Improved Inflammatory Activity With Low-Dose PegIntron

Improved Inflammatory Activity With Low-Dose PegIntron (PEG) Maintenance Therapy in Prior Nonresponders With METAVIR Fibrosis Scores (MFS) of F2/F3: Final Results From the EPIC3 Program - see attached fulk poster report



Reported by Jules Levin,
EASL Apr 14-18 2010 Vienna Austria

T. Poynard,1 J. Bruix,2 E. Schiff,3 M. Diago,4 T. Berg,5 R. Moreno-Otero,6 L. G. Lyra,7 F. Carrilho,8 L. H. Griffel,9 N. Boparai,10 M. Burroughs,10 C. A. Brass,10 and J. K. Albrecht10

1Service d’Hepato-Gastroenterologie, APHP-UPMC Liver Center, Paris, France; 2Centro de Investigación Biomédica en Red de Enfermedades Hepaticas y Digestivas, Liver Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain; 3University of Miami School of Medicine, Miami, Florida, U.S.A.; 4Hospital General Universitario de Valencia, Valencia, Spain; 5Klinik und Poliklinik für Gastroenterologie & Rheumatologie, Sektion Hepatologie, Universitätsklinikum Leipzig, Leipzig, Germany; 6Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepaticas y Digestivas (Instituto de Salud Carlos III), Madrid, Spain; 7Hospital Sao Rafael, Salvador, Brazil; 8Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, Brazil; 9Former employee of Schering-Plough Corporation, now Merck & Co., Inc., Whitehouse Station, New Jersey, U.S.A.; 10Schering-Plough Corporation, now Merck & Co., Inc., Whitehouse Station, New Jersey, U.S.A.



AUTHOR SUMMARY

• In the primary analysis, low-dose PEG-IFN alfa-2b did not significantly improve fibrosis response among patients with METAVIR F2 and F3 compared with the Observed group

• Significantly more patients receiving PEG-IFN alfa-2b had improvement in METAVIR activity score compared with patients in the Observed group

• In the subgroup of patients treated for >2.5 years, both METAVIR fibrosis and activity scores trended toward improvement

— 21% of PEG-IFN alfa-2b recipients and 14% of Observed patients had ≥1-unit improvement in METAVIR fibrosis score

— 26% of PEG-IFN alfa-2b recipients and 10% of Observed patients had ≥1-unit improvement in METAVIR activity score

• The possibility that carry-over effects from full-dose PEG-IFN alfa-2b plus weight-based ribavirin may have obscured maintenance therapy treatment effects cannot be excluded



Author Conclusion

• These data suggest that PEG-IFN alfa-2b decreases hepatic inflammation, but impact on METAVIR fibrosis score could not be demonstrated in the 3 years of maintenance therapy that followed ~18 weeks of full-dose PEG-IFN alfa-2b therapy plus weight-based ribavirin. For those patients with HCV with significant hepatic fibrosis who are unable to clear virus, therapies to slow or reverse

the march toward cirrhosis are still needed. It remains undefined whether longer periods of low-dose PEG-IFN alfa-2b therapy would extend the trend toward improvement in fibrosis observed in patients treated for >2.5 years