icon-folder.gif   Conference Reports for NATAP  
  AASLD (American Association for the Study of Liver Diseases)
Nov 2-5, 2002, Boston, MA
Back grey_arrow_rt.gif
Hard to Treat Patients: African Americans and previous nonresponders
Reported by Jules Levin
  In tody's lunch meeting on African-Americans, Lennox Jeffers talked about his study of 106 patients randomized to receive pegasys plus ribavirin where 78 are non-Hispanic African-Americans and 22 are non-Hispanic caucasians. At the end of 48 weeks of treatment 32% (18/57) had undetectable viral load (<50 IU/ml) and 46% (26/57) had 2 log or greater viral load drop in viral load. For caucasians 52% (13/25) had undetectable viral load and 60% had 2 log or greater viral load drop. In a study at Duke University in about 100 African-Americans receiving PegIntron plus ribavirin 25% had undetectable viral load at week 24. In the RENEW study reported on here previous nonresponders to interferon plus ribavirin were randomized to 1 year of retreatment with PegIntron 0.5 , 1.5, or 3.0 mcg/kg/week each with ribavirin 12-15 mg/kg/day. Treatment doses are reduced by 33% if necessary. 800 patients are being enrolled but after week among 195 that have been enrolled HCV RNA was undetectable in 235 of patients receiving 0.5 PegIntron, 39% receiving 1.5 dose, and 53% receiving 3.0 PegIntron dose. These are preliminary data but so far The rate of response appears to be related to dose and high dose of PegIntron 3.0 mcg/kg/week is yielding better responses. Dose reduction occurred in 22/132 in the 0.5 dose group, 24/213 in the 1.5 group, and 33/213 in the 3.0 group showing not much difference. Discontinuation rates were also similar. Regarding discontinuation just for adverse event 5 in the 1.5 and 9 in the 3.0 group discontinued. We need to wait for more data but raising peginterferon dose presents another possible option for dealing with nonresponders and other hard to treat patients.