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Post Info TOPIC: Merck MK-5172 / Mk-8742 clinical trial


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Merck MK-5172 / Mk-8742 clinical trial
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To everyone who has posted and commented on this thread...

We`ve heard from our member JudeMzr (Judy) who started this thread originally and she has stated that she would prefer people to post their updates in their own threads from now on and not here.  This is because unfortunately she had a very bad reaction to the drugs and was taken off the trial, as reported in July by Milliganus (Marcy).  Please scroll down to Marcy`s post from 23rd July for more details. 

Sorry for the inconvenience but we`d like to respect Judy`s wishes because she found it very upsetting to see the thread still being used for other members` updates after Marcy posted her message.

This thread is now closed.  Thanks, Jill

 

 

 

 



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Jill 

(69 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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RE: Accepted into Merck MK-5172 / Mk-8742 clinical trial
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Milliganus wrote:

Great news Ray!!!  I was very pleased with these meds.  I'm now EOT + 10 and continue to be und.  Merck apparently has a winner!


Happy for you Marcy, early Christmas present.   biggrin 



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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Great news Ray!!!  I was very pleased with these meds.  I'm now EOT + 10 and continue to be und.  Merck apparently has a winner!



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Congratulations Ray !!!

Everyone at my Merck trial center reached SVR.  I have been UND since Oct 2013.  They just didn't get started as soon as Gilead, but they have had Great results on 8-12 week treatments.  Kinda bombed on trying 4 weeks.

Clinical trials (and the new drugs) are really wonderful!!!

SuziQ 



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR

Tig


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Congratulations Ray!!! That's the kind of call we don't mind getting, yeah! Great news buddy, keep it up and good luck...

Tig



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Great news, Ray, you must be thrilled!!  Congrats!  biggrin

Your chances of SVR are looking very promising at this stage and it`s great to hear how well you`ve responded to this Merck combo. 

Looking forward to your next update...well done! 



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Jill 

(69 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

Ray


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Update:

After coming off the study 5 weeks ago I got a call this A.M. tell me I am undetectable, and have been for some time.  I will find out more at the next blood draw.

 

biggrin



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Ray

G-1a, Long Term HCV (1969), Bridging Fibrosis, Started Merck C-Edge 12 Week Trial 07/14 finished 10/6/14, Beginning VL 4.2 Mil, as of Jan 09 still undetected.  Blood test every 4 weeks



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LC wrote:
suziq wrote:

jeez guys--I had to remember my meds everyday.  I kept a pill journal that I turned in at each visit and got a new set of pills and turned in my leftover pills. 


 That's how we are doing it on the AbbVie Topaz II trial too.  I take 5 pills am and 4 pills pm.  How many pills are you all taking?


 I took 1 pill a day for 12 weeks...



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND

LC


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suziq wrote:

jeez guys--I had to remember my meds everyday.  I kept a pill journal that I turned in at each visit and got a new set of pills and turned in my leftover pills. 


 That's how we are doing it on the AbbVie Topaz II trial too.  I take 5 pills am and 4 pills pm.  How many pills are you all taking?



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Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 



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Accepted into Merck MK-51Merck’s Four-Week Hepatitis C Regimen Fails to Top Gilead72 / Mk-8742 clinical trial
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Here is the first presentation from Merck at the AASLD conference.   Did my trial in Arlington Texas rather than San Antonio, Texas.  http://news.yahoo.com/merck-four-week-hep-c-regimen-gileads  here is another post about the 4 week trial Mercks Four-Week Hepatitis C Regimen Fails to Top Gilead   

Glad I was not part of this trial!!!  Looking forward to see what else Merck presents during the conference.  I am very grateful for my Merck trial AND my SVR.

SuziQ



-- Edited by suziq on Monday 10th of November 2014 01:03:15 AM



-- Edited by suziq on Monday 10th of November 2014 01:12:21 AM

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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Merck MK-5172 / Mk-8742 clinical trial
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Hey Grouper 

Ditto on your thoughts for Ray & Marcy

The Merck meds are going to be a real powerhouse in the market especially when they get there NS5B Nuke combined with their other two meds.

With it in mind one of the more exciting presentations from the AASLD will be on Monday  Late Breaking abstract # 33 will garner a lot of interest by my friends from the Texas Liver Inst. (Dr. Lawitz) regimens for 4,6,8 & 12weeks  weeks using MK-5172 (NS3/4A ) and MK-8742 (NS5A) and sofosbuvir (nucleotide NS5B) that data should very enlightening. 

 

matt

 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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RE: Accepted into Merck MK-5172 / Mk-8742 clinical trial
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Congrats Marcy and Ray, you'all are doing great. SVR is just around the bend.   Hoping and praying you both make it.  smile



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.

Ray


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I pray for the same experience as you Milliganus.  My liver stats dropped 75% in the first 4 weeks to normal and stayed there.  That's not bad with stage three fibrosis.  I go back in three weeks.  biggrin



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Ray

G-1a, Long Term HCV (1969), Bridging Fibrosis, Started Merck C-Edge 12 Week Trial 07/14 finished 10/6/14, Beginning VL 4.2 Mil, as of Jan 09 still undetected.  Blood test every 4 weeks



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jeez guys--I had to remember my meds everyday.  I kept a pill journal that I turned in at each visit and got a new set of pills and turned in my leftover pills.  I missed one pill.  One set of pills had to be refrigerated and I must have marked it down and then forgotten to go get it.  I was really careful after that.  But that seems long ago.  I have been UND for over 13 months now. SVR for 4 months. The C-Worthy was a phase 2 trial and not a double blind study.  So glad I did not have to wonder if I was on the "real stuff" or not.  Congrats Marcy on your UND. 

Next week Merck will be presenting at the ASSLD conference.  All the new info will be available.  I was 2 1/2 months into my trial before Merck presented ANY info on their protocol.  And I had to take riba and it was 18 weeks.  Everything still fine at my first post SVR check.

SuziQ 



-- Edited by suziq on Sunday 9th of November 2014 12:02:32 AM



-- Edited by suziq on Sunday 9th of November 2014 02:48:55 AM

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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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I used the same device.  Basically a BLU smartphone which only recorded the data.  My experience matches Rays.  Ray...I expect your experience will be like mine.  My liver enzymes dropped quickly.  After unblinding + 4 weeks, I'm undetected.  My trial coordinator told me that if I hadn't been undetected during the trial, and was on active med, they would have pulled me.  I suspected I was on active med after the 1st blood draw when my liver panel dropped so dramatically.  Also a very slight headache the first week.

Hoping to hear undetected from you soon Ray!



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND

Ray


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Just finished the program last week now waiting for the double blind to be removed.

 

the device I used looked like a cell phone/ smart phone.  An alarm would sound every morning reminding me to take the dose.  After dosing, I would enter the data and connect to a server, and upload data.  Ever visit I would return all the pills and they would give me new ones.



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Ray

G-1a, Long Term HCV (1969), Bridging Fibrosis, Started Merck C-Edge 12 Week Trial 07/14 finished 10/6/14, Beginning VL 4.2 Mil, as of Jan 09 still undetected.  Blood test every 4 weeks

Tig


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The devices I'm familiar with are either containers or bottle caps that register a time stamp to prove the container has been opened. It shows the study coordinator that you have opened the container and hopefully took your medication as instructed. If there is no time stamp, it shows non compliance.

Tig



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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LC


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Tig56 wrote:


Hey Jude,


Every time I hear Jude, Hey Jude starts playing in my head.  Sorry to hear she had a bad reaction and had to end treatment.  I hope all of you doing this trial start some threads and post more about your experiences so we can learn more about the Merck trials.  Enquiring minds want to know.  What's this electronic pill device you speak of?



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Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 



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Thanks Tig,

for the clarification. I am in on the C-Edge study so it is the Phase 3 trial.

Be well,

Skeeziks.



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Tig


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Hi Skeeziks,

According to the Clinical trials database the C-Worthy is still in a Phase 2 status and the C Edge trial is a Phase 3 status. However neither is recruiting new participants.

Welcome to the forum, I'm glad you found us. Congratulations on completing treatment! I wish you the best of luck. Keep us informed of your success!

Tig



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Great to have so many of us now with this combo.  I just finished and am awaiting results.  My trial was a phase 3.  12 weeks were a breeze with minimal side effects.  Liver panel cut in half and have remained there.

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Hi Ray,

Congratulations on getting into Merck's clinical trial.  It has been very successful--just real hard to get into and so little info available.

Just did my first lab for the follow-up of my Merck trial.  Everything is still fine.  My liver scan did not show HCC and all my enzymes remain normal.  I am actually 1 year undetected--my first UND in Oct 2013--  My history is in my signature so won't repeat that.

Skeeziks

Welcome to the forum and congrats on finishing your trial.  I am sure SVR is just around the corner. Marcy (milliganus) also did her double blind trial in California--I think San Diego.  Not sure what phase it was. My study was an early phase 2 trial. 

SuziQ 



-- Edited by suziq on Wednesday 15th of October 2014 02:09:46 PM

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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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I've completed the 12 weeks of treatment on the MK 5172/8742 trial, this October 2014.

The labs indicate my liver enzymes to be reduced by more than half and are well within normal range now. It appears I got the "real deal" pill vs the placebo.

Throughout these three months, I have not really experienced any symptoms. The biggest change I notice is the piercing headaches (however brief) have all but disappeared.

 

I thought this was the Phase 3 arm of the study, but now I read on the internet that it is Phase 2b. Anyone? confuse



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Hi Ray

I start this trial in 2 days on Monday 13th, lucky 13th I hope! We will have to compare notes as we go along. Wish you all the best on the trial.

Barney



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Ray


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Hello.

 

I am one week 7 of this trial.  No side effects and liver enzymes have dropped to normal.

 

Anyone else on this trial?

 

Ray



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Ray

G-1a, Long Term HCV (1969), Bridging Fibrosis, Started Merck C-Edge 12 Week Trial 07/14 finished 10/6/14, Beginning VL 4.2 Mil, as of Jan 09 still undetected.  Blood test every 4 weeks



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Hi Marcy,

So glad you are doing well.  Yes, if your enzymes are dropping, you are probably on the meds.

I didn't have stomach problems early in the trial  but  I also was on ribavirin. 

Keep us posted--the Merck drugs were very successful so I am sure you are on your way to SVR.  My coordinator said the person that didn't reach SVR in my trial was non-compliant.

SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Quick update on my progress....almost 5 weeks in and I'm feeling very good.  I really haven't had any side effects except increased energy, some fatigue, but less than is "normal" for me, but nothing really to note.  I've spent lots of time in the sun with no ill effects.  I am positive that I'm on the active medication because my liver enzymes are the lowest they've ever been.  Cut by over 1/2.  They were never high to begin with, but the fact that they are now so low means I'm on active drug (according to the trial coordinator).  Interesting side note...my mouth sores have all healed up and my fingernails seem stronger.  My mood is very good and I seem to be less depressed than normal for me.

 

Just wanted to let everyone know how I'm doing.  These 2 drugs seems to be virtually side effect free for me.  I put their names in a post further down.  No riba or Inf, virtually no side effects.....another winner I think.

 

Since all these meds are so new, I think it will be interesting to see the numbers on long term SVR in the future.



-- Edited by Milliganus on Wednesday 13th of August 2014 08:40:39 PM

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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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FYI from JudeMzr (Judy). reposted with her permission.....

I was removed from the trial yesterday by the director, (who is also my regular Gastro).  

I felt great right off the bat, no sides at all.  I take Coreg 6.25 for heart arrhythmia twice a day, and even with that, I felt fine, until about 6:00 the night of the first dose. 

After dinner, my heart rate went up, and my blood pressure soared.  This was kind of worrisome because even without the Coreg I have historically low blood pressure.

As the night progressed,  I got cold , and had the mother of all anxiety attacks.   I had to sit outside in the 90 degree heat with a blanket to feel any better.  The palpitations that I had not felt since my cardiac ablation came back as well, which did not help the anxiety.

At first I thought maybe it was the fact that maybe I had overdone it early that day, feeling so excited about starting treatment and all.  I had gone shopping, cleaned house and had a normal if busy day.

I called the trial coordinator that night after about 4 hours of this,  and she called my doctor.  He told her if my blood pressure when up any more than it was, to go to the ER.

I told her I would and did what I could to rest (which was hard, since I felt so awful)

What was strange was , like someone flipped a switch it was gone.  My hubby took my blood pressure, and it was almost normal .  And I went to sleep , dismissing the incident as an anxiety attack.

I went into the research clinic the next day, (Saturday) and they took vitals, and did an EKG, and took some notes.  Everything seemed normal so I was told to not worry about it and continue my meds, which I did.  I put it out of my mind and had a great day.  That evening I was fine, with not symptoms at all.

Sunday, I had a fun day but relaxing day, and went out to eat early around 4:00 pm, taking the evening dose of my heart meds around 6:00.  After I came home, while watching a great movie, I started to feel odd again.  I noted the time , 8:00 pm.  Almost exact time I started feeling odd on Friday.  Same routine, blood pressure crept up, as well as pulse and I started to feel anxious and cold. My mouth went dry and my hands were shaking.  Classic anxiety symptoms !  I told myself that maybe I had hidden stress about the trial and relaxed and tried to ignore it.  I could not . It kept getting worse. 

I thought maybe since I ate dinner so early that my blood sugar had taken a dive (at that point I wanted to pin it on anything BUT the investigational drug , because I was so happy to be on the trial.  I forced myself to eat a snack, and have some warm milk.  Surprisingly, it worked, and the symptoms went away , again suddenly .  Bam , all of a sudden as quickly as it came on, it was gone.  I made a note of it to mention to my research coordinator, and went to bed, slept soundly.

 

Monday,  this pattern happened again.  Wonderful, productive day, uneventful.  At about 8:00 pm , the whole thing started again.  Oh, I forgot to mention, my time for taking the study drug was 11:00 AM every day. I took my heart meds at 6:00 AM and 6:00 PM.   The reason I did not connect the symptoms to my study drug was it had been so long since my dose!  

Anyways,  same thing different day. blood pressure , pulse soars, over the moon anxiety (which is odd since I take a beta blocker!) This time I was bound and determine not to call my research nurse, and rid it out , thinking it would go away if I ate a snack like the other night.  Did not happen this time, and this time it lasted  all night.  I spent all of Monday night sitting on the front porch freezing in 100 degree heat , watching a spider build it's web on my porch lol.   When my husband's alarm went off, I was still awake .  I had my morning dose of beta blocker , and was exhausted , cold and weak.  The symptoms did not go away,  I was too tired to be anxious, but the anxiety (clenching tight feeling with dry mouth ) did not go away.  Oh, by this time I had diarrhea as well. 

 At around 8:00  I called the nurse and she had me come in immediately and go with her to see the Dr.   

After examining me and taking extensive notes, he just looked at me and told me he was taking me off the trial. He ordered extensive tests, including a thyroid panel and blood sugar test.   He called Merck and had me unblinded, turned out I was on active drug.

I was floored, and burst into tears.  I am not normally a very emotional person but the exhaustion combined with the deep disappointment just caused me to lose it.

I  felt like a failure, and if I had known that I would be taken off, I may have just sucked it up and seen if it continued.  The doctor and the staff of the research clinic were SO kind, and made me realize that even this outcome may be of benefit to the drug company, and they were not going to risk my long term health if there was a chance that this was a side effect of drug interaction of some sort .  Still , I am disappointed. 

They especially were interested in my thyroid test.  I had one a while back when I was being diagnosed for Ventricular Tachycardia,  and was borderline high.  After my successful ablation , I totally forgot about my thyroid test,  though it WAS included in my medical records given over to the drug company.

I find out the results of the exhaustive blood work they did , at the end of the week.  I have an appointment with my Electrophysiologist today, and will continue to follow up at the research clinic  for awhile (not sure how long) , since this happened on active drug.  

Marcy you may repost this if you like but I feel like I need to get away from looking at message boards for awhile,  and concentrate of getting healthy again and looking to future.  I am going on a cruise and forgetting all this for a while,  my Gastro told me with such a stellar biopsy report, I can afford to wait, although he would not put me on Merck drugs.  He told me that the results of me going off treatment would most likely cause my virus to mutate , and I be put on a different drug combo.

  



-- Edited by Milliganus on Wednesday 23rd of July 2014 05:38:28 PM



-- Edited by Milliganus on Wednesday 23rd of July 2014 09:35:29 PM

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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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I just had a handwritten log I kept of time and date when I took my pills--I had 2 Merck pills and 2 Riba a day.  Took my Merck pills in the morning with one riba and the other Riba in the afternoon.  Had to sign and turn in the log each time I went in and any pills I had left.  Got new pills each test date. 

You will both do fine.  The SVR rates are really good with Merck.

SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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I don't have to log my food either.  Just when I take the pill on the electronic device.  Keeping my fingers crossed for both of us!!!



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Hi Jude,

Congratulations on getting the trial and no cirrhosis.  Don't think I would have done well with keeping a journal and listing my foods.  I was just lucky that I did not have to do that.  I did a questionnaire several times during my trial, but did not feel it was of a lot of value.  I could only answer with a 1-10 response with no explanation.  Did you get a list of foods you could not eat? 

I am very happy with my Merck results.  As you can see from my signature, I responded rapidly to their drugs.   

    SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Hi Marcy,

Well, if you are really curious, you can always have liver enzyme tests done with your doctor at a different lab-- mine began to drop quickly. I started at ALT 80, AST 87.  By the end of week 2,  I was ALT42 AST 49. week 4-- 29 and 44.  But if you are on placebo, you will still have to just keep doing the trial to get the meds later.  I know I would have thought about it--but not sure that I would have done it.  If your stomach begins to hurt, you probably got the meds. That was my major side effect.  If I had it to do over, I would take my meds with a full meal instead of just a snack. But I did have ribavirin, which you won't have.

Either way, you will get a great combo--sooner or later.  When I started my trial, there was NO published data on Merck new meds.  The first published info came out in November.  And I was not told until week 12 that I was on the week 18 arm of the trial. My coordinator did not know either.  But I am ever so grateful to have done the trial      



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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FYI....found out the generic names of the 2 drugs in this Merck combo:

 

MK-5172   Grazoprevir

MK-8742   Elbasvir

 

 

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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SuziQ...Yes I had to take 1st dose in front of them.  I specifically asked about how the trial center keeps from knowing who is on placebo or real thing.  My coordinator said that after the 1st visit (where I took first pill), they don't see the results of the viral load until after the unblinding, weeks 13-16.

 

BTW...this trial is the C-Edge TN trial.

 

Thanks.



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Marcy, 

That's Great! Please let us know how the trial goes! You're on your way now! Congrats!



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!



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Hi Marcy,

It must be good to have finally started. I'll be following your progress with interest as I'm a big fan of the Merck combo. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Hello Marcy

Congrats on getting accepted into the trial, it can be a real challenge to jump through all the hoops but once you make it you will be glad you did. The liver biopsy alone cost thousands not to mention all the tests.

Not knowing what arm your in can have its effect on your mind but in the end you will be treated with the meds either way. Keep as true as you can to the daily meds and find a guiet place daily to spend at least a half an hour to clear your mind and focus on relaxation.

Wishing the best for you

matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 

Tig


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Hi Marcy,

So glad to hear you're on your way! I know exactly how you're feeling when you mentioned wanting to experience a "side effect", lol! We all understand wanting to know that what you're doing is going to deliver you to the destination we are all hoping to arrive at. The manufacturers have done a good job at reducing these sfx, so you may be waiting for awhile to find out. Let's be positive and realize that what ever arm you are a part of, it is your beginning! Grasp your opportunity and run full speed with it, you won't be disappointed. Treat yourself right, pay attention to your diet and remember that hydration is the key. I also recommend you start a journal (log) and write down everything you experience, lab results, etc. It can be very helpful at your doctors appointment and are very useful in the event you need to refer to anything in the years to come. We're all here to help and will be rooting for you Marcy, good luck!!

Tig



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 



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Congrats!!! Don't expect to feel anything--I didn't and I got Riba too. Did they make you take it in front of them at the trial site with food???  That is how I took my first dose.   Wonder how they keep a study blind when there is such rapid response to the new meds??  If they give you the results of your viral load, you will know immediately if you have the meds or not.  My VL was<25 at end of week 1. 

Keep us posted.

SuziQ

 



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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biggrin

Just took my first daily dose of what I hope is the drug (3:1 chance).  Kept waiting for some side effects so I'd know it was the real thing.  I wonder if I'm the first person here who ever wished for some side effects...LOL!!

 

I am feeling very excited and blessed, either way.   It's a pretty cool feeling to finally have some hope, not to mention possibly being saved many thousands of dollars and insurance headaches to be cured of this monster.

 

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Hi Judy,

Where are you doing your trial?  I did mine in Arlington Texas. Think Marcy is doing hers in San Diego Calif. 

I did a biopsy last year.  They put me out and other than being a little sore on my right side afterward, it was not a problem--at all.  So don't worry.

Thing I like about this forum is that it is so supportive and really calms your fears.  Lots of really great people here.

SuziQ 



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Hi

These are the data for the section of the Merck Clinical Trial I did and have completed with EOT+24  SVR

There were 31 people in my arm of the trial--total of 121 people nationwide in the trial that were treatment naïve with cirrhosis.  I was in the third group  MK5172+MK8742+RBV for 18 weeks. I consider myself very fortunate to have been selected for this trial.  I was also in the group that had no relapse.
  
Interim Analysis of the C-WORTHy Trial: Treatment-Naïve, Cirrhotic Patients with HCV
GT1 Infection (Intention-to-Treat Analysis (ITT), Excluding Patients Yet to Reach FU4)
 
Parameter 

MK-5172 + MK-8742 +
RBV
(12 Weeks)
(N = 31)
 MK-5172 + MK-8742
(NO RBV)
(12 Weeks)
(N = 29)
 MK-5172 + MK-8742 +
RBV
(18 Weeks)
(N = 32)
 MK-5172 + MK-8742
(NO RBV)
(18 weeks)
(N = 31)
 
SVR4/8, % (n/m)
 90% (28/31) 97% (28/29) 97% (30/31) 97% (29/30) 
No SVR, % (n) 
Breakthrough 3% (1) 0% (0) 0% (0) 0% (0) 
Relapse 7% (2) 3% (1) 0% (0) 3% (1) 
Non-virologic Discontinuation 0% (0) 0% (0) 3% (1) 0% (0) 
m = patients who have reached the FU4 visits (all patients in the 12-week arms, and 61/63 patients in the 18-week arms have reached FU4).

You can check out all the data available from the previous trials done with these meds by checking Merck C-Worthy trial.  The results were very impressive--Side effects were minimal for me and I also had ribavirin.  And as you can see in my signature line--I am not young.  Lots of luck on your new journey with Merck.



-- Edited by suziq on Tuesday 8th of July 2014 06:49:14 PM



-- Edited by suziq on Tuesday 8th of July 2014 11:02:06 PM

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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Judy,

Keeping fingers crossed.  Liver biopsies aren't bad nowadays.  They put you into the "twilight sleep" so its painless.  I guess the worst part is the IV, but a good nurse makes that fine!  In the old days, I never got the twilight sleep, just local anesthesia around puncture site.  That was not good....You may have some slight soreness after procedure the next day, maybe a little bruising, but nothing bad.

 

Take care and keep us posted.

 

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Hey Marcy 

Congrats on being included in the screening, this is only the first step in the trial process. Make sure you asked them for the qualifying  and disqualifying liver function test limits that they are looking for. Also ask if you will get a second chance if your out of range on the first try. Everyone of the trials have all these hidden qualifiers that we are not aware of until we ask about them.

Hoping the best for you.

matt   



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Tomorrow 8am.   Thanks!!

 



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Hi Milli,

They generally don't call for screening unless they have a slot available. I did my screening at midnight on the first day the slots became available.  I got in.  It was the trial coordinator's idea.  There were nine of us there.

Wish you lots of luck in getting a spot.  I go for my EOT+24 on July 1.  Merck has a great SVR rate so far.  When are you going for screening?  Let us know how it goes.

SuziQ   



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Hope it works out for you.   Be well



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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Got the call to go in for screening this.  The nurse said there are only 5 GT1 slots at this center (San Diego).  Once all GT1's are filled nationwide no more will be accepted.  Fingers crossed that I am not too late.  



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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Hello Jude

I merged your two threads into one since it all had to do with your Trial information and introduction about the yourself and the trial so everyone can get a clear picture.

matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi and Welcome,

I think I am the only one on this forum who has done the Merck trial.  I did my trial in Arlington Texas.  I go for my end of treatment + 24 week labs on July 1st.  You can see from my signature at the bottom how I did on the trial.  The data presented from Merck is VERY promising.  I will be happy to answer any questions you might have. I see you live in Tulsa.  Are you doing the trial there or going down to Arlington?  The 2 hour appointment is generally the initial screening or have you completed that?  Drink lots of water as they want you hydrated --they take lots of blood--but the tech at Arlington was very skilled and got a vein first try every time I went in.  Once I was accepted, I was told to eat  with the meds so take a snack.  Also, there is a list of foods you cannot eat and NO supplements during the trial.  You will do fine.  I got the arm with ribavirin for 18 weeks--so  I did "the max"  Also posted on real or placebo thread.

Congratulations!!!!

SuziQ 



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR

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