Background: According to current recommendations diagnosis and management of HCV infection need detection and quantification of nucleic acids. In the era of direct-acting antivirals (DAA) it is essential to develop an inexpensive and simple method replacing polymerase chain reaction. Since there is no available data on HCV core antigen (HCVcAg) versus HCV RNA kinetics in the early phase of treatment with DAA, we carried out this study to evaluate the possible application of HCVcAg quantitative measurement for management of HCV infection.
Methods: 33 patients with HCV infection were enrolled and treated with either ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PRV/r±DSV±RBV) or ledipasvir/sofosbuvir (LDV/SOF). Samples for quantitative HCV RNA and HCVcAg measurement were collected at the baseline, after 1, 7, 28 days and at the end of treatment, and then after 12 and 24 weeks of post-treatment follow-up.
Results: There was positive correlation between HCVcAg and HCV RNA levels at the baseline and after 1 day of treatment. Mean HCVcAg concentration declined faster than HCV RNA levels during the treatment phase. At week 4 HCV RNA was undetectable in 24, whereas HCVcAg in 28 patients. At the end of treatment and after 12 weeks of follow-up all patients were undetectable for both HCV RNA and HCVcAg.
Conclusions: HCVcAg concentration and its early on-treatment testing can predict virological response. Simple testing procedures and significantly lower cost compared to HCV RNA testing support possible replacement of the viral load measurement in management of the majority of HCV-infected patients.