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*Only for medical professionals to read for reference.
Not only kidney transplants, but also in organ transplants such as liver and heart, SOF/VEL also shows good safety and effectiveness
.
The safety of kidney transplantation End-stage renal disease (ESRD) is the fifth stage of the development of chronic kidney disease.
The glomerular filtration rate (eGFR) of the patient is less than 15mL/min/1.
73m2, and the renal function is lower than 10% of normal function, which means The kidneys have almost lost all their functions
.
Kidney transplantation is the best treatment for ESRD
.
A kidney that meets the criteria can save not only an ESRD patient, but also a family
.
However, because the number of organ transplants is much higher than the number of donor organs, more families are waiting for the kidney source.
Every year, 5%-10% of patients die while waiting for a kidney transplant [1]
.
In order to improve the accessibility of kidney transplantation and reduce the risk of death while waiting for an organ, the kidney donor standard has been relaxed, and hepatitis donors are also considered as kidney donors
.
However, the hepatitis C virus (HCV) may be transmitted from the donor to the recipient, causing the recipient’s liver to be affected and affecting the patient’s long-term prognosis
.
If you want to use HCV-positive donor organs, you must solve this problem
.
In this regard, the American Association for the Study of Liver Diseases (AASLD) [2] and the European Society of Liver (EASL) [3] have all put forward relevant guidance in the HCV guidelines issued
.
For HCV-negative recipients who have received HCV-positive donor transplantation, the AASLD guidelines recommend the use of a fixed-dose daily pan-genotypic regimen of sofosbuvir vipatavir (SOF/VEL) for 12 weeks, with genotypes 1, 4, and 5 Or type 6 patients are recommended to use a fixed daily dose of Dipavir sofosbuvir (LDV/SOF) for 12 weeks; the EASL guidelines recommend a fixed dose of SOF/VEL for 12 weeks, and there is no need to adjust the dose of immunosuppressive agents
.
China is also facing the problem of a large gap in the supply of kidneys
.
It is urgent to expand the standard for optimal organ donation and increase the ways of donating kidneys .
Recently, our team (the Renji Hospital of Shanghai Jiaotong University, Renji Hospital Urology Kidney Transplant Center and Kidney Disease Dialysis Transplant Comprehensive Diagnosis and Treatment Center) published the latest research results once again proved that DAA (direct-acting antiviral agents) is here.
The safety and effectiveness of preventive treatment for a special population has brought hope to more patients waiting for kidney transplantation [4]
.
The results of the study showed that HCV-negative recipients received kidney transplantation from HCV-positive donors and were treated with sofosbuvir vepatavir (SOF/VEL) for 12 weeks.
All patients achieved HCV RNA-negative with good safety.
Stable function
.
This is China's first study on the safety and effectiveness of SOF/VEL for HCV-negative recipients receiving HCV-positive donor kidney transplantation
.
The article was published on Annals of Transplantation
.
Screenshot of the article This study is a single-center retrospective study that evaluated the efficacy and safety of HCV-negative recipients who received HCV-positive donor kidney transplantation, who took SOF/VEL for the first time 2 hours before kidney transplantation and continued preventive treatment for 12 weeks
.
The study included 26 HCV-negative recipients who received kidney transplants from HCV-positive donors
.
The patient took SOF/VEL (400mg/100mg) for the first time 2 hours before undergoing kidney transplantation, and then took one tablet a day for 12 weeks
.
The patients were followed up at 2, 4, 8, and 12 weeks after the operation and at the 4, 8, and 12 weeks after the end of the treatment
.
At the same time, the patient received intravenous injection of rabbit anti-human thymocyte immunoglobulin or basiliximab as induction therapy, combined with hormones, calcineurin inhibitors, mycophenolate mofetil and other immunosuppressants for maintenance therapy
.
The primary endpoint was the proportion of HCV RNA-negative patients at the 12th week after DAA treatment was discontinued.
The secondary endpoints included patients' liver and kidney function, rejection, and graft survival
.
All patients completed 12 weeks of DAA treatment and 12 weeks of follow-up, the median age was 42 years (20-73 years), the proportion of men was 73.
1% (19 cases), none of them had liver cirrhosis, and they were all at baseline HCV RNA is negative
.
In terms of efficacy, all patients remained undetectable HCV RNA until the end of follow-up
.
Throughout the study period, the patient's renal function parameters remained stable
.
At the 12th week after kidney transplantation and at the last follow-up, the median values of the patient's eGFR were 67.
22mL/min/1.
73m2 and 74.
09mL/min/1.
73m2, respectively
.
In terms of safety, a total of 15 patients reported adverse events, none of which were related to SOF/VEL
.
Rejection occurred in 3 patients, all of which were deemed unrelated to SOF/VEL treatment
.
No patients in the study experienced graft failure
.
Image source: veer.
com Other solid organ transplantation In the past few years, the preventive treatment of HCV-negative recipients receiving HCV-positive solid organ transplantation has gradually attracted attention.
Not only kidney transplantation, but also liver, heart and other organ transplants, SOF/VEL Also demonstrated good safety and effectiveness
.
In a prospective multicenter study in the United States [5], a total of 24 HCV-negative recipients received organ transplants from HCV-positive infections (including 11 kidney transplants and 13 liver transplants)
.
Early after transplantation, if the recipient is confirmed to be positive for HCV RNA, he will receive a 12-week SOF/VEL treatment
.
A total of 23 patients developed HCV infection after transplantation, and all received sustained virological response (SVR)
.
In another heart/lung transplantation study [6], 36 HCV-negative recipients received HCV-positive lung transplantation, 8 received heart transplantation, and received SOF/VEL treatment for 4 weeks within a few hours after transplantation, completing 6 months The first 35 recipients who were followed up all obtained SVR, and the transplanted organs functioned well
.
Since patients undergoing organ transplantation need to take large doses of immunosuppressive drugs for a long time, another important consideration in the preventive treatment of HCV is drug interactions
.
Some commonly used DAA drugs have been found to have complex interactions when combined with immunosuppressive agents, resulting in a significant increase in the area under the DAA concentration-time curve [7]
.
However, SOF/VEL has no drug interaction with commonly used immunosuppressive drugs, and there is no need to adjust the drug dose [3]
.
Drug-drug interactions between HCV DAA and immunosuppressive agents [3] Real-world research data suggest that SOF/VEL treatment can effectively prevent HCV infection in recipients after kidney transplantation from HCV-positive donors, and can not only expand donors The library can also reduce the waiting time for a kidney transplant to a certain extent
.
I look forward to more end-stage renal disease patients and their families who are waiting for kidney transplantation to get the hope and future of returning to normal life
.
Author profile reference: [1]Sise ME, Chute DF, Gustafson JL, et al.
Transplantation of hepatitis C virus infected kidneys into hepatitis C virus uninfected recipients[J].
Hemodialysis International,2018,22:S71-S80.
[2 ]Ghany MG,Morgan TR,AASLD‐IDSA hepatitis C guidance panel.
Hepatitis C guidance 2019 update:American Association for the Study of Liver Diseases--Infectious Diseases Society of America recommendations for testing,managing,and treating hepatitis C virus infection[J] .
Hepatology,2020,71(2):686-721.
[3]Pawlotsky JM,Negro F,Aghemo A,et al.
EASL recommendations on treatment of hepatitis C:final update of the series☆[J].
Journal of Hepatology ,2020,73(5):1170-1218.
[4]Chen R,Li D,Zhang M,et al.
Sofosbuvir/Velpatasvir Prophylaxis for 12 Weeks in Hepatitis C Virus(HCV)-Negative Recipients Receiving Kidney Transplantation from HCV- Positive Donors[J].
Annals of Transplantation,2021,26.
[5]Terrault NA,Burton J,Ghobrial M,et al.
Prospective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors[J].
Hepatology,2021,73 (6):2110-2123.
[6]Woolley AE,Singh SK,Goldberg HJ,et al.
Heart and lung transplants from HCV-infected donors to uninfected recipients[J].
New England Journal of Medicine,2019,380(17 ):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58(5): 666-673.
Get more latest literature, guidelines and cutting-edge information in infectious diseases, hepatitis, AIDS and other fields.
Welcome to follow the "Jizhiyi" statement: This content is only for Chinese medical and health professionals, and is intended to provide and only provide medical and health services.
Professionals provide scientific information for personal study and referenceProspective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors[J].
Hepatology,2021,73(6):2110-2123.
[6]Woolley AE,Singh SK,Goldberg HJ,et al.
Heart and lung transplants from HCV-infected donors to uninfected recipients[J].
New England Journal of Medicine,2019,380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58(5):666-673.
Get more latest literature, guidelines and cutting-edge information in the fields of infectious diseases, hepatitis and AIDS Welcome to pay attention to the "Jizhiyi" statement: This content is only for Chinese medical and health professionals, and aims to provide scientific information to and only to medical and health professionals for personal learning and reference purposesProspective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors[J].
Hepatology,2021,73(6):2110-2123.
[6]Woolley AE,Singh SK,Goldberg HJ,et al.
Heart and lung transplants from HCV-infected donors to uninfected recipients[J].
New England Journal of Medicine,2019,380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58(5):666-673.
Get more latest literature, guidelines and cutting-edge information in the fields of infectious diseases, hepatitis and AIDS Welcome to pay attention to the "Jizhiyi" statement: This content is only for Chinese medical and health professionals, and aims to provide scientific information to and only to medical and health professionals for personal learning and reference purposes380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58( 5):666-673.
Get more latest literature, guidelines and cutting-edge information in infectious diseases, hepatitis and AIDS Provide scientific information to medical and health professionals for personal learning and reference purposes380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58( 5):666-673.
Get more latest literature, guidelines and cutting-edge information in infectious diseases, hepatitis and AIDS Provide scientific information to medical and health professionals for personal learning and reference purposes
.
If you are not a medical and health professional, please do not participate or spread
.
-End-This article is only used to provide scientific information to medical professionals and does not represent the platform's position
Not only kidney transplants, but also in organ transplants such as liver and heart, SOF/VEL also shows good safety and effectiveness
.
The safety of kidney transplantation End-stage renal disease (ESRD) is the fifth stage of the development of chronic kidney disease.
The glomerular filtration rate (eGFR) of the patient is less than 15mL/min/1.
73m2, and the renal function is lower than 10% of normal function, which means The kidneys have almost lost all their functions
.
Kidney transplantation is the best treatment for ESRD
.
A kidney that meets the criteria can save not only an ESRD patient, but also a family
.
However, because the number of organ transplants is much higher than the number of donor organs, more families are waiting for the kidney source.
Every year, 5%-10% of patients die while waiting for a kidney transplant [1]
.
In order to improve the accessibility of kidney transplantation and reduce the risk of death while waiting for an organ, the kidney donor standard has been relaxed, and hepatitis donors are also considered as kidney donors
.
However, the hepatitis C virus (HCV) may be transmitted from the donor to the recipient, causing the recipient’s liver to be affected and affecting the patient’s long-term prognosis
.
If you want to use HCV-positive donor organs, you must solve this problem
.
In this regard, the American Association for the Study of Liver Diseases (AASLD) [2] and the European Society of Liver (EASL) [3] have all put forward relevant guidance in the HCV guidelines issued
.
For HCV-negative recipients who have received HCV-positive donor transplantation, the AASLD guidelines recommend the use of a fixed-dose daily pan-genotypic regimen of sofosbuvir vipatavir (SOF/VEL) for 12 weeks, with genotypes 1, 4, and 5 Or type 6 patients are recommended to use a fixed daily dose of Dipavir sofosbuvir (LDV/SOF) for 12 weeks; the EASL guidelines recommend a fixed dose of SOF/VEL for 12 weeks, and there is no need to adjust the dose of immunosuppressive agents
.
China is also facing the problem of a large gap in the supply of kidneys
.
It is urgent to expand the standard for optimal organ donation and increase the ways of donating kidneys .
Recently, our team (the Renji Hospital of Shanghai Jiaotong University, Renji Hospital Urology Kidney Transplant Center and Kidney Disease Dialysis Transplant Comprehensive Diagnosis and Treatment Center) published the latest research results once again proved that DAA (direct-acting antiviral agents) is here.
The safety and effectiveness of preventive treatment for a special population has brought hope to more patients waiting for kidney transplantation [4]
.
The results of the study showed that HCV-negative recipients received kidney transplantation from HCV-positive donors and were treated with sofosbuvir vepatavir (SOF/VEL) for 12 weeks.
All patients achieved HCV RNA-negative with good safety.
Stable function
.
This is China's first study on the safety and effectiveness of SOF/VEL for HCV-negative recipients receiving HCV-positive donor kidney transplantation
.
The article was published on Annals of Transplantation
.
Screenshot of the article This study is a single-center retrospective study that evaluated the efficacy and safety of HCV-negative recipients who received HCV-positive donor kidney transplantation, who took SOF/VEL for the first time 2 hours before kidney transplantation and continued preventive treatment for 12 weeks
.
The study included 26 HCV-negative recipients who received kidney transplants from HCV-positive donors
.
The patient took SOF/VEL (400mg/100mg) for the first time 2 hours before undergoing kidney transplantation, and then took one tablet a day for 12 weeks
.
The patients were followed up at 2, 4, 8, and 12 weeks after the operation and at the 4, 8, and 12 weeks after the end of the treatment
.
At the same time, the patient received intravenous injection of rabbit anti-human thymocyte immunoglobulin or basiliximab as induction therapy, combined with hormones, calcineurin inhibitors, mycophenolate mofetil and other immunosuppressants for maintenance therapy
.
The primary endpoint was the proportion of HCV RNA-negative patients at the 12th week after DAA treatment was discontinued.
The secondary endpoints included patients' liver and kidney function, rejection, and graft survival
.
All patients completed 12 weeks of DAA treatment and 12 weeks of follow-up, the median age was 42 years (20-73 years), the proportion of men was 73.
1% (19 cases), none of them had liver cirrhosis, and they were all at baseline HCV RNA is negative
.
In terms of efficacy, all patients remained undetectable HCV RNA until the end of follow-up
.
Throughout the study period, the patient's renal function parameters remained stable
.
At the 12th week after kidney transplantation and at the last follow-up, the median values of the patient's eGFR were 67.
22mL/min/1.
73m2 and 74.
09mL/min/1.
73m2, respectively
.
In terms of safety, a total of 15 patients reported adverse events, none of which were related to SOF/VEL
.
Rejection occurred in 3 patients, all of which were deemed unrelated to SOF/VEL treatment
.
No patients in the study experienced graft failure
.
Image source: veer.
com Other solid organ transplantation In the past few years, the preventive treatment of HCV-negative recipients receiving HCV-positive solid organ transplantation has gradually attracted attention.
Not only kidney transplantation, but also liver, heart and other organ transplants, SOF/VEL Also demonstrated good safety and effectiveness
.
In a prospective multicenter study in the United States [5], a total of 24 HCV-negative recipients received organ transplants from HCV-positive infections (including 11 kidney transplants and 13 liver transplants)
.
Early after transplantation, if the recipient is confirmed to be positive for HCV RNA, he will receive a 12-week SOF/VEL treatment
.
A total of 23 patients developed HCV infection after transplantation, and all received sustained virological response (SVR)
.
In another heart/lung transplantation study [6], 36 HCV-negative recipients received HCV-positive lung transplantation, 8 received heart transplantation, and received SOF/VEL treatment for 4 weeks within a few hours after transplantation, completing 6 months The first 35 recipients who were followed up all obtained SVR, and the transplanted organs functioned well
.
Since patients undergoing organ transplantation need to take large doses of immunosuppressive drugs for a long time, another important consideration in the preventive treatment of HCV is drug interactions
.
Some commonly used DAA drugs have been found to have complex interactions when combined with immunosuppressive agents, resulting in a significant increase in the area under the DAA concentration-time curve [7]
.
However, SOF/VEL has no drug interaction with commonly used immunosuppressive drugs, and there is no need to adjust the drug dose [3]
.
Drug-drug interactions between HCV DAA and immunosuppressive agents [3] Real-world research data suggest that SOF/VEL treatment can effectively prevent HCV infection in recipients after kidney transplantation from HCV-positive donors, and can not only expand donors The library can also reduce the waiting time for a kidney transplant to a certain extent
.
I look forward to more end-stage renal disease patients and their families who are waiting for kidney transplantation to get the hope and future of returning to normal life
.
Author profile reference: [1]Sise ME, Chute DF, Gustafson JL, et al.
Transplantation of hepatitis C virus infected kidneys into hepatitis C virus uninfected recipients[J].
Hemodialysis International,2018,22:S71-S80.
[2 ]Ghany MG,Morgan TR,AASLD‐IDSA hepatitis C guidance panel.
Hepatitis C guidance 2019 update:American Association for the Study of Liver Diseases--Infectious Diseases Society of America recommendations for testing,managing,and treating hepatitis C virus infection[J] .
Hepatology,2020,71(2):686-721.
[3]Pawlotsky JM,Negro F,Aghemo A,et al.
EASL recommendations on treatment of hepatitis C:final update of the series☆[J].
Journal of Hepatology ,2020,73(5):1170-1218.
[4]Chen R,Li D,Zhang M,et al.
Sofosbuvir/Velpatasvir Prophylaxis for 12 Weeks in Hepatitis C Virus(HCV)-Negative Recipients Receiving Kidney Transplantation from HCV- Positive Donors[J].
Annals of Transplantation,2021,26.
[5]Terrault NA,Burton J,Ghobrial M,et al.
Prospective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors[J].
Hepatology,2021,73 (6):2110-2123.
[6]Woolley AE,Singh SK,Goldberg HJ,et al.
Heart and lung transplants from HCV-infected donors to uninfected recipients[J].
New England Journal of Medicine,2019,380(17 ):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58(5): 666-673.
Get more latest literature, guidelines and cutting-edge information in infectious diseases, hepatitis, AIDS and other fields.
Welcome to follow the "Jizhiyi" statement: This content is only for Chinese medical and health professionals, and is intended to provide and only provide medical and health services.
Professionals provide scientific information for personal study and referenceProspective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors[J].
Hepatology,2021,73(6):2110-2123.
[6]Woolley AE,Singh SK,Goldberg HJ,et al.
Heart and lung transplants from HCV-infected donors to uninfected recipients[J].
New England Journal of Medicine,2019,380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58(5):666-673.
Get more latest literature, guidelines and cutting-edge information in the fields of infectious diseases, hepatitis and AIDS Welcome to pay attention to the "Jizhiyi" statement: This content is only for Chinese medical and health professionals, and aims to provide scientific information to and only to medical and health professionals for personal learning and reference purposesProspective Multicenter Study of Early Antiviral Therapy in Liver and Kidney Transplant Recipients of HCV-Viremic Donors[J].
Hepatology,2021,73(6):2110-2123.
[6]Woolley AE,Singh SK,Goldberg HJ,et al.
Heart and lung transplants from HCV-infected donors to uninfected recipients[J].
New England Journal of Medicine,2019,380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58(5):666-673.
Get more latest literature, guidelines and cutting-edge information in the fields of infectious diseases, hepatitis and AIDS Welcome to pay attention to the "Jizhiyi" statement: This content is only for Chinese medical and health professionals, and aims to provide scientific information to and only to medical and health professionals for personal learning and reference purposes380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58( 5):666-673.
Get more latest literature, guidelines and cutting-edge information in infectious diseases, hepatitis and AIDS Provide scientific information to medical and health professionals for personal learning and reference purposes380(17):1606-1617.
[7]Feng HP,Caro L,Fandozzi CM,et al.
Pharmacokinetic interactions between elbasvir/grazoprevir and immunosuppressant drugs in healthy volunteers[J].
The Journal of Clinical Pharmacology,2018,58( 5):666-673.
Get more latest literature, guidelines and cutting-edge information in infectious diseases, hepatitis and AIDS Provide scientific information to medical and health professionals for personal learning and reference purposes
.
If you are not a medical and health professional, please do not participate or spread
.
-End-This article is only used to provide scientific information to medical professionals and does not represent the platform's position
