A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation
dc.contributor.author | Everson, Gregory T. | en_US |
dc.contributor.author | Terrault, Norah A. | en_US |
dc.contributor.author | Lok, Anna S. | en_US |
dc.contributor.author | Rodrigo, Del R. | en_US |
dc.contributor.author | Brown, Robert S. | en_US |
dc.contributor.author | Saab, Sammy | en_US |
dc.contributor.author | Shiffman, Mitchell L. | en_US |
dc.contributor.author | Al‐osaimi, Abdullah M.s. | en_US |
dc.contributor.author | Kulik, Laura M. | en_US |
dc.contributor.author | Gillespie, Brenda W. | en_US |
dc.contributor.author | Everhart, James E. | en_US |
dc.date.accessioned | 2013-05-02T19:35:06Z | |
dc.date.available | 2014-07-01T15:53:31Z | en_US |
dc.date.issued | 2013-05 | en_US |
dc.identifier.citation | Everson, Gregory T.; Terrault, Norah A.; Lok, Anna S.; Rodrigo, Del R.; Brown, Robert S.; Saab, Sammy; Shiffman, Mitchell L.; Al‐osaimi, Abdullah M.s. ; Kulik, Laura M.; Gillespie, Brenda W.; Everhart, James E. (2013). "A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation ." Hepatology 57(5): 1752-1762. <http://hdl.handle.net/2027.42/97469> | en_US |
dc.identifier.issn | 0270-9139 | en_US |
dc.identifier.issn | 1527-3350 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/97469 | |
dc.description.abstract | Hepatitis C virus (HCV) infection recurs in liver recipients who are viremic at transplantation. We conducted a randomized, controlled trial to test the efficacy and safety of pretransplant pegylated interferon alpha‐2b plus ribavirin (Peg‐IFN‐α2b/RBV) for prevention of post‐transplant HCV recurrence. Enrollees had HCV and were listed for liver transplantation, with either potential living donors or Model for End‐Stage Liver Disease upgrade for hepatocellular carcinoma. Patients with HCV genotypes (G) 1/4/6 (n = 44/2/1) were randomized 2:1 to treatment (n = 31) or untreated control (n = 16); HCV G2/3 (n=32) were assigned to treatment. Overall, 59 were treated and 20 were not. Peg‐IFN‐α2b, starting at 0.75 μg/kg/week, and RBV, starting at 600 mg/day, were escalated as tolerated. Patients assigned to treatment versus control had similar baseline characteristics. Combined virologic response (CVR) included pretransplant sustained virologic response and post‐transplant virologic response (pTVR), defined as undetectable HCV RNA 12 weeks after end of treatment or transplant, respectively. In intent‐to‐treat analyses, 12 (19%) assigned to treatment and 1 (6%) assigned to control achieved CVR ( P = 0.29); per‐protocol values were 13 (22%) and 0 (0%) ( P = 0.03). Among treated G1/4/6 patients, 23 of 30 received transplant, of whom 22% had pTVR; among treated G2/3 patients 21 of 29 received transplant, of whom 29% had pTVR. pTVR was 0%, 18%, and 50% in patients treated for <8, 8‐16, and >16 weeks, respectively ( P = 0.01). Serious adverse events (SAEs) occurred with similar frequency in treated versus untreated patients (68% versus 55%; P = 0.30), but the number of SAEs per patient was higher in the treated group (2.7 versus 1.3; P = 0.003). Conclusion : Pretransplant treatment with Peg‐IFN‐α2b/RBV prevents post‐transplant recurrence of HCV in selected patients. Efficacy is higher with >16 weeks of treatment, but treatment is associated with increased risk of potentially serious complications. (H EPATOLOGY 2013) | en_US |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.title | A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Internal Medicine and Specialties | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | Department of Internal Medicine, University of Michigan, Ann Arbor, MI | en_US |
dc.contributor.affiliationum | Department of Surgery, University of Michigan, Ann Arbor, MI | en_US |
dc.contributor.affiliationum | Department of Biostatistics, University of Michigan, Ann Arbor, MI | en_US |
dc.contributor.affiliationother | Department of Medicine and Surgery, Northwestern University, Chicago, IL | en_US |
dc.contributor.affiliationother | Section of Hepatology, University of Colorado Denver, Aurora, CO | en_US |
dc.contributor.affiliationother | Division of Gastroenterology, University of California, San Francisco, CA | en_US |
dc.contributor.affiliationother | Department of Medicine and Surgery, Columbia University College of Physicians and Surgeons, New York, NY | en_US |
dc.contributor.affiliationother | Department of Medicine and Surgery, University of California, Los Angeles, CA | en_US |
dc.contributor.affiliationother | Department of Medicine, Virginia Commonwealth University, Richmond, VA | en_US |
dc.contributor.affiliationother | Department of Medicine, University of Virginia, Charlottesville, VA | en_US |
dc.contributor.affiliationother | Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD | en_US |
dc.contributor.affiliationother | Section of Hepatology, University of Colorado Denver, 1635 North Aurora Court, B‐154, Aurora, CO 80045 | en_US |
dc.identifier.pmid | 22821361 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/97469/1/25976_ftp.pdf | |
dc.identifier.doi | 10.1002/hep.25976 | en_US |
dc.identifier.source | Hepatology | en_US |
dc.identifier.citedreference | Shiffman ML, Ghany MG, Morgan TR, Wright EC, Everson GT, Lindsay KL, et al. Impact of reducing peginterferon alfa‐2a and ribavirin dose during retreatment in patients with chronic hepatitis C. Gastroenterology 2007; 132: 103 ‐ 112. | en_US |
dc.identifier.citedreference | Gillespie BW, Chen Q, Reichert H, Franzblau A, Hedgeman E, Lepkowski J, et al. Estimating population distributions when some data are below a limit of detection by using a reverse Kaplan‐Meier estimator. Epidemiology 2010; 21 ( Suppl 4 ): S64 ‐ S70. | en_US |
dc.identifier.citedreference | Carrion JA, Martinez‐Bauer E, Crespo G, Ramirez S, Perez‐del‐Pulgar S, Garcia‐Valdecasas JC, et al. Antiviral therapy increases the risk of bacterial infections in HCV‐infected cirrhotic patients awaiting liver transplantation: a retrospective study. J Hepatol 2009; 50: 719 ‐ 728. | en_US |
dc.identifier.citedreference | Thomas RM, Brems JJ, Guzman‐Hartman G, Yong S, Cavaliere P, Van Thiel DH. Infection with chronic hepatitis C virus and liver transplantation: a role for interferon therapy before transplantation. Liver Transpl 2003; 9: 905 ‐ 915. | en_US |
dc.identifier.citedreference | Forns X, Garcia‐Retortillo M, Serrano T, Feliu A, Suarez F, de la Mata M, et al. Antiviral therapy of patients with decompensated cirrhosis to prevent recurrence of hepatitis C after liver transplantation. J Hepatol 2003; 39: 389 ‐ 396. | en_US |
dc.identifier.citedreference | Crippin JS, McCashland T, Terrault N, Sheiner P, Charlton MR. A pilot study of the tolerability and efficacy of antiviral therapy in hepatitis C virus‐infected patients awaiting liver transplantation. Liver Transpl 2002; 8: 350 ‐ 355. | en_US |
dc.identifier.citedreference | Sulkowski MS, Shiffman ML, Afdahl NH, Reddy KR, McCone J, Lee WM, et al. Hepatitis C virus treatment‐related anemia is associated with higher sustained virologic response rate. Gastroenterology 2010; 139: 1602 ‐ 1611. | en_US |
dc.identifier.citedreference | Everson GT, Trotter J, Forman L, Kugelmas M, Halprin A, Fey B, Ray C. Treatment of advanced hepatitis C with a low accelerating dosage regimen of antiviral therapy. HEPATOLOGY 2005; 42: 255 ‐ 262. | en_US |
dc.identifier.citedreference | Poynard T, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, et al. Peginterferon alfa‐2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. Gastroenterology 2009; 136: 1618 ‐ 1628. | en_US |
dc.identifier.citedreference | Everson GT, Hoefs JC, Seeff LB, Bonkovsky HL, Naishadham D, Shiffman ML, et al. Impact of disease severity on outcome of antiviral therapy for chronic hepatitis C: lessons from the HALT‐C trial. HEPATOLOGY 2006; 44: 1675 ‐ 1684. | en_US |
dc.identifier.citedreference | Shiffman ML, Di Bisceglie AM, Lindsay KL, Morishima C, Wright EC, Everson GT, et al. Peginterferon alfa‐2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology 2004; 126: 1015 ‐ 1023. | en_US |
dc.identifier.citedreference | Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management and treatment of hepatitis C: an update. HEPATOLOGY 2009; 49: 1335 ‐ 1374. | en_US |
dc.identifier.citedreference | Wiesner RH, Sorrell M, Villamil F; and the International Liver Transplantation Society Expert Panel. Report of the first international liver transplantation society expert panel consensus conference on liver transplantation and hepatitis C. Liver Transpl 2003; 9 ( Suppl ): S1 ‐ S9. | en_US |
dc.identifier.citedreference | Hadziyannis SJ, Sette H, Jr., Morgan TR, Balan V, Diago M, Marcellin P, et al. Peginterferon alfa‐2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004; 140: 346 ‐ 355. | en_US |
dc.identifier.citedreference | Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. Peginterferon alfa‐2b plus ribavirin compared with interferon alfa‐2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358: 958 ‐ 965. | en_US |
dc.identifier.citedreference | Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL, Jr., et al. Peginterferon alfa‐2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002; 347: 975 ‐ 982. | en_US |
dc.identifier.citedreference | Charlton M, Wiesner R. Natural history and management of hepatitis C infection after liver transplantation. Semin Liver Dis 2004; 24 ( Suppl ): S79 ‐ S88. | en_US |
dc.identifier.citedreference | Berenguer M. What determines the natural history of recurrent hepatitis C after liver transplantation? J Hepatol 2005; 42: 448 ‐ 456. | en_US |
dc.identifier.citedreference | Forman LM, Lewis JD, Berlin JA, Feldman HI, Lucey MR. The association between hepatitis C infection and survival after orthotopic liver transplantation. Gastroenterology 2002; 122: 889 ‐ 896. | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
Files in this item
Remediation of Harmful Language
The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.
Accessibility
If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.