Inadequate data are available about re-treatment of nonresponders to interferon (IFN) and ribavirin. Thus, this study, conducted at La Sapienza University, Rome, Italy, evaluated the efficacy and tolerability of a 48-week therapy with pegylated IFN alfa-2b (PegIntron) plus high-dose ribavirin in patients who have failed to respond to the combination.

Treatment up to 48 weeks was also evaluated in patients who have failed to clear hepatitis C virus (HCV) RNA by week 24.

One hundred forty-one patients who previously did not respond to IFN and ribavirin, 86% with genotype 1 or 4 infection, 52% with high viral load (>800.000 IU/mL), 22% with cirrhosis, were retreated with pegylated IFN-alpha-2b 1.5 microgram/kg per week and ribavirin 1000-1200 mg/day for 48 weeks and followed up for 24 weeks.

Results

• By intent-to-treat analysis, 20% of patients achieved a sustained virologic response (SVR).
• SVR of genotype 1 patients was 19%.
• Independent predictors of SVR were low gamma-glutamyltransferase levels and low viral load.
• Twelve (23%) out of 51 patients who were HCV RNA positive after 24 weeks of therapy achieved a late virologic response (after week 24) and 5 (10%) of them, all with genotype 1, achieved an SVR.
• Genotype was not associated with response (P = .2) or with early response (P = .3).

The authors conclude, “Retreatment with pegylated IFN-alpha-2b and ribavirin of multi-experienced and "difficult to treat" nonresponder patients produced a very promising SVR. Accurate selection of patients, such as those with low viral load and low gamma-glutamyltransferase levels, and prolongation of therapy beyond 24 weeks also in HCV RNA-positive patients may further increase the rate of SVR.”

05/23/06

Reference

HIV and Hepatitis.com

FDA-approved Monotherapies for HCV

Intron A Roferon Infergen Pegasys PEG-Intron

FDA-approved Combination Therapies for HCV

Pegasys + Copegus PEG-Intron + Rebetol Intron A + Rebetol Roferon A + Ribavirin