merck vioxx trial

I will know then if that is EOT or I go for 6 more weeks. The Merck trial presented wonderful results at the ASSLD conference. 97 out of 98 reached SVR. That was a 12 week study but did not include hard to treat such as null responders, cirrhotics and HIV. These new drugs are changing the way Hep C is treated---rapidly. The future looks bright for all of us. Still have a way to go, but I am optimistic about my trial and others.

For clinical trials, the sponsor (merck) seldom does any of the testing, that is done by the investigator at the clinical trial site. Merck would have taken the investigator's information and reported it in the marketing application. I don't understand the comment regarding for $50k it should work. If you are talking about Victrellis, it does work. Not for everybody, but I'm sure there are lots of people on this forum that will tell you it does.

Hello All, I completed a 12 week clinical trial of two meds in one pill from Merck. Grazoprevir is an improved pan genotypic protease inhibitor, and Elbasvir is a NS5A inhibitor. These Merck drugs should hit the market this Summer, I would think. The director of the clinical trial wrote me, and said the relapse rate of those in the clinical trials who achieved a SVR is 1%. It is worth noting that figure may change, as these meds are still so new.

Hello Fellow Travellers, My EOT with Merck 5172-068 clinical trail meds was 10-31-14. I went to the hospital conducting the trial on 12-2, and the blood draw from 10-31 showed the viral load as still "TND". Which may not mean anything, because I took my last pill that day. So, now I get viral titers once a month for a few months, then every other month, then @ 6 months, then 1 year >EOT. Merck considers you to have a SVR if you are TND @ 6 months >EOT. Seems a bit premature IMHO.

Symptons are always have been cold, tired, joint and muscle pain worse in fingers, I took Vioxx before it was removed , high blood pressure , tinnitus, completely deaf over 2,500 cycles in both ears. Hearing aids made no difference. Dentist last month couldn't freeze my gums with 2 needles of Carbocaine. 7mm nodule on thyroid. Blood tests TSH 2.15 ( range .465 to 4.68 ) FT4 11.17 ( range 10 to 28.2 ) Total T3 2.02 ( range .92 to 2.

Hey All, The clinical trial I participated in "Merck 5172-068" was a combo of two drugs in one pill. 100 mg. of Grazoprevir, and 50 mg. of Elbasvir. I had a viral titer of 585,000+ IU/ml before tx, dropped to 396 IU/ml in 7 days, by week 3, " $100K. Here is the link: http://www.healio.com/hepatology/hepatitis-c/news/online/%7B9a1b0106-c598-4a2f-83d2-11419d9fa981%7D/fda-grants-new-breakthrough-therapy-designations-for-grazoprevirelbasvir?

Thats the key. Inf free. The trial results have been eye popping and with such short trial durations and fast track Tele and Boce might be short lived.

"Larger U.S. rival Merck & Co is expected to acquire Schering-Plough in coming weeks, thereby becoming an instant global leader in the hepatitis C field".

Hello Gang, I just had my bi-weekly consultation by the clinical trial administrators, and so far, so good. Week 10 viral load remains undetectable, ( EOT, Merck considers you "cured". I will be followed for several years afterward, with it eventually becoming a semi-annual event, with a viral load titer, Fibro Scan imaging of the liver, and overall health assessment. I have no data to support the decision, but if I am offered 16 weeks of tx, I will accept.

Still TND, as it has been since my third week on the Merck 5172-068 clinical trial. The consumer med will most likely be the two combined in one pill as mine was, 100 mg. of Grazoprevir, and 50 mg. of Elbasvir. Last tablet was 10-31-14, so I guess I can finally let myself believe it is a wrap. Merck wanted to pronounce me SVR @ 12 weeks post tx, but I wanted to wait. It is still a bit difficult to come to grips with the fact those little !@#$%^&* are finally gone.

As mentioned by searching both sites I mentioned in my overly verbose post, you might find a trial near you for one of the many new 97%+ success rate medications. Merck will want $84,000 for 12 weeks of this med I am using, which is unfathomable to me. We can only hope competition and public pressure will force the prices down. Good luck with your next attempt at getting access to a drug that provides you with a SVR.

Glen, I sent you a private message on this, but now, I'll post publicly, since I didn't hear from you on the PM. I may be doing the same trial with the Merck. I've been contacted by one of my former trial sites and they've reviewed my records and want me to screen sometime in Dec. before Christmas. I am like you in that I have done 12-13 treatments (I've lost count). Double dosing on Infergen, Double dosing on Peg, Double Dosing Infergen and then, high dose of Riba with it.

I'm surprised that they told you that about the Merck trial. I have been told by my trial site that there is a Merck trial starting in Dec. and this particular trial site, I've been to before for a previous trial, so they KNOW that I've done many treatments. They also have all my records documenting the other treatments. This is a reputable trial site that told me this.

anyone here on this trial? mid feb I was in for a screening and my hcv count was 664,547 and alt/sgpt 41 and my counts as of 4/1/13 (day 3 of meds, this is a 12 week study) are: hcv: 35!!! alt/sgpt 20 . they (trial dr`s) are saying these drugs are seeing at least 98% healing!

This is part of a long term (3 year) follow up of patients who achieved SVR in a clinical trial. The Merck trial number was MK5172-068. Each tablet, (#84 in all, 12 weeks of tx), consisted of Grazoprevir 100mg., and Elbasvir 50 mg. This med produced a 97%+ SVR in patients with GTs1,1a, 4 and 6. Results were basically identical in both cirrhotic and non-cirrhotic trial participants. It has been Mid November, 2014 since my last dose.

NCT02613403 it is a Merck trial as you said.

Getting mutation info from Merck is not happening. They will not release any info for anyone at my trial center and to quote my doc, not abiding by the consent is "reprehensible behavior." In my Sprint trial the consent form read: If there is evidence of mutations, your treatment with Boceprevir will be stopped, and you will either continue treatment with PegIntron and ribavirin alone, or you will discontinue all study drugs and proceed to the follow-up period.

//www.protomag.

Hi all! I am just putting this out there, because i just noticed when I opened up a new container of boceprevir I was surprised to see they were not blue anymore they ar yellow and red. Because it is a sunday night I won't be able to ask the trial team. Thankfully I have one more day supply of the blue ones. I rec"d the wrong meds early on in the trial so now I am checking everything. Any information would be helpful??

I have read in other trials with drugs which now have names, the addition of RBV ( in the vast majority of cases) was clinically insignificant. I know of no data that confirms that 16 weeks of this Phase III trial comination tx from Merck yields clinically significant higher percentaghes of a lasting SVR than 12 weeks of tx. The trial coordinators have assured me there is no difference in the groups they have been able to follow thus far.

Merck is working on a vaccine and it is successful. They now have the Cervical Cancer Vaccine ( Gardasil) and are working on an OVCA vaccine. They are in the second trial and need one more before the FDA approves. By giving it to patients with OVC in recurrence, they have prevented it from returning for two years. They are tweeking that and want total prevention. They have also been successful with prostrate cancer and as you heard last week, skin cancer.

This failure was a blessing in disguise, as it was one of the many criteria I had to meet to be accepted into the Merck 5172-068 clinical trial, which has apparently eradicated my GT1a HCV. Merck wants to break out the beer keg with a ND viral titer @ 12 weeks >EOT, which I have met, but I'm not ready to tap that keg yet. My upcoming 4-14 viral titer will be 3 weeks shy of 6 months >EOT. If I'm still ND then, its time to declare SVR.

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