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PubMed ID:
22821361
Public Release Type:
Journal
Publication Year: 2013
Affiliation: Section of Hepatology, University of Colorado Denver, Aurora, CO, USA. greg.everson@UCDenver.edu
DOI:
https://doi.org/10.1002/hep.25976
Authors:
Lassiter A,
Hoffman C,
Shiffman M,
Everhart JE,
Sherker A,
Hoofnagle JH,
Brown RS Jr,
Ashworth A,
Busuttil RW,
Mooney J,
Saab S,
Freise CE,
Terrault NA,
MacLeod D,
Merion RM,
Lok AS,
Ojo AO,
Gillespie BW,
Howell MH,
Holloway L,
Arrington CJ,
Golden B,
Lowe M,
Smith A,
Hayashi PH,
Russell T,
Berg CL,
Davis J,
Green C,
Al-Osaimi AM,
Fisher RA,
Stravitz R,
Hong JC,
Herman A,
Kam I,
Everson GT,
Shaw M,
Conboy B,
Olthoff KM,
Shaked A,
Al-Saden P,
Kulik LM,
Abecassis MM,
Heese S,
Emond JC,
Adult-to-Adult Living Donor Liver Transplantation Cohort Study,
Everhart JE,
Gillespie BW,
Kulik LM,
Al-Osaimi AM,
Shiffman ML,
Saab S,
Brown RS Jr,
Rodrigo del R,
Lok AS,
Terrault NA,
Everson GT
Studies:
Adult Living Donor Liver Transplantation Studies
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).
