Hep C Discussion Forum

Beacon · Senior Member

RE: OPTIMIST trial: What happened with recruiting?

OldenSlow · Senior Member

Bruce - PPO here. Became medicare eligible during 2nd month of treatment, but they did not factor into coverage as tx underway before turning 65. BC/BS provided all coverage.

Mike - Forgot to mention.. OptumRX was specialty pharm handling the meds.

Beacon · Senior Member

Wayne,

Are you BC/BS PPO or are you HMO?

Mike- see a thread can prompt a question that maybe it's not necessary or worthy of a new thread and this keeps your thread alive. So be happy with any posts that will keep your thread going because once it dies it will fade into the abyss.

Mike716 · Member

> I have BC/BS, which has been problematic for others, as well. I'm sure they'd > like to get me cured, though. I've cost them a small fortune in the past several > years.

That must be it. They want you cured and out of their hair <grin>.

OldenSlow · Senior Member

Mike716 wrote:
You may be right that it's the cirrhosis that slowed the cure. How did you get them to extend the meds fpr another month? Do you have a specialty pharmacy that handled it?
Good luck with the EOT+4 VL.

Thanks. Appreciate it. The approval surprised me, given the troubles others are having securing any treatment at all. I have BC/BS, which has been problematic for others, as well. I'm sure they'd like to get me cured, though. I've cost them a small fortune in the past several years. wink

wayne

Mike716 · Member

You may be right that it's the cirrhosis that slowed the cure. How did you get them to extend the meds fpr another month? Do you have a specialty pharmacy that handled it?

Good luck with the EOT+4 VL.

OldenSlow · Senior Member

VL checks were initially set up for weeks 4 & 12. Being detectable at 4, they checked again at week 8. Chances are solid that I became und closer to wk 4 than 8, but it got me curious as to how much the cirrhosis might be contributing to the slower response. I decided to pursue a 4th month of tx as added insurance. Unnecessarily perhaps, but I went with it and it was approved.

There are forum members with much higher VL's than mine who cleared in 2 weeks, so I don't think that was a factor. I do think cirrhotics are a trickier treatment group and that was my rationale for pursuing the extra month. Time will tell. My eot + 4 blood draws are this coming Monday.

wayne

Mike716 · Member

Hi, Wayne.

You seem to have had an unusual Tx. If I'm reading your signature right, you were still detectable at 4 weeks. Is that why it was prolonged from 12 to 16 weeks?

Why do you think it took longer than usual to get your VL down? Was it because you started out with a high load?

Mike

OldenSlow · Senior Member

Hi Mike,

I ordinarily post informational links as new topics in the appropriate forum sections. I will occasionally post links in response to a given post if it's at least somewhat germane to the topic. Such was the case here. Like you, I prefer that threads remain on topic and I've been frustrated from time to time by the evolving/devolving nature of threads in a public forum. But it's the nature of the beast. As Isiscat pointed out, additional posts serve to keep a thread alive. The longer one goes without response, the deeper it becomes buried in the thread graveyard.

The fact remains that this in one of the most supportive and informationally accurate Hep C forums on the planet. Some of us have the time and inclination to read research articles, financial analysis etc., but many do not. In that sense, hopefully, most of what is posted will be helpful/educational for someone tuning in.

Sorry if it upset you.

wayne

Isiscat2011 · Guru

Mike716 wrote:
As someone who badly needs to get into a trial and get cured, emphasis on markets instead of drug efficacy makes me angry. Justifiably, I believe.

___________________________________________________________________________________________________________

Hi Mike: I appreciate what you are saying but the fact is the market both dictates and reflects what is happening with new treatments including what is happening with trial recruiting. This is information many patients are interested in from a treatment point of view.

Be well.

Mike716 · Member

Thanks, tgcd78. I sent you a private message.

M.

Mike716 · Member

Isiscat-

Maybe I'm overreacting, but it's bad enough having to get news about HCV meds from the financial press without reading the same conversations in patients' forums that I've seen on investors' blogs.

A lot of what's going on, including trials, is more related to finances and stock price than to health, so much so that a recent armed services guideline warns doctors treating hepatitis-c patients not to trust trial results.

As someone who badly needs to get into a trial and get cured, emphasis on markets instead of drug efficacy makes me angry. Justifiably, I believe.

Mike

Cinnamon Girl · Guru

Hi Mike, I can see your point, and appreciate how confusing it can be when you`ve asked for specific information and people are going off topic from that. Because this is a discussion forum, rather than a medical advise website, threads often become quite lively and the conversation broadens out across a subject. Please don`t take this personally as lots of our members have replied to your questions and would like to help.

Maybe you could skip over the comments you don`t want to read? And at the same time if any members would like to follow up on a particular topic they are welcome to start a new thread to make it easier for Mike.

Isiscat2011 · Guru

Mike716 wrote:
To all-
Would it be too much to ask the people who are sending posts to this thread that have nothing to do with my query, or with getting into trials in general, to stop it?
You can make a new thread for posts of investor interest or whatever. Why deny me the chance to get some help here? Just because you are maybe more-senior members of this forum doesn't give you the right to trample all over me.
You're insulting someone who's sick. Think about it.
Mike

Come on, Mike. We are all sick. You are getting lots of replies and people are doing the best they can to try to help you. In fact, more posts keep the thread going. Threads do tend to veer off topic sometimes; it isn't intended to be disrespectful, but it happens. In reality what pharma is up to is relevant to recruiting for clinical trials. We are not speaking as investors (and btw I do not purchase stock in pharma) but as interested patients. Best regards. :)

tgcd78 · Member

Hi Mike,

I am on the trial. I can tell you that I was fortunate enough to be in the right place at the right time. My doctor put me in touch with the Clinical Trial Coordinator at his office. I go to Concorde Medical Group in Murray Hill. They are affiliated with NYU. I had to call the office a few times to ensure they had me on the list and sure enough they did call me when they were ready to fill the positions. Unfortunately, it is like applying for jobs....if you apply online your chances to be considered are slim to none but if you know someone you'll get noticed right away.

Since you are also in NYC, an area that has done and continues to do a considerable amount of clinical trials, I would suggest you keep trying. If you want, send me a private message and I will give you the contact information for the Clinical Trial Coordinator. I am sure they are busy with the current OPTIMIST trial but at least this way they can keep you informed of any upcoming trials that you may qualify for.

TC

Mike716 · Member

To all-

Would it be too much to ask the people who are sending posts to this thread that have nothing to do with my query, or with getting into trials in general, to stop it?

You can make a new thread for posts of investor interest or whatever. Why deny me the chance to get some help here? Just because you are maybe more-senior members of this forum doesn't give you the right to trample all over me.

You're insulting someone who's sick. Think about it.

Mike

Mike716 · Member

Thanks again for your support and good words, Matt.

Matt Chris · Guru

Hey Mike

Sounds like you have done a lot of local investigating of the NY HCV research centers, best advice is just stay in friendly contact with the biggest and best trial centers.

The doctors trial nurse that is the coordinator of the studies is the person you want to get friendly with, either call email or even hand written letter can have a personal effect on the coordinator. Make sure they know your human side of your life not just your lab reports and contact them monthly or bi-monthly. I'm sure you have heard the saying before but it is true that the squeaky wheel gets the grease. I know it can be frustrating but don't give up something will turn up, but remember getting a call for a trial test is just the first hurdle, HCV trials can be a series of stressful qualifying steps but once your in they typical care good care of you.

Hoping the best either way you go.

matt

Isiscat2011 · Guru

Matt Chris wrote:
Hey all
It seems to me that Merck is counting on the price of the cure to remain very high. But by the time they push it thru trials the competition between BMS, Abbvie, JJ, and Gilead should have pushed the price to a more realistic amount. So its a gamble for them hoping the price stays high.
The thing we have to remember is that the need for a HCV cure will be around for many more years to come because because a large percentage of people don't even know they have it yet and many of the nations like China and India have the largest percentage.
matt

I'm thinking that Merck will be coming in to mop up the crumbs after a certain number of Sovaldi tx failures (hey, nobody's perfect). They may target the hardest to treat population who don't SVR on Sovaldi. And, then there is the international market which will still have unmet needs.

Isiscat2011 · Guru

OldenSlow wrote:
Laughing all the way to the bank, no doubt. Link is to a market analyst's perspective on the acquisition:
_________________________________________________________________________________________________________

I'm feeling a little guilty for hijacking Mike's thread but am fascinated by this battle of the "nucs." Wasn't Idenix just involved in a patent dispute with Gilead over Sovaldi? And, what is Merck thinking? Face it, Merck. Sovaldi nailed the nuc.

I guess a 10% share of 100 billion (anticipated sales of hep c orals over the next 10 years) is better than nothing, but perhaps not by much, considering Merck just spent 4 billion in one day.

Matt Chris · Guru

Hey all

It seems to me that Merck is counting on the price of the cure to remain very high. But by the time they push it thru trials the competition between BMS, Abbvie, JJ, and Gilead should have pushed the price to a more realistic amount. So its a gamble for them hoping the price stays high.

The thing we have to remember is that the need for a HCV cure will be around for many more years to come because a large percentage of people don't even know they have it yet and many of the nations like China and India have the largest percentage.

matt

OldenSlow · Senior Member

mallani wrote:
The mind boggles!
Merck have paid $3.85 billion to acquire IDX-21437. OK, it's a nucleotide NS-5B antagonist like Sovaldi, and it's cheaper than Gilead's price. OK, it's pan-genotype, like Sovaldi. What makes them think they can reduce treatment time to one month? By the time they get through Trials, Gilead will be laughing. It's too much for my small brain.

Laughing all the way to the bank, no doubt. Link is to a market analyst's perspective on the acquisition:

SeekingAlpha/Merck-Idenix

From the article:

"MRK's track record in business development in the past has been far from exemplary, with many acquisitions failing to realize their touted potential. While a new business development team was put in place last year, we question why analysts accredit MRK such credibility with such a poor track record of generating returns on shareholder capital. The fundamental takeaway is that MRK only purchased IDIX after the realization that its internal combination regimen required Sovaldi for true pan-genotypic activity, or at least something similar to Sovaldi (IDIX21437). The point we are highlighting is that the market is increasingly valuing these names incongruently, fully ignoring the value of the Phase I/II assets of GILD, the world's top antiviral innovator, while ascribing exorbitant value to the mediocre, more risky Phase I/II assets of MRK/IDIX."

Isiscat2011 · Guru

Gracie wrote:
Any news on the ledispasvir being approved in Canada eh? Still patiently waiting to see my hepologist. I guess when he said I'd see him soon, he meant .... Well. Not soon...grrr

Hi Gracie:

Olden Slow recently posted an articale about Sovaldi and Canada (see below). This information doesn't pertain to the S/L combo specifically, but it does at least indicate that one Canadian province has taken the forward step of providing access to Sovaldi. Interestingly, Sovaldi is available only to treatment naive patients who are G/Ts 1 and 4 and regardless of level of fibrosis. I don't know much about how the Canadian Health Care system works but perhaps you can infer something meaningful from this about how things might play out in Canada.

Priority Review by INESSS Provides Recommendation to Treat Patients with Genotypes 1 and 4 HCV Infection Regardless of Fibrosis Level

Montreal, June 2, 2014 /CNW/ - "Gilead Sciences Canada, Inc. is pleased to announce that the Health and Social Services Ministry has placed Sovaldi^® (sofosbuvir), the newest treatment for chronic hepatitis C virus (HCV) infection approved for sale in Canada, on the Liste de médicaments (effective June 2, 2014). With this listing, Quebec becomes the first Canadian province to provide access to Sovaldi for treatment-naïve patients with genotypes 1 and 4 HCV infection regardless of liver severity."

Full Article

CAPAHC Article

Tig · Admin

Hi Gracie,

I don't think you'll see much of a delay between the time the FDA approves it (tentatively set for Oct. 10) and approval by Health Canada. But that doesn't mean it will become readily available for the masses under the Canadian health care system. If you've been watching the recent posts, you've seen the drive to improve humanitarian (compassionate) access to treatment utilizing Daclatasvir in Europe and Australia for those with advanced fibrosis. I think Canadian physicians will petition the Special Access Programme for access to Sov/Led, for those patients that are experiencing advanced fibrosis and/or ESLD and needing this combo to avoid a health crisis. I think if that were an issue now, the access to Daclatasvir would be worth trying, but I would prefer Sov/Led over anything else if I had the time to wait.

Tig

Mike716 · Member

Hi, Matt.

Thanks for the suggestions. I live in New York City and have no easy means of travelling as I don't drive. Also, I don't see how I could financially live somewhere else for twelve weeks (hotel, meals, etc.), not to mention Tx-ing alone in a hotel room. So I'm limited to my immediate area, or at most a three- or four-hour train ride.

Where on the .gov website are the major study centers named? That would be a good place to start, anyway.

I think the trials are being filled by patients of the study centers before the .gov website even announces that the trial is open for recruiting. The whole thing doesn't seem honest, to put it mildly. But what can you do?

I connected up by email in February with five study centers in my area that I got from a the .gov webpage for the BMS trial, sent them my test results, and they promised to put me on their waiting lists and notify me when there's a trial. So far none of them has. I don't think any of them does a lot of trials. I never heard about the Optimist trials from any of them.

I really don't feel right about going to them all and signing up as a patient. I would feel like I'd entered into the vicious circle of dishonesty. One of them asked me to come in for a consultation and become a patient, so I went. But calling up the others and saying I want to become a patient of theirs is beyond my sense of honor.

I think that the two major hospitals in Manhattan, Columbia Presbyterian and Mt. Sinai, do quite a lot of trials. But it isn't so easy to become a patient at either of them. I tried five years ago and ran into problems, like not having insurance. One of the hepatologists agreed to see me anyway, for $750. I refused. I just couldn't do it. Even if I could afford it, I'd be so angry that I wouldn't be able to speak to him at the consultation.

Another New York hospital pre-screened me for a trial in 2010, but I was axed for having hemoglobin too high (!). It was a special trial for people with low hgb.

Maybe one of the study centers that said they put me on their list will eventually call me for a trial that's worthwhile (I'm not going to do any Phase II trials with placebos or with INF/RBV). I'm waiting patiently. Meanwhile, I applied for patient assistance from Gilead and Janssen for Sovaldi and Olysio, through a hep MD in Manhattan who doesn't do trials but agreed to precribe S+O for me when he saw my test results.

Something's gotta work out sooner or later. I've been trying to get therapy for six years. I haven't given up, but I am getting awfully tired of the whole thing. At 70, I don't have much energy left for the fight.

Mike

Gracie · Guru

Any news on the ledispasvir being approved in Canada eh? Still patiently waiting to see my hepologist. I guess when he said I'd see him soon, he meant .... Well. Not soon...grrr

Matt Chris · Guru

Hey Mike

I can help you with the study trial dilemma. I did one of Abbvies HCV trials (Turquoise II) the key to getting in the most coveted HCV trials is

(1) To connect ahead of the trials release via by finding out which research / trial sites have and are running ongoing HCV trials. They are typical the same ones. Like Miami, Chicago, Texas, CA. etc. I can provide you the exact names and Doctors but the .gov site has most of them. It likely would require you to travel. The HCV journal are full of all the Doctors names that write research articles like doctor Eric Lawitz in San Antonio, TX (Texas Liver Institute)

(2) Most of these trial sites have a waiting list already of their own patients which to enroll in the study before the general public ever gets notice of. In a lot of smaller studies they are full before they open to the general public. The way to get invited and become one of the trialist is to make an appointment with the doctor/research center that continually sponsor HCV trials then you have an in. It will require you to be an investigator to find out which doctors are connected to which drug companies that you are interested in. Some larger research centers like (TLI) have done them all. Its a lot of phone work more that anything else.

Mike if you live in a larger city area their is likely a research center that is drivable, you just have to do the phone work.

matt

Mike716 · Member

Hi, Charlie.

Thanks for the suggestion and the link. Unfortunately, I doubt if I would be eligible for compassionate use. I'm not sick enough yet.

BTW, that webpage doesn't give any contact information.

Mike

CharlieC · Member

Mike I am on compassionate use for Daclatasvir (but I do have insurance for the Solvadi not sure how you would deal with that). But here is a link if this can help in anyway (I am in Maryland FYI):

http://www.clinicaltrials.gov/ct2/show/NCT02097966

Mike716 · Member

Hi, Cinnamon.

Thanks for your good words, and especially for the link to the post from the person in the Optimist trial.

The fact is, clinicaltrials.gov is virtually useless. Their information isn't timely, and they aren't posting the study sites when trials are recruiting. I queried the people running the gov website about this problem back when the BMS trial started, and they said they only posted info they got from the pharmaceutical companies. Pretty lame excuse, if you ask me, for not creating a level playing field by making study site data public.

I still don't understand how people found out where to go and got into the trial. Maybe the study sites are only accepting their own patients. But anyone could become a patient at a study site. It doesn't make sense to me.

Re Sovaldi + Ledipasvir, while it's true that it wouldn't be off-label like Sovaldi + Olysio, but does the trial data show that it's more effective? And what about the cost? Will it be lower than S + O? If not, it's just a way for Gilead to keep all the Tx money in-house. And it's about share price, not curing people.

I'm hoping that Merck and Achillion will get their trials going and post the trial site data. And there's that one-shot vaccine, too. That would solve all the problems. The big question for me and everyone else is if we can wait.

BTW, I like your red hair. Very attractive.

Mike

Mike716 · Member

Hi, Lisa. Thanks for your message.

I guess a lot of people are in a worse situation than mine. But I thought the new meds were approved and available in Europe. No?

I don't really know what fibrosis stage I'm at. I've had a lot of tests done (biopsy, Fibroscan, Fibrotest, MRE), but they gave contradictory results. However, at age 70 the disease will progress more rapidly, and the older you are the worse it gets. I don't think I can wait any longer.

I applied for patient assistance from Gilead and Janssen (Sovaldi and Olysio) and am waiting to hear from them. Meanwhile, I have contacted some places that do trials and am on their waiting lists. But none of them are doing the current Sovaldi + Olysio Phase III trial, which would be perfect for me, and I simply have not been able to discover who is conducting the trial. It's maddening, and the US Gov trial info website is no help at all.

Hopefully, some of the other pharmaceutical companies will have their new meds approved and the prices will go down. The costs are just crazy.

I hope you are okay and can wait and that you finally get the neds you need.

Cheers.

Mike

Loopy Lisa · Guru

Hi Mike, I did read that a few of the pharmaceutical companies have a program for non insured people to access drugs if it is life threatening or essential. I do not see which stage you are, but do go to the drug company sites and see if you are eligible.

We have one member that I know of that is in Eastern Europe and a non-responder to old therapy, he will not be able to access new drugs for many years because of the costs involved.

We in Western Europe also cannot access new drugs until 2015-2017. Those with life threatening stages of the disease can access a compassionate program as it is imperative to treat or death will ensure before drug release.

I'm afraid a lot of us are playing the waiting game as we also cannot access the drugs. If it is not life threatening your disease stage, then time will fly. We all want to cure but sometimes the bitter sweet waiting game will be worth it once we have achieved our SVR.

Wishing you the best :)

Cinnamon Girl · Guru

Hi Mike, you`re very welcome here, and I`m sorry we haven`t replied to your question so far, we`re here to help whenever we can.

I think the point Malcolm was making was that now we have a release date for the more effective combo of Sovaldi and Ledipasvir (in Oct of this year) then it could be a better idea for you to wait for that, rather than trying to get onto the Optimist trial of Sovaldi with Olysio. However I see from your post in the `New Members` Area` that you have no medical insurance so I can understand why you would want to get into a clinical trial. Our members from the U.S have made some good suggestions in their replies to you there so you do have other options you could look into.

I didn`t realise the Optimist trial was no longer recruiting, and I`m sorry you`ve had no luck with it. The clinical trials listing hasn`t been updated yet with that information, as I expect you`ve seen...

http://clinicaltrials.gov/ct2/show/study/NCT02114177?term=NCT02114177&rank=1#contacts

We do have one member who has started this trial who lives in NYC, and here`s her thread you might like to read. Although if they are no longer recruiting then it`s probably best to consider waiting for other trials to become available, or looking into Patient Assistance programs to help with funding for treatment.

http://hepcfriends.activeboard.com/t57737712/hi-from-nyc/

Going by your liver biopsy result in your bio I can understand that you are keen to get on with treatment bu maybe it would be best to spend some time researching what else is available for you and weighing up what would be the best way forward.

Wishing you all the best, and do keep in touch! smile

-- Edited by Cinnamon Girl on Tuesday 10th of June 2014 11:20:15 AM

Mike716 · Member

None of the posts so far in this thread is a response to my query, which was about how to find out the trial sites before the trial is closed. Maybe I made a mistake. I thought this forum was for people with hepatitis-C.

Doesn't anyone here want to help? I'm more depressed than before I posted.

mallani · Guru

The mind boggles!

Merck have paid $3.85 billion to acquire IDX-21437. OK, it's a nucleotide NS-5B antagonist like Sovaldi, and it's cheaper than Gilead's price. OK, it's pan-genotype, like Sovaldi. What makes them think they can reduce treatment time to one month? By the time they get through Trials, Gilead will be laughing. It's too much for my small brain.

Isiscat2011 · Guru

Looks like Merck won't be packing up its bags and going home anytime soon. It just announced that it will be purchasing Idenix (another hepc drug maker) for 4 billion dollars.

http://www.forbes.com/sites/matthewherper/2014/06/09/merck-makes-big-hep-c-bet-buying-idenix-for-3-9-billion-to-challenge-gilead/

Isiscat2011 · Guru

Thanks, Tig.

Olysio is, of course, a protease inhibitor and I believe Merck's MK-5172 and Abbvie's ABT-450 are as well. What does the future hold for PIs in general? Will they become a thing of the past?

Tig · Admin

C-Edge trial for coinfected. No trial data released at all on this, makes you wonder as Malcolm stated, they may be saving research money.

An Efficacy and Safety Study of MK-5172 + MK-8742 (Not recruiting yet)

Isiscat2011 · Guru

mallani wrote:
Hi Mike,
Now we have an approval date for Sovaldi/ Ledipasvir, Janssen won't be spending any money on Olysio. They must know it's days are numbered.. Cheers.

I'm wondering if Merck is still intending its 2016 roll out of the MK-5172 and MK-8742, and what is going on with Abbvie's "3D" combo which is supposed to be approved in 2015? Both Merck and Abbvie have been granted Breakthrough Therapy status by the FDA, right?

Maybe they will all just pack up and go home in surrender: "You are too good for us, Mr. Sovaldi/Ledipasvir." "We give up." LOL

mallani · Guru

Hi Mike,

Now we have an approval date for Sovaldi/ Ledipasvir, Janssen won't be spending any money on Olysio. They must know it's days are numbered.. Cheers.

Mike716 · Member

Hi, Forum members.

I hope everyone is enjoying the spring weather (if it's spring in your part of the world), and that you're having more luck than I am getting therapy.

I just found out that the OPTIMIST trial (Sovaldi + Olysio for treatment-naive genotype 1) is no longer recruiting. I've been following this trial on clinicaltrials.gov since it was first posted, and as soon as recruiting was open I filled out the search form. No study sites are listed, but there's a link to a company named Sylogent that's supposed to be doing pre-selection through a web form.

I never received a response from Sylogent and I was never able to find out what study sites in my area are doing the trial. Now it's closed!!!

What gives? Does anyone know? Is there a solution to this maddening head-kicker?

Mike (depressed and angry)

Hep C Discussion Forum

C-Edge trial for coinfected. No trial data released at all on this, makes you wonder as Malcolm stated, they may be saving research money.

An Efficacy and Safety Study of MK-5172 + MK-8742 (Not recruiting yet)

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