Abstract | BACKGROUND: The aim of the study was to compare the efficacy and tolerability of pegylated interferon (PEG-IFN) plus ribavirin (RIB) and PEG-IFN monotherapy after unsuccessful initial therapy with interferon-α2b (IFN) plus RIB after recurrent post- transplantation hepatitis C. METHODS: Twenty-four patients with either no response (n = 10) or relapse (n = 14) after treatment with IFN plus RIB were prospectively randomized in the two treatment arms: 1) PEG-IFN monotherapy at a dosage of 0.8 μg/kg per week (n = 12) and 2) PEG-IFN (0.8 μg/kg per week) plus RIB (800-1200 mg/d) (n = 12). RESULTS: Twenty-one patients (86%) were treated for at least six months. Three patients are still being treated. At the end of therapy, 18 patients (75%) were HCV RNA negative. Five (45%) patients in PEG-IFN and five (50%) in PEG-IFN plus RIB arms had sustained virological response. Two patients (10%) died from recurrent hepatocellular carcinoma. The histologic activity indices significantly improved in both treatment arms. In the PEG-IFN arm, one patient experienced an acute rejection and discontinued therapy. CONCLUSIONS: Both treatment arms showed to be effective, well tolerated and lead to an improvement in histologic outcome. Because of lower rates in side effects and equal outcome, PEG-IFN monotherapy is an adequate option for antiviral re-treatment.
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Authors | Süleyman Yedibela, Resit Demir, Nathaniel Melling, Ünal Aydin, Detlef Schuppan, Volker Müller, Werner Hohenberger, Frank Schönleben |
Journal | Clinical transplantation
(Clin Transplant)
2011 Jan-Feb
Vol. 25
Issue 1
Pg. 131-5
ISSN: 1399-0012 [Electronic] Denmark |
PMID | 20438578
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2010 John Wiley & Sons A/S. |
Chemical References |
- Antiviral Agents
- Interferon alpha-2
- Interferon-alpha
- RNA, Viral
- Recombinant Proteins
- Polyethylene Glycols
- Ribavirin
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Topics |
- Adult
- Antiviral Agents
(therapeutic use)
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Hepacivirus
(genetics, pathogenicity)
- Hepatitis C
(therapy)
- Humans
- Interferon alpha-2
- Interferon-alpha
(therapeutic use)
- Liver Transplantation
- Male
- Middle Aged
- Polyethylene Glycols
(therapeutic use)
- Prospective Studies
- RNA, Viral
(genetics)
- Recombinant Proteins
- Retreatment
- Ribavirin
(therapeutic use)
- Secondary Prevention
- Survival Rate
- Treatment Outcome
- Viral Load
(drug effects)
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