first set of labs for PSL 7977 and BMS 790052 study no interferon

[gonnabhepcfree]

When I started on Aug 3 my viral load was 2,355,050.99 units/mil  first dose Aug 3..labs on Aug 4- 4838...should have more results on Saturday..I am now allowing myself to get a little excited. Anyone thoughts would be appreciated for a one day drop of this kind..thank you ..

[nygirl7]

Wow that is absolutely amazing one whole day later down that much.......great news keep it up.

[lapis]

Yes!  Amazing!  Congratulations, I would feel fabulous too with that kind of news.

Lapis

[sandysf]

Nice!  Great news..

[zako7]

This is amazing. Plse can u explain this drug combination and ur genotype.

[curiouslady1]

Zako's got a point.  There have been some dramatic results with 7977 and 790052 with geno 2 and 3 but no one has heard about geno 1a and 1b.

[his3707]

Wow!  Please keep up informed about this trial and the results you are getting.  That is amazing.    What did Dr D Say, "this is the beginning of the end for HCV!"

[gonnabhepcfree]

my genotype is 3 and subtye cc...I  have not seen anything monotherapy for either of my study drugs without interferon and the ribavirin..I do know my dr's office is also involved with a study I believe it is call ATOMIC with one of my study drugs with interferon and I believe they did the first phase of that with 100 percent undetected ..it was a 12 week with standard of care.  I spoke to someone today while I was waiting and he said he cleared in like week. Where do you live and have you ever been treated?  I will continue to post resutlts as I get them..thank you for the support

[gonnabhepcfree]

I didn't see the Dr today only the coordinator that gives me the tubes for my blood to be drawn every day and then my meds after.  She says they are having great results with everyone so far in the study..two people started a week before..I am hopeful..have a nice evening..

[attagrl]

Oh my god. What great news! For you obviously but also because I'm starting the same study on Monday. ;D (Or at least Day -1, when I find out my study arm. Start drugs on Tuesday.) Please keep us updated on your results and any of the side effects you experience. It's good to know I have a study buddy on here. :) All the best luck and wishes to you!!

PS: I'm nervous about the ribavirin - nervous to get it, and nervous not to get it. lol

[joemc34606]

Great news any side effects yet and how long is treatment. Joe

[Mari5116]

Sounds very promising.
I hope we all are gonnabehepcfree soon - this is looking good!

Attagirl,
Ditto, on the ribavarin.  I'm "on the list" scheduled to be screened and begin as soon as they get the paperwork and have shared those thoughts.

[gonnabhepcfree]

I have had NO SIDE EFFECTS ..I walk/run every moring at 6:00 am and then work and walk again..I feel bad writing this for everyone that is struggling with SOC but it's news for hep c..good luck on Monday and Tuesday.  I have my nine hour appt on Tuesday again..

[joemc34606]

That's awesome don't feel bad, that's great news to everyone.

[gonnabhepcfree]

What is happening with your study?..

[zako7]

Thanks for your reply. I am in San Francisco, California. I have an appointment to see the GI at kaiser on tuesday 08/16. I am genotype 4f with 2.7mil VL and planning to treat. This your result is amazing more amazing  with zero side effects. Is there anyway you can link me with this study so that I can see how to discuss it with my GI?
Thanks

[gonnabhepcfree]

http://www.clinicaltrials.gov/ct2/show/NCT01359644  It looks like they are recruiting in SF..I would inquire they only have 84 or 86 spots total..good luck with whatever you decide..

[Mary4now]

Heres to the beginning of the end of Hep C for all genotypes.  Good luck to all of you cirrhotics in getting rid of the virus and healing the liver.
Mary

[Mari5116]

As for my beginning time line I can't say.  I've met with the trial folks a total of three times and spoken on the phone with them 3 more times.  They ordered preliminary bloodwork,  summoned medical records, etc.  They called today to reassure me I'm on the list and they will be conducting the trial and contacting me when they get the paperwork, as of yet they don't even have the consent forms.  
Somehow typing this is making it more real for me.  This in between place is kinda strange.

[curiouslady1]

I don't mean to burst anybody's bubble here but the study that gonna is talking about and which 2 or 3 other people are waiting to enter or applying to enter (including myself) has 6 arms.  Each arm has 14 people in it.  There are 42 with geno 1a or 1b, 42 with geno 2 or 3.  There is no arm for geno 4.  Once they have enough subjects (and they are currently actively recruiting and running subjects now) recruitment will stop.  Some entry criteria are evident from the clinicaltrials.gov web site . . . nobody who has liver disease, all subjects must be treatment naive, etc.  Some entry criteria are not so evident.  For example, the individual has got to be able to tolerate SOC which will be added to the other drugs if the person does not go UND within a specified time.  That means they have to have reasonable cardiovascular function, the absence of certain eye problems, no current drug problems, no underlying thyroid disorder, a BMI under 35 etc.  Study doc says they are particular at Phase IIa (that's why they are still looking) and much broader at Phase III.  

[attagrl]

@mari: I know EXACTLY how you feel.

I found out about the study in early July, and I wasn't able to schedule screening until July 29th; during that time I was in a weird limbo wondering if the clock was going to run down before I would qualify for inclusion, trying not to get my hopes up. Then I found out I failed the drug test (due to a valium taken for a dental procedure a month before) and I nearly got booted -- just found out Monday that they decided to keep me anyway. It doesn't feel real yet, even though I have my appointment for D-1 on Monday, when I'll be randomized. I'm this weird mix of excited and terrified.

As for the waiting list, I can say that last week at my screening, the study coordinator said only about 18 people had started the study already, nationally. She said it jokingly, in that there's already a group of "guinea pigs" testing it out, so I'd know if there were any weirdo side effects before actually starting the drugs. :P Either way, it looks like they're not quite 1/4 full (at least, as of last week) so hopefully that means good things when it comes to you qualifying. *HUGS*

[attagrl]

Oh, and according to the study coordinator, I'll be the first person with Genotype 1 to start. HOLY CRAP. That's some pressure. lol

[curiouslady1]

attagrl I was told the same thing last week in terms of others being the guinea pigs but I was also told that 30 had started.  I am sweating acceptance right now and it will be another week before I find out the test results.  I was a little freaked by your post about the valium so I fessed up about having two bloody mary's two weeks before (believe it or not I was emailing mari at the time LOL).

[attagrl]

@curiouslady - Well, at least 30 is still a long ways from 80+! I'm sure you'll be fine, especially when you consider how many big research universities are the study sites, and the whole process there moves incredibly slow due to the whole college bureaucracy. My mom (who is also doing the study, long story lol) and I were actually the first two to even be screened at our site, let alone start.

I'll keep my fingers, toes, and eyes crossed for you!!!

Oh, and @gonnabhepcfree, sorry for hijacking your thread. ;)

[curiouslady1]

Keep fingers crossed for Mari too.  Seriously though what is taking time I am told is that everyone is freakin over the rescue therapy so they are walking before they even start.  I don't even want to think of not one but four drugs which could cause nausea.  It makes me nauseous.