; Shimizu, Motohiro; Mukae, Haru; Toyoda, Kazuhiro; Hotta, Taeko; Uchiumi, Takeshi; Hayashi, Jun

doi:10.1016/j.antiviral.2015.12.001

Cited by 4 publications

(9 citation statements)

References 24 publications

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“…Furthermore, since the authors did not provide any information about whether patients were naive or had failed previous antiviral therapy, other factors that could influence the success of treatment could not be excluded. Furthermore, our findings on the predictive power of the US HCV RNA value corroborate the results described by Nishida [12] and Ogawa [35] concerning antiviral triple therapy with simeprevir, peg-interferon and ribavirin.…”

Section: Discussionsupporting

confidence: 90%

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Ultrasensitive HCV RNA Quantification in Antiviral Triple Therapy: New Insight on Viral Clearance Dynamics and Treatment Outcome Predictors

et al. 2016

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ObjectivesIdentifying the predictive factors of Sustained Virological Response (SVR) represents an important challenge in new interferon-based DAA therapies. Here, we analyzed the kinetics of antiviral response associated with a triple drug regimen, and the association between negative residual viral load at different time points during treatment.MethodsTwenty-three HCV genotype 1 (GT 1a n = 11; GT1b n = 12) infected patients were included in the study. Linear Discriminant Analysis (LDA) was used to establish possible association between HCV RNA values at days 1 and 4 from start of therapy and SVR. Principal component analysis (PCA) was applied to analyze the correlation between HCV RNA slope and SVR. A ultrasensitive (US) method was established to measure the residual HCV viral load in those samples which resulted “detected <12IU/ml” or undetectable with ABBOTT standard assay, and was retrospectively used on samples collected at different time points to establish its predictive power for SVR.ResultsAccording to LDA, there was no association between SVR and viral kinetics neither at time points earlier than 1 week (days 1 and 4) after therapy initiation nor later. The slopes were not relevant for classifying patients as SVR or no-SVR. No significant differences were observed in the median HCV RNA values at T0 among SVR and no-SVR patients. HCV RNA values with US protocol (LOD 1.2 IU/ml) after 1 month of therapy were considered; the area under the ROC curve was 0.70. Overall, PPV and NPV of undetectable HCV RNA with the US method for SVR was 100% and 46.7%, respectively; sensitivity and specificity were 38.4% and 100% respectively.ConclusionHCV RNA “not detected” by the US method after 1 month of treatment is predictive of SVR in first generation Protease inhibitor (PI)-based triple therapy. The US method could have clinical utility for advanced monitoring of virological response in new interferon based DAA combination regimens.

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Section: Discussionsupporting

confidence: 90%

“…The relevance of method sensitivity in monitoring the therapy represents an open question regarding new [34], and second generation DAA [35]. Our data apparently differ from that of Vermeheren et al [14].…”

Section: Discussioncontrasting

confidence: 80%

Ultrasensitive HCV RNA Quantification in Antiviral Triple Therapy: New Insight on Viral Clearance Dynamics and Treatment Outcome Predictors

et al. 2016

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“…Testing was performed at Kyushu University Hospital according to the manufacturer's instructions. Performance characteristics of the two assays have been described in detail previously [13]. CAP/CTM assay results are reported as target not detected (TND), target detected but lower limitation of quantification (TD/<LLOQ; <15 IU/ml) or absolute number (quantifiable results: ≥15 IU/ml).…”

Section: Determination Of the Hcv Rna Levelmentioning

confidence: 99%

“…Among them is the most widely used HCV assay, the Roche COBAS AmpliPrep/ COBAS TaqMan HCV test (CAP/CTM). The utility of a more sensitive assay for very low viraemia, the Abbott RealTime HCV (ART) assay, has been reported for DAA-based triple therapy [10][11][12][13]. The major difference between these assays is the discordance in the detection of HCV RNA at the lower limits of quantification, which could influence treatment outcome.…”

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confidence: 99%

Comparison of the Abbott RealTime HCV and Roche COBAS Ampliprep/COBAS TaqMan HCV Assays for the Monitoring of Sofosbuvir-Based Therapy

et al. 2017

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“…Additionally, there has been a report on CAP/CTM and ART for evaluating patients receiving triple therapy with the protease inhibitors TVR or simeprevir. The study found that ART can detect lower levels of HCV RNA in the early period than CAP/CTM, and relapse in the late period [17]. Although DCV/ASV dual therapy has now been used in Japan for more than 1 year, to the best of our knowledge, there are no reports of studies comparing CAP/CTM and ART for the evaluation of patients receiving DCV/ASV dual therapy.…”

Section: Introductionmentioning

confidence: 99%

Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy

et al. 2017

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The aim of this study was to determine the efficacy of two hepatitis C virus (HCV) real-time PCR assays, the COBAS AmpliPrep/COBAS TaqMan HCV test (CAP/CTM) and the Abbott RealTime HCV test (ART), for predicting the clinical outcomes of patients infected with HCV who received telaprevir (TVR)-based triple therapy or daclatasvir/asunaprevir (DCV/ASV) dual therapy. The rapid virological response rates in patients receiving TVR-based triple therapy were 92% (23/25) and 40% (10/25) for CAP/CTM and ART, respectively. The false omission rate (FOR) of ART was 93.3% (14/15), indicating that CAP/CTM could accurately predict clinical outcome in the early phase. In an independent examination of 20 patients receiving TVR-based triple therapy who developed viral breakthrough or relapse, the times to HCV disappearance by ART were longer than by CAP/CTM, whereas the times to HCV reappearance were similar. In an independent experiment of WHO standard HCV RNA serially diluted in serum containing TVR, the analytical sensitivities of CAP/CTM and ART were similar. However, cell cultures transfected with HCV and grown in medium containing TVR demonstrated that ART detected HCV RNA for a longer time than CAP/CTM. Similar results were found for 42 patients receiving DCV/ASV dual therapy. The FOR of ART was 73.3% (11/15) at week 8 after initiation of therapy, indicating that ART at week 8 could not accurately predict the clinical outcome. In conclusion, although CAP/CTM and ART detected HCV RNA with comparable analytical sensitivity, CAP/CTM might be preferable for predicting the clinical outcomes of patients receiving protease inhibitor-based therapy.

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Impact of HCV kinetics on treatment outcome differs by the type of real-time HCV assay in NS3/4A protease inhibitor-based triple therapy

Cited by 4 publications

References 24 publications

Ultrasensitive HCV RNA Quantification in Antiviral Triple Therapy: New Insight on Viral Clearance Dynamics and Treatment Outcome Predictors

Ultrasensitive HCV RNA Quantification in Antiviral Triple Therapy: New Insight on Viral Clearance Dynamics and Treatment Outcome Predictors

Comparison of the Abbott RealTime HCV and Roche COBAS Ampliprep/COBAS TaqMan HCV Assays for the Monitoring of Sofosbuvir-Based Therapy

Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy

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