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Post# of 253533
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Re: DewDiligence post# 210864

Tuesday, 04/25/2017 5:45:21 PM

Tuesday, April 25, 2017 5:45:21 PM

Post# of 253533
> what you mean by "the original fibrosis/cirrhosis argument."
> reluctant to treat non-cirrhotic patients who have advanced fibrosis using a regimen that hasn't been shown to work in cirrhotic patients

Yes! That was my (unspoken) hypothesis.

To go into more detail: We do not know yet, how efficient the JNJ/ACHN's regimen will be in cirrhotic patients. But we know a) they need all 3 drugs and b) the dosis appears to be already "maxed out" and cannot be increased (except in terms of duration of treatment) due to safety concerns*.

As well, if I see correctly, cirrhotic patients are mentioned in this new trial only and they will be treated probably only contingent on the non-cirrhotic results (cf. description: "Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 8 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).", source https://clinicaltrials.gov/ct2/show/NCT02993250)

Well, this will be the interesting aspect to look at later smile



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