Unknown

Dataset Information

0

A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation.


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-?2b/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-?2b, starting at 0.75 ?g/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).Pretransplant treatment with Peg-IFN-?2b/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.

SUBMITTER: Everson GT 

PROVIDER: S-EPMC3510348 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

altmetric image

Publications

A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation.

Everson Gregory T GT   Terrault Norah A NA   Lok Anna S AS   Rodrigo Del R del R   Brown Robert S RS   Saab Sammy S   Shiffman Mitchell L ML   Al-Osaimi Abdullah M S AM   Kulik Laura M LM   Gillespie Brenda W BW   Everhart James E JE  

Hepatology (Baltimore, Md.) 20130117 5


<h4>Unlabelled</h4>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. Patien  ...[more]

Similar Datasets

| S-EPMC7590751 | biostudies-literature
| S-EPMC3664282 | biostudies-other
| S-EPMC7889372 | biostudies-literature
| S-EPMC4394366 | biostudies-literature
| S-EPMC7689804 | biostudies-literature
| S-EPMC2500252 | biostudies-literature
| S-EPMC4125198 | biostudies-literature
| S-EPMC3243106 | biostudies-literature
| S-EPMC4110555 | biostudies-literature
2010-08-17 | E-GEOD-14700 | biostudies-arrayexpress