A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation
Year: 2012
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: UNLABELLED: 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.
Source: Hepatology
DOI: 10.1002/hep.25976
Institutions: University of Colorado Denver, University of California, San Francisco, University of Michigan, Columbia University Irving Medical Center, Columbia University, University of California, Los Angeles, Virginia Commonwealth University, University of Virginia, Northwestern University, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Adult-to-Adult Living Donor Liver Transplantation Study Data Coordinating Center, G1433264716, Living Donor Liver Transplant :Short & Long-Term Impact on Donors and Recipients, G2418409112, General Clinical Research Center, G3732980780, Adult to Adult Living Donor Liver Transplantation Cohort Study, G4475632246, G4666963181, G4864599442, Adult to Adult Living Donor Liver Transplantation, G5638158834, G6485789737, G6533405083, G6605201205, G673218189, G6736743890, G8224452681, G8384303206, G8651806682, G8885385322, UCSF Liver Center
OpenAlex ID: W2121781429