first set of labs for PSL 7977 and BMS 790052 study no interferon
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 ..
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
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..
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
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..
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?
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.
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.
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 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).
@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. ;)
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.
Someone asked about the type of drugs involved. I believe I wrote this down accurately. Telaprevir and Victrellis are NS 3 inhibitors. PSI 7977 is a NS 5b inhibitor and BMS 790052 is a NS 5a inhibitor. The theory is to administer both since they are from different classes and each will defeat the virons left behind or the mutants. In one arm NS b is administered first for about a week because it has a very low chance of developing drug resistance and then the NS 5a is added. In some arms Ribaviron is added to the two drug combination for comparison purposes.
this is the link for the study.-..http://www.clinicaltrials.gov/ct2/show/NCT01359644
I would suggest anyone interested to call one of the sites..My Dr is the first one listed Dr Hassanein...Southern California Liver Centers..
Robin, I am mentioning Telaprevir and Victrellis because they belong to a different class of drugs. These other, newer drugs belong to two different classes, different from each other and different from the ones on the market. This has some value for members of this site because, theoretically, they can take these new drugs in the future even if they have failed the others. Also, the information I have been giving on this thread is not just taken from the the clinicaltrials.gov web site, it is taken from my consent form and from discussions with the study doctor.
This has some value for members of this site because, theoretically, they can take these new drugs in the future even if they have failed the others.
You are possibly getting a little ahead of the data..with this statement.
As we speak the drug companies are doing resistance testing on patients that have failed triple. and to date there is no conclusive data on resistance .. or cross resistance.
I know. That is why I said "theoretically". The whole study here is theoretical actually. The study in question is a Phase IIa and the study doc repeatedly used the term "theoretically". That is why it is a research study. That is why we get a stipend for these things because we really don't know. Yep, I know I am preaching to the choir but there could be someone who reads this who might find it informative. As for me, I am still waiting to see if this will be the time I give up my "40 year old virgin" (treatment naive) status. ;)
Will, although I can understand the cynicism, I am not there yet. I had written "everything" but changed it because, well after all, even evolution is theory. Even when data is in and compiled, the theory remains, perhaps with a little more evidence but it is still a question when applied to a given individual. But my reason for writing back is to clarify that this is not the study doc's "theory" but rather the theory of the researchers who put the study together. Oh yes, I am aware that Big Pharma is involved with all its ambiguous motivations as well as a lot of half baked ideas and sloppy experiments. But somewhere along the line one has to trust someone. The time pressures for someone in their sixties is obvious. I turned down a chance at interferon therapy in 1992 knowing close to nothing about the disease or the therapy but simply because I had other things to do like finish my education. Fortunately after the biopsy, the doctor suggested I didn't really have to treat at the time. It was only gradually that I came to understand, as genotyping and other tests came out, that I had dodged a bullet. I had a righteous doc. I am sorry for those with hysterical and panicked docs but I don't condemn the profession and take off on my own because of a few frogs. I sometimes see people on this list do that because they have had bad experiences. Perhaps I am being unfair in my interpretation of your comments but I think we do have to have some trust in the medical profession in order to get better.
I don't know what your reading from and stating "theoretically" I just read over my signed consent and did not find one. For me, I am keeping it simple..My Dr ..is world renowned..Dr Tarrek Hassanein..I have been with him before Hep C had a name and was called Non a Non b..he said this is a good study and that should I need rescue four drugs are even better. I will continue to post my labs results.. I wish you well but..really way to technical for me..
I treated with peg/riba in 2007 as an acute geno 1b. I would do it again tomorrow. My chances at SVR with that geno were much higher treating acutely, but frankly, I also wouldn't have wanted to risk the long term systemic inflammatory damage from the virus. Everyone has to make their own decision on that.
But are you saying that doctors who have advocated SOC for their patients over the years are hysterical? I'd be more concerned about a doctor who didn't discuss treatment options. My opinion is that historically, hcv patients have just as often been marginalized by the medical community and neither their options nor their disease have been adequately discussed with them.
gonnabhepcfree & others enrolled in this study:
I'm really interested in any updates from this study as you're able to post them. I have been only intermittently on the site lately so I've only recently been reading about this.
I think you have definitely misread my post. I was responding to one poster and one comment. If you look carefully you will see that I am very supportive of doctors who treat and doctors who do not recommend treatment. In general I am more supportive of the doctors than what is posted in the forums when I do not know for certain otherwise. Oftentimes patients do not understand, overstate or understate their conditions and the interactions they have had with doctors. I was speaking of the "few" doctors who are not very good. Our job as consumers is to look for and find those who are good. I definitely agree with your first paragraph and what medical science knew in 2007 and what was known in 1991 and earlier are two different things. There are those who hasten to recommend treatment of all types for all types of conditions when to leave it alone and watch it would have been better advised. The very best doctors do not recommend unnecessary or ill thought out/ untried treatment or procedures. In my case, I would have been very unlucky indeed if I had not gotten the doc I did in 1992 and with what we eventually came to understand about interferon and genotype 1a. I am not sure what you mean by "marginalized"? Discussing both treatment and non treatment options would seem standard for most good docs. For you and your condtion and what was known in 2007 it was a good recommendation to treat in the way you were treated. For me and my condtion in 1992 treating would not have been a good move.
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