scholarly journals Survey of Clinician Opinions on Kidney Transplantation from Hepatitis C Virus Positive Donors: Identifying and Overcoming Barriers

Kidney360 ◽  
2020 ◽  
Vol 1 (11) ◽  
pp. 1291-1299
Author(s):  
Krista L. Lentine ◽  
John D. Peipert ◽  
Tarek Alhamad ◽  
Yasar Caliskan ◽  
Beatrice P. Concepcion ◽  
...  

BackgroundTransplant practices related to use of organs from hepatitis C virus–infected donors (DHCV+) is evolving rapidly.MethodsWe surveyed US kidney transplant programs by email and professional society LISTSERV postings between July 2019 and January 2020 to assess attitudes, management strategies, and barriers related to use of viremic (nucleic acid testing positive [NAT+]) donor organs in recipients who are not infected with HCV.ResultsStaff at 112 unique programs responded, representing 54% of US adult kidney transplant programs and 69% of adult deceased donor kidney transplant volume in 2019. Most survey respondents were transplant nephrologists (46%) or surgeons (43%). Among the responding programs, 67% currently transplant DHCV antibody+/NAT− organs under a clinical protocol or as standard of care. By comparison, only 58% offer DHCV NAT+ kidney transplant to recipients who are HCV−, including 35% under clinical protocols, 14% as standard of care, and 9% under research protocols. After transplant of DHCV NAT+ organs to recipients who are uninfected, 53% start direct-acting antiviral agent (DAA) therapy after discharge and documented viremia. Viral monitoring protocols after DHCV NAT+ to HCV uninfected recipient kidney transplantation varied substantially. 56% of programs performing these transplants report having an institutional plan to provide DAA treatment if declined by the recipient’s insurance. Respondents felt a mean decrease in waiting time of ≥18 months (range, 0–60) justifies the practice. Program concerns related to use of DHCV NAT+ kidneys include insurance coverage concerns (72%), cost (60%), and perceived risk of transmitting resistant infection (44%).ConclusionsAddressing knowledge about safety and logistic/financial barriers related to use of DHCV NAT+ kidney transplantation for recipients who are not infected with HCV may help reduce discards and expand the organ supply.PodcastThis article contains a podcast at https://www.asnonline.org/media/podcast/K360/2020_11_25_KID0004592020.mp3

2021 ◽  
Vol 8 ◽  
pp. 205435812110334
Author(s):  
Susan Cuvelier ◽  
Paul Van Caeseele ◽  
Matthew Kadatz ◽  
Kathryn Peterson ◽  
Siyao Sun ◽  
...  

Purpose of program: The ongoing shortage of organs for transplant combined with Manitoba having the highest prevalence of end-stage renal disease (ESRD) in Canada has resulted in long wait times on the deceased donor waitlist. Therefore, the Transplant Manitoba Adult Kidney Program has ongoing quality improvement initiatives to expand the deceased donor pool. This clinical transplant protocol describes the use of prophylactic pan-genotypic direct-acting anti-viral agents (DAA) for transplanting hepatitis C (HCV)-viremic kidneys (HCV antibody positive/nucleic acid [nucleic acid amplification testing, NAT] positive) to HCV-naïve recipients as routine standard of care. We will evaluate the provincial implementation of this protocol as a prospective observational cohort study. Sources of information: Scoping literature review and key stakeholder engagement with interdisciplinary health care providers and health system leaders/decision markers. Methods: Patients will be screened pre-transplant for eligibility and undergo a multilevel education and consent process to participate in this expanded donor program. Incident adult HCV-naïve recipients of an HCV-viremic kidney transplant will be treated prophylactically with glecaprevir-pibrentasvir with the first dose administered on call to the operation. Glecaprevir-pibrentasvir will be used for 8 weeks with viral monitoring and hepatology follow-up. Primary outcomes are sustained virologic response (SVR) at 12 weeks and the tolerability of DAA therapy. Secondary outcomes within the first year post-transplant are patient and graft survival, graft function, biopsy-proven rejection, HCV transmission to recipient (HCV NAT positive), and HCV nonstructural protein 5A (NS5A) resistance. Safety outcomes within the first year post-transplant include fibrosing cholestatic hepatitis, acute liver failure, primary and secondary DAA treatment failure, HCV transmission to a recipient’s partner, elevated liver enzymes ≥2-fold, abnormal international normalized ratio (INR), angioedema, anaphylaxis, cirrhosis, and hepatocellular carcinoma. Key findings: This program successfully advocated for and obtained hospital formulary, provincial Exceptional Drug Status (EDS), and Non-Insured Health Benefits (NIHB) to provide prophylactic DAA therapy for this indication, and this information may be useful to other provincial transplant organizations seeking to establish an HCV-viremic kidney transplant program with prophylactic DAA drug coverage. Limitations: (1) Patient engagement was not undertaken during the program design phase, but patient-reported experience measures will be obtained for continuous quality improvement. (2) Only standard criteria donors (optimal kidney donor profile index [KDPI] ≤60) will be used. If this approach is safe and feasible, then higher KDPI donors may be included. Implications: The goal of this quality improvement project is to improve access to kidney transplantation for Manitobans. This program will provide prophylactic DAA therapy for HCV-viremic kidney transplant to HCV-naïve recipients as routine standard of care outside a clinical trial protocol. We anticipate this program will be a safe and effective way to expand kidney transplantation from a previously unutilized donor pool.


2017 ◽  
Vol 26 (4) ◽  
pp. 381-386
Author(s):  
Mircea Manuc ◽  
Carmen M. Preda ◽  
Corneliu P. Popescu ◽  
Cristian Baicuș ◽  
Theodor Voiosu ◽  
...  

Background & Aims: Literature data suggest that HCV genotype-1b is present in 93-99% of the Romanian patients infected with hepatitis C virus (HCV). We present the genotyping tests recently performed on patients with HCV and advanced fibrosis eligible for the Direct-Acting Antiviral (DAA) therapy, as well as the prevalence of these cases across Romania.Methods: The genotyping method was performed on 7,421 HCV patients with advanced fibrosis. The detection method was automatic real time PCR platform M2000 (Abbott). Every subject was introduced into a database including age, sex, county and address.Results: Genotype 1b was almost exclusively present: 7,392/7,421 (99.6%). Genotype 1b patients were 19.6% from Bucharest, 49% were males, with a median age of 60 years. Genotype non-1b was encountered in 29/7,421 subjects (0.4%), 62% were males, 69% from Bucharest and the median age was 52 years. Most of the subjects (75%) were in the 6th and 7th age decade. The prevalence of these cases varied significantly across Romanian counties: the highest was in Bucharest (61.3/105), Bihor (47/105), Iasi (46/105) and Constanța (43/105), and the lowest in Ilfov (2.8/105), Harghita (3.7/105), Covasna (5.4/105) and Maramureș (8.8/105) (p<0.001).Conclusions: Genotype 1b is encountered in 99.6% of patients with chronic hepatitis C and advanced fibrosis from Romania. The presence of genotypes non-1b is more common in Bucharest, in males and at a younger age. There are significant differences regarding the distribution of these cases across Romania: the highest rates are in Bucharest, Bihor, Iasi and Constanta.Abbreviations: BMI: body mass index; DAA: direct-acting antiviral agent; GT: genotype; HBV: hepatitis B virus; HCC: hepatocellular carcinoma; HCV: hepatitis C virus; IDU: intravenous drug users; MELD: model for end stage liver disease; NASH: non-alcoholic steatohepatitis; SVR; sustained virologic response.


2020 ◽  
Vol 18 ◽  
Author(s):  
Mohammed Al Atbee ◽  
Saad Shaheen Al-Taher ◽  
Majid Alabbood

Background: Up to date, there is no consensus on the best combination of direct-acting antiviral to treat hepatitis C virus in kidney transplant recipients. Objective: This study aims to analyze the efficacy of combination of sofosbuvir and ledipasvir regimen for treatment of hepatitis C virus infected kidney transplant patients. Method: A cross-sectional study conducted in a nephrology clinic and the Nephrology Center in Basrah Teaching Hospital from June 2015 to June 2018. Ledifos (90 mg Ledipasvir and 400 mg Sofosbuvir fixed-dose) was given as a single daily dose for all the participants for 12 weeks. Response for therapy was tested by follow up hepatitis C virus load at the end of 12 weeks and 24 weeks. The sustained virological response was defined as negative viral load of hepatitis C virus (aviremia) at the end of therapy. This study was done according to the Helsinki Congress. Results: A total of 60 (16 females) patients with renal transplantation and hepatitis C virus infection were included. Mean age was 40±6.2 years. A sustained virological response observed in all of the patients who received Ledifos after 12 and 24 weeks of therapy for all genotypes (1a, 1b and 4); p= 0.0001. Genotype 1a was more prevalent among males, 34 (56.6%); p= 0.0001, and it was the most common genotype tested negative serologically, 11 (18.3%). Conclusion: Ledifos therapy is effective and safe option for the treatment of hepatitis C virus infection in the post–renal transplant setting.


2008 ◽  
Vol 21 (9) ◽  
pp. 873-878 ◽  
Author(s):  
Juan Torres ◽  
Jose María Aguado ◽  
Rafael San Juan ◽  
Amado Andrés ◽  
Prado Sierra ◽  
...  

Hepatology ◽  
2011 ◽  
Vol 54 (5) ◽  
pp. 1570-1579 ◽  
Author(s):  
Meital Gal-Tanamy ◽  
Larisa Bachmetov ◽  
Amiram Ravid ◽  
Ruth Koren ◽  
Arie Erman ◽  
...  

2018 ◽  
Vol 12 (4) ◽  
pp. 100-104 ◽  
Author(s):  
William A. Werbel ◽  
Christine M. Durand

2020 ◽  
Vol 19 (4) ◽  
pp. 389-393
Author(s):  
Nobuhiro Fujita ◽  
Akihiro Nishie ◽  
Yoshiki Asayama ◽  
Kousei Ishigami ◽  
Tomohiro Nakayama ◽  
...  

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 223 ◽  
Author(s):  
Sara Sobhy Kishta ◽  
Reem El-Shenawy ◽  
Sobhy Ahmed Kishta

Recent improvements have been made in the treatment of hepatitis C virus (HCV) infection with the introduction of direct-acting antiviral agents (DAAs). However, despite successful viral clearance, many patients continue to have HCV-related disease progression. Therefore, new treatments must be developed to achieve viral clearance and prevent the risk of HCV-related diseases. In particular, the use of pitavastatin together with DAAs may improve the antiviral efficacy as well as decrease the progression of liver fibrosis and the incidence of HCV-related hepatocellular carcinoma. To investigate the management methods for HCV-related diseases using pitavastatin and DAAs, clinical trials should be undertaken. However, concerns have been raised about potential drug interactions between statins and DAAs. Therefore, pre-clinical trials using a replicon system, human hepatocyte-like cells, human neurons and human cardiomyocytes from human-induced pluripotent stem cells should be conducted. Based on these pre-clinical trials, an optimal direct-acting antiviral agent could be selected for combination with pitavastatin and DAAs. Following the pre-clinical trial, the combination of pitavastatin and the optimal direct-acting antiviral agent should be compared to other combinations of DAAs (e.g., sofosbuvir and velpatasvir) according to the antiviral effect on HCV infection, HCV-related diseases and cost-effectiveness.


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