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Combination of interferon alfa-2b and ribavirin in liver transplant recipients with histological recurrent hepatitis C.

Abstract
Recurrent hepatitis C virus (HCV) infection is an important cause of fibrosis and cirrhosis after liver transplantation (LT), with histological recurrence developing in at least 50% of patients within the first year. The aim of this study is to assess the safety and efficacy of interferon alfa-2b plus ribavirin in treating histological recurrent HCV after LT. Since 1998, patients with HCV with significant histological recurrence (fibrosis >/= 3 and/or histological activity index >/= 5) or progressive cholestatic disease after LT were treated with interferon alfa-2b (3 million units subcutaneously three times weekly) plus ribavirin (800 to 1,000 mg/d) for 12 months. Immunosuppression was tapered to cyclosporine/FK506 monotherapy. HCV RNA was assessed at entry, week 24, end of treatment, and 6 months after therapy. The primary end point was loss of HCV RNA 6 months after therapy, whereas the secondary end point was histological response. Fifty-four patients met criteria for treatment and have completed follow-up. Patients were mainly men (71% men; mean age, 51 +/- 5 years) with genotype 1 infection (88%) and high viral load (mean HCV RNA, 38 +/- 9 mEq/mL). Dose modification was required in 72% of patients because of cytopenia or side effects. Intent-to-treat analysis showed that serum HCV RNA was undetectable in 19 patients (35%) week 24, 21 patients (38%) week 48, and 16 patients (30%) at the 6-month follow-up. Paired liver biopsy results (before and within 6 months after treatment) were available for 35 patients. Patients who achieved viral eradication had no significant progression of fibrosis after 1 year of therapy. In summary, combination therapy is a reasonable antiviral option for recurrent HCV infection for established post-LT hepatitis and appears to prevent histological progression of disease if viral eradication is successful.
AuthorsRoberto J Firpi, Manal F Abdelmalek, Consuelo Soldevila-Pico, Alan Reed, Alan Hemming, Richard Howard, William Van Der Werf, Gregory Lauwers, Chen Liu, James M Crawford, Gary L Davis, David R Nelson
JournalLiver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society (Liver Transpl) Vol. 8 Issue 11 Pg. 1000-6 (Nov 2002) ISSN: 1527-6465 [Print] United States
PMID12424712 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article)
Chemical References
  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • Ribavirin
  • Alanine Transaminase
Topics
  • Adult
  • Alanine Transaminase (blood)
  • Antiviral Agents (adverse effects, therapeutic use)
  • Drug Therapy, Combination
  • Female
  • Graft Rejection (epidemiology)
  • Hepacivirus (genetics)
  • Hepatitis C (drug therapy, enzymology, surgery, virology)
  • Humans
  • Incidence
  • Interferon alpha-2
  • Interferon-alpha (adverse effects, therapeutic use)
  • Liver (metabolism, pathology)
  • Liver Transplantation
  • Male
  • Middle Aged
  • RNA, Viral (metabolism)
  • Recombinant Proteins
  • Recurrence
  • Ribavirin (adverse effects, therapeutic use)

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