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Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition) are updated and revised based on the research advances in chronic hepatitis B virus infection in China and globally and the previous editions of the guidelines. This article introduces the updates in natural history and the noninvasive diagnosis and treatment of fibrosis. In particular, the guidelines further expand the indications for patients with chronic hepatitis B virus infection, clearly defines the selection of the population benefiting from interferon therapy, and strictly limits the standard of oral nucleos(t)ide analogues. Meanwhile, the guidelines also recommend more active treatment of patients with low-level viremia and children in the immune-tolerant phase. The new edition of the guidelines will provide an important basis for expanding the screening for hepatitis B virus infection, improving diagnostic rate, optimizing treatment regimens, and standardizing clinical management in China.
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The Infectious Diseases Society of America and the American Association for the Study of Liver Diseases have collaboratively developed evidence-based guidance regarding the diagnosis， management， and treatment of hepatitis C virus （HCV） infection since 2013. A panel of clinicians and investigators with extensive expertise in infectious diseases or hepatology specific to HCV infection periodically reviews related evidence and update existing recommendations or introduce new recommendations based on such evidence. This update focuses on the changes to the guidance since the update in 2020， including recommendations for extensive universal screening， simplified treatment and testing regimens， treatment of poor compliance， and management of unique and key populations such as children aged <3 years and patients undergoing transplantation.
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Objective:By strengthening the management of external provision of data generated by clinical trials in medical institutions, to improve the effectiveness of supervision of human genetic resource information, and to promote the legal sharing and effective use of data.Methods:Analyzed problems identified in filing human genetic resource information in clinical trials since July 1, 2019, put forward possible solutions and suggestions.Results:Main problems were identified in external provision of human genetic resource information, including the specification and time limit of external provision of information, the information recipient, the storage location and the final disposal method of information.Conclusions:Hospital and regulatory authority need to carry out more tailored training, optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.
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Objective:The authenticity and accuracy of medical device related clinical trial data is crucial for the efficacy and safety of tested products. This article analyzed issues identified during previous data inspections of medical device clinical trials in our hospital, summarized experiences and findings, and proposed solutions.Methods:According to the " Medical Device Clinical Trial Inspection Points and Judgment Principles" , this study retrospectively analyzed the data inspection of medical device clinical trials in our hospital since 2016, summarized and analyzed the common issues identified.Results:A total number of six data inspections on medical device clinical trials were carried out in our hospital, during which 30 findings were identified. These findings include 4 items of pre-trial preparation, 2 items of patient rights protection, 7 items of trial processes, 12 items of records and reporting, as well as 5 items of experimental medical device management.Conclusions:The completeness, accuracy and consistency of clinical trial records in clinical trials of devices in our hospital have a lot space for improvement. And there is still room for improvement in the compliance to the protocol and the management of medical devices during the trial process. Based on the common findings, our drug clinical trial center will strengthen training and quality control, improve informatization and centralized management, and emphasize the importance of records. Through that the accuracy and authenticity of trial data for medical devices, and the credibility and objectiveness of trial results would be assured.
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There is still a large number of patients with chronic hepatitis B virus (HBV) infection in China, which greatly affects the health of Chinese people. With the change in lifestyle, the incidence rate of nonalcoholic fatty liver disease (NAFLD) is increasing year by year in China. Some clinical studies have shown that there is a relatively low incidence rate of chronic HBV infection with NAFLD, while there are still reports on NAFLD in promoting the progression of chronic hepatitis B-related diseases. Based on literature search and review, this article attempts to investigate the interaction between HBV replication, abnormal lipid metabolism, and fatty liver disease in patients with chronic hepatitis B and NAFLD, in order to provide ideas for HBV antiviral treatment and prevention of NAFLD.
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In December 2019, National Medical Products Administration of China issued Guidelines for Clinical Trials of Drugs for Treatment of Nonalcoholic Steatohepatitis (Interim), which mainly targeted at adult patients with nonalcoholic steatohepatitis with significant liver fibrosis and compensated liver cirrhosis (F2-F4). This article introduces related considerations from the aspects of clinical trial endpoint, overall clinical trial design, specific research and development stages, and safety. With reference to related guidelines of the United States and the European Union, this article attempts to explore the association between clinical trial and clinical practice.
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Objective@#To explore the correlation between the level of anti-mitochondrial antibody (AMA) and clinical indicators of first visited primary biliary cholangitis (PBC) patients with positive AMA.@*Methods@#From January 2013 to December 2016, the clinical data of 1 323 patients with positive AMA and/or AMA-M2 detected for the first time were collected through the Information System of Peking University People′s Hospital. Among them, 183 were detected by indirect immunofluorescence assay, 431 were measured by immunoblotting, and 709 were determined by enzyme-linked immunosorbent assay (ELISA). Patients were divided into undiagnosed PBC group (non-PBC group, 973 cases) and newly diagnosed PBC group (new-PBC group, 350 cases including 268 cases of non-liver cirrhosis and 82 cases of liver cirrhosis); among 709 cases detected by ELISA, there were 567 cases in the non-PBC group and 142 cases in the new-PBC group (115 cases of non-liver cirrhosis PBC group and 27 cases of liver cirrhosis PBC group). Among 183 cases determined by indirect immunofluorescence assay, there were 118 cases in the non-PBC group and 65 cases in the new-PBC group. Among them 69 cases with low AMA titer (1∶40—1∶80) (53 cases of non-PBC group and 16 cases of new-PBC group), 95 cases with medium titer (1∶160—1∶320) (59 cases of non-PBC group and 36 cases of new-PBC group) and 19 cases with high titer (≥1∶640) (six cases of non-PBC group and 13 cases of new-PBC group). AMA levels among groups were compared, and its correlation with clinical serology and cirrhosis indicators of PBC including immunoglobulin (Ig)G, IgM, platelet, alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltranspeptadase (GGT), alkaline phosphatase (ALP), serum total protein, serum albumin, total bilirubin (TBil), total cholesterol (TC), and aspartate aminotransferase to platelet ratio index (APRI) and fibrosis (Fib-4) was analysed. Mann-Whitney U test, Kruskal-Wallis test, and linear regression analysis were performed for statistical analysis.@*Results@#By ELISA method, the median titer of AMA-M2 of 709 patients was 53 RU/mL, the serum AMA and AMA-M2 levels of new-PBC group were both higher than those of non-PBC group (1∶320 vs. 1∶80, 180 RU/mL vs. 47 RU/mL), and the differences were statistically significant (χ2 = 14.111, Z = -7.531, both P < 0.01). In non-PBC group, the AMA-M2 value was positively correlated with age, serum IgG, IgM, AST, GGT, ALP, serum total protein and TC, all of which were statistically significant (Rho = 0.114, 0.108, 0.337, 0.089, 0.197, 0.086, 0.121 and 0.073, all P<0.05). In new-PBC group, AMA-M2 value was positively correlated with age, IgM, serum total protein and TC, however was negatively correlated with platelet count, all of which were statistically significant (Rho = 0.218, 0.483, 0.230, 0.161, and -0.183, all P<0.05). The median values of serum AMA and AMA-M2 of PBC without liver cirrhosis group were both tended to be lower than those of PBC with liver cirrhosis (1∶160 vs. 1∶320; 174 RU/mL vs. 495 RU/mL), however the differences were not statistically significant (both P>0.05). AMA-M2 value of patients in PBC with liver cirrhosis group was positively correlated with IgM level (r = 0.38, P = 0.039), but was not correlated with APRI and Fib-4 (all P > 0.05). The median of AMA value of 183 patients who underwent indirect immunofluorescence test was 1∶160. In non-PBC group, the IgM levels of patients with low, medium and high AMA titers gradually increased (the median levels were 1.2, 1.7 and 1.8 g/L, respectively); in new-PBC group, the levels of IgM, GGT and ALP of patients with low, medium and high AMA titers gradually increased (median IgM levels were 1.5, 3.7 and 4.1 g/L, respectively; GGT levels were 144, 182 and 317 U/L, respectively; and ALP levels were 137, 168 and 221 U/L, respectively), and the differences were statistically significant (χ2 =6.260, 7.081, 8.030, 15.226, all P<0.05). In non-PBC group, the median level of serum AMA-M2 of men was lower than that of women (41 RU/L vs. 50 RU/L), and the difference was statistically significant (Z = -2.945, P = 0.003). In new-PBC group, the median level of serum AMA-M2 of men tended to be lower than that of women (113 RU/mL vs. 206 RU/mL), but the difference was not statistically significant (P=0.257).@*Conclusion@#Serum AMA level is correlated with many clinical parameters and may be related with the disease severity in patients with PBC.
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Objective:To explore the correlation between the level of anti-mitochondrial antibody (AMA) and clinical indicators of first visited primary biliary cholangitis (PBC) patients with positive AMA.Methods:From January 2013 to December 2016, the clinical data of 1 323 patients with positive AMA and/or AMA-M2 detected for the first time were collected through the Information System of Peking University People′s Hospital. Among them, 183 were detected by indirect immunofluorescence assay, 431 were measured by immunoblotting, and 709 were determined by enzyme-linked immunosorbent assay (ELISA). Patients were divided into undiagnosed PBC group (non-PBC group, 973 cases) and newly diagnosed PBC group (new-PBC group, 350 cases including 268 cases of non-liver cirrhosis and 82 cases of liver cirrhosis); among 709 cases detected by ELISA, there were 567 cases in the non-PBC group and 142 cases in the new-PBC group (115 cases of non-liver cirrhosis PBC group and 27 cases of liver cirrhosis PBC group). Among 183 cases determined by indirect immunofluorescence assay, there were 118 cases in the non-PBC group and 65 cases in the new-PBC group. Among them 69 cases with low AMA titer (1∶40—1∶80) (53 cases of non-PBC group and 16 cases of new-PBC group), 95 cases with medium titer (1∶160—1∶320) (59 cases of non-PBC group and 36 cases of new-PBC group) and 19 cases with high titer (≥1∶640) (six cases of non-PBC group and 13 cases of new-PBC group). AMA levels among groups were compared, and its correlation with clinical serology and cirrhosis indicators of PBC including immunoglobulin (Ig)G, IgM, platelet, alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltranspeptadase (GGT), alkaline phosphatase (ALP), serum total protein, serum albumin, total bilirubin (TBil), total cholesterol (TC), and aspartate aminotransferase to platelet ratio index (APRI) and fibrosis (Fib-4) was analysed. Mann-Whitney U test, Kruskal-Wallis test, and linear regression analysis were performed for statistical analysis. Results:By ELISA method, the median titer of AMA-M2 of 709 patients was 53 RU/mL, the serum AMA and AMA-M2 levels of new-PBC group were both higher than those of non-PBC group (1∶320 vs. 1∶80, 180 RU/mL vs. 47 RU/mL), and the differences were statistically significant ( χ2 = 14.111, Z = -7.531, both P < 0.01). In non-PBC group, the AMA-M2 value was positively correlated with age, serum IgG, IgM, AST, GGT, ALP, serum total protein and TC, all of which were statistically significant ( Rho = 0.114, 0.108, 0.337, 0.089, 0.197, 0.086, 0.121 and 0.073, all P<0.05). In new-PBC group, AMA-M2 value was positively correlated with age, IgM, serum total protein and TC, however was negatively correlated with platelet count, all of which were statistically significant ( Rho = 0.218, 0.483, 0.230, 0.161, and -0.183, all P<0.05). The median values of serum AMA and AMA-M2 of PBC without liver cirrhosis group were both tended to be lower than those of PBC with liver cirrhosis (1∶160 vs. 1∶320; 174 RU/mL vs. 495 RU/mL), however the differences were not statistically significant (both P>0.05). AMA-M2 value of patients in PBC with liver cirrhosis group was positively correlated with IgM level ( r = 0.38, P = 0.039), but was not correlated with APRI and Fib-4 (all P > 0.05). The median of AMA value of 183 patients who underwent indirect immunofluorescence test was 1∶160. In non-PBC group, the IgM levels of patients with low, medium and high AMA titers gradually increased (the median levels were 1.2, 1.7 and 1.8 g/L, respectively); in new-PBC group, the levels of IgM, GGT and ALP of patients with low, medium and high AMA titers gradually increased (median IgM levels were 1.5, 3.7 and 4.1 g/L, respectively; GGT levels were 144, 182 and 317 U/L, respectively; and ALP levels were 137, 168 and 221 U/L, respectively), and the differences were statistically significant ( χ2 =6.260, 7.081, 8.030, 15.226, all P<0.05). In non-PBC group, the median level of serum AMA-M2 of men was lower than that of women (41 RU/L vs. 50 RU/L), and the difference was statistically significant ( Z = -2.945, P = 0.003). In new-PBC group, the median level of serum AMA-M2 of men tended to be lower than that of women (113 RU/mL vs. 206 RU/mL), but the difference was not statistically significant ( P=0.257). Conclusion:Serum AMA level is correlated with many clinical parameters and may be related with the disease severity in patients with PBC.
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The application of electronic informed consent has the advantages of speeding up the recruitment of subjects, helping the less educated to understand research and recruit groups, facilitating direct communication between subjects and researchers, minimizing human omissions and errors, and effectively improving the efficiency of clinical research. However, there are also some challenges, such as privacy, ethical censorship, hardware costs and so on. On the basis of the above discussion, this paper believed that electronic informed consent, as a new form, would provide a more powerful tool for clinical research in an era full of opportunities and challenges, with research value and potential.
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Objective@#To understand the basic information of anti-mitochondrial antibody (anti-AMA)-positive patients after initial diagnosis, and to set groundwork for further exploring the clinical significance of AMA in various diseases.@*Methods@#Demographic data and related clinical information recorded through the Information System of Peking University People's Hospital from January 2013 to December 2016 were collected. Patients whose AMA and/or AMA-M2 first- tested as positive were recorded. Complications were classified according to the International Classification of Diseases.@*Results@#A total of 1323 AMA positive cases were discovered for the first time. Among them, 78.0% were women, and the age of initial diagnosis was 56.8 ± 16.0 years. The first three initially diagnosed departments were rheumatology and immunology (37.4%), liver Disease (15.9%) and hematology (15.9%) relevant to musculoskeletal and connective tissue diseases (45.2%), hematology and hematopoietic organs and immune diseases (30.6%) and circulatory system diseases (29.7%). There were 297 newly confirmed cases of primary biliary cholangitis (PBC); accounting for 89.2% of women, and the age of initial diagnosis was 60.1 ± 12.4 years. The top three departments of initially diagnosed as PBC were liver disease (37.7%), rheumatology (33.0%) and gastroenterology (15.2%), of which 39.7% had musculoskeletal and connective tissue diseases, 27.9% had circulatory diseases, and 24.9 % were combined with endocrine and metabolic diseases.@*Conclusion@#Besides PBC and other autoimmune diseases, AMA and / or AMA-M2 positivity can be observed in a variety of diseases in several clinical departments, and its clinical significance remains to be further clarified.
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Objective@#To investigate the incidence and related independent risk factors of depression in treatment-naïve Han ethnic Chinese patients with chronic hepatitis C.@*Methods@#Nine hundred and ninety-seven Han Chinese patients with confirmed chronic HCV infection were enrolled. Beck’s depression inventory scale was used to assess depression score. Patients were divided into two groups according to the score: score≥17, depression group (16.85%, 168/997); score <17, no depression group (83.15%, 829/997). Multivariate logistic regression was used to analyze independent risk factors related with the onset of depression in patients with chronic hepatitis C.@*Results@#There was a statistically significant difference between the two groups in terms of gender distribution, marital status, education level, income level and smoking status (P < 0.05). Independent risk factors were female [odds ratio (OR) = 3.85; 95% CI: 2.28-6.50, P = 0.001], decompensated cirrhosis [OR = 2.31; 95% CI: 1.20-4.48, P = 0.013], unmarried [OR = 2.01; 95% CI: 1.12-3.60, P = 0.019], separated [OR = 17.39; 95% CI: 1.64-184.47, P = 0.018], divorced [OR = 3.82; 95% CI: 1.36-10.74, P = 0.011], without higher education [OR = 2.04; 95% CI: 1.22-3.42, P = 0.007], low income [OR = 3.94; 95% CI: 1.38-11.28, P = 0.011], middle income [OR = 2.96; 95% CI: 1.02-8.62, P = 0.047], uninterrupted smoking [OR = 3.67; 95% CI: 2.13-6.31, P = 0.001], and previously smoked [OR = 3.33, 95% CI: 1.66-6.68, P = 0.001].@*Conclusion@#The incidence of depression in patients with chronic hepatitis C is relatively high. The independent risk factors related with depression include female, unmarried, separated, and divorced, without higher education, low and middle-income level, smoking and disease progression to decompensated cirrhosis, but no significant correlation between hepatitis C virus genotypes and viral load.
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Objective To assess the efficacy and safety of 100 mg or 200 mg yimitasvir phosphate combined with sofosbuvir in patients with non-cirrhotic chronic hepatitis C virus ( HCV) genotype 1 infection who were treatment-na?ve or had a virologic failure to prior interferon-based treatment.Methods A multicenter, randomized, open-label, phase 2 clinical trial was conducted.The patients were randomly assigned to yimitasvir phosphate 100 mg+sofosbuvir 400 mg group (Group 100 mg) and yimitasvir phosphate 200 mg+sofosbuvir 400 mg group ( Group 200 mg) in a 1∶1 ratio with the stratified factors of " treatment-naive" or"treatment-experienced" for 12 weeks and followed up for 24 weeks after the end of treatment.During the clinical trial, HCV RNA was tested in all patients.Resistance of virus in patients who didn′t achieved sustained virological response (SVR) was monitored.Safety and tolerability were assessed by monitoring adverse events , physical examination , laboratory examination, electrocardiogram, and vital signs during the study.The primary end point was SVR12 after the end of therapy.Descriptive statistics were used for categorical variables and eight descriptive statistics were used for continuous variables.Descriptive statistics were used and summarized according to HCV genotypes and treatment groups.Safety data were presented using descriptive statistics and summarized according to treatment groups.Results A total of 174 subjects were screened from July 31, 2017 to September 26, 2018.One hundred and twenty-nine patients were successfully enrolled and received treatment , and 127 completed the study.There were 64 patients and 65 patients assigned to Group 100 mg and Group 200 mg, respectively.Among the 129 patients who underwent randomization and were treated , 18.6% were treatment-experienced and: 100%were HCV genotype 1b infection.The total SVR rate was 98.4%(127／129), with 98.4%(63／64, 95%confidence interval [CI]: 91.60%-99.96%) in the Group 100 mg, and 98.50%(64／65, 95%CI: 91.72%-99.96%) in the Group 200 mg.There was no significant difference between the two groups (χ2 ＝0.000 2, P＝0.989 2).The SVR rates in treatment-naive group and treatment-experienced group were 98.10%(95%CI: 93.29%-99.77%) and 100.00%(24／24, 95%CI: 85.75%-100.00%), respectively.Virological failure during treatment ( including breakthrough , rebound and poor efficacy) and relapse after treatment did not occur during the trial.By Sanger sequencing , 11.6%(15／129) patients had baseline NS5A Y93H／Y or Y93H resistance-associated substitutions ( RAS), 1.6%( 2／129) patients had baseline NS5A L31M RAS.No mutation was observed in NS5B S282 at baseline.There was no S282 mutation in HCV NS5B.A total of 100 (77.5%) subjects had adverse events.No adverse events ≥Grade 3 or severe adverse events related to the study treatment.No patient prematurely discontinued study treatment owing to an adverse event.No life-threatening adverse event was reported.Conclusion Twelve weeks of yimitasvir phosphate 100 mg or 200 mg combined with sofosbuvir 400 mg daily is a highly effective and safe regimen for patients without cirrhosis with HCV genotype 1b infection who had not been treated previously or had a virologic failure to prior interferon-based treatment.
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At present, there are still no effective drugs launched for the treatment of nonalcoholic fatty liver disease (NAFLD), and many drugs are being evaluated in clinical trials. These drugs have different mechanisms of action in treatment, such as improvement of glycolipid metabolism, anti-inflammation, anti-fibrosis, and improvement of intestinal microbiota. This article elaborates on the research and development of drugs from the following aspects: inflammatory response and immune activation, lipid metabolism and insulin resistance, lipotoxicity, oxidative stress, cell apoptosis and necrosis, collagen formation and degradation, and proliferation of intestinal microbiota.
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Objective@#To evaluate the affect of hepatitis C virus (HCV) education in chronic hepatitis C patients’ disease related knowledge and antiviral treatment acceptance in rural china.@*Methods@#Rural HCV patients of attended CHC project of HCV education. Doctor delivered subsequent interactive lecture, and patients completed pre- and post-education questionnaires before and after taking the lectures.@*Results@#151 CHC patients were included. Mean age was 57.3 years old, 50.3% were male, 51.0% of the students had primary school education or illiterate, and 76.2% had a monthly income below RMB 3,000. 98.0% of patients defined their baseline HCV knowledge as "nothing" or "a little bit". A multivariate analysis reveled baseline knowledge scores were associated with age and household income. After education, mean knowledge score (range: 0-28) increased from 13.1 to 23.0 (P < 0.001) and average percent of patients with correct answers from the topic rose from 46.8% to 82.1% (P < 0.001), and patients’ antiviral treatment acceptance increased from 33.9% to 65.6% (P < 0.001).@*Conclusion@#A rural Chinese patients had less education, HCV education delivered on the preferred format of patients substantially improved hepatitis C patients’ disease-related knowledge and antiviral treatment acceptance in rural china.
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Objective To evaluate the prevalence and risk factors of metabolic syndrome among hepatitis C patients in Chinese Han population .Methods This was a multicenter ,cross-sectional study . A total of 997 Chinese Han patients with hepatitis C virus (HCV) infection were enrolled .Demographic data ,anthropometric data and clinical parameters related to metabolic syndrome were collected .Statistical analysis was performed by t-test (normal distribution) or Mann-Whitney U two-sample test (non-normal distribution) and χ test .Binary logistic regression analyses were used to determine the parameters significantly related to metabolic syndrome .Results Among the 997 patients ,170 (17 .1%) patients were diagnosed with metabolic syndrome .Binary logistic regression showed that genotype 2 (OR＝1 .594 ;95% CI :1 .045－2 .431 , P＝ 0 .030) ,older age (OR＝ 1 .040 ;95% CI :1 .022 －1 .058 , P＜ 0 .01) , overweight (OR＝3 .876 ;95% CI :2 .593－5 .792 ,P＜0 .01) ,fatty liver history (OR＝2 .106 ;95% CI : 1 .384－3 .204 ,P＝0 .001) ,homeostasis model assessment insulin (HOMA-IR) (OR＝1 .263 ;95% CI :1 .118－1 .427 , P＜0 .01) ,fasting insulin (OR＝0 .949 ;95% CI :0 .915 －0 .985 , P＝0 .006) ,lower serum albumin level (OR＝0 .957 ;95% CI :0 .915 －1 .000 , P＝0 .049) and higher γ-GT level (OR＝1 .004 ;95% CI :1 .000 －1 .008 , P＝ 0 .0041 ) were all significantly associated with the presence of metabolic syndrome .Conclusions Hepatitis C patients with genotype 2 ,older age ,overweight ,fatty liver history ,higher HOMA-IR ,lower fasting insulin level ,lower serum albumin level or higher γ-GT level should be screened for metabolic syndrome .
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Hepatitis C virus (HCV) is a blood-borne virus transmitted through contact with blood and blood products,and it is a major cause of liver cirrhosis and hepatocellular carcinoma.Many epidemiological studies have confirmed the association between HCV infection and renal disease.Membranoproliferative glomerulonephritis associated with mixed cryoglobulinemia is the most common type of HCV-related renal disease manifesting as nephropathy or nephritic syndrome,proteinuria,hematuria,and reduced glomerular filtration rate.The treatment of HCV-related renal disease includes antiviral therapy,B cell clearance,and non-specific immunosuppressive therapy.At the same time,the launch of rnew antiviral drugs has brought hope to the patients who cannot tolerate conventional regimens.This article reviews the research advances in epidemiology,clinical manifestations,pathogenesis,and treatment of HCV-related renal injury.
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Patients with chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infection are frequently complicated by autoimmune disorders, which is commonly seen in patients with hepatitis C. This article introduces the mechanism of immune disorders in patients with chronic hepatitis C, the proportion of patients with non-organ specific autoantibody, and the clinical manifestations, diagnosis, and treatment of related immune diseases, such as mixed cryoglobulinemia, glomerulonephritis, Sjogren's syndrome, thyroid disease, and type 2 diabetes, as well as the mechanism of immune disorders, related immune manifestations, and effect of antiviral therapy in patients with chronic hepatitis B. Antiviral therapy for chronic hepatitis B and C can alleviate related immune diseases, but interferon therapy is not appropriate. Therefore, the patients with hepatitis B should be treated with nucleos(t)ide analogues, while those with hepatitis C should be treated with direct-acting antiviral agents.
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Objective To evaluate the efficacy of pegylated interferon ( PegIFN ) α-2a plus ribavirin ( RBV) therapy for chronic hepatitis C ( CHC) in non-responders, and to investigate the related influencing factors.Methods A prospective, open, multicenter and randomized study was conducted.A total of 81 CHC non-responders were recruited from 10 clinical centers during February 2009 to November 2011.Patients were randomly assigned into two groups:group A (n=37) was given PegIFNα-2a plus RBV treatment for 72 weeks and group B (n=44) was given PegIFNα-2a plus RBV treatment for 96 weeks.Both groups were followed up for 24 weeks after treatment.Virological responses in two groups were observed, and treatment efficacies among patients with different genotypes, and among those with different previous treatment were compared.SAS software was used for statistical analysis.Results Fifty-two patients ( 28 from group A and 24 from group B) completed the study in total.The rates of rapid virological response ( RVR) , complete early virological response ( cEVR ) , end of treatment viral response ( ETVR ) and sustained virological response (SVR) in group A were 25.0% (7/28), 60.7% (17/28), 67.9%(19/28) and 60.7%(17/28), respectively; while those in the group B were 41.7% (10/24), 70.8%(17/24), 70.8%(17/24) and 70.8% (17/24), respectively; and there were no significant differences between two groups (P>0.05).SVR was observed in 82.9%(29/35) of patients with CC genotype of IL-28B, which was higher than that in patients with other genotypes ( 3/13 ) , and the difference was of statistical significance (P0.05).The rates of RVR, cEVR, ETVR and SVR in patients who were previously treated with IFN were 36.4%(12/33), 81.8%(27/33), 81.8%(27/33) and 75.8%(25/33), and the rates of cEVR, ETVR and SVR were higher than those in patients who were previously treated with PegIFN (P0.05).Adverse events occurred in 38 patients (46.9%), but no severe ones were observed. Conclusion The efficacy of PegIFNα-2a plus RBV therapy for CHC in non-responders is satisfactory, which may influenced by IL-28B genotypes and previous treatment.
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<p><b>OBJECTIVE</b>To perform a prospective,multicenter,open,randomized study to determine a treatment regimen for treatment-naive patients with refractory chronic hepatitis C (RHC) using the predictive value (PV) of early virological response (EVR).</p><p><b>METHODS</b>A total of 438 patients from 18 hospitals were recruited between December 2008 and December 2010 and administered peg-interferon/ribavirin treatment for 12 weeks. Patients who achieved complete EVR (cEVR) were assigned to group A for a 48-week course of treatment, while patients without cEVR were randomly allocated to either group B 1 for a 72-week course of treatment or to group B2 for a 96-week course of treatment. Serum hepatitis C virus RNA levels at baseline,treatment weeks 4, 12 and 24, end of treatment, and post-treatment week 24 were measured and used to evaluate the efficiency of therapy.</p><p><b>RESULTS</b>The overall sustained virological response (SVR) rate was 85.1%. In all, 91.0% of patients achieved cEVR and were assigned to group A, which had an SVR rate of 90.8%. There was no statistically significant difference in the SVR rates of groups B1 and B2 (29.4% vs. 25.0%, P more than 0.05). The positive PV of rapid virological response (RVR), cEVR and delayed virological response (DVR) for SVR was 93.4%, 90.8% and 77.8% respectively, and the negative PV of RVR, EVR and DVR for SVR was 28.0%, 93.3% and 100% respectively. Overall, 66.9% of the patients experienced adverse events (AEs), but only 1.9% of patients experienced sevcre AEs.</p><p><b>CONCLUSION</b>The majority of Chinese RHC treatmentna(i)ve patients (91.0%) can achieve cEVR and a high SVR rate with a low rate of severe AEs using the cEVR guided personal treatment regimen.</p>
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Humans , Antiviral Agents , Asian People , Drug Therapy, Combination , Hepatitis C, Chronic , RibavirinABSTRACT
<p><b>OBJECTIVE</b>To investigate Lanzhou area cases of hepatitis C virus (H-CV) infection with a 5'-non coding region (NCR) 2i genotype and core (C), envelope protein (E) and non-structural protein (NS5) 2a genotype and the relationship with therapeutic response to interferon-alpha (IFNa).</p><p><b>METHODS</b>Nine patients who received IFNa-based treatment for HCV between 2007 and 2009 at the Second People's Hospital of Gansu Province were selected for analysis.Restriction enzyme analysis was carried out for the 5'-NCR and sequencing was carried out for the other gene areas.The relationship between genetic variants and IFNaresponse was examined.</p><p><b>RESULTS</b>Of the total nine HCV cases treated with IFNa-based therapies, five of the patients achieved sustained virological response (SVR), which included two cases with type 2 genotype and three cases with no MboI restriction enzyme point of tangency (i.e.type 1b). The remaining four patients that did not achieve SVR included one case of type 2a, with a 1b and 2a mixed state, and one case with 5'-NCR 2i genotype and C area, NS5 area 2a genotype; the other two cases had 5'-NCR and C area type 1b. Of the five cases with 5'-NCR 2i genotype, all had C 2a genotype and two had C/E 2a and NS5 2a genotypes.The seven patients that showed no response to ordinary IFNa were converted to long-term IFNa plus ribavirin combination antiviral treatment; five (71.4%) of the cases showed response in HCV RNA level and the patients treated with the pegylated form showed greater response.</p><p><b>CONCLUSION</b>HCV genotyping can only provide information on the particular region of gene sequence examined, and it is important to sequence all gene regions where mutations related to antiviral drug response are located. Peg-IFNa-2a combined with ribavirin may achieve better therapeutic effect in patients infected with 2i/2a recombinant forms of HCV.</p>