Clinical trial: peg-interferon alfa-2b and ribavirin for the treatment of genotype-1 hepatitis C recurrence after liver transplantation
Version of Record online: 28 JUN 2008
© 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 28, Issue 4, pages 450–457, August 2008
How to Cite
LODATO, F., BERARDI, S., GRAMENZI, A., MAZZELLA, G., LENZI, M., MORELLI, M. C., TAME, M. R., PISCAGLIA, F., ANDREONE, P., BOLOGNA LIVER TRANSPLANTATION GROUP (BLTG), BALLARDINI, G., BERNARDI, M., BIANCHI, F. B., BISELLI, M., BOLONDI, L., CESCON, M., COLECCHIA, A., D’ERRICO, A., DEL GAUDIO, M., ERCOLANI, G., GRAZI, G. L., GRIGIONI, W., LORENZINI, S., PINNA, A. D., RAVAIOLI, M., RODA, E., SAMA, C. and VIVARELLI, M. (2008), Clinical trial: peg-interferon alfa-2b and ribavirin for the treatment of genotype-1 hepatitis C recurrence after liver transplantation. Alimentary Pharmacology & Therapeutics, 28: 450–457. doi: 10.1111/j.1365-2036.2008.03761.x
- Issue online: 23 JUL 2008
- Version of Record online: 28 JUN 2008
- Publication data Submitted 16 January 2008 First decision 10 February 2008 Resubmitted 6 April 2008 Second decision 29 April 2008 Resubmitted 5 June 2008 Accepted 6 June 2008 Epub Accepted Article 28 June 2008
Background Treatment of hepatitis C virus (HCV) recurrence after liver transplantation (LT) is difficult with low response rates.
Aim To assess the safety and efficacy of pegylated-interferon (PEG-IFN) alfa-2b + ribavirin (RBV) in patients with post-LT recurrent genotype-1 HCV and to establish stopping rules according to response.
Methods Fifty-three patients with post-LT HCV recurrence were enrolled. Patients received PEG-IFN alfa-2b 1.0 μ/kg/week plus RBV 8–10 mg/kg/day for 24 weeks. Those with ‘early virological response at week 24’ (EVR24) continued treatment for 24 weeks (group A). Patients without EVR24 were randomized to continue (group B) or to discontinue (group C).
Results Overall sustained virological response (SVR) was 26% (14/53). Alanine aminotransferase, rapid virological response, EVR12, EVR24, undetectable serum HCV-RNA at weeks 12 (cEVR12) and 24 (cEVR24) were related to SVR. cEVR12 and cEVR24 (OR: 14.7; 95% CI: 2.02–106.4) were independent predictors of SVR. All patients with SVR, had cEVR12. No patient in groups B and C achieved end-of-treatment response. One patient in group B had SVR.
Conclusions Pegylated-interferon alfa-2b was effective in one of four of patients with HCV genotype 1 after LT. Treatment should be discontinued in patients with no virological response at week 12. Further studies are needed to evaluate whether a longer treatment period may be beneficial in patients with ≥2 log10 drop in HCV-RNA at week 24.