ABSTRACT
ObjectiveTo investigate the efficacy and safety of elbasvir/grazoprevir in patients with genotype 1 hepatitis C in the real world. MethodsA total of 35 patients with hepatitis C who received elbasvir/grazoprevir treatment in Guangzhou Eighth People’s Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, and Guangdong General Hospital from August 2018 to March 2019 were enrolled, treated for 12 weeks, and then followed up for 12 weeks after drug withdrawal. The patients were observed in terms of sustained virologic response at week 12 after drug withdrawal (SVR12), biochemical response, and incidence rate of adverse events during treatment and follow-up. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups, and the Mann-Whitney U test was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups. A logistic regression analysis was used to investigate the risk factors for virologic response in patients with hepatitis C. ResultsAmong the 35 patients with HCV infection, 97.1% (34/35) had genotype 1b HCV and 2.9% (1/35) had genotype 1a HCV; of all patients, 28 (80%) were non-cirrhotic patients with chronic hepatitis C and 7 (20%) had compensated liver cirrhosis. At the end of treatment, the virologic response rate of 100% (28/28) and SVR12 was 94.74% (18/19). In addition, age, sex, baseline HCV RNA load, previous treatment history, presence or absence of liver cirrhosis, renal function, and presence or absence of other diseases did not affect the treatment outcome (all P＞0.05). There were significant changes in the levels of alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and albumin from baseline to the end of 12-week treatment (Z=-7.131, -6.797, -3.060, and -2.875, all P＜0.05). No patient experienced drug withdrawal during treatment. ConclusionThis study confirms that elbasvir/grazoprevir has good efficacy and safety in the treatment of hepatitis C in domestic real-world studies.
ABSTRACT
Objective To establish a simple scoring system for the diagnosis of liver fibrosis in chronic hepatitis B (CHB), and to observe its sensitivity and specificity. Methods Two hundred and thirty-three patients diagnosed as CHB by liver biopsy were divided into model group (N = 154) and validation group (N = 79). The general information, biochemical parameters and imaging data of all patients were observed. With hepatic fibrosis being obvious or not as the end point of primary study in the model group, we established a simple scoring system for the diagnosis. The cut-off, sensitivity and specificity of the system were tested in the model group by ROC curve, and its diagnostic efficacy was tested in the validation group. Results(1) A simple scoring system for the diagnosis of liver fibrosis called MDFS was established in the model group, and the dimensions of the system included sex, HBV-DNA, Fibroscan (FS) value and splenomegaly. In MDFS, male, HBV-DNA≥ 107 U/mL,FS value≥7.3 kPa, and splenomegaly were assigned 1 point, -2 points, 3 points, and 2 points respectively. (2) The best cut-off value in MDFS was 2 points.(3) ROC curve of the model group indicated that the specificity and sensitivity were 92.86% and 54.76% respectively, the area under curve(AUC) was 0.790, and the Youden index was 0.4762. In the validation group, the diagnostic cut-off value was over 2 points, and the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were 52.17%, 82.35%, 2.96, and 0.58 respectively. (4) The scoring results of MDFS for different traditional Chinese medical syndromes of CHB showed that the scores of blood stasis blocking collaterals > damp-heat accumulation > deficiency of spleen and kidney yang> liver depression and spleen deficiency = stagnation of liver Qi. Conclusion The MDFS diagnostic scoring system has medium efficiency. The specificity of MDFS is relatively high and MDFs has a relatively low misdiagnosis rate for the diagnosis of obvious hepatic fibrosis in CHB. The MDFS is expected to be a noninvasive and simple diagnosing way for hepatic fibrosis in CHB.