Correlation between efficacy of daclatasvir/asunaprevir combination therapy and HCV NS3/NS5A resistance-associated variants detected by the PCR-Invader assay

吉康, 狩野; 成司, 豊田; 一彰, 茶山; 博光, 熊田

doi:10.2957/kanzo.56.113

Cited by 1 publication

(2 citation statements)

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“…The second cleavage reaction releases fluorophore, resulting in the generation of a fluorescent signal, the strength of which is determined quantitatively [17]. In this study, we used a commercially available Invader assay for detection of RASs in the NS5A region at baseline (BML, Inc., Saitama, Japan) [14,18]. The targeted mutations were L31F/M/V and Y93H in the NS5A region.…”

Section: Invader Assaymentioning

confidence: 99%

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Pre-existing minor variants with NS5A L31M/V-Y93H double substitution are closely linked to virologic failure with asunaprevir plus daclatasvir treatment for genotype 1b hepatitis C virus infection

et al. 2020

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Background L31 and Y93 in the NS5A region of the hepatitis C virus (HCV) are the most important substitution positions associated with resistance to direct-acting antiviral (DAA) treatment. Methods We analyzed the frequency of NS5A L31M/V and Y93/H in NS5A inhibitor-naive HCV genotype 1 patients who received asunaprevir plus daclatasvir combination treatment using a conventional sequencing method and a deep sequencing method that can distinguish a single substitution at either position and a double substitution at both positions with a 0.1% detection threshold. Results The frequency of substitutions at both sites using the conventional method was very low, with 1 in 14 non-responders and 0 in 42 randomly selected responder patients. On the other hand, for the deep sequencing method, cases with double substitutions in the tandem sequence were detected in 8/14 non-responders and 1/42 responders (p<0.0001). For the conventional method, substitutions were detected at any position in 6/14 non-responders and 2/42 responders (p = 0.0019), with a clear difference between the two groups. The difference was also clear with the deep sequencing method, with 11/14 non-responders and 8/ 42 responders. Interestingly, for the deep sequencing method, the single substitution of L31

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Section: Invader Assaymentioning

confidence: 99%

“…We defined positive as significant in this study. The results for RASs were determined to be negative (<1%), weakly positive (1-20%) and positive (>20%) according to the signal strength of the Invader reaction [18]. We defined a positive result as significant in this study.…”

Section: Invader Assaymentioning

confidence: 99%