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Hard to Treat Patients: African Americans and previous nonresponders
Reported by Jules Levin
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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.
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