Phase II trial BMS daclatasvir-asunaprevir-and-bms-791325

[mike716]

Hi, Medhelpers!

Is there anyone here who participated in the Phase II Bristol-Myers Squibb trial of daclatasvir-asunaprevir-and-bms-791325? If so, I'd appreciate hearing about their experience, especially side effects.

Thanks (and Happy New Year to all).

Mike716

[Faithdove]

Mike716
Check the BMS clin trial site now!!!! Recruiting!!! http://www.bms.com/StudyConnect/Pages/directory_of_clinical_studies.aspx

I hope you see this !! Faith

[mike716]

You got lucky. Those BMS meds are going to knock out the virus for sure.

[mike716]

Sorry to hear about your hubby's accident.

Maybe you should press your MD on getting the new IFN-free DAAs for him ASAP. It looks like patient assistance ($) works, with the right MD behind you.

As for me, I don't think I'm ever going to get into a trial. I'm not around to go to a lot of screening evaluations.

Frankly, the whole thing gets my dander up. The pharmas and the trial study centers can pick and choose, and we're left to beg.

I can't believe that woman was excluded for being too skinny. What do they want, fat people? I'm skinny, too. What should I do, scarf down a lot of fat burgers and ice cream before going to a screening?

I'll ask Louie and the guys to case out these study centers and have a sit-down with 'em. Sounds like they need a little correction.

Mike

[mike716]

You're right and that's what I'm going to try and do. It's kinda hard from down here in Buenos Aires, but maybe not impossible. At least get the ball rolling and get on some lists.

M.

[haroldh]

Hey Mike
I am starting BMS Stage 3 in NC on Jan 15, this wednr. It is a 12 wk tx with Daclatasvir, Asunaprevir, one that is unnamed and they will add Ribivarin to half of the patients, the others will receive a placeholders. In 2010-11 I did 68 wks Interferon/RV and failed at the last week of tx. One of my request was if I tried again, no interferon. It has taken a while but got the call mid November and things moved really fast. So keep your eyes and ears open and hopefully something will break. In the meantime,I'll be posting my thoughts and results along the way. Good luck!

[Faithdove]

I also want to add, I see other people that get their names on a list at a clinical trial site and the actually get called by the site when a trial comes up as Boobert mentions above. Then the person comes in and gets checked out to see if they can participate. One woman said she was told she was too skinny to participate! So I can see it know, a line of folks get called in and get screened, that takes time....then some can't participate, and so more get called in....or some drop out...it could be a while before they get it all together. Food for thought...?
Tell cousin Louie we said hi!!! Omg, you are too funny.

[Faithdove]

I do understand how frustrating it is. I have been the one doing the legwork for my husband. He can't deal with it and gets a temper when things get too overwhelming and dealing with an illness is bad enough not to mention dealing with doctors, drug choices, and lack of funds. If he didn't have me doing hours of research, he would probably not even get treated, because he is not one to trust anyone ;p. Hey, there was a woman that posted on another thread, that she got the two new meds for Free. I think you actually posted a question to the group asking about the different strains of the virus and wanted. "Clear" answer? I am having that same conversation in my head. So my husband is very clearly at a late stage with early cirrhosis so he too needs to do something now. Next, he was in a major accident last Feb, and almost died (was in drug induced coma for a few weeks), he had many issues.
I too want the best for him with least amounts of side effects. (Vested interest is that I have to live with him!!! ) Plan A: I asked his doc about Sovaldi with interferon and RBV for 12 weeks. If people can deal with 48 plus weeks of Interferon and RBV, 12 would be at least not as bad. So his doctor gave me the script to put in for him. Then I kept worrying about that Interferon and RBV and saw someone get the Sovaldi and Olysio .....and my mind went to that Plan B, I am now toying with the idea of asking his doc about that. Reasoning, so far the side effects don't appear to be as bad, but as we discussed above, who the hell knows until all these drugs are out for a few years and all different types of people start to use them. Hey, but my husband could have another accident or get hit by a bus too!! As for the mutant strains of virus, I will ask his doc if he can have that blood test done to check it out before he does that treatment. So if he had the mutant virus (let's call it that), then I will have to think and ask more questions to his doc, to see if he should go back to plan A. It is a lot of work to baby step my way through this, but I do want to cover all the bases, or at least make myself feel better knowing I tried. Hang in there, we are all in this together.

[Boobert]

Mike what you NEED to do is to go visit one of the trial sites and give them all of your information and they will put you on a list for upcoming trials or a trial that someone drops out of but go down there, even 2 places and prescreen with all your info. They will contact you but do it ASAP because these trials are winding down.

[mike716]

Thanks, everyone, for the comments and suggestions.

Before giving up altogether on this trial, I started a new thread ("Is the BMS Phase III trial still recruiting") in the hope that someone might know of a study site that hasn't filled their quota. I put my most recent news in that thread. It ain't good.

I do think it's very poor practice for the gov website to list study sites as "Recruiting" when they're not. It wastes everyone's time, the study sites' and ours. But maybe the study sites don't keep the gov website updated. Or maybe they're on a fishing expedition, huh?

I guess the drug companies sneak around giving info to their chosen study sites before it's available to the general public. If I had an inside track I'd probably join the sneaky-news-network. But I don't. No hep MD. No insurance. No nothing.

Well, once burned twice shy, as they say. I won't waste any more time trying to get into a trial the honorable, up-front  way. It doesn't work.

So, let's see, what does twelve weeks of Sovaldi plus Olysio cost? $150 grand? I'll just give my cousin Louie the Finger a call, see what he's got cookin.

Heh-heh. Just kidding.

Mike

[JimmyMose]

Oops "many have commented" wasn't supposed to be in copy and paste.  i know editing isn't possible but a preview button would be nice.

[JimmyMose]

BMS doesn't provide much detail about any of their clinical trials at their website unless I can't find it.

From what other have said usually by the time it states Now recruiting at clinical trials gov they have already selected the test patients.

You could look and see if you meet the requirements of that study.
Check the Study Locations to see if you are near any.of them
Then talk to your hep doctor as ask them about it. They should know if not that might be a clue to wonder why?
Then you could ask doc to contact or allow you to contact them. Phone numbers are listed for sites currently recruiting

For those not yet recruiting near you or doc can email: Clinical.Trials (at) bms.com   First line of the email MUST contain NCT# NCT01973049 and Site #. (note site number are usually different for other trials by same Drug company at the same location)
the zip code is shown to help identify possible sites.

Maybe your doctor can or ok you to contact them via letter, phone or secure internet with contact info including your medical criteria. Ask them to please consider you.If they are participating in a future trial where you meet the inclusion criteria and not any exclusion criteria.

Note:depending on all your current condition, urgency and etc. your doctor may not think that a clinical trial is an option. .



.  


many have commented

[Boobert]

Mike for some reason they don't list most on there site. Even my phase II BMS trial was never on there site. I wouldn't hesitate these trials get filled FAST.

[Faithdove]

If it is not listed on the company website, maybe they are no longer recruiting? I wonder if the clinical trials gov site is lagging behind? I wish I had the answer..

[mike716]

Sure, but that doesn't answer my question.

[Boobert]

NCT01973049

http://clinicaltrials.gov/ct2/show/study/NCT01973049?term=Daclatasvir&recr=Open&rank=12&show_locs=Y#locn

[mike716]

The BMS website doesn't list the current Phase III trial of daclatasvir-asunaprevir-and-bms-791325.

I wonder why not?

M.

[Faithdove]

Here is a link directly to BMS trials

http://www.atthecoreofhcvresearch.com/bms-commitment-to-hcv.aspx

[mike716]

Congratulations. The BMS triple-drug Tx sounds like the best stuff.

Now if I can just get into a trial. . .

M.

[Boobert]

I just got a call telling me I'm still UD after 36 weeks of treatment. She also told me of all the trials with the different drug companies BMS has had the best results with NO relapsers. Well worth my headache and insomnia for a couple weeks.

[mike716]

I take it back .

Very sorry to hear you have MS. I hope your chosen medication is working.

And thanks very much for the link to FDA drug approvals. I didn't have that one.

Cheers!

Mike

[mike716]

Hi, Jimmy.

Thanks for your reply, especially the quotes and comments on the real world versus trial data. Very interesting.

I guess we are both in the club of waiters.

Good luck with Sovaldi/RBV!

Mike

[Faithdove]

Hi Mike,
Thank you for your observation, trust me, I am my own advocate. I was diagnosed with MS and when my doctor wanted me to add on another treatment to the one I was currently on, I said "No". Do you know why? I was doing great on the injectable I was on and the new drug was to be approved by FDA soon.  Since they still do not even know what causes MS, I was even more concerned to add this new drug....why upset the apple cart????

A few deaths occurred from the drug and a BIG BLACK BOX appears in the insert in regard to Progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability, has occurred in patients who have received TYSABRI.
Three factors that are known to increase the risk of PML in TYSABRI-treated patients have been identified:
- Longer treatment duration, especially beyond 2 years. There is limited experience in patients who have received more than 6 years of TYSABRI treatment.
-Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil).
-The presence of anti-JCV antibodies. Patients who are anti-JCV antibody positive have a higher risk for developing PML.
• Because of the risk of PML, TYSABRI is available only through a restricted distribution program called the TOUCH® Prescribing Program.

PML occurred during Clin Trial and more deaths followed post marketing, hence a Big Black Warning box and now you can't get the drug unless you go through the TOUCH program.

Does the benefit outweigh the risk? Yes, for some people it does. For me, it did not. The choice to be in a Clinical trial is always more risky, but if no one takes the first step, then what?
At the end of the day, no one can force you to do anything, can they?

[JimmyMose]

"Your trust in pharma labels is rather naive, don't you think?"  is a little harsh and assumes Faithdove trust in pharma labels is rather naive. I know myself I have made statements similar in the past that I wish i had said differently.

You do bring up some valid points that should be taken in to consideration. The patient makes the decision about treatment and when. That may be based on available treatment options, recommendations of their provider (including second opinions), their own research on the treatments available (side effects and medical conditions) and their current chronic Hepatitis condition.

Yes people do have to have to have some faith when doing a trial or a newly approved treatment. Depending on their current situation some may decide on one of these new treatments now is worth the risks rather than waiting.


VA - New Regimens with Direct Acting Antivirals for Hepatitis C
"But, it is also important to know that these results have been obtained in carefully selected clinical rial populations and that effectiveness in the real-world is unlikely to be as high. In addition, the relatively small numbers of patients treated in these trials mean that these new drugs may show unexpected side effects".
http://www.hepatitis.va.gov/provider/hcv/DAA-update.asp

SOVALDI PRESCRIBING INFORMATION
"Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice."
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

Their have been may drugs approved even INF and riba that first showed better cure rates but as time when on those dropped and more side effects became known.  These new drug trials only show side effects within a year or two.  The potential of other long term effects maybe unknown util a few years or more after treatment.

I have Genotype 2a/2c treatment naive and have declined treatment with INF/Riba since 2008.  But waiting for VA to approve SOVALDI/Riba 12 week treatment. My journal has some detailed history biopsy and recent blood test results

[mike716]

Hi, Willy.

I wasn't basing my cynicism regarding side effects just on your experience. As a matter of fact, what most worried me were all the posts from people who have taken these new meds and then had dental problems, because my dental situation is precarious, to say the least.

OTOH, I don't doubt that the new meds are much better than SOC, for cure rates and for sides. Interferon is poison, and the first-generation DAAs potentiated its bad effects.

That said, the percentage of people who drop out of Tx due to sides is not necessarily a good indication of the true situation. Sides can develop slowly during treatment, maybe not even appear at all, and then become serious later. This has been the history of hundreds of pharmaceuticals, some of which cured illness but were later withdrawn because of their long-term side effects, in some cases worse than the original illness.

I think it's important to keep an objective POV on all new medicines. The collaboration, not to say collusion, between big-business pharma and the medical profession is a fact, and should make us all wary. I'm always suspicious of a "free lunch" (cure without consequences) until I'm proven wrong.

Of course, every individual with HCV has to evaluate things for her- or himself. If you must treat urgently, I'm sure the new meds are better than the old ones. For those of us with early- or mid-stage fibrosis, it's not so clear.

Here are a couple of recent articles I found useful:

HCV F1/F2 patients: treat now or continue to wait
http://onlinelibrary.wiley.com/doi/10.1111/liv.12408/full

HCV direct-acting antiviral agents: the best interferon-free combinations
http://onlinelibrary.wiley.com/doi/10.1111/liv.12423/full

Cheers!

Mike