Background and Aims:Tenofovir amibufenamide(TMF)is a novel phosphoramidated prodrug of tenofovir with nonin-ferior efficacy and better bone and renal safety to tenofovir disoproxil fumarate(TDF)in 48 weeks of treatmen...Background and Aims:Tenofovir amibufenamide(TMF)is a novel phosphoramidated prodrug of tenofovir with nonin-ferior efficacy and better bone and renal safety to tenofovir disoproxil fumarate(TDF)in 48 weeks of treatment.Here,we update 96-week comparison results.Methods:Patients with chronic hepatitis B were assigned(2:1)to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks.The virological suppression was defined as HBV DNA levels<20 IU/mL at week 96.Safety was evaluated thoroughly with focusing on bone,renal,and metabolic pa-rameters.Results:Virological suppression rates at week 96 were similar between TMF and TDF group in both HBeAg-positive and HBeAg-negative populations.Noninferior efficacy was maintained in the pooled population,while it was first achieved in patients with HBV DNA≥7 or 8 log10 IU/mL at baseline.Non-indexed estimated glomerular filtration rate for renal safety assessment was adopted,while a smaller decline of which was seen in the TMF group than in the TDF group(p=0.01).For bone mineral density,patients receiv-ing TMF displayed significantly lower reduction levels in the densities of spine,hip,and femur neck at week 96 than those receiving TDF.In addition,the lipid parameters were stable after week 48 in all groups while weight change still showed the opposite trend.Conclusions:TMF maintained similar efficacy at week 96 compared with TDF with continued superior bone and renal safety profiles(NCT03903796).展开更多
With the improved efficacy and accessibility of antiviral agents as well as the concerns about disease progression,there is a hot discussion on whether HBeAg-negative chronic hepatitis B(CHB)patients with normal alani...With the improved efficacy and accessibility of antiviral agents as well as the concerns about disease progression,there is a hot discussion on whether HBeAg-negative chronic hepatitis B(CHB)patients with normal alanine aminotransferase(ALT)and positive HBV DNA should be treated.According to the international guidelines on the stages of the natural history of HBV infection,HBeAgnegative CHB patients with normal ALT and positive HBV DNA can be divided into two groups:one is the well-known“inactive carrier phase”,which is defined as serum HBV DNA<2000 IU/ml and no significant liver inflammation;and the other is the“indeterminate phase”,which is defined as serum HBV DNA≥2000 IU/mL regardless of the pathological changes in liver tissue,or HBV DNA<2000 IU/mL but accompanied by significant pathological changes in the liver.In this minireview,we will expound the disease characteristics,disease progression,and clinical management status of these two groups.Based on the analysis,we propose that HBeAg-negative patients with normal ALT but detectable serum HBV DNA should be treated,regardless of their age,family history of hepatocellular carcinoma(HCC)or the severity of liver necroinflammation.Expanding the indications of antiviral therapy will help improve the survival and quality of life of patients by preventing disease progression,and consequently reduce the risk of HCC development.展开更多
Severe acute respiratory syndrome Coronavirus 2(SARS-CoV-2)currently has spread all over the world.However,the dynamic characteristics of SARS-CoV-2 infections have not previously been described in detail.Here,we repo...Severe acute respiratory syndrome Coronavirus 2(SARS-CoV-2)currently has spread all over the world.However,the dynamic characteristics of SARS-CoV-2 infections have not previously been described in detail.Here,we report a cured patient in West China Hospital,and describe the dynamic detection of SARS-CoV-2-RNA in different specimens and viral specific IgM and IgG antibodies in blood.The findings suggest that the fecal SARS-CoV-2-RNA negativity may be considered as a new standard for de isolation.Serum IgM and IgG antibodies detection were helpful for early diagnosis of SARS-CoV-2 infection and judgment of patients in recovery stage,respectively.展开更多
文摘Background and Aims:Tenofovir amibufenamide(TMF)is a novel phosphoramidated prodrug of tenofovir with nonin-ferior efficacy and better bone and renal safety to tenofovir disoproxil fumarate(TDF)in 48 weeks of treatment.Here,we update 96-week comparison results.Methods:Patients with chronic hepatitis B were assigned(2:1)to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks.The virological suppression was defined as HBV DNA levels<20 IU/mL at week 96.Safety was evaluated thoroughly with focusing on bone,renal,and metabolic pa-rameters.Results:Virological suppression rates at week 96 were similar between TMF and TDF group in both HBeAg-positive and HBeAg-negative populations.Noninferior efficacy was maintained in the pooled population,while it was first achieved in patients with HBV DNA≥7 or 8 log10 IU/mL at baseline.Non-indexed estimated glomerular filtration rate for renal safety assessment was adopted,while a smaller decline of which was seen in the TMF group than in the TDF group(p=0.01).For bone mineral density,patients receiv-ing TMF displayed significantly lower reduction levels in the densities of spine,hip,and femur neck at week 96 than those receiving TDF.In addition,the lipid parameters were stable after week 48 in all groups while weight change still showed the opposite trend.Conclusions:TMF maintained similar efficacy at week 96 compared with TDF with continued superior bone and renal safety profiles(NCT03903796).
基金supported by the National Natural Science Fundation of China(Grant No.30972622)the Clinical Research Incubation Project of West China Hospital of Sichuan University(Grant No.2022HXFH013).
文摘With the improved efficacy and accessibility of antiviral agents as well as the concerns about disease progression,there is a hot discussion on whether HBeAg-negative chronic hepatitis B(CHB)patients with normal alanine aminotransferase(ALT)and positive HBV DNA should be treated.According to the international guidelines on the stages of the natural history of HBV infection,HBeAgnegative CHB patients with normal ALT and positive HBV DNA can be divided into two groups:one is the well-known“inactive carrier phase”,which is defined as serum HBV DNA<2000 IU/ml and no significant liver inflammation;and the other is the“indeterminate phase”,which is defined as serum HBV DNA≥2000 IU/mL regardless of the pathological changes in liver tissue,or HBV DNA<2000 IU/mL but accompanied by significant pathological changes in the liver.In this minireview,we will expound the disease characteristics,disease progression,and clinical management status of these two groups.Based on the analysis,we propose that HBeAg-negative patients with normal ALT but detectable serum HBV DNA should be treated,regardless of their age,family history of hepatocellular carcinoma(HCC)or the severity of liver necroinflammation.Expanding the indications of antiviral therapy will help improve the survival and quality of life of patients by preventing disease progression,and consequently reduce the risk of HCC development.
基金This research was supported by Special Funds for Prevention and Control of COVID-19 of Sichuan University and West China Hospital(No.2020scunCoV10004 and HX-2019-nCoV-010)grant of Chengdu Bureau of Science and technology(2020-YF05-00216-SN and 2020-YF05-00218-SN).
文摘Severe acute respiratory syndrome Coronavirus 2(SARS-CoV-2)currently has spread all over the world.However,the dynamic characteristics of SARS-CoV-2 infections have not previously been described in detail.Here,we report a cured patient in West China Hospital,and describe the dynamic detection of SARS-CoV-2-RNA in different specimens and viral specific IgM and IgG antibodies in blood.The findings suggest that the fecal SARS-CoV-2-RNA negativity may be considered as a new standard for de isolation.Serum IgM and IgG antibodies detection were helpful for early diagnosis of SARS-CoV-2 infection and judgment of patients in recovery stage,respectively.