Background and Aims
Hepatitis C virus (HCV)‐viremic organs are underutilized, and there is limited real‐world experience on the transplantation of HCV‐viremic solid organs into recipients who are HCV negative.
Approach and Results
Patients listed or being evaluated for solid organ transplant after January 26, 2018, were educated and consented by protocol on the transplantation of HCV‐viremic organs. All recipients were HCV nucleic acid test and anti‐HCV antibody negative at the time of transplant and received an HCV‐viremic organ. The primary outcome was sustained virological response (SVR) at 12 weeks after completion of direct‐acting antiviral (DAA) therapy (SVR12). Seventy‐seven patients who were HCV negative underwent solid organ transplantation from a donor who was HCV viremic. No patients had evidence of advanced hepatic fibrosis. Treatment regimen and duration were at the discretion of the hepatologist. Sixty‐four patients underwent kidney transplant (KT), and 58 KT recipients had either started or completed DAA therapy. Forty‐one achieved SVR12, 10 had undetectable viral loads but are not eligible for SVR12, and 7 remain on treatment. One KT recipient was a nonresponder because of nonstructural protein 5A resistance. Four patients underwent liver transplant and 2 underwent liver‐kidney transplant. Three patients achieved SVR12, 1 has completed DAA therapy, and 2 remain on treatment. Six patients underwent heart transplant and 1 underwent heart‐kidney transplant. Six patients achieved SVR12 and 1 patient remains on treatment.
Conclusions
Limited data exist on the transplantation of HCV‐viremic organs into recipients who are HCV negative. Our study is the largest to describe a real‐world experience of the transplantation of HCV‐viremic organs into recipients who are aviremic. In carefully selected patients, the use of HCV‐viremic grafts in the DAA era appears to be efficacious and well tolerated.
Recurrence of hepatitis C virus (HCV) infection after orthotopic liver transplantation is a major cause of graft failure. The aim of our study was to determine the safety, efficacy, and tolerability of combination therapy with interferon and ribavirin in the treatment of recurrent hepatitis after liver transplantation. Twenty-six patients (18 men) with histologically established HCV recurrence after liver transplantation for cirrhosis secondary to chronic HCV infection were treated with a combination of interferon alfa-2b (3 million units three times weekly) and ribavirin (800 to 1,000 mg/d). Dosage modifications were according to a standard protocol incorporating laboratory values and clinical side effects. Fifty percent of patients completed 1 year or more of therapy. On an intention-totreat basis, nine patients (35%) showed an end-of-treatment virological response. Six of these nine patients completed greater than 6 additional months of follow-up, and all have had sustained virological responses. A histological response (decrease in histological activity index 2 2) was seen in 75% of virological responders and 67% of nonresponders. Adverse events requiring dose modification or cessation of therapy occurred in 66% of patients. Adjuvant therapies used to support hemoglobin levels included erythropoietin and red blood cell transfusions. There were no independent pretreatment predictors of a virological response, perhaps because of the small sample size. Combination therapy with interferon and ribavirin may be beneficial in patients with recurrent HCV after liver transplantation. The majority of patients require dose modifications because of side effects. Histological response is common in virological nonresponders. Unfortunately, the plethora of robust data in the nontransplantation setting is not available in transplant recipients. Although the number and size of studies are small, studies that reported the efficacy of nonpegylated interferon alfa have ribavirin combination therapy in the treatment of posttransplantation HCV infection suggest that the overall efficacy of these agents is broadly similar to that in the nontransplantation setting, with end-of-treatment virological response rates varying between 15% and 50%. [15][16][17][18][19][20] Reversal of fibrosing cholestatic posttransplantation HCV infection, although reported,21,20 appears to be unusual. 22 We designed a protocol to determine the efficacy and tolerability of posttransplantation interferon and ribavirin therapy initiated on histological documentation of recurrence of HCV infection.
Methods
Study PopulationAll patients who underwent transplantation for end-stage liver disease secondary t o H C V infection were eligible for combination antiviral therapy with interferon and ribavirin.
Patients with indeterminate total AFP values of 10-200 ng/mL present a diagnostic dilemma. We found that an AFP-L3% greater than 35% has 100% specificity for HCC in these patients. AFP-L3%, used in combination with AFP, may be a clinically useful adjunct marker for the diagnosis of HCC.
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