Aim:
To determine SVR rates among Peg2a/2b (n=820) and alfa-interferon (n=1203) Non Responder's (NRs) retreated with P/R and to evaluate predictors of SVR. Methods: NRs or those who relapsed after previous I/R treatment and had Metavir F2-F4 fibrosis received PegIntron 1.5 microgram/kg/wk plus Rebetol 800-1400 mg/d for up to 48 weeks. Plasma HCV-RNA was assessed at treatment weeks (TW)12, 24, and 48 and follow-up weeks 12 and 24 by quantitative Taq-Man assay (SPRI; sensitivity 125 IU/mL).
Results
Overall (full cohort) SVR rate was 22%. The likelihood of achieving SVR was greatly influenced by subject’s baseline characteristics. Generally, prior relapsers responded better than NRs (38% vs. 14%). However, genotype, degree of fibrosis, and prior treatment received were also important factors predictive of SVR; G2/3 subjects responded better than G1 subjects regardless of prior response.
Undetectable HCV-RNA at TW12 remained the most important predictor of SVR: 56% of subjects with undetectable HCV-RNA at TW12 achieved SVR vs 5% with a =2-log decrease in, yet detectable, HCV-RNA. Among subjects with undetectable HCV-RNA at TW12, the only significant predictors of SVR were genotype and fibrosis.
Conclusions:
Genotype is the most predictive factor for SVR upon retreatment of subjects who failed previous treatment with I/R. G2/3 subjects respond better than G1 subjects, independent of prior treatment received and prior response. Across genotypes, fibrosis is also an important predictor of response.
T. Poynard1, E. Schiff2, R. Terg3, R. Moreno Otero4, S. Flamm5, W. Schmidt6, T. Berg7, F. Goncales Jr.8, J. Heathcote9, M. Diago10, T. McGarrity11, P. Bedossa12, W. Deng13, P. Mukhopadhyay13, L. Griffel13, M. Burroughs13, C. Brass13, J.K. Albrecht13
1 Groupe Hospitalier Pitié-Salpêtrière, Paris, France;
2 University Of Miami School Of Medicine, Miami, Florida, USA;
3 Hospital Municipal De Gastroenterologia Dr Bonorino Udaondo, Capital Federal, Argentina;
4 Hospital Universitario De La Princesa, Madrid, Spain;
5 Northwestern University, Chicago, Illinois, USA;
6 University Of Iowa Hospitals And Clinics, Iowa City, Iowa, USA;
7 Universitatsklnik Charite, Campus Virchow Klinikum, Berlin, Germany;
8 Hospital Das Clinicas Da Unicamp Cidade Universitaria Zefirina Vaz, Campinas, Brazil;
9 University Health Network, Toronto, Ontario, Canada;
10 Hospital General Universitario De Valencia, Valencia, Spain, 11_Milton S. Hershey Medical Center, Hershey, PA USA, 12_Hopital Beaujon, Clichy, France, 13_Schering-Plough Research Institute, Kenilworth, New Jersey, USA
