A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis c after liver transplantation
Everson GT et al. – Pretransplant treatment with PEGIFN/RBV prevents post–transplant recurrence of HCV in selected patients. Efficacy is higher with o16 weeks of treatment, but treatment is associated with increased risk of potentially serious complications.
- Enrollees had HCV and were listed for liver transplantation, with either potential living donors or MELD 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. PEGIFN alfa–2b, starting at 0.75 μg/kg/wk, and ribavirin (RBV), starting at 600 mg/d, were escalated as tolerated.
- Patients assigned to treatment versus control had similar baseline characteristics. Combined virologic response (CVR) included pre–transplant sustained VR (SVR12) and post–transplant VR (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, 23/30 received transplant of whom 22% had pTVR; among treated G2/3 patients 21/29 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% vs. 55%, p=0.30) but the number of SAEs per patient was higher in the treated group (2.7 vs. 1.3, p=0.003).