A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients

Davis, Gary L.; Nelson, David R.; Terrault, Norah A.; Pruett, Timothy L.; Schiano, Thomas D.; Fletcher, Courtney V.; Sapan, Christine V.; Riser, Laura; Li, Yufeng; Whitley, Richard J.; Gnann, John W.

doi:10.1002/lt.20405

Cited by 165 publications

(127 citation statements)

References 25 publications

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“…HCV antibody therapy starts in the anhepatic phase and then is continued for 12 to 14 wk after transplant. Three trials [110][111][112] comparing high dose HCV antibody vs. low dose HCV antibody were included in a Cochrane meta-analysis [113] . There was no difference in patient and graft survival, virological response or fibrosis on histology.…”

Section: Post-transplant Antiviral Treatmentmentioning

confidence: 99%

Strategies to reduce hepatitis C virus recurrence after liver transplantation

Ciria

Pleguezuelo²,

Khorsandi³

et al. 2013

WJH

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Hepatitis C virus (HCV) is a major health problem that leads to chronic hepatitis, cirrhosis and hepatocellular carcinoma, being the most frequent indication for liver transplantation in several countries. Unfortunately, HCV re-infects the liver graft almost invariably following reperfusion, with an accelerated history of recurrence, leading to 10%-30% of patients progressing to cirrhosis within 5 years of transplantation. In this sense, some groups have even advocated for not retransplanting this patients, as lower patient and graft outcomes have been reported. However, the management of HCV recurrence is being optimized and several strategies to reduce post-transplant recurrence could improve outcomes, decrease the rate of re-transplantation and optimize the use of available grafts. Three moments may be the focus of potential actions in order to decrease the impact of viral recurrence: the pretransplant moment, the transplant environment and the post-transplant management. In the pre-transplant setting, it is not well established if reducing the pre transplant viral load affects the risk for HCV progression after transplant. Obviously, antiviral treatment can render the patient HCV RNA negative post transplant but the long-term benefit has not yet been fully established to justify the cost and clinical risk. In the transplant moment, factors as donor age, cold ischemia time, graft steatosis and ischemia/reperfusion injury may lead to a higher and more aggressive viral recurrence. After the transplant, discussion about immunosuppression and the moment to start the treatment (prophylactic, pre-emptive or once-confirmed) together with new antiviral drugs are of interest. This review aims to help clinicians have a global overview of posttransplant HCV recurrence and strategies to reduce its impact on our patients.

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Section: Post-transplant Antiviral Treatmentmentioning

confidence: 99%

Strategies to reduce hepatitis C virus recurrence after liver transplantation

Ciria

Pleguezuelo²,

Khorsandi³

et al. 2013

WJH

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show abstract

“…On the other hand, the finding of neutralization (epitope I) and nonneutralization (epitope II) epitopes within a short E2 peptide could assist the establishment of a specific ''epitope-based'' neutralization assay for monitoring the neutralizing antibody titer in patients' plasma and HCIGIV products. Currently, the level of anti-HCV antibody is measured by using recombinant HCV envelope proteins (16,17). However, binding of antibody to nonneutralization epitope(s) can lead to an overestimation of the actual level of neutralizing antibodies in HCIGIV preparations, as well as in patients' plasma.…”

Section: Hcv-specificmentioning

confidence: 99%

“…Unfortunately, the in vivo efficacy of HCIGIV in both chimpanzees and humans has been disappointing. Two clinical studies failed to show that anti-HCV Ig preparations could decrease HCV RNA levels or prevent recurrent infections after liver transplantation (16,17). One current hypothesis is that insufficient amounts of the HCV-specific Ig preparations were administered (reviewed in ref.…”

mentioning

confidence: 99%

Hepatitis C virus epitope-specific neutralizing antibodies in Igs prepared from human plasma

Zhang¹,

Mihalik

et al. 2007

Proc. Natl. Acad. Sci. U.S.A.

115

136

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“…Hepatitis C immune globulin (HCIg) therapy -although tolerated well by patients -could not reduce HCV-RNA titres in an open randomised study [33]. Monoclonal anti-HCV antibodies neutralised the virus in human liver tissue in an in vitro study and reduced viral titres in HCVpositive animals [34].…”

Section: Diagnosis Of Recurrent Hepatitis Cmentioning

confidence: 99%

Treatment of recurrent hepatitis C virus infection in patients after liver transplantation

Lengyel¹,

Tulassay²

2009

Clinical and Experimental Medical Journal

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The main indication for liver transplantation is the final stage of hepatic cirrhosis developed due to hepatitis C virus (HCV) infection. The recurrence of HCV infection after transplantation is a common situation. Recurrent hepatitis C is a progressive disease; in 20% of patients it produces liver cirrhosis without treatment beside immunosuppression within 5 years. Treatment of recurrent HCV infection is the most important factor of survival in patients with transplantation. Based on literary data and their observations, the authors review the factors influencing the progression of recurrent HCV infection. They discuss in details the effect of immunosuppressive therapy, the importance of selecting appropriate immunosuppressive drugs. They review the key points in the diagnosis of recurrent hepatitis C; underline the decisive role of liver biopsy carried out according to protocol in the diagnosis, as well as the hard consultation between specialists of pathology, hepatology and surgery. They demonstrate their observations with the treatment of patients on the waiting list, the results of early pre-emptive treatment of recurrent chronic hepatitis, furthermore treatment modalities and results in patients with histologically proven chronic hepatitis C. The drug of choice for chronic hepatitis C after transplantation is combined therapy with pegylated interferon and ribavirin. This therapy is able to assure sustained virological negativity in 20-50% of patients. In virus-free patients the inflammatory activity in the liver significantly decreases, and the histologic activity index improves. There are data showing a fibrosis-inhibiting effect of the treatment, however, multicentric studies are required for their confirmation. No advantage of early antiviral treatment without histologic alteration has been confirmed by most of the trials. In this group of patients common side effects of the treatment include anaemia and neutropenia, and therefore administration of erythropoietin and granulocyte stimulating factor is recommended. Further research and clinical studies are required in order to establish optimal treatment of patients with recurrent hepatitis C, to determine the dosage of pegylated interferon and ribavirin, to decrease duration of therapy, to reduce side effects and finally to achieve the healing phase in a greater percentage of patients.

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A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients

Cited by 165 publications

References 25 publications

Strategies to reduce hepatitis C virus recurrence after liver transplantation

Strategies to reduce hepatitis C virus recurrence after liver transplantation

Hepatitis C virus epitope-specific neutralizing antibodies in Igs prepared from human plasma

Treatment of recurrent hepatitis C virus infection in patients after liver transplantation

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