Hi Matt,

I don't know how the determination to stop or go on to 18 weeks is made. It may have been done at the beginning or Merck may have some formula they use as they get the data on each participant during the trial.  Since we don't know at the beginning, I suspect it is determined at some point during the trial. They take about 8 vials of blood at each visit and then at week 4 and 12, they take blood at the beginning of the visit and 2 hours later and then again two hours after that-- probably to see how well meds are being digested and getting into the blood stream. And they also do an EKG at weeks 4 and 12. We take our meds at the office on the days of our visits.  We also take all our meds (and empty bottles) into the office at each visit and receive new bottles.  They count our pills and check our pill taking diary.  That is how they found that I had somehow missed one pill.  We even bring a snack as the pills have to be taken with food.

A lot will be determined for Merck from this trial as it accepted cirrhotics, null responders and HIV participants (and at least one really old person). We need several companies with good meds so hopefully there will be some competition on pricing. Gilead is running away with the PR race--at least for now. 

This forum has been wonderful for me as it has a group doing clinical trials. I felt sort of in a vacuum before I found this.  I follow the ION group here and it really helps me not feel alone.  Thank you and all for your support.

SuziQ

Hi Suziq

It's wonderful to hear that everything is going so well, sounds like you really have a great team of medical staff It can really make the whole trial experience much easier.

How is your Merck trial going to determind if you go the extra weeks or not?

The Merck combo is going to be a great competitor to the other DAA's hopefully it's will lower the high price of the coming Meds.

Wishing only the best for you, keep up your postings they are very encouraging for many of us.

Matt

Hi Malcolm,

The coordinator just emailed me again--Said she felt the Hbg was fine for now and to stay on current dose and said again that I am doing great.   I didn't ask her about it--just wrote that I was glad the Hgb wasn't dropping fast.  Her study center participated in the last Merck study. All her people reached SVR. Of course, she couldn't tell me until Merck published their data at the Liver Conference last week.  She attended the conference. 

 She is one dedicated lady.  Daughter of a doctor and nurse--got her RN and then went on to get her PhD in medical research.  Says she really loves it and it shows. I feel very fortunate to be doing the trial there.  She treats me like an equal and does not talk down to me.  All the staff is very pleasant and kind.  Nice atmosphere with no tension in the air. 

There are no words to express my gratitude for being able to participate in a trial at my age.  Somehow, I got the right place for me.  I just decided one day last Spring that it was time to treat and the rest just followed.  I was disappointed that I could not get in the first trial.  She just kept looking for me and here I am--going into my 10th week tomorrow.

SuziQ

Hi Suziq,

Inspirational news. Don't let them drop the Riba dose. You can last 2 weeks with a Hb of 10.5. This is an excellent Trial. Cheers.

Yeah!!!  I was still undetected at week 8.  My Hgb is down to 10.5, but that is not too bad.  She did not give me the other labs results.  I missed her call so she emailed me.  I was a little worried as I missed one pill sometime during the last 4 weeks.  That med has to be kept in the fridge and I must have marked it down as taken and then gotten distracted and didn't go get it.  I put them in a pill minder so I can double check that I have taken one every day.

Next visit (week 12 on Dec 3rd) will be the last---OR I will have 6 more weeks.  Won't know until I go in.  Waiting 4 weeks between labs can seem like a long time. Can't believe I start week 10 tomorrow. 

All else is fine.  I am a little low on energy and itch a little more than usual. No rash--just itch. 

Well, gotta go eat something and take my nightly ribavirin  Still on 1200mg. 

SuziQ 

Hi Malcolm,

The info is out on the Merck trial that I am doing.  100% on 2 arms and one failure on one arm.  I logged in on AASLD 2013 and got the info this afternoon.  They did not have cirrhotic participants in this last trial. But it sure looks good.  Go for my week 8 tests next Wednesday.  I am one of 400 people worldwide who was lucky enough to get into this new trial and probably one of 80 in the arm with cirrhosis. Merck is right up there with the  Gilead/BristolMeyers trial now AND that combination was discontinued by Gilead.  Late start or not, looks like Merck is in the running now!!!  I feel very up right now--but realize nothing is guaranteed.  Thanks for your ongoing help. 

This is the study data released yesterday.

http://finance.yahoo.com/news/merck-announces-presentation-interim-data-130000587.html?soc_src=mediacontentsharebuttons

I'll post my week 8 results when I get them next week.  I go in Wednesday, but have to wait for results.

SuziQ

-- Edited by suziq on Sunday 3rd of November 2013 03:44:46 PM

Hi Malcolm.

I'm on 100mg MK5172 and 50mg Mk 8742.

Yes, I am on 1200 mg ribavirin.  Our coordinator added 1 iron capsule plus B12 daily.

Wish my local doctor had added viral load to my labs, but he didn't.  So it is 2 weeks to see if I am still UND.

Think the A1C is wrong as I have not been below 6.5 since I was diagnosed with diabetes several years ago.

Since I have no sides, it just feels like a waiting game to see if I remain UND.  I simply take my meds and wait for my next appointment. 

SuziQ

Hi SuziQ,

I'm impressed by your liver enzymes. Do you know what dose of MK-5172 you are on? The earlier Trials found that liver enzyme elevation was a problem using the 400 mg and 800 mg dosage. You are probably on 100mg/day. I'm also impressed with your Hb and platelets.  I think you're still on 1,200mg/day of Ribavirin, and if so, I'm surprised your Hb hasn't dropped further.  Victrelis used to accentuate the haemolytic effect of Riba. but it appears this does not happen with MK-5172. You seem to be coping well, and this seems a great drug combination. Carry on!

Thanks so much

You did well on your Abbott trial.  The nearest location for that was San Antonio. I live in Central Texas nearer Dallas and Ft Worth.  I think they had an upper age limit.  And many of the earlier trials did not take people with cirrhosis.  It is exciting, isn't it??  New trials for people with transplants or on transplant lists.  It is so wonderful that the newer treatments are "just around the corner" for everyone. 

Now, if the doctors will just start testing everyone. 

SuziQ

Hi Suzi,

It's always such pleasure to read your good results ! Merck seems to be a real good choice !

Warm hugs

Do

Mallani,

At week 6 by local doctor--

ALT  30

AST  33

Platelets 190-- up from 133 at start of treatment

Hemoglobin holding steady at  11.1  same as week 4.(Ribavirin)

My blood sugar seems to be running high, but my A1C came back 5.1.

I go in to study center on Nov 6th for 8 week tests and the coordinator will have all the news on the Merck trial from her attendance at the Liver Forum in Wash DC.  It is Merck's first presentation on the study I am doing.  It has received Breakthrough Designation. 

Thanks Matt

I do believe my body is saying Ahhh.  My naps have reduced themselves from 2-3 hours to one hour.  I actually feel better than in a long time.  I didn't expect any change in my general health during the trial.  But each day my fatigue seems to be a little less.  Because my health is fairly good for my age, I didn't realize that Hep C was wearing me down.  It is raining today and my hands don't ache.  Just hope the change continues. 

SuziQ 

Hey Susiq

Late congrats onn your 4 weeks UND its a real milestone after so many years.

Your body is saying Ahhhh!

Hoping your car trouble will also be a thing of the past.

Matt

Thanks Suziq and Jill ! seems very interesting and brings hope for us patients with cirrhosis. More years waiting however,but better than nothing like it was till now  

Got this off the net 

press release

Sept. 10, 2013, 8:00 a.m. EDT

Galectin Therapeutics Receives US Patent for Potential Ground-Breaking Treatment for Fatty Liver Disease

That is the article. You can look it up on the internet 

Sorry about this.  Sometimes things just don't work like I want them to

SuziQ

Hi SusiQ, that`s great, congrats to you on your 4 week Undected result!  Your blood levels are looking very good too. 

Hope you get your car sorted out soon...what a nuisance!   Look forward to hearing your next results, good to know it`s going so well for you.

Ps.. Your link doesn`t work for me either..would you mind reposting it, please? 

Hi Suzig,

Oh your hemoglobin number was nice before treatment, you'r great !

133 for platelets is usual for those having cirhosis, it will ger better after treatment will have ended, no worries.

The link you gave us does not work,it says "wrong address", could you have a look ?

Thanks a lot and have a great day,

Dominique

My hemoglobin is 11.1.  It started at around 15.  She did not mention platelets on her message.  They were 133 at start of trial. 

Just got this article from someone about anti-fibrotics. I knew I had seen it somewhere. 

http://www.marke****ch.com/story/galectin-therapeutics-preclinical-data-published-in-plos-one-show-its-galectin-inhibitors-reverse-cirrhosis-and-significantly-reduce-fibrosis-and-portal-hypertension-2013-10-10?reflink=MW_news_stmp

Well, first we stop the virus and then we reverse the damage.  The future looks very promising for us.  Maybe when I am "elderly". 

SuziQ

Here you are, SusiQ, I`ve found another link and some more info.  I think your link didn`t work because of the forum`s automatic spam filter which blocks out certain words.  Very interesting, thanks! 

http://www.fiercebiotech.com/press-releases/galectin-therapeutics-receives-us-patent-potential-ground-breaking-treatmen

So basically Galectin Therapeutics have been granted U.S. patents for 2 drugs they currently have in development, GM-CT-01 and GR-MD-02 , which are carbohydrate-based `galectin inhibitor compounds`, for use in patients with fibrosis, end-stage scarring,or cirrhosis. They haven`t been tested on humans yet so it will be interesting to see the results of the phase 1 study they are intending to carry out

Here`s another link which explains more about it..

http://biotuesdays.com/2013/08/20/galectin-targets-silent-epidemic-in-liver-fibrosis/

The four letters missing in previous edited posts are ****.  Can't get market watch to post

SuziQ

http://www.marke****ch.com/story/galectin-therapeutics-preclinical-data-published-in-plos-one-show-its-galectin-inhibitors-reverse-cirrhosis-and-significantly-reduce-fibrosis-and-portal-hypertension-2013-10-10?reflink=MW_news_stmp

Hope this works --The word after www. is. marke****ch.com  Don't know why it posted with **** in it.  I can't make it post with marke****ch.  The four letters ****--guess **** won't post

SuziQ

-- Edited by suziq on Monday 14th of October 2013 08:30:37 PM

-- Edited by suziq on Monday 14th of October 2013 08:36:54 PM

-- Edited by suziq on Monday 14th of October 2013 08:38:33 PM

Hi Suzi,

Congrats on the 4 week Undetected. I'm interested in your Hb and Platelet levels. Could you post them if you get a chance? I'm very pleased you are coping well with the Merck drugs- I wish they had started Trialling them earlier. Cheers.

Just got the call that I am undetectable at the end of week 4.  Still have either 8 or 14 weeks to go, but for now, I'm doing fine. My cars, however, are still having problems with taking me to the clinic.  My hemoglobin is still falling, but not dramatically.  Enzymes are 29 and 44, but she didn't say which.  I missed her call so just got a message.  I'll call her back on Tuesday when she is in the office.  She said I am right on target for the trial.  Now, my goal is to stay UND. 

SuziQ   

Hi Suzi, I was definitely in the same rowboat as you a year or so ago...hep c from 1970 had never gone away and I didn't know it until then.  I wound up with cirrhosis and bewilderment.  I went through a Bristol Myers clinical trial a couple of hundred miles away from where I live-and in fact just finished up a grueling day driving and flying there for my 6 month labs.  It was worth it for me, though and I know it will work out for you too.  Hugs and best wishes!  Eat well, take care of yourself.

Dear Suzi,

It is great that your viral load is under 25 it means the next will be undetectable .  Hopefully your car is getting better as well. It is so nice to read your optimistic  words. Since I was diagnosed with Hep C infection in 2007 I barely had any day without thinking  about my future. Interferon treatment wasn't so bad but it did not worked on me.  

Have a great weekend,

Veronica

Hi Veronique,

Looks like we will be doing treatment together--yet far apart. I, too, have had Hep C about 50 years.  I've heard good things about the Abbvie trial.  Are you on ribavirin?  I'm on 1200mg a day.  Waiting for my 4 week labs to get back. Weeks 1 and 2 were <25.  I have very few side effects--maybe a little tired some days. Some days I feel really good.   

And as I promised in my last post--all went well on Tuesday.  I drove about 30 miles and rented a car for the day.  It was wonderful--no worries about the car all day.  Had three blood draws--one before meds, one 2 hours after and one four hours after. 

I am determined to do my part for this trial.  I have refused treatment with interferon all these years and really feel it is miraculous that I have been given this chance, especially since my liver damage has progressed into cirrhosis and my age.  I really feel that the strong people are those who treated with interferon-- My hat's off to all of you !!! Sure hope these clinical trials produce new treatments and great results for everyone soon. 

I'll post results as soon as I get them.

SuziQ 

Dear Suzy,

I just red your last post from Monday. I don't think your lost your humor. I guess you are so strong that nothing will stop you to go cross this therapy. You got a big fan from 6000 miles away. Please keep posting!!!

Veronika

Dear Suzi,

Sorry to welcome you so late, I had not seen the new thread. I feel a lot of hapyness to know that some labs agree to have an over 70 patient in one of their Trial. Hurrah Merk !

I hope those problems you have will soon be just souvenirs. I have to go now, but wanted you to know you have one more fan here

Cheers

Do

Hi.

Well, hopefully I go in on Tuesday for my 4 week blood work.  Still having all kinds of car problems.  Can't believe all the things that have happened in this four weeks.  The riba does not make them easier!!!  Two teeth have broken off (never happened before in my 79 years), had about 30 hours of serious pain on my right side this week, my eyes are getting foggier (diagnosed with cataracts the first week of my study) and a tenant didn't pay Sept rent of $600. I ordered a thermostat for my car and got a little bitty sensor--They are so sorry--must have been a computer error.  And none of this directly relates to being on the study.  I do believe that my reaction does relate to the ribavirin.  I am so anxious--not my usual manner.  Can't find my sense of humor. There are other things, staying hydrated does not mix well with old-age incontinence.  But, tomorrow is another day and I will spend it making sure I have a ride to my appointment which is 70 miles away and is a four hour appointment--several blood draws at various intervals.  I'd rent a car, but there are no car rental places within 40 miles. 

That is my rant for the week--I'll write on Wednesday that all went well.

SuziQ    

Hey Susie

Good to hear you are getting along fine, keeping your 1200 mg level is a good thing as it helps to saturate the blood with proper levels of Ribavirin.

That is great news about the 100% results so far.

Yes also noticed that google has a lot of links of dialog on its search engine from HepC friends web site, I guess that part of having an open web site.

Glad to hear you are doing so well.

Matt

Turns out that I am 1A instead of 1B. I noticed it on some study paperwork and asked today when they called.  Everything is ok so I will keep the 1200 mg of ribavirin for now.  Go in next week for a four hour appt.  They draw blood at intervals before and after my pills.  They said that 100% of this same trial that started earlier is UND.  Sounds good to me.

No sides except that I get rather weak and dizzy mid-afternoon, but a short nap clears that up.

  Noticed that if I put in the name of the trial that my post shows up on the internet when I search for my pharmaceutical company.  Same with other companies. 

SuziQ    

Hi suziq,

Your transport problems gave me a smile.I hope you get them sorted. Congrats on the 2 week VL result. Seems the drugs are working well. Being Geno 1b, Ribavirin may not be as important as if you were a 1a. Typically, cirrhotics drop their Hb more rapidly, but if your Hb drops below 10, a small drop in Riba dose probably won't matter for you.

Just for your info. Replicons are cloned molecular copies of the HCV virus. The virus can't be cultured, so little was known about the life cycle or replication until the first replicon was produced in 1989. You probably mean drug-resistant mutations, which have become a real problem in those patients who fail Rx.  In patients who fail Rx with Victrelis or Incivek, drug-resistant mutations (RAV's)  develop, which makes re-treatment impossible. However MK-5172 has been shown to be effective against all known RAV's.  You are quite correct: Merck have been very quiet, and most of the Dollars will be earned by Gilead and Abbott.

Your blood tests show a fairly low VL, and the typical cirrhotic reversal of the ALT:AST ratio. Your platelets are a bit low and may drop a bit, but not to the extent they would using Interferon. I look forward to following your progress. Cheers.

Got a call today (Sunday) for my week 2 results.  I am still<25 on viral load, but my hemoglobin is dropping faster than they want it to.  I go in for more blood work tomorrow (locally) and they will make a decision about my dosage of ribavirin.  At least I know they are keeping a check on my labs.  Certainly didn't expect a Sunday call.  Several arms of the study are without ribavirin so I don't think I will be dropped from study.  I'll ask when she calls with new lab results. 

SuziQ

Hi Mallani,

You are still the oldest male--I will take a place beside you as oldest female--not one above you.

Thank you for the info BUT I am not sure what it means.  It appears that less replicons (whatever they are) survive with the new Merck treatment than from other meds. Looks like it is an excellent new drug combo. I have been looking for info on Merck, but they are less vocal than Gilead or Abbott about their new drugs. On the clinical trials site, the Merck study was not taking cirrhotics.  They opened new slots mid-trial and notified the study centers about them.

Just found some paperwork--my viral load was 733,000  ALT 80  AST 86 Platelets 133  when I screened for the Gilead trial in May 2013.  My liver is not enlarged.  They did not give much detail on the biopsy--just stage 4 of 4 fibrosis (cirrhosis).  Since I refused interferon, my doctors just sort of ignored me and tested yearly.  And really what could they do since I refused treatment? 

 I am waiting on my week two blood work.  My radiator burst a seam on the way to my blood work appt.  I went the next day in my old truck and my battery died on the way back.  Found a way up there with no freeways so if I have problems again, I won't be on an interstate highway.  Luckily, I had not reached the interstate yet when the radiator burst and I was in a parking lot when the battery died, but I was 40 miles or so from home each time.  Had to borrow a step ladder from a store to get in the tow truck that brought my car home.  It was an adventure getting there and back.  The man who helped with my battery (it could not be jumped) turned out to be the service manager for a Lexus dealer.  He took me to get a new battery and installed it for me.  The people who helped me were so very nice!!!  Keeps my faith alive. So glad none of this happened when I went in for the midnight screening for the Merck trial

SuziQ    

Hi Susan,

I relinquish my position as the oldest member of the Forum to you!  I'm very impressed you have got onto the Merck Trial.  I have been complaining about Merck's lack of initiative with MK-5172, as it is probably the best of the second generation anti-proteases. The combination using it with their NS-5A blocker (MK-8742) showed good results (see link), so I'm glad Trials are underway. You must be happy with your results.

Please keep us informed of your progress. Best of luck! Cheers.

http://www.natap.org/2012/AASLD/AASLD_10.htm

Hi Kellie,

I am geno 1B. I was diagnosed in 1999 and had biopsy in 2000.  I was early stage 2 then.  I have probably had Hep C since before 1966 when I was told I had liver damage.  Los Angeles in the 60's !!!  I stopped drinking, drugs in 1966.  But who really knows??? 

Actually I am in pretty good shape.  Have diabetes controlled with glipizide.  Added berberine on my own and blood sugar is normal since.  A couple of blood pressure pills daily and that is normal now.  Just got told that I have cataracts in both eyes.  The center had me checked for free as I told them my vision was sort of foggy at times. FibroSure test about six years ago came up stage two--but it is unreliable in mid-scale.  The center did a lot of tests on me and considered me healthy enough to do the trial.  Spleen is slightly enlarged from Hep C.  I was healthy enough that Gilead did the biopsy, but refused me because of cirrhosis.  But I passed for the Merck trial, which did take cirrhosis.

I have been taking supplements( ALA, selenium, milk thistle, D3, B12 etc) for about five years.  I can be achey now and then, but attribute that to my age.  I am rarely depressed--was born an optimist.   I live alone and just do what I please most of the time--nap when I choose etc.  It is an interesting time of life.  Kids, grandkids and great grandkids don't live nearby so I don't have to please them.  Parents, of course, are gone.  I was really surprised that I had progressed to cirrhosis

.I think that Hep C affects different people differently.  Some have a lot more side effects than others.  I do believe that the supplements helped with possible side effects.

Now, hopefully, I can find out about life without Hep C.  I think it was my curiosity that spurred me on to do a clinical trial.  But, curiosity aside, I really hope it works for me. I was very disappointed not to get in the Gilead trial.  The coordinator was really hoping she could find a trial for me--and she did.  Next step is anti-fibrotics which are just getting underway.  At present time, they are looking at them for people with fatty liver disease.  Duke Univ is doing a one shot and you are cured study for Hep C.  Great time for all of us--great new treatments are just around the corner--especially for the youngsters in their 50's or so.

SuziQ

Welcome SuziQ! Best wishes to you for a sucessful clinical trial with a big SVR.

I'm curious, do you know how long you have had the virus and were you suffering any side effects that you know of from the virus? I have a good friend who is 76 and has had it 30+ years. She is suffering from a lot of side effects. Some peripheral neuropathy, confusion, depression, unexplained body pain etc. Also do you know your genotype? Best to you, Kellie

Thanks so much for your thumbs up.  If anyone lives near the Dallas Ft Worth area, The center will be doing new trials around the first of the year.  It is best to start early so you have all your medical history in before they start recruiting.  They do trials for both Gilead and Merck and maybe others.  I live about 70 miles south of the center so it is a drive for me,  Phone number for the center is 817-471-1070 if anyone is interested.  I drove up at midnight for this trial as there was a limited number of slots nationwide and the coordinator wanted us to get a slot.  It was first come. first serve.  The whole staff came in and each of us who came in at midnight got a slot. I was really impressed that they cared so much.  They would not let us sign anything until one minute after midnight on the start date of recruiting.  Actually, Aug 26th was my 79th birthday and I signed up one minute after midnight on Aug 27th.  What a birthday present.

SuziQ  

Welcome Susan, alot of great info here in our forum. But you seem pretty well informed already. Would like to hear more from you so stick around and keep us posted on your trial.

~BOB~

Hi Susan,

brave decision indeed. We are all here very keen on clinical trials, so please keep us updated how it goes with Merck one. Good luck!

best

Hello Susan

Welcome to the forum you have found a helpful place. It's vey nice to have a participant from the Merck study on their new HCV drugs (MK-5172 and MK-8742). The forum is very keen on  following new trials.

We are very happy for you on your 1 week result (<25) its a good sign of things to come.

I am very impressed with Merck and yourself for the willingness to be in a trial at this stage in your life, you must be one special lady and we are very happy to have you as a member that will contribute your experiences.

Wishing you all the best.

Matt

Hi Susan, welcome from me too, and well done for getting on this trial!  Good to hear you`re responding so well with such an amazing drop in viral load after just one week, that`s impressive!  This combo of MK-5172, a second generation protease inhibitor, and MK-8742, an NS5A blocker, looks very promising, especially with the addition of ribavirin.

Thanks for sharing the details with us, we`ll look forward to following your progress.  All the best of luck! 

Just started Merck clinical trial NCT01717326 two weeks ago in Arlington Texas.  I was <25 at end of week 1. Don't have week 2 labs yet.  Was denied Gilead trial in April as my free biopsy came back cirrhosis. I have refused interferon since I was diagnosed in 1999 so was treatment naïve.  It is a big step for an old woman (79), but what the heck. A real miracle that I was even accepted in a trial.  No real side effects except a brief rash that stopped with cortisone cream.  I am on group with riba.  It is 12 to 18 weeks , but I won't know which until week 12. No results from Merck as the original trial is ongoing.  Mid trial Merck decided to add some people with cirrhosis and my study site called to see if I was interested.  It is not a blind study.  Two pills once a day and riba twice daily. So I am off on this new adventure.