New All Oral Phase II Trial Coming

[curiouslady1]

PSI-7977 Polymerase Inhibitor  PSI-938 Polymerase Inhibitor  Pharmasset Aug 23, 2011
Comments:

Phase 1 combination study to evaluate once daily doses of PSI-7977 and PSI-938 (both dosed QD) in 30 patients with HCV who have not been treated previously. The antiviral properties of the drugs (alone and in combination) will be observed for 14 days.

EASL 2011: In the patients who received the PSI-7977 and PSI-938—92% were HCV RNA negative at day 14. The side effects were considered mild with no treatment discontinuations in the PSI containing arms.

A new study (QUANTUM) with PSI-938 and PSI-7977 (without interferon) is expected to begin in the third quarter of 2011.

[curiouslady1]

Another quarter heard from:

http://www.xconomy.com/san-diego/2011/09/06/dramatic-changes-in-hepatitis-c-treatment-expected-to-continue/?single_page=true

[Alatyr55]

For what it's worth, I asked my nurse about DAA resistance if I failed SVR in the trial I am in, and she guessed it would be 2 years before they would have enough information to know if I would be able to try again.

[curiouslady1]

Thanks Willy.  Very helpful . . . and hopeful :)

[burned74]

This is a great discussion. Thanks so much for the web links, Wil.

[Willy50]

But, as far as I know NOBODY has ever been SVR without interferon
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I don't believe that statement is correct, but look at the interim results of this trial;
(100% 17/17 virus free at 28 days)

http://www.natap.org/2010/AASLD/AASLD_30.htm
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For people who are interested in this interferon sparing treatments this is a nice presentation;

http://www.colloquium.eu/congres/11PHC/presentation/Monday_Amphi_bleu/E_GANE.pdf

willy

[kirk8]

These all orals sound great.  I’ve heard a lot of people say they are only a few years away.  But, as far as I know NOBODY has ever been SVR without interferon.  Seems like we’ll all have cirrhosis by the time that changes.

[susan400]

I'm not against interferon, however, it no longer works against the virus in my body, as of this trial that I just ended, it turned out I was on SOC alone because I got the placebo and I only got it for 10 wks.  At my last appt., it was unblinded because the trial was cancelled and I got the first 8 wks of viral loads and I barely responded to the SOC alone, I had like a 1 log drop (barely) by 8 wks, which is considered VERY poor in term of viral response, i.e. null responder.  Susan400

[curiouslady1]

I cant write well with a needle up my arm but got released to come home for a bit.  I am 14 days in and my VL went down to 53 in 6 doses of one oral drug alone (from 13 mill in mid August).  In Phase 2 they are more careful about participants than in Phase 3, that is correct.  And in Phase 3 they get more trials stopped in the middle because the people in Phase 3 are not the healthiest and Adverse Reactions can bring a drug down.  I am 64 and have diabetes, overweight and FLD and LP and Graves disease and arthrities.  I am hardly a perfect specimen.  But I don't have any conditions which are deal breakers.  My BMI is under 35 and my heart and eyes and liver are ok.  I could withstand SOC if I had to and if it came to that in rescue.  They are getting good results Upbeat and that is what you and everyone who is waiting want because in Phase 3 you have a better chance and in general you have a better chance to have it get to market sooner.  If they put out that we all GT 1a's went UND by 1 month, imagine the publicity and the pressure to move forward.  Phase 2 is a good time to tweak but not if people are too sick.  Investors do need some assurance for their money.  Millions of dollars for each drug I am told and so many fall by the wayside.  All you need is for a couple old geezers to drop dead for an unknown reason and that is the end.  

[willbb]

hey Bill.. I remember those days...when I was first diagnosed  11  years ago...like many here...there was only mono INF. and the doc said you got about a 20% chance...I passed.  :)

Things have really changed...and thankfully folks  now have some real hope and things are just going to get better and better  IMO.

Best to you..
..
Will

[Bill200]

BTW, I don't why you guys are so against interferon.  Of course some of you will have bad effects but with the triple therapy and a near 70% I'd jump all over that before trying new stuff.  When I first started there was around a 15% chance of cure with straight interferon.  I worked my regular job through all three attempts.  You should try the well-known SOC first, I think, at least until there's more data back.  Those studies they posted only had about 45 patients. Very promising but it is a brand new thing.  I'd wait until they had a few more trials under the belt.  I only wish the standard triple therapy had been around a few years ago.

[suezeeque]

I'm in a PI trial (BI 20133) and there are 6 spots at my hospital for participants.  They have only 5.  Korea was also supposed to have a number of participants that they didn't reach, giving more spots to North America.

I guess there are just lots of trials going on now and people are being smart about what they choose to participate in.  I don't know why my hospital didn't reach its number except that it was only available to treatment naive patients...

I just chose the first darned thing I was offered.  ;)

[Upbeat]

As a person who was denied partisapation in this trial because my fibro score was a little high I have a different take on these trials.  The way they cherry pick who will be in the trial does not give a true picture of how the drugs will really work with all stages of Hep-C.  As the investigator told me they are looking for young healty people with little liver damage.  Its been over two months since I applied and since there was only to be 84 people in the trial I find it strange it has not filled yet.

[willbb]

I obvoiusly hope that your treatment is successful...as I hope all people treating have success...This particular therapy is also very interesting to myself .down the road..so I hope you didn't think I was trying to dash any hope..
The only thing I mentioned in this thread is that   ..given there is still no  conclusive data on variants that may survive...I thought it was an off handed remark made by someone in the medical field...to  say" conclusively"if any one fails this treatment you can just treat with a protease with no worries"
It is actually because I am always concerned for us as patients  that are in the experimental phase of trying new therapies that I think very seriously about what all the doctors are telling us  while we are involved in the trials
Actually I believe it was you that started talking about certain doctors hurting people and other things that had no bearing on your original post.
As I said here previously I hope your tx. is succsessful..as it looks like it very well may be..and that will be good for all of us.....

Best to you...
Will


Susan 400...I didn"t see anywhere in this thread were anyone questioned the OP"s choices of tx....however I may have missed it.

[curiouslady1]

Sorry for the snide remark.  A better term may have been "enhanced" rather than create.  The thread was, in fact, created in order to give people hope.  Especially those who choose to or for whom it would be a better idea to wait for less brutal treatments than those on the market now.  Not everyone can engage in such treatments either because of life circumstance, health considerations, lack of family support, psychological issues etc.  This thread was instituted on behalf of such people.  I get defensive when I see such hope once again being picked apart.  

[susan400]

Curiouslady1 is entitled to make whatever choices she wants in her treatments,  just like we all are.  Who are we to question her decision?  Curiouslady, I am hoping that you clear with your current trial and that this is the only treatment that you have to do.  Susan400

[curiouslady1]

Of course Doc.  The vernacular is used "creating mutations" because it is an easier concept for people who aren't talking heads.  But thanks for the explanation.

[lynda607]

DAA's are not creating mutations.  It is a matter of fact that all these variants are typically preexisting before the patient even starts therapy.  When you use a direct antiviral compound which has a different susceptibility for the wild type or preexisting variant you're going to select your eradicating those viruses which are sensitive to the compound but the ones that are resistant are going to survive and they can even grow into an increasing replication space, can grow out, can become a major quasi-species, can have a rise in total HCV RNA for this mutant and this may or may not be associated with the gain of other mutations which is called secondary mutations or mutations which lead to a gain of function which increase viral fitness and could lead to expansion and increase of viral load.

[curiouslady1]

And that's not all"

http://www.xconomy.com/san-diego/2011/09/06/dramatic-changes-in-hepatitis-c-treatment-expected-to-continue/?single_page=true

[curiouslady1]

Kate:  This was just posted today:

http://hepatitiscnewdrugs.blogspot.com/2011/09/hepatitis-c-psi-7977-pharmasset.html

[willbb]

The PSi 7977 / BMS 790052 combo looks very promising ... hopefully they will be on the market  as an INF.free therapy  sooner rather than later. Most in the field believe it could still be from 3 to 5 years away .
best to you.

Will  

[appleboy]

I have had Hep C for 28 years. The last few years have been a rough time for me not b/c of the disease (I am very lucky and it seems to never want to be an every-day issue with my liver) but because of PIs coming  and going when they get to near the line where they have to cross before they can be released.This last one sounds like a miracle with no Tx side effects (although none they mention). Maybe we do get favours from God now and again.  

[willbb]

You aren"t treatment naive now.....you are treating with 2 polys...

meant to say  you are now treating with a poly and an NS5A

[willbb]

You aren"t treatment naive now.....you are treating with 2 polys...and again.  for the fourth time..there is no conclusive data that there is not cross.   They are still working on this aspect of Daa treatment..

I never mentioned anything about anyone hurting anyone....No one  has hurt me in the least.  I do know tho,,,in order to treat again(like anyone in a failed trial with a Daa..regardless of the mechanism) the resistance profiles will need more clarification to be able to treat again...that includes you also if you happen to fail (very much hoping you don"t)...      also no-one said your doctors were irresponsible...I said ..that any doctor that states categorically " if you fail in this experiment ..you can just swith to a Protease.. ...without the word "possibly inserted  when the data is not yet finished .."is irresponsible"   and   it is....if he showed you  any studies on cross on polys  please post them for others  to look over

Best to you...
Will
Will