Clinical relevance of detectable hepatitis C virus RNA in the context of direct-acting antivirals

摘要

Harrington et al. discuss the clinical relevance of detectable, but not quantifiable, hepatitis C viral (HCV) RNA during treatment with the two recently approved direct-acting antivirals (DAAs), boceprevir and telaprevir. The clinical trials used to assess the efficacy of these new DAAs were not designed to assess response-guided therapy using the less than lower limit of quantification [LLOQ] cutoff. However, a viremia below the LLOQ, but with detectable amounts of virus, clearly indicates that peripheral clearance has not occurred and, by implication, that replicating virus is still present in the liver. The endpoint for the LLOQ for most clinical trials is 25 IU/mL (1.39 logio).