Introduction:Liver cancer and cirrhosis represent the most prevalent forms of end-stage liver diseases(ESLDs).Notably,in China,deaths attributed to ESLDs contribute significantly to the global mortality rate of these ...Introduction:Liver cancer and cirrhosis represent the most prevalent forms of end-stage liver diseases(ESLDs).Notably,in China,deaths attributed to ESLDs contribute significantly to the global mortality rate of these disorders.Enhanced comprehension of the mortality profile associated with ESLDs in China could provide crucial insights into intervention prioritization,which could in turn help reduce the overall global burden of these diseases.Methods:Data were obtained from China’s Disease Surveillance Points system.The presentation includes both crude and age-standardized mortality rates,stratified by sex,residential location,and region.Using Joinpoint Regression,trends in annual mortality rates were estimated from the period of 2008 to 2020 and expressed as the average annual percentage change(AAPC).Results:In 2020,the gross mortality rate of ESLD stood at 30.08 cases per 100,000 individuals.A higher age-standardized ESLD mortality rate was observed in males and rural populations in comparison to their female and urban counterparts,respectively.Noticeably,the highest mortality rates associated with liver cancer and cirrhosis were reported in South and Southwest China,respectively.A positive correlation was noticed between age-specific ESLD mortality rates and advancing age.Interestingly,an annual decrease in the ESLD mortality rate was observed from 2008 to 2020.In urban contexts,the AAPC of cirrhosis was noted to be higher than that of liver cancer.Conclusions:The mortality rate associated with ESLDs in China decreased between 2008 and 2020.Nevertheless,the death burden attributable to ESLD continues to be alarmingly high.Future initiatives should prioritize the reduction of ESLD mortality in particular populations:males,elderly individuals,and those residing in rural regions of South and Southwest China.The emphasis of future interventions should beplaced on antiviral therapy for adults diagnosed with viral hepatitis,and on the prevention of hepatitis B virus(HBV)infection across all demographics.展开更多
Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Efficacy and Safety of All-oral Emitasvir and Sofosbuvir in Patients with Genotype 1b HCV ...Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Efficacy and Safety of All-oral Emitasvir and Sofosbuvir in Patients with Genotype 1b HCV Infections without Cirrhosis Huiying Rao1,Xingxiang Yang2,Youwen Tan3,Qin Ning4,Daokun Yang5,Jiefei Wang6,Yongfeng Yang7,Sujun Zheng8,Dongliang Yang9,Jinlin Hou10,Qing Xie11,Caiyan Zhao12,Lunli Zhang13,Xiaorong Mao14,Tong Sun15,Lang Bai16,Fuchun Zhang17,Jinglan Jin18,Yingren Zhao19,Maorong Wang20,Wen Xie21,Yingjie Ma22,Jun Quan23,Xuebing Yan24,Ping An25,Feng Lin26,Jidong Jia27,Xiaoxuan Hu28,Zuojiong Gong29,Jie Wu30,Yongping Chen31,Zhansheng Jia32,Minghua Lin33,Guiqiang Wang34,Yueyong Zhu35,Yingjun Zhang*,36,Hongming Xie36,Lin Luo36,Qingyun Ren36,Rui Huang1 and Lai Wei*,37 Author information Journal of Clinical and Translational Hepatology 2020;8(3):255-261DOI:10.14218/JCTH.2020.00031 Abstract Background and Aims:Emitasvir is a new type of hepatitis C virus(HCV)nonstructural protein 5A(NS5A)inhibitor,and the data of phase 2 trial has shown emitasvir-sofosbuvir to have good safety and tolerance.We conducted this phase 3 trial to further verify the efficacy and safety.Methods:We evaluated the antiviral activity and safety of a 12-week regimen of emitasvir phosphate(100 mg)combined with sofosbuvir(400 mg)once daily in non-cirrhotic patients with genotype 1 HCV infection.The primary endpoint was a sustained virological response at 12 weeks(SVR12)after the end of treatment.Results:Of the 362 patients enrolled in the trial,39.8%were male,99.2%had HCV genotype 1b,0.8%had genotype 1a and 79.8%were treatment-naïve.The average age was 47.2 years.All patients completed the treatment and follow-up.All 3 patients with genotype 1a achieved SVR.Two genotype 1b treatment-naïve patients experienced virologic relapse.The rate of SVR12 was 99.7%(358/359),and SVR24 was 99.4%(357/359)in genotype 1b.Overall,36.2%had resistance-associated substitutions(RASs)in NS5A and 98.3%had RASs in NS5B at baseline.The RASs at baseline had no effect on the rates of response.Serious adverse events were reported in 16 patients and were not related to emitasvir-sofosbuvir.Most adverse events did not require therapy.Conclusions:The 12 weeks of treatment with emitasvir-sofosbuvir was a highly efficient and safe treatment for a wide range of patients with HCV genotype 1b infection without cirrhosis,who had not been treated or who had been treated with interferon-based regimen previously.展开更多
Background and aims:Tenofovir disoproxil fumarate(TDF)is the first-line therapy for chronic hepatitis B.This interim analysis presents the efficacy and safety data for TDF at Week 144 in patients with chronic hepatiti...Background and aims:Tenofovir disoproxil fumarate(TDF)is the first-line therapy for chronic hepatitis B.This interim analysis presents the efficacy and safety data for TDF at Week 144 in patients with chronic hepatitis B and advanced fibrosis or compensated cirrhosis from China.Methods:Patients were assessed for incidence of newly diagnosed hepatocellular carcinoma(HCC)and disease progression,liver stiffness measurement(LSM),virological suppression(serum hepatitis B virus DNA<20 IU/mL),alanine aminotransferase normalization,hepatitis B e antigen(HBeAg)loss and seroconversion,histological liver fibrosis score,and safety at Week 144.Results:Overall,197 patients were enrolled.At Week 144,the incidence of newly diagnosed HCC was observed in 2.1%patients,and the incidence of disease progression was observed in 3.6%patients.The mean(standard deviation)change in LSM from baseline was5.1(5.85)kPa.Serum hepatitis B virus DNA<20 IU/mL was observed in 94.1%patients,alanine aminotransferase normalization in 33.5%patients,HBeAg loss in 35.6%patients,and HBeAg seroconversion in 14.4%patients.Among patients with stage F3 or F4 fibrosis at baseline by LSM,38.3%patients regressed to stage F0/1,and 22.0%of patients regressed to stage F2 at Week 144.Overall,67.7%patients experienced≥1 adverse events,13.8%patients experienced TDF-related adverse events,and 16.4%patients experienced serious(none were TDF-related).Conclusions:At Week 144 of TDF treatment,low incidence of HCC and disease progression were reported.Virological suppression was observed in 94.1%patients,which was associated with fibrosis regression.No new safety events were identified.展开更多
基金Supported by the Beijing Natural Science Foundation[No.7232195]National Natural Science Foundation of China[No.81870406,and No.81602939]+2 种基金Capital’s Funds for Health Improvement and Research[No.2020-4-4087]Peking University Medicine Sailing Program for Young Scholars’Scientific&Technological Innovation[No.BMU2023YFJHPY025]Chinese foundation for hepatitis prevention and control-TianQing liver disease research fund subject[No.TQGB20210139]。
文摘Introduction:Liver cancer and cirrhosis represent the most prevalent forms of end-stage liver diseases(ESLDs).Notably,in China,deaths attributed to ESLDs contribute significantly to the global mortality rate of these disorders.Enhanced comprehension of the mortality profile associated with ESLDs in China could provide crucial insights into intervention prioritization,which could in turn help reduce the overall global burden of these diseases.Methods:Data were obtained from China’s Disease Surveillance Points system.The presentation includes both crude and age-standardized mortality rates,stratified by sex,residential location,and region.Using Joinpoint Regression,trends in annual mortality rates were estimated from the period of 2008 to 2020 and expressed as the average annual percentage change(AAPC).Results:In 2020,the gross mortality rate of ESLD stood at 30.08 cases per 100,000 individuals.A higher age-standardized ESLD mortality rate was observed in males and rural populations in comparison to their female and urban counterparts,respectively.Noticeably,the highest mortality rates associated with liver cancer and cirrhosis were reported in South and Southwest China,respectively.A positive correlation was noticed between age-specific ESLD mortality rates and advancing age.Interestingly,an annual decrease in the ESLD mortality rate was observed from 2008 to 2020.In urban contexts,the AAPC of cirrhosis was noted to be higher than that of liver cancer.Conclusions:The mortality rate associated with ESLDs in China decreased between 2008 and 2020.Nevertheless,the death burden attributable to ESLD continues to be alarmingly high.Future initiatives should prioritize the reduction of ESLD mortality in particular populations:males,elderly individuals,and those residing in rural regions of South and Southwest China.The emphasis of future interventions should beplaced on antiviral therapy for adults diagnosed with viral hepatitis,and on the prevention of hepatitis B virus(HBV)infection across all demographics.
基金supported by the National Major Scientific and Technological Special Project for“Significant New Drugs Development”during the Thirteenth Five-Year Plan Period of China(Nos.2017ZX09201006004 and 2017ZX09201006009)the Chinese National Research Grant of the Thirteenth Five-Year Plan for the Key Projects in Infectious Diseases(No.2017ZX10202202)+1 种基金the Key Research and Development Program of Guangdong(No.2019B02021002)funded by Sunshine Lake Pharma Co.,Ltd.(ClinicalTrials.gov number,NCT 03487107).
文摘Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Efficacy and Safety of All-oral Emitasvir and Sofosbuvir in Patients with Genotype 1b HCV Infections without Cirrhosis Huiying Rao1,Xingxiang Yang2,Youwen Tan3,Qin Ning4,Daokun Yang5,Jiefei Wang6,Yongfeng Yang7,Sujun Zheng8,Dongliang Yang9,Jinlin Hou10,Qing Xie11,Caiyan Zhao12,Lunli Zhang13,Xiaorong Mao14,Tong Sun15,Lang Bai16,Fuchun Zhang17,Jinglan Jin18,Yingren Zhao19,Maorong Wang20,Wen Xie21,Yingjie Ma22,Jun Quan23,Xuebing Yan24,Ping An25,Feng Lin26,Jidong Jia27,Xiaoxuan Hu28,Zuojiong Gong29,Jie Wu30,Yongping Chen31,Zhansheng Jia32,Minghua Lin33,Guiqiang Wang34,Yueyong Zhu35,Yingjun Zhang*,36,Hongming Xie36,Lin Luo36,Qingyun Ren36,Rui Huang1 and Lai Wei*,37 Author information Journal of Clinical and Translational Hepatology 2020;8(3):255-261DOI:10.14218/JCTH.2020.00031 Abstract Background and Aims:Emitasvir is a new type of hepatitis C virus(HCV)nonstructural protein 5A(NS5A)inhibitor,and the data of phase 2 trial has shown emitasvir-sofosbuvir to have good safety and tolerance.We conducted this phase 3 trial to further verify the efficacy and safety.Methods:We evaluated the antiviral activity and safety of a 12-week regimen of emitasvir phosphate(100 mg)combined with sofosbuvir(400 mg)once daily in non-cirrhotic patients with genotype 1 HCV infection.The primary endpoint was a sustained virological response at 12 weeks(SVR12)after the end of treatment.Results:Of the 362 patients enrolled in the trial,39.8%were male,99.2%had HCV genotype 1b,0.8%had genotype 1a and 79.8%were treatment-naïve.The average age was 47.2 years.All patients completed the treatment and follow-up.All 3 patients with genotype 1a achieved SVR.Two genotype 1b treatment-naïve patients experienced virologic relapse.The rate of SVR12 was 99.7%(358/359),and SVR24 was 99.4%(357/359)in genotype 1b.Overall,36.2%had resistance-associated substitutions(RASs)in NS5A and 98.3%had RASs in NS5B at baseline.The RASs at baseline had no effect on the rates of response.Serious adverse events were reported in 16 patients and were not related to emitasvir-sofosbuvir.Most adverse events did not require therapy.Conclusions:The 12 weeks of treatment with emitasvir-sofosbuvir was a highly efficient and safe treatment for a wide range of patients with HCV genotype 1b infection without cirrhosis,who had not been treated or who had been treated with interferon-based regimen previously.
基金supported by GlaxoSmithKline(China)R&D Company Limited.
文摘Background and aims:Tenofovir disoproxil fumarate(TDF)is the first-line therapy for chronic hepatitis B.This interim analysis presents the efficacy and safety data for TDF at Week 144 in patients with chronic hepatitis B and advanced fibrosis or compensated cirrhosis from China.Methods:Patients were assessed for incidence of newly diagnosed hepatocellular carcinoma(HCC)and disease progression,liver stiffness measurement(LSM),virological suppression(serum hepatitis B virus DNA<20 IU/mL),alanine aminotransferase normalization,hepatitis B e antigen(HBeAg)loss and seroconversion,histological liver fibrosis score,and safety at Week 144.Results:Overall,197 patients were enrolled.At Week 144,the incidence of newly diagnosed HCC was observed in 2.1%patients,and the incidence of disease progression was observed in 3.6%patients.The mean(standard deviation)change in LSM from baseline was5.1(5.85)kPa.Serum hepatitis B virus DNA<20 IU/mL was observed in 94.1%patients,alanine aminotransferase normalization in 33.5%patients,HBeAg loss in 35.6%patients,and HBeAg seroconversion in 14.4%patients.Among patients with stage F3 or F4 fibrosis at baseline by LSM,38.3%patients regressed to stage F0/1,and 22.0%of patients regressed to stage F2 at Week 144.Overall,67.7%patients experienced≥1 adverse events,13.8%patients experienced TDF-related adverse events,and 16.4%patients experienced serious(none were TDF-related).Conclusions:At Week 144 of TDF treatment,low incidence of HCC and disease progression were reported.Virological suppression was observed in 94.1%patients,which was associated with fibrosis regression.No new safety events were identified.