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1.
Journal of Clinical Hepatology ; (12): 14-21, 2023.
Article in Chinese | WPRIM | ID: wpr-960680

ABSTRACT

Expanding antiviral therapy is currently the new trend for the diagnosis and treatment of chronic hepatitis B, and related research evidence should be studied and discussed. Reducing the threshold of alanine aminotransferase (ALT) for initiating antiviral therapy is one of the most important changes during the expansion of antiviral therapy. Chronic hepatitis B patients with a low-level increase in ALT or a high normal level of ALT still have a higher risk of liver cancer and thus require further intervention. At present, nucleos(t)ide analogues show a certain clinical effect in some patients in terms of virological inhibition and improvement in fibrosis, while reducing ALT threshold places higher requirements for biochemical response after treatment. In addition, although the mechanism and definition of low-level viremia (LLV) after treatment remain unclear, further intervention of LLV is an important strategy for optimizing patient management in clinical practice. Switch to another potent nucleos(t)ide analogue may improve the virologic response rate of patients with LLV, and nucleos(t)ide analogues combined with interferon or other new targeted drugs will be an important research direction for the treatment of LLV in the future.

2.
Journal of Clinical Hepatology ; (12): 1269-1274, 2022.
Article in Chinese | WPRIM | ID: wpr-924695

ABSTRACT

Objective To investigate the impact of the change in anti-hepatitis B virus (HBV) therapy indication on treatment rate and the features of the population requiring treatment. Methods The treatment-naïve patients with chronic hepatitis B (CHB) in the China Registry of Hepatitis B (CR-HepB) database were selected as subjects, and related demographic, virological, hematological, and biochemical data were collected. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Kruskal-Wallis H test was used for comparison between multiple groups; the chi-square test or the Fisher's exact test was used for comparison of categorical data between groups. Results A total of 3640 treatment-naïve CHB patients were included in this study, among whom 64.4% were male, 68.7% had an age of 30-59 years, and 46.8% had an indeterminate clinical stage. According to the 2015 and 2019 editions of Guidelines for the prevention and treatment of chronic hepatitis B and the 2022 edition of expert consensus, the number of patients who had the indication for antiviral therapy was 625(17.2%), 1333(36.6%), and 2890(79.4%), respectively. The number of patients requiring treatment was increased by 1557 according to the 2022 edition of expert consensus, among whom 1424(91.5%) met the treatment threshold of alanine aminotransferase (ALT) > 30 U/L for male patients or ALT > 19 U/L for female patients. The additional patients requiring treatment according to the 2022 edition of expert consensus had significantly higher levels of ALT and HBV DNA and significantly lower scores of APRI and FIB-4 than the additional patients requiring treatment according to the 2019 edition of Guidelines (all P < 0.05). Conclusion The expansion of antiviral therapy indications for CHB may significantly increase the proportion of CHB patients receiving antiviral treatment and help mild CHB patients at the risk of disease progression to receive timely treatment and achieve the improvement in long-term prognosis.

3.
Journal of Clinical Hepatology ; (12): 499-504, 2022.
Article in Chinese | WPRIM | ID: wpr-922941

ABSTRACT

It is an effective way to improve the early diagnosis rate of hepatocellular carcinoma (HCC) in China by conducting standardized screening among the population with chronic liver diseases, achieving accurate stratification and standardized management of the population at a risk of HCC, and realizing the early warning for HCC through effective technical means. In clinical practice, the risk scoring models for liver cancer including aMAP can be used for preliminary risk screening of the population with chronic liver diseases to identify the population with a moderate or high risk of liver cancer. Novel serum biomarkers can be used to further screen out the population with an extremely high risk of liver cancer, and then imaging technology can be used for early diagnosis. Constant exploration and improvement of the "pyramid" screening and management mode through stratified enrichment may help to achieve the goal of improving early diagnosis rate of HCC and reducing HCC-related mortality.

4.
Journal of Clinical Hepatology ; (12): 1016-1021., 2021.
Article in Chinese | WPRIM | ID: wpr-876643

ABSTRACT

Chronic hepatitis B (CHB) is a major global public health issue, and although direct-acting antiviral agents can control hepatitis B virus (HBV) replication, it is difficult to achieve the cure of CHB. Host adaptive immune response plays a key role in eliminating HBV, and it is expected to achieve the functional cure of CHB by rebuilding the patient’s adaptive immunity. Great progress has been made in therapeutic vaccines, cellular immunotherapy, immune checkpoint blockade, T cell metabolic reprogramming, and strategies of neutralizing antibody targeting adaptive immunity for the treatment of hepatitis B. This article summarizes the above-mentioned therapies for hepatitis B in recent years.

5.
Journal of Clinical Hepatology ; (12): 601-605, 2021.
Article in Chinese | WPRIM | ID: wpr-873805

ABSTRACT

ObjectiveTo investigate the effect of entecavir (ETV) antiviral therapy on the prognosis of patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) receiving transcatheter arterial chemoembolization (TACE). MethodsA total of 170 HCC patients who received TACE for the first time in Liver Cancer Center of Nanfang Hospital from January 2011 to March 2018 were enrolled, among whom 114 patients were treated with ETV (ETV treatment group) and 56 patients did not receive antiviral therapy (control group). Baseline demographic data, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), albumin (Alb), platelet count (PLT), Child-Pugh class, HBeAg and HBV DNA levels, alpha-fetoprotein, and BCLC stage were recorded before treatment, and the changes in HBV DNA level, ALT, AST, TBil, Alb, and Child-Pugh class were observed at weeks 4-8 after treatment; long-term survival was also observed after treatment. Short- and long-term clinical benefits (overall survival) were observed for all patients. The t-test or the Wilcoxon signed-rank test was used for comparison of continuous data between two groups, and the chi-square test was used for comparison of categorical data between two groups. Multivariate logistic regression analyses were performed for related clinical indices before treatment to identify the risk factors for HBV reactivation. The Kaplan-Meier method was used to analyze the survival curves of overall survival, and the log-rank test was used for comparison of survival curves. ResultsThere was no significant difference in the incidence rate of HBV reactivation between the ETV treatment group and the control group (15.79% vs 16.07%, χ2=0.002,P=0.962). The univariate analysis showed that PLT was a risk factor for HBV reactivation (Z=-2.183,P=0.029), and the multivariate analysis showed that HBV DNA level was an independent risk factor for HBV reactivation (hazard ratio =1.000, 95% confidence interval: 1.000-1.000, P=0.015). The 1-, 3-, and 5-year survival rates were 56.20%, 30.30%, and 13.20%, respectively, in the ETV treatment group and 60.60%, 27.20%, and 16.30%, respectively, in the control group. There was no significant difference in overall survival rate between the two groups (χ2=0.049,P=0.755). ConclusionAntiviral therapy can reduce the incidence rate of HBV reactivation after TACE in patients with HBV-related HCC.

6.
Chinese Journal of Infectious Diseases ; (12): 139-144, 2020.
Article in Chinese | WPRIM | ID: wpr-867598

ABSTRACT

Objective:To establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig)M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance.Methods:A total of 278 patients who were respectively treated at Wuhan Hankou Hospital and the People′s Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with positive 2019-nCoV nucleic acid, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant nuclear protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed.Results:The positive rates of IgM and IgG with the colloidal gold detection in confirmed patients with positive 2019-nCoV nucleic acid were 78.7%(70/89) and 73.0%(65/89), respectively. The positive rates of IgM and IgG in medical examiners were 1.8%(5/273) and 0.7%(2/273), respectively. The sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8%(113/189) and 52.9%(100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1%(125/189).Conclusion:This reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR.

7.
Chinese Journal of Infectious Diseases ; (12): E017-E017, 2020.
Article in Chinese | WPRIM | ID: wpr-811505

ABSTRACT

Objective@#To establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig) M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance.@*Methods@#A total of 278 patients who were treated at Wuhan Hankou Hospital and the People's Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with 2019-nCoV nucleic acid positive diagnosis, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant N protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed.@*Results@#The sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8% (113/189) and 52.9% (100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1% (125/189).@*Conclusion@#This reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR.

8.
Chinese Journal of Hepatology ; (12): 102-105, 2019.
Article in Chinese | WPRIM | ID: wpr-804767

ABSTRACT

The China Foundation of Hepatitis Prevention and Control (CFHPC) initiated a project named, "getting to zero mother-to-child transmission of Hepatitis B," in July 2015, which aims to further reduce the incidence of mother-to-child transmission through standardized follow-up management of pregnant women and their infants with chronic hepatitis B virus infection by means of mobile medical application. Over the past three years, the project has established a nationwide collaborative network for interruption of mother-to-child transmission of hepatitis B virus, with 123 hospitals as project members. In addition, it has formulated a technical guidance document (Clinical Management Algorithm for Interrupting Mother-to-Child Transmission of HBV), which is designed and developed as a mobile medical application (SHIELD APP), and was released in an international conference on the theme to eliminate viral hepatitis. Following the measures mentioned above, the public's awareness rate of hepatitis B have been raised, and a good social atmosphere has been formed, which has played a positive role in promoting the prevention and control of viral hepatitis in China.

9.
Chinese Journal of Hepatology ; (12): 81-84, 2019.
Article in Chinese | WPRIM | ID: wpr-804762

ABSTRACT

The World Health Organization(WHO)has set the goal to eliminate viral hepatitis as a public health threat by 2030, and the key to achieve this ambitious goal lies on the standardized and precise management of pregnant women and their infants by effectively blocking mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Standardized management includes screening and antiviral intervention during pregnancy, infant immunization, and evaluation of immune effect, breastfeeding and mode of delivery. The results of randomized controlled clinical trials and real-world data have confirmed that the comprehensive prevention strategy based on combined immune prophylaxis of neonates can effectively block MTCT of HBV. It is one of the key links to eliminate viral hepatitis in our country, and to formulate a new strategy in line with the public health needs at home and abroad and thereby promote the implementation and application of standardized management process to improve the public's awareness of the disease.

10.
Chinese Journal of Hepatology ; (12): 817-821, 2019.
Article in Chinese | WPRIM | ID: wpr-801300

ABSTRACT

The World Health Organization has proposed a 65% reduction in viral hepatitis-related mortality by 2030, and the key to achieve this ambitious goal is to reduce mortality from viral hepatitis-related hepatocellular carcinoma (HCC). HCC is the second leading cause of death in patients with malignant tumors in China. Notably, one of the important links to reduce the risk of HCC is based on HCC risk factors and very early warning HCC biomarkers. Therefore, constructing a HCC risk prediction model, accurately identifying high-risk HCC population, developing an individualized HCC screening strategy, may improve the early HCC diagnosis and cure rate in China.

11.
Chinese Journal of Hepatology ; (12): 352-357, 2019.
Article in Chinese | WPRIM | ID: wpr-810626

ABSTRACT

Objective@#To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection.@*Methods@#Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval.@*Results@#132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death.@*Conclusion@#Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.

12.
Chinese Journal of Hepatology ; (12): 347-351, 2019.
Article in Chinese | WPRIM | ID: wpr-810625

ABSTRACT

Objective@#To investigate the prevalence and risk factors of non-alcoholic fatty liver disease(NAFLD) in patients with chronic hepatitis B(CHB) receiving antiviral treatment.@*Methods@#The cross-sectional study included 3 477 cases with CHB who received antiviral therapy. The prevalence of NAFLD was investigated, and then the risk factors were screened and analyzed by stepwise regression method in CHB patients with NAFLD as the dependent variable and the related influencing factors as independent variables.@*Results@#The prevalence of NAFLD was 24.1% in CHB patients who received antiviral therapy. After adjusting for age and gender, central obesity (OR: 7.44, 95%CI: 6.06 ~ 9.14), hypertension (OR: 1.74, 95%CI: 1.51 ~ 2.20), and triglyceride (OR: 1.52, 95%CI: 1.18 ~ 1.96) were positively associated with NAFLD, and cirrhosis was negatively associated with NAFLD (OR: 0.42, 95%CI: 0.34 ~ 0.53). Patients with long-term antiviral therapy had increased risk of NAFLD.@*Conclusion@#A significant proportion of CHB patients receiving antiviral therapy have suffered from NAFLD. Therefore, CHB patients receiving long-term antiviral treatment should pay more attention to the prevalence of NAFLD.

13.
Journal of Clinical Hepatology ; (12): 2156-2158, 2019.
Article in Chinese | WPRIM | ID: wpr-778727

ABSTRACT

Hepatitis B virus (HBV) infection is a global public health problem. Hepatitis B core antibody (anti-HBc) is one of the serum immunological markers in human body after HBV infection. Previous studies have shown that the low serum level of anti-HBc in HBeAg-positive mothers are associated with immunoprophylaxis failure in infants. In addition, anti-HBc is an important biomarker associated with liver inflammatory activity and therapeutic outcome and can be used to evaluate liver inflammation and predict the efficacy of antiviral therapy and sustained response after drug withdrawal. Anti-HBc quantification provides a new direction for individualized treatment of hepatitis B patients.

14.
Chinese Journal of Infectious Diseases ; (12): 420-429, 2019.
Article in Chinese | WPRIM | ID: wpr-754671

ABSTRACT

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.

15.
Chinese Journal of Hepatology ; (12): 359-364, 2018.
Article in Chinese | WPRIM | ID: wpr-806560

ABSTRACT

Objective@#To evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily combined with dasabuvir 250mg, twice daily in non-cirrhotic Chinese adult patients with newly diagnosed and treated chronic HCV genotype 1b infection. @*Methods@#A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial was conducted in mainland China, Korea, and Taiwan.Safety and efficacy of OBV/PTV/r plus DSV administered for 12 weeks were evaluated in a newly diagnosed and treated (interferon alpha /pegylated interferon alpha) and ribavirin non-cirrhotic adults with chronic HCVgenotype 1b infection. Patients randomly received OBV/PTV/r plus DSV for 12 weeks (Group A), or placebo for 12 weeks (Group B) followed by an open-label phase of OBV/PTV/r plus DSV for 12 weeks. Sustained response (SVR12) rate obtained at 12 weeks and (SVR24) 24 weeks after discontinuation of treatment, and the incidence of adverse events and laboratory abnormalities after double-blind and open-label phase treatment were assessed. @*Results@#A total of 410 cases of Chinese patients were included and randomly assigned to group A and B (with 205 cases in each group) in a 1:1 ratio. The rates of SVR12 and SVR24 were 99% (95% CI: 94.8% - 99.8%) in the newly diagnosed patients in group A (205 patients) and the rates of SVR12 and SVR24 were 100% in treated patients (95% CI: 96.3% - 100%). Different baseline characteristics had no effect on SVR12 and SVR24 rates. Most of the adverse events occurred were mild, asymptomatic, and≥ 3 laboratory abnormalities during treatment were rare, including elevation of alanine aminotransferase (2 cases in double-blind stage A group), aspartate aminotransferase (Double-blind stage A (3 cases) and total bilirubin (1 case in open-label phase B group); however, those mild adverse events could be recovered after drug withdrawal or discontinuation. only1 person discontinued drugs due to adverse events (Group B, open-label phase). @*Conclusion@#The 12 weeks treatment course of OBV/PTV/r combined with DSV produced 99% ~ 100% rates of SVR12 and SVR24 in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection, and the tolerance and safety were good.

16.
Chinese Journal of Hepatology ; (12): 353-358, 2018.
Article in Chinese | WPRIM | ID: wpr-806559

ABSTRACT

Objective@#To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis. @*Methods@#An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs. @*Results@#A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal. @*Conclusion@#Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.

17.
Chinese Journal of Hepatology ; (12): 262-265, 2018.
Article in Chinese | WPRIM | ID: wpr-806390

ABSTRACT

To eliminate viral hepatitis as a public health threat, the World Health Organization has set the ambitious goal of reducing the prevalence of hepatitis B surface antigen (HBsAg) in children to 0.1% by 2030, and the key to this grand goal is cutting off hepatitis B virus (HBV) transmission from mother-to-child. Previously, national and international guidelines for the management of chronic hepatitis B recommended the use of hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) or combination of any in neonates and antiviral drugs for pregnant women with high viral load in late pregnancy. However, a recent study in Thailand found that the addition of antiviral drugs in pregnant women with high viral load in the third trimester did not significantly lower the incidence of mother-to-child HBV transmission, but no case of chronic HBV infection was seen with strict standards hepatitis B vaccine and HBIG combined immunoprophylaxis and the use of tenofovir disoproxil in pregnant women with high viral load in the third trimester. In addition, the incidence of mother –to- child transmission of HBV in the antiviral group was 0, while the incidence of HBV transmission in the placebo group was 2%. Therefore, it is not possible to deny the efficacy of adding antiviral drugs in treating pregnant women with high viral load in the third trimester with combined immunoprophylaxis. There is an urgent need for more real-world studies in clinical practice to further reveal the principles and existing problems of mother- to- child transmission of HBV.

18.
Chinese Journal of Hepatology ; (12): 756-764, 2018.
Article in Chinese | WPRIM | ID: wpr-810222

ABSTRACT

Objective@#Hepatitis B surface antigen (HBsAg) loss is seldom achieved with nucleos(t)ide analog (NA) therapy in chronic hepatitis B patients but may be enhanced by switching to finite pegylated-interferon (Peg-IFN) alfa-2a. We assessed HBsAg loss with 48- and 96-week Peg-IFN alfa-2a in chronic hepatitis B patients with partial response to a previous NA.@*Methods@#Hepatitis B e antigen (HBeAg)-positive patients who achieved HBeAg loss and hepatitis B virus DNA < 200 IU/mL with previous adefovir, lamivudine or entecavir treatment were randomized 1:1 to receive Peg-IFN alfa-2a for 48 (n = 153) or 96 weeks (n = 150). The primary endpoint of this study was HBsAg loss at end of treatment. The ClinicalTrials.gov identifier is NCT01464281.@*Results@#At the end of 48 and 96 weeks' treatment, 14.4% (22/153) and 20.7% (31/150) of patients, respectively, who switched from NA to Peg-IFN alfa-2a cleared HBsAg. Rates were similar irrespective of prior NA or baseline HBeAg seroconversion. Among those who cleared HBsAg by the end of 48 and 96 weeks' treatment, 77.8% (14/18) and 71.4% (20/28), respectively, sustained HBsAg loss for a further 48 weeks. Baseline HBsAg < 1 500 IU/mL and week 24 HBsAg < 200 IU/mL were associated with the highest rates of HBsAg loss at the end of both 48- and 96-week treatment (51.4% and 58.7%, respectively). Importantly, extending treatment from 48 to 96 weeks enabled 48.3% (14/29) more patients to achieve HBsAg loss.@*Conclusion@#Patients on long-term NA who are unlikely to meet therapeutic goals can achieve high rates of HBsAg loss by switching to Peg-IFN alfa-2a. HBsAg loss rates may be improved for some patients by extending treatment from 48 to 96 weeks, although the differences in our study cohort were not statistically significant. Baseline and on-treatment HBsAg may predict HBsAg loss with Peg-IFN alfa-2a.

19.
Journal of Clinical Hepatology ; (12): 1351-1356, 2018.
Article in Chinese | WPRIM | ID: wpr-694789

ABSTRACT

Acute -on -chronic liver failure (ACLF) is characterized by the rapid deterioration of liver function resulting from acute insults in patients with pre -existing liver disease,which is usually correlated with multisystem organ failure .There is still no ideal therapy available for ACLF untill now.An early and accurate evaluation of the prognosis of patients with ACLF is helpful for physicians to optimize treatment strategies and improve the outcome of these patients .This article highlights the characteristics and predictive power of diffrent scoring systems in an attempt to guide the therapeutic strategy and prognostic assessment by reviewing the prognostic models for ACLF in recent years .

20.
Journal of Clinical Hepatology ; (12): 2296-2302, 2017.
Article in Chinese | WPRIM | ID: wpr-663452

ABSTRACT

Nonalcoholic fatty liver disease (NAFLD)is becoming a primary etiology underlying the chronic liver injury - related fibrogenesis among general population. Histologic fibrosis has been demonstrated as the most important independent predictor for the major outcomes of NAFLD patients. NAFLD - related fibrosis has distinct characteristics through the disease course,which is largely attributed to its " metabol-ic" pathophysiology:The progression of fibrosis is correlated to the factors including obesity,metabolic syndrome components,aging,etc.;and the patterns of histologic distribution and evolution as well as the association with the other histological features are remarkably different from those of the other chronic liver diseases. Based on the criteria of current standard histology,accurate quantitative assessment of NAFLD fibrosis could be relevant in terms of research and utilization to stratifying the disease risk,monitoring the therapeutic response,as well as to facilitating the development of new diagnostic tools.

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