Clinical utility of the HCV drug resistance assay using the direct sequencing method and the cycleave PCR method in the dual therapy with daclatasvir and asunaprevir

Abstract

In this study, we evaluated the sensitivity and performance of HCV drug resistance assay for detection of DCV-resistant mutations using direct sequencing and cycleave PCR. Direct sequencing analysis revealed that SVR rates were 93.5％ (43[1]46) for the patients with Y93 wild, and 40.0％ (6[1]15) for the patients with Y93H mutant. Furthermore, cycleave PCR analysis revealed that SVR rates were 97.4％ (37[1]38) for the patients with Y93 wild, and 45.0％ (9[1]20) for the patients with Y93H mutant. The SVR rate in patients with Y93 wild was higher in the combination method of direct sequencing and cycleave PCR (97.6％) than in the cycleave PCR alone. These results suggested that this assay may be useful indicator for treatment with DCV/ASV dual therapy.