Anti-HCV Core Protein Monoclonal antibody, Clone 12-C4

Background: Direct acting antiviral (DAA) agents are the standard of care for treatment of hepatitis C virus (HCV)-infected individuals. Hepatitis B virus (HBV) reactivation during HCV treatment has been reported, the incidence and clinical outcome remains unclear. The aim of our study is to examine the risk of HBV reactivation in actively infected or previously exposed patients during or after HCV treatment with DAAs. Methods: Adults with chronic HCV infection previously exposed or actively infected with HBV and treated with DAAs between December 2015 to 2016 were included. Electronic medical records were reviewed for HCV treatment dates, HCV treatment response, DAA used, HBV status, and concurrent HBV treatment. Primary end-point was to determine the risk of HBV reactivation during or up to 3 months after DAA treatment. Results: We identified 283 patients, and 100% of patients completed HCV treatment with ledipasvir-sofosbuvir. 93% had HCV genotype-1 of whom 91% achieved sustained viral response at 12 weeks post-treatment (SVR-12). In total, 7% had HCV genotype-4 who achieved SVR-12 of 84%. Mean (+/- SD) age was 59.7 (+/- 7) years, and 58% were male. A total of 45% of patients had hepatitis B core antibody (HBcAb) positive and hepatitis B surface antigen (HBsAg) negative. In total, 55% of patients had a positive HBsAg before HCV DAA treatment. No HBV reactivation was encountered in the (HBcAb) positive HBsAg-negative cohort nor in the (HBsAg) positive group with 95% confidence interval (0-0.023) and (0-0.019), respectively. Conclusion: In our study of patients with HCV and isolated hepatitis B core or HBsAg positivity, no HCV patients treated with DAA experienced HBV reactivation.

This study aimed to establish a general and efficient dissociation technique for detecting antibodies in circulating immune complexes (CICs) in serum and to evaluate its clinical application. CICs were efficiently separated from specimens using polyethylene glycol double-precipitation. The best conditions for anti-HBs dissociation from HBsAg-ICs were a pH of 1.80, incubation at 15 degrees C for 5-10min, and detection within 10min after neutralization. The mean dissociation rate, reproducibility, mean dissociation recovery rate and specificity of the new technique were 64.3%,<5.97, 95.4 and 100%, respectively. They had a favourable linear relationship (r=0.9932), and the stability of the reagents exceeded 24months, except the CIC antibody dissociation reagent (>12months). Conditions for the dissociation of other CICs tested were similar, but there were differences inthe rate of antibody dissociation. Different HBV-M patterns had significantly different levels and rates of antibody dissociation from HBsAg-IC (P<0.05), and the detection rates of the corresponding antibodies in HCV, core-anti-HCV core antibody (HCV-ICs), HIV P24-anti-HIV P24 antibody (HIV-ICs), insulin-anti-insulin antibody (INS-ICs) and thyroid globulin-anti-thyroid globulin antibody CICs (TG-ICs) were 34.8, 66.7, 20 and 14.3%, respectively. These data suggest that our CIC antibody dissociation technique is a good general pretreatment technique for the detection of antibodies after the precipitation, separation and dissociation of multiple CICs.