Objective:To evaluate the clinical utility of a novel quantitative assay named hepatitis B virus (HBV) simultaneous amplification and testing (SAT) using a kit for HBV RNA detection (RNA probes).Methods:HBV RNA was detected in 170 serum samples of chronic hepatitis B patients and 30 serum samples of patients without HBV infection collected by simple random sampling method from June 2017 to June 2018 in Huashan Hospital, Fudan University, Shanghai using HBV SAT and reverse transcription polymerase chain reaction (PCR) method. The sensitivity, specificity, kappa value and quantitative correlation of the two methods were analyzed and compared.The detection rates of HBV RNA from samples with different HBV DNA concentrations of the two methods were analyzed and compared. Statistical analysis was performed by chi-square test.Results:Based on the clinical diagnosis, the detection sensitivity, specificity, kappa value of HBV SAT were 97.06%(165/170), 100.00%(30/30) and 0.908, respectively, while the reverse transcription PCR were 92.94%(158/170), 100.00%(30/30) and 0.798, respectively. Among samples with lower concentration of HBV DNA (HBV DNA<100 IU/mL), the detection rates of HBV SAT and reverse transcription PCR were 77.27%(17/22) and 59.09%(13/22), respectively. The linear correlation coefficient of the two methods was r=0.987 8. Conclusions:Quantitation results of HBV RNA by HBV SAT and reverse transcription PCR method are consistent. HBV SAT is a rapid and accurate method for HBV RNA quantitative detection, which has a slightly higher detection rate than reverse transcription PCR in samples with low concentration of HBV DNA.

Objective:To analyze the changes and efficacy of antiviral treatment regimens in patients with chronic hepatitis C.Methods:This was a single center retrospective study. A total of 157 patients with chronic hepatitis C in Huashan Hospital, Fudan University from January 2014 to February 2019 were included. Clinical informations of antiviral treatment and follow-up were collected. The sustained virologic response (SVR) rate and adverse events in patients receiving different antiviral regimens were compared. Chi-square test was used for statistical analysis.Results:Among the 157 patients, 133 patients had sufficient follow-up data. Seventy-one patients received treatment before 2017, among which 63 patients received interferon regimens and the SVR rate was 74.65%(53/71). Sixty-two patients received treatment after 2017, among which 61 patients received direct-acting antiviral agents (DAA) regimens and the SVR rate was 98.39%(61/62). The difference in SVR rate between the two groups was statistically significant ( χ2=15.230, P<0.01). In 69 patients who received DAA regimens from 2014 to 2019, the SVR at post-treatment week 12 (SVR12) was 95.65%(66/69). Among 43 patients who received DAA regimens containing sofosbuvir, the SVR12 rates of patients with hepatitis C virus genotype 1, 3 and other genotypes were 15/15, 5/6 and 90.91%(20/22), respectively. All the 26 patients who received DAA regimens non-containing sofosbuvir achieved SVR12. The SVR12 rates of patients with different hepatitis C virus genotypes and DAA regimens were not significantly different ( χ2=5.243, P=0.263). The incidences of adverse events in pre-2017 group and post-2017 group were 84.62%(77/91) and 6.06% (4/66), respectively. The difference was statistically significant ( χ2=94.520, P<0.01). The most common adverse events were decreases in neutrophil cell count, decreases in hemoglobin level and decreases in platelet count. Treatment was ceased in six patients due to adverse events. Conclusions:After 2017, the majority of patients with chronic hepatitis C received DAA regimens instead of interferon regimens. The SVR rate increases and the incidence of adverse events decreases along with the changes of leading treatment regimens.The SVR12 rate is higher in patients receiving DAA regimens, regardless of hepatitis C virus genotypes.