Effects of ursodeoxycholic acid (ursodiol) treatment on chronic viral hepatitis in heart transplant patients: results of a prospective, double-blind, placebo-randomized study

Transplantation is the best treatment for end-stage organ failure. Hepatitis virus infections, mainly hepatitis B virus (HBV) and hepatitis C virus (HCV) infections still constitute a major problem because they are common in allograft recipients and are a significant cause of morbidity and mortality after transplantation. Recently, hepatitis E virus infection has been added as an emergent cause of chronic hepatitis in organ transplantation. The prevalence of HBV and HCV infections has markedly decreased in patients who are candidates for transplantation since the introduction of screening, hygiene and prevention measures, including systematic screening of blood and organ donations, use of erythropoietin, compliance with universal hygiene rules, segregation of HBV-infected patients from non-infected patients and systematic vaccination against HBV. A liver biopsy is preferable to non-invasive biochemical and/or morphological tests of fibrosis to evaluate liver fibrosis before and even after transplantation. Treatment with entecavir or tenofovir is indicated in HBV-infected dialyzed patients who have moderate or severe disease (≥A2 or F2 on the Metavir scale) in preparation for renal transplantation. Due to the risks of severe reactivation, fibrosing cholestatic hepatitis or histological deterioration after transplantation, systematic use of nucleoside or nucleotide analogues shortly before or at the time of transplantation is recommended (tenofovir or entecavir are preferable to lamivudine) in all patients, whatever the baseline histological evaluation. In HCV-infected dialyzed patients who are not candidates for renal transplantation, the indication for antiviral therapy is limited to significant fibrosis (fibrosis ≥2 on the Metavir scale). Treatment must be proposed to all candidates for renal transplantation, whatever their baseline histopathology, and interferon-α should be used as monotherapy. After transplantation, interferon-α is contraindicated but may be used in patients for whom the benefits of antiviral treatment clearly outweigh the risks, especially that of allograft rejection. All cirrhotic patients, notably after solid organ transplantation, should be screened for hepatocellular carcinoma. Sustained suppression of necro-inflammation may result in regression of cirrhosis, which in turn may lead to decreased disease-related morbidity and improved survival. Finally, due to the high mortality after renal transplantation, active (namely without sustained viral suppression) cirrhosis should be considered a contraindication to kidney transplantation, but an indication to combined liver-kidney transplantation; on the contrary, inactive (namely with sustained viral suppression) compensated cirrhosis may permit renal transplantation alone. Organ transplantations other than kidney (cardiac or pulmonary transplantations) involve the same diagnosis and therapeutic issues.

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“…In heart transplant patients, the prevalence of HCV -mainly transmitted by transfusion or heart donation -is about 11-16% [6][7][8].…”

Section: Hepatitis C Virusmentioning

confidence: 99%

VIRAL hepatitis in solid organ transplantation other than liver

Vallet-Pichard¹,

Fontaine²,

Mallet³

et al. 2011

Journal of Hepatology

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“…The reported prevalence of HCV among HT recipients, mainly transmitted by transfusion or heart donation, ranges from 7% to 18%; however, these data do not differentiate between preexisting chronic HCV infection from acquired HCV (95,96). Only few studies have assessed the outcome of HT in HCV-positive recipients (97Y102) ( Table 2), and based on the most recent data, survival is reduced in this population.…”

Section: Heart Transplantation In Hcv-infected Candidatesmentioning

confidence: 83%

Hepatitis C Virus and Nonliver Solid Organ Transplantation

Carbone

Mutimer

Neuberger³

2013

Transplantation

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: Hepatitis C virus (HCV) infection is common in solid organ allograft recipients and is a significant cause of morbidity and mortality after transplantation, so effective management will improve outcomes. In this review, we discuss the extent of the problem associated with HCV infection in donors and kidney, heart, and lung transplant candidates and recipients and recommend follow-up and treatment.Patients with end-stage kidney disease without cirrhosis and selected patients with early-stage cirrhosis can be considered for kidney transplant alone. In HCV-infected kidney allograft recipients, the progression of fibrosis should be evaluated serially by Fibroscan or serologic measures of fibrosis. Transplantation of kidneys from HCV-positive donors should be restricted to HCV-positive recipients as it is associated with a reduced time waiting for a graft and does not affect posttransplant outcomes. Hepatitis C virus antiviral therapy should be considered for all HCV-RNA-positive kidney transplant candidates, irrespective of the baseline liver histopathology. Protease inhibitors have yet to be fully evaluated in patients with renal dysfunction and in the transplant population. As these agents may cause anemia in patients with normal renal function, tolerability may be a problem in patients with end-stage kidney disease.The impact of HCV infection on survival in heart and lung transplantation is unclear. Because of the shortage of organs, few HCV-infected patients are accepted for transplantation.Universal use of nucleic acid amplification testing (NAT) for the screening of potential organ donors should be reserved to high-risk donors. Assays that quantify HCV core antigen may become more cost-effective than NAT for the screening of potential organ donors.

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“…The range of treatment duration was from 1 month 11,23 to 36 months. 24 Selected trials enrolled subjects with chronic hepatitis, 8,9,25 primary biliary cirrhosis, [26][27][28][29][30][31][32] chronic viral hepatitis, 33 autoimmune hepatitis, 34 nonalcoholic fatty liver disease (NAFLD), 35,36 nonalcoholic steatohepatitis (NASH), 37,38 primary sclerosing cholangitis, 24,39,40 alcohol-induced cirrhosis, 10 biliary complications after liver transplantation, 11 and healthy volunteers. 23…”

Section: Characteristics Of Clinical Trialsmentioning

confidence: 99%

Effect of ursodeoxycholic acid on liver markers: A systematic review and meta‐analysis of randomized placebo‐controlled clinical trials

Simental‐Mendía

Sánchez‐García

Simental‐Mendía

2020

Brit J Clinical Pharma

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The objective of this meta-analysis was to evaluate the effect of ursodeoxycholic acid (UDCA) therapy on serum liver function tests.Methods: PubMed, Web of Science, Scopus and Google Scholar databases were searched to identify randomized placebo-controlled trials assessing the impact of UDCA on hepatic parameters. Meta-analysis was conducted using a random-effects model and sensitivity analysis through the leave-one-out method in the Review Manager statistical software version 5.3.

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Effects of ursodeoxycholic acid (ursodiol) treatment on chronic viral hepatitis in heart transplant patients: results of a prospective, double-blind, placebo-randomized study

Abstract: A 12-month course of ursodiol therapy had no effect on liver enzymes or liver histology in heart transplant patients with chronic hepatitis.

Cited by 11 publications

References 26 publications

VIRAL hepatitis in solid organ transplantation other than liver

VIRAL hepatitis in solid organ transplantation other than liver

Hepatitis C Virus and Nonliver Solid Organ Transplantation

Effect of ursodeoxycholic acid on liver markers: A systematic review and meta‐analysis of randomized placebo‐controlled clinical trials

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