The ALT increases at 1.5 microg/kg were most likely due to dosing. Liver toxicity also shows up at the highest dose of 3 micrg/kg, but can be resolved by decreasing the dose. Yes, it is likely to pop back up in larger studies. but the concern is lessening as data rolls out.
from the ZGEN presentation:
Grade 3/4 events occurred in 3 subjects
2 treated at 1.5 microg/kg QW + ribavirin
• Grade 3 hepatotoxicity and increased serum lipase/amyalse without
signs of pancreatitis, probably related to PEG-IFN-lambda;
– Occurred after dosing in violation of protocol (DLT criteria met)
• Grade 4 adverse drug reaction to meperidine (ARDS) in a subject with
history of migraine headaches and COPT, unrelated to PEG-IFN-lambda;
In addition:
6 of 56 (11%) subjects experienced increases in ALT/AST that met protocol-defined criteria for DLT or withholding a PEG-IFN-lambda dose
Phase 1b protocol did not allow for dose reduction
Reversible after study drug discontinuation
I will also add that in healthy patients DL liver toxicity was seen at 7.5 microg/kg. Suggesting that HCV patients have fragile livers....duh!
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