trail NCT01359644 for protease failures. News??

[Cheesegrater]

Back in March-April arms were added to the trial NCT01359644 (PS-7977 / BMS-790052) for protease experienced patients who failed treatment with telaprevir or boceprevir. The new ubjects were split to 2 arms, one 7977-790052 and the other 7977-790052-Ribaviri.  Initially the treatment length was for 12 weeks, but it seems this was extended to 24 weeks.   Patients were being accepted  may 2012, possibly earlier.  I would have thought there would have been some mention of this in the AASLD 2012, but I have not heard anything of it.

Has anyone seen interim results from this study for these two arms (previous protease failures)?

Cheese

[Willy50]

I don't have a firm start date on this trial, but I see there is a person who just finished the 24 hour arm who just got a SVR4.  This means an "official" SVR12 is still a few months away.

Factor in that these types of results are sometimes saved for liver conferences and one may not see results until even later.

At times companies will give out preliminary results, so one does not know when one will see the results revealed, even if they are preliminary or incomplete results.

I will note that Gilead's new trial w/ 7977 and 5885 has started and the trial has BOTH 12 and 24 week trial arms, with and without riba.

I believe that they already know the answer, but that they need to provide some additional numbers to the FDA to prove safety and efficacy of the new all oral combination.

FWIW.....they intend to start an 8 week trial of the same to see if people can be treated successfully in even less time.  They claim that trial will start before the end of this year.
http://clinicaltrials.gov/ct2/show/NCT01726517?term=Sofosbuvir%2C+5885%2C+8+weeks&rank=2

willy

[HectorSF]

You are correct. Thanks.

I'm surprised they didn't change the Inclusion Criteria to reflect the change.
If I see anything on the trial I will let you know.

Take care
Hector

[Cheesegrater]

Hector,
You have the correct study but you are missing some prime info.

Re-read the trial arm description in the post at clinical trials.
Arm I and arm J are for Nulls and Protease experienced. These arms got added later.
We should be hearing about these patients soon, and I had expected to hear interim data at least at AASLD.

[HectorSF]

According to www.clinicltrials.og The NCT01359644 study is ongoing, but not recruiting participants..
There is no data available, so there is nothing to mention at AASLD.

"The purpose of the study is to determine whether therapy with the combination of PSI-7977 and BMS-790052 with or without Ribavirin is effective in treating Hepatitis C infection when given for 12 or 24 weeks as measured by sustained virologic response (SVR) with undetectable HCV RNA 12 weeks post treatment."

It is a trial for Treatment Naive patients ONLY. NOT for peg-INF, Ribavirin or protease experienced patients who failed treatment with telaprevir or boceprevir.

"HCV-Infected Genotype 1, 2 or 3 subjects who have no previous exposure to an interferon formulation [ie interferon-alfa (IFNα), pegylated interferon-alfa (pegIFNα)], Ribavirin (RBV); or other HCV-specific direct acting antiviral (including BMS-790052 and PSI-7977)."

Here is the link.
http://www.clinicaltrials.gov/ct2/show/NCT01359644?term=NCT01359644&rank=1

Cheers!
Hector