Journal
HEPATOLOGY
Volume 57, Issue 5, Pages 1752-1762Publisher
WILEY
DOI: 10.1002/hep.25976
Keywords
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Categories
Funding
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [U01-DK62536, U01-DK62444, U01-DK62467, U01-DK62483, U01-DK62484, U01-DK62494, U01-DK62496, U01-DK62498, U01-DK62505, U01-DK62531]
- Schering-Plough
- NIH-NIDDK
- Ortho-Biotech
- NIDDKD
- Health Resources and Services Administration
- American Society of Transplant Surgeons
- Merck
- Roche
- Genentech
- Vertex
- Idenix
- Novartis
- Gilead
- Valeant
- Intermune
- Pharmasset
- HemoLife Medical
- Genzyme
- Ortho Biotech
- GalxoSMithKline
- Sanofi-Aventis
- Bayer Healthcare
- Hyperion
- Bristol-Myers Squibb
- Vital
- Octapharma
- Achillion
- Boehringer-Ingelheim
- Globeimmune
- Inhibitex
- Zymogenetics
- Conatus
- Anandys
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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-alpha 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-alpha 2b, starting at 0.75 mu 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). Conclusion: Pretransplant treatment with Peg-IFN-alpha 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. (HEPATOLOGY 2013;57:1752-1762)
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