Pa. Sheiner et al., THE EFFICACY OF PROPHYLACTIC INTERFERON-ALPHA-2B IN PREVENTING RECURRENT HEPATITIS-C AFTER LIVER-TRANSPLANTATION, Hepatology, 28(3), 1998, pp. 831-838
Clinical recurrence of hepatitis C after liver transplantation can lea
d to cirrhosis, liver failure, and death. In patients undergoing liver
transplantation for hepatitis C, we assessed the efficacy of interfer
on alfa-2b (IFN) in preventing recurrent hepatitis. We randomized 86 p
atients to either an IFN group (3 MU three times a week starting withi
n 2 weeks after transplantation and continued for 1 year) or a control
(no IFN) group. Recurrence, the primary end point, was diagnosed on b
iopsy performed at 1 year or for abnormal biochemistries. HCV RNA leve
ls were measured by branched-chain DNA (bcDNA) assay and arbitrarily d
efined as low, moderate, or high (<10 x 10(5), 10-100 x 10(5), or >100
x 10(5) Eq/mL, respectively). Data on 30 IFN patients and 41 no-IFN p
atients who survived greater than or equal to 3 months were reviewed.
Mean follow-up was 669 +/- 228 days for IFN patients and 594 +/- 254 d
ays for no-IFN patients. IFN patients were less likely to develop recu
rrent hepatitis (8 IFN vs. 22 no-IFN patients, P =.017, log rank analy
sis). IFN and 1-month HCV RNA level were independent predictors of rec
urrence. IFN reduced the risk of recurrence by a factor of 0.4 (P=.04,
Cox proportional hazards model); HCV RNA level >100 x 105 Eq/mL at 1
month after transplantation increased the risk by a factor of 3.1 (P=.
01), Low moderate, and high viral levels at 1 and 3 months were associ
ated with significantly different rates of recurrence in IFN patients
(P =.05 at 1 month and P =.003 at 3 months) but not in untreated patie
nts (P =.28 at 1 month and P =.25 at 3 months). In patients with two o
r more rejections, the risk of recurrence was increased by a factor of
2.17 (P=.05), On 47 1-year biopsies (24 IFN; 23 no IFN), piecemeal ne
crosis was more common in untreated patients (P <.02). One- and 2-year
patient survival, respectively, was 96% and 96% with IFN and 91.2% an
d 87.2% without (P = NS), Prophylactic IFN reduced the incidence of re
current hepatitis after transplant. Although IFN was most effective in
patients with low HCV RNA levels, we also noted an effect in patients
with moderate levels. IFN did not prevent viremia, suggesting that it
may work through alternative mechanisms.