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dangerM

04/25/17 5:45 PM

#210865 RE: DewDiligence #210864

> 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 :-)



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