Direct-acting antiviral prophylaxis in kidney transplantation from hepatitis C virus-infected donors to noninfected recipients: an open-label nonrandomized trial. . Fabrizi F, Martin P, Dixit V, Bunnapradist S, Kanwal F, Dulai G. Am J Transplant. Although no published data are available regarding the long-term (beyond 1 to 2 years) consequences to HCV-negative recipients transplanted with organs from HCV-viremic donors who are treated post-transplant with DAAs, limited short-term data from liver, kidney, heart, and lung transplant programs are encouraging. A comprehensive guide to kidney transplantation, this book describes the principles and practice of clinical renal transplantation. This book is a continuation of the efforts of InTech to expand the scientific know-how in the field of immunopathology and bring valuable updated information to medical professionals and researchers. 1297 Seem DL, Lee I, Umscheid CA, Kuehnert MJ. Am J Transplant. There were no significant differences between recipients of allografts from HCV-viremic vs HCV-negative donors in terms of other clinical outcomes such as acute cellular rejection, kidney dysfunction, or survival. Scalea J, Barth RN, Munivenkatappa R, et al. PMC A few years ago, as the editor of Kidney International, I was ap proached by Drs. Cohen, Kassirer, and Harrington who suggested that a new feature should be included in each monthly issue of the journal. 2018;(102):1179-1187. Transpl Infect Dis. Early initiation of glecaprevir/pibrentasvir (target was within 3 days posttransplant) for 8 weeks resulted in 100% SVR12; there were no significant treatment-related adverse events (Sise, 2020). Transplantation of hepatitis C viremic (HCV+) deceased donor kidney transplants (DDKT) into aviremic (HCV-) recipients is a strategy to increase organ utilization. Prospective multicenter study of early antiviral therapy in liver and kidney transplant recipients of HCV-viremic donors. Am J Kidney Dis. Gidea CG, Narula N, Reyentovich A, et al. Jay Seltzer, MD Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world's hepatocellular carcinoma and more than half of all fatal cirrhosis. To evaluate the efficacy and safety of these regimens for hepatitis C treatment of patients with CKD and after renal transplantation, as well as the . reported a 10-yr survival rate of 65% among patients with antibodies to HCV and 80% among those without serologic evidence of previous hepatitis B or C (P < 0.001), with age at transplantation (P < 0.001) and anti-HCV status (P . Up to date and practical, this book gives nephrologists and providers that treat kidney transplant patients a succinct resource on management. This concise book provides an overview of the essential aspects of transplant nephrology. 2017;30:865-873. Survival advantage of kidney transplantation over dialysis in patients with hepatitis C: a systematic review and meta-analysis. [105] [106] People with moderate-severe renal impairment (eGFR < 50 mL/min/1.73 m 2) should be . Despite reduced access to transplantation, patients who are HIV+ have excellent outcomes and clearly benefit from receiving one. Lancet Gastroenterol Hepatol. This book introduces readers to Direct Acting Antiviral (DAAs) agents, newly developed drugs to treat chronic hepatitis C virus infection, which have an excellent anti-viral effect on virus replication. National trends in utilization and 1-year outcomes with transplantation of HCV-viremic kidneys. The median time from transplant to initiation of DAA therapy was 16.5 days; all kidney transplant recipients in this study achieved SVR12. You are just a few steps away from free CE credits! 2019;19(9):2533-2542. Needless to say, pre-transplant treatment can improve the risk of HCV-related morbidity, incidence of diabetes and possibly cardiovascular disease in waitlist candidates but they do have to wait longer (3-5 years) for an HCV negative kidney post treatment. 2012;60:112-120. Investigators noted a higher proportion of acute cellular rejection in the HCV-viremic vs HCV-aviremic donor study groups (14/22 vs 5/28, respectively; p=0.001) in the first 2 months and at 180 days (17/22 vs 12/28, respectively; p=0.02). The efficacy and safety of direct-acting antivirals (DAAs) for treating hepatitis C virus (HCV)-infected renal transplant recipients (RTRs) has not been determined. However, there are concerns around inferior recipient outcomes due to delayed initiation of direct-acting antiviral (DAA) therapy and sustained HCV replication when implemented . a Prior to HCV RNA results, typically immediately pre-transplant or day 0 post-transplant Hepatitis C Treatment May Decrease the Risk for End-Stage Kidney Disease Natasha Persaud. Treatment with grazoprevir/elbasvir for renal transplant recipients with chronic hepatitis C virus infection and impaired allograft function. Results: Two patients had DAA interruptions. Because of the significant risk for HCV infection when transplanting an organ from an HCV-viremic donor into an HCV-uninfected recipient, rigorous informed consent and post-transplantation, HCV-related follow-up processes are recommended. b Day 0 to within the first week post-transplant, typically as soon as the patient is deemed clinically stable, b 8 weeks is recommended for prophylactic/preemptive treatment approaches. Fibrosing cholestatic hepatitis after kidney transplantation from HCV-viremic donors to HCV-negative recipients: A unique complication in the DAA era. Treatment with glecaprevir/pibrentasvir was initiated at the time of detectable viremia (mean 7 days) among the heart recipients and within 3 days after transplantation for the lung recipients; all participants achieved SVR12 (Smith, 2021). 1, 2 Accompanying the demonstration of disease transmission were data reporting the development of an aggressive form of chronic cholestatic hepatitis in some patients associated with poor . Leonardo Riella, MD (Kidney Transplantation), Faculty Advisors Brian Stotter, Skeleton Key Group 2018;67(5):1673-1682. doi:10.1002/hep.29704. Instead, if they choose to receive a HCV+ kidney and get treatment post-transplant they just have to wait only for 6 months to 1 year. Keywords: Hepatitis C virus , kidney transplant , direct antiviral drug , genotype , ledipasvir , sofosbuvir , sustained virological response. Transplanting HCV-infected kidneys into uninfected recipients. Notably, organ recipients in this study received the first dose of elbasvir/grazoprevir on call to the operating room. Hepatitis C virus (HCV) infection a major disorder that is not only a liver-related disease but also a cardiovascular complication in renal transplant recipient. All patients should be evaluated for antiviral, interferon-free therapy. Transplant programs should have a programmatic strategy to: Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg), Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg), Risk of transmission from an HCV-viremic donor, Risk of liver disease if HCV treatment is not available or treatment is unsuccessful, Risk of extrahepatic complications, such as HCV-associated renal disease, Benefits, specifically reduced waiting time and possibly lower waiting list mortality, Other unknown long-term consequences (hepatic and extrahepatic) of HCV exposure (even if cure is attained), Assure access to HCV treatment and retreatment(s), as necessary, Ensure long-term follow-up of recipients (beyond SVR12). 2020. doi:10.1002/hep.31551. Bookshelf Franco A, Moreso F, Merino E, et al. N Engl J Med. Unable to load your collection due to an error, Unable to load your delegates due to an error. Reese PP, Abt PL, Blumberg EA, et al. The donor hepatitis C genotype will be tested. In the DONATE HCV trial, 44 HCV-uninfected lung (n=36) and heart transplant (n=8) recipients from HCV-viremic donors sofosbuvir/velpatasvir was administered prophylactically/preemptively, starting within a few hours after transplantation and continued for 4 weeks (compared to the standard 12-week course). N Engl J Med. 2021;33(2):407-415. Mavyret was safe and efficacious for patients with chronic hepatitis C who underwent liver or kidney transplantation, according to a recently published study."The study design and research were . Save my name, email, and website in this browser for the next time I comment. 2019;380(17):1606-1617. doi:10.1056/NEJMoa1812406. "Kidney transplantation is the preferred renal replacement therapy, with organ shortage being the . Am J Transplant. Impact of willingness to accept hepatitis C seropositive kidneys among hepatitis C RNA-positive waitlisted patients. Abhilash Koratala, MD, Home Hemodialysis Series Liver transplantation using hepatitis C virus-viremic donors into hepatitis C virus-aviremic recipients as standard of care. The median time from transplantation to treatment initiation was 43 days (interquartile range [IQR] 20-59 days). Meta-analysis of observational studies. Unlike with other organs, shorter durations of HCV therapy should not be used in recipients of livers from HCV-viremic donors because of the large reservoir of HCV in the transplanted organ. Early detection and treatment of HCV infection and HCV-related kidney disease after kidney transplantation improves posttransplant outcomes in this population [ 1 ]. Hepatology. Hepatitis C and CKD. However, among increased-risk donors (as defined by the US Public Health Service [PHS] guidelines) who had a recent HCV exposure, HCV RNA may not yet be detectable and transplant recipients from these donors should be monitored for HCV in addition to HBV and HIV per the increased-risk donor testing protocols (Levitsky, 2017); (Seem, 2013b). 2021;27(4):548-557. With this short therapy, none of the 30 individuals developed chronic HCV infection. doi: 10.1111/hdi.12659. This e-book is an overview of recent advances in the realm of kidney transplantation. The volume discusses developments in surgical procedures while presenting a perspective on possibilities for kidney transplant research in the future. Renal transplantation from seropositive hepatitis C virus donors to seronegative recipients in Spain: a prospective study. Ann Intern Med. Since the introduction of direct antiviral agents (DAAs), morbidity of HCV has considerably decreased but still no guidelines have been formulated in renal transplant recipients (RTRs). 3.2 | Treatment of HCV infection after transplant of kidneys from HCV‐viremic donors All renal allograft recipients were treated with sofosbuvir‐based DAA regimens for 8 or 12 weeks. Lancet Respir Med. The patients' renal function was stable during and after the treatment with no deterioration of graft function, and no adjustments to the immunosuppressive therapy were required. Meta-analysis of observational studies: hepatitis C and survival after renal transplant. Anna Gaddy, MD (2020-2022) eCollection 2019. Monitoring During and After HCV Treatment; 6 Treatment of Key Populations and Unique Situations. Transpl Infect Dis. Buggisch P, Wursthorn K, Stoehr A, et al. If treatment is delayed until the recipient has quantifiable HCV RNA, the recipientâs genotype can be used to guide DAA treatment selection if a pangenotypic regimen is not used. In a prospective, multicenter (n=6), single-arm, open-label clinical trial, 13 HCV-negative liver transplant recipients received allografts from HCV-viremic donors. Short-course, direct-acting antivirals and ezetimibe to prevent HCV infection in recipients of organs from HCV-infected donors: a phase 3, single-centre, open-label study. Kukla M, Piotrowski D, Waluga M, Hartleb M. Clin Exp Hepatol. A study of 22 heart transplants from HCV-viremic donors evaluated an 8-week course of glecaprevir/pibrentasvir initiated 6â11 days after transplantation, once the viremia developed. Woolley AE, Singh SK, Goldberg HJ, et al. Hepatitis C is a liver disease caused by . Objective: Besides the liver, hepatitis C virus (HCV) infection also affects kidney allografts. 2021;74(4):873-880. Epidemiology of HCV in Patients on Hemodialysis (HD) •In US, estimated HCV prevalence of 8% . Stage 2 kidney disease means you have mild kidney damage. In a prospective, multicenter (n=7) study to transplant hepatitis C-infected kidneys (ie, the MYTHIC trial), 30 HCV-negative recipients of kidney allografts from HCV-viremic donors. 2018, 155:1120-7. Data sources: Am J Transplant. Liver transplantation for hepatitis C virus (HCV) non-viremic recipients with HCV viremic donors. This book covers the latest advances in hepatitis C and hepatitis B therapeutics as well as the emerging and investigational treatment strategies. The book begins with an overview of infections in various modalities. This is followed by chapters on clinical disorders, etiologic agents, therapeutics, and infection prevention. Kelly Hyndman, PhD (Basic Science) However, many patients will be diagnosed with significant liver disease caused by HCV after kidney transplantation, and some with known HCV infection, but with essential normal liver histology at . Joel Topf Extrahepatic manifestations are more common in hepatitis C virus (HCV) than HBV[].CHC patients may have renal failure even in the absence of liver disease[].HCV-infected individuals have a 23% higher risk of developing CKD than non-HCV-infected individuals[].Hepatitis C is a leading cause of liver disease among patients with CKD, particularly those on dialysis. 2016 Apr;14(2):121-8. Kaplan-Meier curves showed patients treated with an IS alone experienced kidney complications at faster rate (Figures 1 & 2) and had a lower 5-year OS (72% vs All 10 patients achieved SVR12 and there were no adverse outcomes noted (Durand, 2021). There was an increase in the proportion of the HCV-viremic lung cohort who had acute cellular rejection compared to the non-HCV lung cohort, although this finding was not statistically significant and longer-term follow-up is needed to assess for chronic rejection. Furthermore, treatment regimens may be complicated by drug interactions and the need to maintain immunosuppression to avoid allograft rejection. Noteworthy was the high rate of acute cellular or antibody-mediated rejection (30%) during or after DAA therapy in this study. Due to the limited and heterogeneous experience and lack of longer-term safety data, strong consideration should be given to performing these transplantations under IRB-approved protocols as recommended by the American Society of Transplantation consensus panel (Levitsky, 2017). Reyentovich A, Gidea CG, Smith D, et al. 1 To learn more about the results from the trial, Nephrology Consultant reached out to lead author Christine M. Durand, MD, who is an associate professor of medicine in Transplant Infectious . In 2017, I wrote a 2-part blog on the HCV and kidney transplantation, focusing on the past and present in one blog post, and… 2019, 14:e0214795. Background and Aims: Hepatitis C Virus (HCV) is uniformly recurrent after liver transplant (LT) and recurrence is associ-ated with an increased risk of mortality. Transpl Int. 2019;30:1939-1951. doi: 10.1371/journal.pone.0250263. Shelton BA, Sawinski D, Mehta S, Reed RD, MacLennan PA, Locke JE. José Antonio Tesser Poloni, MD, Interventional Nephrology Series Prevention and treatment information (HHS). Immediate administration of antiviral therapy after transplantation of hepatitis C-infected livers into uninfected recipients: implications for therapeutic planning. HCV-infected kidney transplant recipients have worse patient and allograft survival after transplantation compared with uninfected kidney transplant recipients. Transpl Int. Serious adverse events possibly related to study participation among the liver recipients included antibody mediated rejection, biliary sclerosis, cardiomyopathy, and graft-versus-host disease (which eventually led to the patientâs death). A retrospective study of deceased donor liver transplantations in the US from January 2008 through January 2018 demonstrated that 2-year graft survival was similar, regardless of HCV status concordance or discordance between the allograft donor and recipient (Cotter, 2019). Preethi Sekar, MD Methods . These are some of many evolving issues in liver transplant which will be addressed to update our readers and which in turn will enhance the care of patients with liver disease. Successful early sofosbuvir-based antiviral treatment after transplantation of kidneys from HCV-viremic donors into HCV-negative recipients. Aqel B, Wijarnpreecha K, Pungpapong S, et al. Most experts recommend that persons with chronic HCV infection who are renal transplantation candidates receive treatment of HCV prior to renal transplantation, if possible. In the THINKER trial, 10 HCV-uninfected kidney transplant recipients received allografts from genotype 1 HCV-viremic donors and were treated with 12 weeks of elbasvir/grazoprevir; 100% achieved SVR (Goldberg, 2017).In a 1-year follow-up study that included 10 additional participants (n=20) who received 12 to 16 weeks of elbasvir/grazoprevir (± ribavirin), all . Kidney transplantation and waitlist mortality rates among candidates registered as willing to accept a hepatitis C infected kidney. Conclusions: Grazoprevir/elbasvir combination without ribavirin is an effective andsafe treatment option for post-KT patients with genotype 4 HCV infection. Bari K, Luckett K, Kaiser T, et al. Juan Carlos Velez, MD Another clinical trial evaluated 22 HCV-uninfected lung transplant recipients of allografts from HCV-viremic donors; the 20 patients who became viremic after transplantation were treated with 12 weeks of sofosbuvir/velpatasvir beginning 2 to 6 weeks after transplantation (median 21 days; IQR 16.76-24.75 days). Ponnuvel S, Fletcher GJ, Anantharam R, Varughese S, David VG, Abraham P. PLoS One. Vighnesh Walavalkar, MD In both of these studies, initiation of treatment within a few days after transplantation was associated with an occasional need for treatment interruption, although all recipients still achieved SVR12 (Reyentovich, 2020); (Smith, 2021). An HCV infection is difficult to treat after renal transplantation due to the conflicting actions of immunosuppressant therapy to maintain the function of the transplanted kidney and viricidal interferon (IFN) or ribavirin (RBV) treatment. The American Society of Transplantation Consensus Conference on the use of hepatitis C viremic donors in solid organ transplantation. Bethea E, Arvind A, Gustafson J, et al. Another study evaluated 38 thoracic organ transplants (22 heart; 16 lung) from HCV-viremic donors. This book was created because of the importance of kidney transplantation. This volume focuses on the complexities of the transplant patient. Design: Friebus-Kardash J, Gackler A, Kribben A, et al. Ann Intern Med. Anna Burgner, MD, MEHP 2019;4:771-780. The various hepatic diseases, whether they are benign or malignant, require surgical expertise in their management, especially given the complex anatomy and physiology of the liver, as well as its critical role in a variety of different ... PLoS One. Based on the metabolism of grazoprevir and elbasvir, a 15-fold increase in grazoprevir AUC and a 2-fold increase in elbasvir AUC can be expected with cyclosporine coadministration. The aim of this paperwork is to evaluate the impact of DAAs treatment in pre- or peri-operative period in liver transplantation when grafts ≥ 70 years are used. Public Health Rep. 2013;128(4):247-343. 10.1053/j.gastro.2018.06.042 16. However, if treatment initiation is delayed beyond the first week after transplant, treatment should be continued for 12 weeks. Edgar Lerma, MD, Let’s Talk About Peritoneal Dialysis Transplantation. Non-immunological complications following kidney transplantation. Shorter waitlist times and improved graft survivals are observed in patients who accept hepatitis C virus+ renal allografts, PHS guideline for reducing human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission through organ transplantation, Shelton BA, Sawinski D, Mehta S, Reed RD, MacLennan PA, Locke JE, Kidney transplantation and waitlist mortality rates among candidates registered as willing to accept a hepatitis C infected kidney, Multicenter study to transplant hepatitis C-infected kidneys (MYTHIC): an open-label study of combined glecaprevir and pibrentasvir to treat recipients of transplanted kidneys from deceased donors with hepatitis C virus infection, Impact of early initiation of direct-acting antiviral therapy in thoracic organ transplantation from hepatitis C virus positive donors, Prospective multicenter study of early antiviral therapy in liver and kidney transplant recipients of HCV-viremic donors, Heart and lung transplants from HCV-infected donors to uninfected recipients, Cost, Reimbursement, and Cost-Effectiveness, Patients Who Develop Recurrent HCV Infection Post Liver Transplantation, DAA Interactions With Calcineurin Inhibitors. Notably, organs from HCV-viremic donors may be used in transplant candidates with current or prior HCV infection (see Patients Who Develop Recurrent HCV Infection Post Liver Transplantation). Increasing utilization and excellent initial outcomes following liver transplant of hepatitis C virus (HCV)-viremic donors into HCV-negative recipients: outcomes following liver transplant of HCV-viremic donors.
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