Finally, some Merck news

Blog: HCV New Drug Research
Post: AASLD: Merck to Present Interim results of C-SWIFT Study/MK-5172/MK-8742 plus sofosbuvir
Link: http://hepatitiscnewdrugs.blogspot.com/2014/10/aasld-merck-to-present-interim-results.html 

SuziQ

Praying for your success and long life hepc free.

Feeling about the same as when I was on treatment.  I had more energy than usual and that has remained.  I have had some fatigue, but that was normal for me.  Really nothing earth shattering to report.  I should know within a week or two my final VL.....

Thanks for asking! 

Marcy, how are you feeling after tx?  Are you noticing any positive changes in health or energy?  Just curious.   Hope this does it for you. 

Thanks all.

I'll put something in tag line later. 

I probably contracted the virus in 1969 because the Army used pneumatic needles then.  Blood became positive with unknown virus in 1976.  In 1990, I was told not to give blood any longer (I had a 5gal pin).  Dia. in 04, but did not seek treatment.  I don't know how I got into the trial.  I have an angel somewhere.  I've had 4 liver biopsies, but for the trial, another was scheduled.  In that one they found bridging fibrosis.  I live in Chesapeake, VA and travel to Richmond Va Center(2 hr drive) for blood work and Dr visits.  I have an electronic diary and take the med at 11am every morning.  This is a double blind research trial.  My nurse did tell me that my liver enzymes have dropped near 80 percent to normal and that may indicate I'm on the real deal.

Regardless, I will eventually receive the real drug if not receiving now.  They have promised to take care of me for many years for research purposes and any major illness that occurs.   I think it a great deal. It's costing nothing and they're paying for gas too.

My knowledge from what the nurses are saying is no one is experiencing major side effects.  I have headaches and ringing in the ears.  Once I became violently ill for about 15 min.  But from what I hear, that's nothing.

Hi Ray,

I just finished the C-Edge 12 week trial  last week.  I am pretty sure I was on the real drug, not placebo.  Within the first 2 weeks my labs, particularly liver panel dropped by 50%.  I had very few side effects.  A very slight headache the first week was about it.  

Where are you doing your trial?  I did mine at Scripps in La Jolla Ca.  

Welcome to the forum! 

Hi Ray,

Welcome to the forum and congratulations on getting into the Merck trial.  I think the only other person who has done Merck on the forum is Milliganus, who is finishing up the double blind study.  I did the 18 week phase 2 trial last year.  One other person on the forum started the trial, but had a severe reaction to it and had to drop out.

My history is in my signature lines so won't repeat it here. 

I just did my first follow-up study last Friday.  My scan was good with no evidence of cancer.  Everything was normal, but my platelets were a little low (126). Still SVR.  I got my first undetected in early October last year--so I am a year without the virus-

Just noticed that Milliganus just posted while I am writing this--Hope it is about her results. 

Glad Tig posted some info on Merck's phase 2 trial.  Merck just doesn't give out much information.  I am sure they will present at the Liver Conference in November. 

SuziQ

Hi Ray,

Welcome to the forum! Glad you're here. We've got some members that have participated in these trials and should respond. We've also got some that completed the C-worthy trial as well. The information I located is from Merck and you've probably seen it but I'll post the link in case you missed it.

http://www.mercknewsroom.com/news-release/corporate-news/mercks-investigational-chronic-hepatitis-c-combination-therapy-mk-5172mk

The Clinical Trials site isn't very giving of information, so no help there. Will keep digging and hoping for your success with the trial. Please feel free to provide us with some background, it helps us provide better informed opinions. It's nice to see your labs which allows us to follow your progress along the way. We often add that to our signature line so it accompanies our future posts. I hope you stick around and share your good news and results!

Tig

Hello all,

I'm new to this forum and on week 7 of Merck trial (C-edge).  At week 6, my liver enzymes were normal - dropped 80%.

I'm hoping to find others who are either on this trail or have completed phase 1 or 2.

Thanks

Hey Suziq

I'm so sad to hear the report on your fire, its devastating to all your memories but one can feel comfort in the realization that your life is the really only thing that can't' really be replaced. Having no insurance is the worse, but with your spirit and will you will come out  of this alright. 

Congrats on the 9 week report SVR 12 is right around the corner.

matt

Hi SusiQ, it`s good to hear from you again and great that you`re were still undetected at 9 weeks post tx.

I can`t tell you how sorry I am about the fire though, and the loss of your home and some of your dear kittens, and my heart goes out to you with what you must have been through over recent weeks.  Thank goodness you were unhurt though, and it sounds like you`re starting to put your life back together now.  You must have been delighted to see some of the kittens again!

Wishing all the best to you as you move forward, your strength and determination are great assets, and we`re here for you anytime you need some friendly support.

Keep in touch, and hope to hear from you again soon!  Sending hugs... 

Hi Susan,

Im so sorry to hear the news of your fire and the loss of your beloved kitties. I know how very important each of them are and the comfort both bring to you. My thoughts and prayers are with you and if there is anything I can do, please let me know. There are people here and our personal networks reach far and wide. You're not alone, okay?

So pleased to hear that you remain undetectable! I'm going to say that with 3 weeks to go, SVR12 is likely and that's very good news, especially at a time when it may seem kind of thin in quantity. Keep the faith and try to keep that smile on your face and in your heart! We're here for you. Good luck and stay in touch, better days ahead!

Hugs,  Tig  

Oh no Suziq, a fire, how terrible.  I can't imagine what you are having to go through every day right now.   You are definitely a survivor....fighting for life on two fronts! 

Congratulations on the UND status nine weeks after EOT.  Great news!!!

Hi SuziQ,

Wow! Very sorry to hear about the fire. Bummer. I was wondering what had happened to you.

Congrats on the 9 week post-Rx Undetected. That's looking like SVR to me. Merck have great drugs but are getting late for the party. Keep in touch. Cheers.

Hi All,

 Did my 8 week post treatment labs at 9 weeks and have my 12 week post treatment next Tuesday.  I was still undetected at 9 weeks.

My house burned down on March 7 so I have been without my computer or much of anything else.  Got a new insurance policy last year and they cancelled recently and I didn't get back in for a new policy-- so no insurance.  Lost some of my beloved kitties of smoke inhalation.  I've been camping out in an old motorhome with no water or electricity next to the house so the remaining kitties can come home.  They scattered into the woods, but most are back. Just got electricity in a house I foreclosed on that is in pretty bad condition, but it will be a roof over my head.  Water and a toilet later this week (I hope) The laptop screen sort of melted, BUT the computer still works so I am using a monitor with it now that I have electricity in the new? place.  Actually watched TV on my computer today--first time since the fire.  All in all, I am doing fine.

I'll catch up on all the news soon. I' sure many are coming back UND with the new meds.

SuziQ  

My parents were also very conscious of diet, no candy or cookies allowed, lots of fruits and vegetables, etc. and this has made a bid difference in my life. We had a garden and my mother made our bread herself. I still try to eat this way as an adult.

People have made fun of me for my eating habits but 1) I am alive and some of them are not and 2) I am healthy despite HCV.

Congragulations on UND!!

Hi Jill and Mallani,

Not sure that my SVR date is July, but I got a schedule to return Feb March April and July, so I sort of felt that Merck wanted to be sure I am still UND in July.  If they have concerns, then would I be considered SVR earlier?  Of course, I am not privy to what tests they are taking or why.  I do realize that few relapse after 12 weeks EOT--actually after 8 weeks EOT.  I, of course, have no plans to relapse LOL..  My coordinator said if I did relapse, then she would just find me another trial.  She is sort of quiet and serious, but very upbeat and supportive.  So glad I got to do my trial there.  She did say that none of her people on this or previous Merck trial have relapsed and that she has great confidence in the Merck combo. 

I talked to her about gastro issues and if they continue, the MD there could schedule a colonoscopy and endoscopy in a month or so.   Haven't had one in about 5 years.  My father died of stomach cancer and my brother of colon cancer.  Hep C is not the only thing that can give serious consequences.  I feel very fortunate to have so few health issues at my age. My mom taught foods and clothing so she was very conscious of nutrition.  Lots of veggies in our diet and few sweets or snacks and no sodas in our house.

SuziQ

SuziQ

That is wonderful news, SusiQ, congrats!  Really pleased for you, and what a boost this must be after all these weeks!

I`m surprised too that you`ll have to wait for 6 months, that`s unusual for a clinical trial, but it will give you time to forget all about Hep C and the routine of daily medications. 

Relax and make the best of your time now, the hardest part is over with, well done! 

All the best for a speedy recovery. 

Hi Suziq

You have made it to your last week and now the waiting comes.

Best advice take a nice long walk in a beautiful park enjoy the fresh air and the moments of freedom and comes with being off the meds.

You have made it home after all these years

matt

Susan, 

Congratulations on the good news and EOT! It's such a relief to know that you're done with the counting and done with the worry about "what if" during your march to the end of treatment. Now you can concentrate on reaching your SVR in the months ahead and I believe that will be your next bit of great news! You've waited a very long time for this and you absolutely deserve it! Good luck and we will all look forward to the day when we can all celebrate SVR together.

Tig

Hi SuziQ,

Congrats again on your EOT labs. I'm surprised you have to wait 6 months as most Trials seem to accept SVR12 as the endpoint. Recover quickly. Cheers.

Congrats! hope you are getting back your pre-tx energy levels :)
July and good SVR news will come soon. I am sure you will still be UND and you can then put this hcv episode in your life behind. Thanks for all the help on this forum!

cheers

Great News SuziQ

Time to start Living Hope your SVR comes quickly

BillS 

Hi All,

Just got my EOT results.  UND  Enzymes 27 and 33  Hgb 11.5  Not bad after 18 weeks of riba.

Now it just waiting and testing until July 1--my 6 month test date after EOT and, hopefully, my SVR date.

The coordinator has no idea when Merck will start phase 3 trials.  They are pretty secretive until they announce prior results. 

SuziQ

Hi Suziq,

Congrats on getting to 16 weeks. Great enzymes and Hb. Sorry to hear about your problems. There will be time to sit in that rocking chair when you're older and HepC free. Cheers.

Hi SusiQ, congrats on your latest UND result, great to know you`re still on course. 

Very sorry you have such difficult issues going on in your life at the moment though, and how sad that your daughter has lost her long term companion, you must all be devastated by such a great loss.  So frustrating for you living so far away too, but you can only do your best, which is exactly what you are doing.

Good news anyway that your local sheriff is helping out with the rent situation, that should take some of the stress off your shoulders at least.

Just keep moving forward, and I really hope that this year will bring better times your way.  

Sending hugs, and all best wishes for peaceful days ahead! xx

Hi SuziQ,

I'm happy to hear that your Tx is progressing as desired. However, I'm so sorry to hear about the loss of your daughter's companion over the holidays. That must've been doubly difficult for both of you. My prayers are there for your family and her companion's as well. Please feel free to share these difficulties with us here. You have all of our support.

Best wishes,  Tig

Week 16  Still UND.  Enzymes 40 and 42,  Hgb 11.3 ( holding steady)  I am having some stomach pain But read on my contract that it is a possible side effect.  I have 9 days to go until EOT. 

My stress levels are way up there.  Two tenants haven't paid Dec rent.  My 61 yr old daughter unexpectedly lost her companion of 18 years on Dec 29 and she is devastated.  He had COPD.  She got laid off about 10 months ago and hasn't found work and now there is no income at all. She is buying her home.  Since they weren't married, his family has stepped in and picked up funeral expense.  They have been very nice about it, but live 2000 miles away so he is being cremated and sent home to his family plot.  She couldn't have children so she has no one but me to help.  It is such a mess.  She lives 250 miles away.  Went over last weekend and going back next week. 

I am so glad that treatment is almost over and that I don't have interferon to cope with on my trial.  I have been getting less and less energetic over the last four weeks. Just a few days left to go and hope I rebound quickly.

On the up side, the sheriff called last night and said he and his wife would help with collecting rent--and possibly manage the properties for me.  That would be such a blessing.  I somehow envisioned getting old as a time of sitting in a rocking chair and being serene. 

Enough of my worries--  Happy New Year Everyone !!!

SuziQ

Congrats on your 12 week UND, SusiQ, that`s great to hear.  You`re responding very well to this Merck combo and have every reason to be very pleased with your progress so far.  The grouchiness is quite normal, anyone who`s had experience of treatment with riba will understand what it feels like! 

Thanks for keeping us updated.  Not much longer to go...Merry Christmas to you! 

Hey Suziq

Great to hear your 12 week result, reminds me how fast time travels when your not looking.

Keep on truckin and receive the reward.

matt

Hi Suziq,

Congrats on the Undetected. 'Grouchy' is to be expected and it soon eases after EOT. Relax and finish those wonderful pills, and coast to the finish line. All the best.

Great news SuziQ, your doing great..

Congrats Suziq. Very Happy for you and hope you have A Wonderful Christmas!!

that's great news.Keep it up.

Congratulations on your UND SuziQ! That's great news and a great indication for more good news to come? Hope you have a great Christmas too!! 

congrats! :) you must be thrilled with results.

thanks for asking for us "outcasted" GT3s ;) i think i will be patient until something new gets our (or there is always an option to rob Gilead's lab) ;)

cheers!

That is great news on your results.  I saw earlier you posted that you will be on meds for 18 weeks.  You can do it. 

Hi SuziQ, that's great news! So glad your Hgb is going back up. That has to be giving you some much needed energy. I hope the upswing continues, along with the promising information! Good luck 

Sounds very good to me too SusiQ, very good luck to you.

Hi SusiQ, great results, all sounds good to me too!  Very encouraging progress, let us know about your VL test result when you get it...best of luck! 

Partial report from week 12.  My enzymes are the best ever  27 and 35.  My Hgb has gone up instead of down- It was 10.5 at week 8 and 11.2 at week 12.  She does not have my VL back yet--Reported on Liver Imaging thread that my scan had some good results--liver is shrinking and spleen is normal--compared to April scan.  All sounds good to me. 

Hi SusiQ, thanks for posting the info on your trial, and yes, many people will no doubt be interested in following your progress.  It`s good to hear you`ll be doing 18 weeks actually, the longer you can be on the medications the better your chances of a successful outcome.

I`ve joined your 2 threads together now, so that all your updates are in one place, and if any new member joins who is on the same Merck trial we`ll be sure to direct them to you. 

Best of luck with your appointment next Tues! 

Hi Matt,

Yes, I read/scanned that post.  If you will post the link to it again, I will reply to it.   It would be helpful to have more info available.  If there is something we can do to be more receptive to treatment--then we will know.  Or look for a combo that is successful where our treatment failed. 

SuziQ 

Hey Suziq

Looks like your odds just went up. If I may speculate they may extend the participants that did not achieve RVR ( those who were UND by week four) but there are bound to be more criteria than that.

One the factors that I have learned about HCV clinical trials is all these drug companies hold very (secretly) discreetly is the Rav's data about there individual drugs because it's what most doctors and scientists agree to be the Achilles' heel of DAA's. In my trial they draw 12 tubes of blood and more than one is for testing for Rav's. The positive about Mercks MK-5172 is its has shown one of the highest barriers to Rav's to date. 

Even at this point in my trial ( 6 months post treatment ) I still have not been informed about my Rav's status and don't know why I relapsed, but hopefully I will someday. 

Suziq I don't know if your interested in contributing to the input, but the FDA is currently asking for input into its HCV Clincial trials Guideline. It's a document that will guide all clinical trials in the future. I called via telephone one of the directors and she mentioned they would like to have more patient input in the content of the document. I posted a early thread on this if you want the link.

matt

Hmmm,

Looks like I didn't do adequate research.  This is the info on the current trial.  Looks like only some of us with cirrhosis and null responders will go on to 18 weeks.  The prior trial was 12 weeks. Also says there are about 400 people in this trial. Below is what I found.  

The most frequently reported adverse events occurring in the study were fatigue (26 per cent), headache (22 per cent), nausea (18 per cent), diarrhea (12 per cent), dizziness (11 per cent) and rash (11 per cent). The incidence of anemia (10 mg/dL hemoglobin) and elevated total bilirubin levels to 2 times the upper limit of normal was 19 percent and 4 per cent, respectively, in the RBV containing arms (combined arms 1 and 2), and 0 per cent and 0 percent, respectively, in the RBV-free arm. No grade 3 or 4 laboratory abnormalities were observed. There were eight cases of rash. Seven cases of rash were observed in the ribavirin-containing arms; half of these cases were attributed to ribavirin. The single case in the RBV-free arm was not study drug related and was mild in intensity. No early discontinuations due to drug-related adverse events were recorded.

The C-WORTHY trial has been expanded to evaluate the safety and efficacy of MK-5172 and MK-8742, with or without RBV, in difficult-to-cure HCV genotype 1-infected patient populations. Approximately 400 additional HCV genotype 1-infected patients have been enrolled in this trial. The expanded C-WORTHY study is testing:

• 8 week regimen of MK-5172/MK-8742 + RBV in treatment naïve non-cirrhotic patients
• 12 week regimen of MK-5172/MK-8742 without RBV in treatment-naïve non-cirrhotic patients
• 12 week regimens (MK-5172/MK-8742 with or without RBV) among HIV co-infected patients
• 12 or 18 week regimens (MK-5172/MK-8742 with or without RBV) in patients with cirrhosis
• 12 or 18 week regimens (MK-5172/MK-8742 with or without RBV) in patients who had failed to respond to prior peginterferon and RBV therapy ("null responders").

Details on the C-WORTHY Study, as well as additional phase II trials for MK-5172 and MK-8742, can be viewed on ClinicalTrials.gov

SuziQ

Hi Matt, Decided to post again under my trial after reading C girls post about people who read the posts. At least someone on the trial now --or who might be offered the trial later-would have some info on the trial. I have no idea how many slots there were available for this trial.

My contract states that the length of trial would be a random choice. I don't know if it is totally random or is made by a computer that has evaluated our prior labs and status--like cirrhosis, prior treatment, HIV and maybe even age. Since I will be receiving my meds (or not) at the week 12 blood draw, I will know next Tuesday. So, for the moment, it is wait and see. My coordinator did say that the one person who did not reach SVR in the prior trial had other issues.

After reading posts from others on different trials, I feel so fortunate to be on a trial with so few side effects. Just hope it comes through with flying colors, so that it will be successful and available for others in the future. Gilead needs some strong competition. Hopefully that will bring the prices down.

Happy Thanksgiving to All.

SuziQ

Hey Suziq

Nice to hear from you, sounds like things are flowing along normal for you. The Riba rage is a very common thing but it starts the diminish soon after ending the Meds.

I am surprised that the forum has not found another member that would be in the C-worthy trial group, but that does not mean that they do not read your threads. I hope your visit on the 3rd goes well, perhaps you will be extended. Sounds like someone in the group will why not you. You might ask your great nurse about what considerations that will determine who gets the longer treatment times.

matt 

I've been checking out the great results on other trials. Didn't get a response for this trial. Of course, only had 98 people in the earlier part of this phase II trial and I am not sure how many in this later part of Phase II.  I have 6 days to my week 12 blood draw.  It will be EOT or 6 more weeks of meds, depending on which as yet undisclosed arm I am on. 

Not a lot in way of side effects--mostly from ribavirin.  Hgb was 10.1 at end of week 8--started at a little over 15.  I am more irritable and easily frustrated as time goes by. And my energy levels go slowly down. Having difficulties dealing with neighbors and renters 20 years younger than me who are acting helpless.  Didn't bother me much before treatment. 

This combo got great reviews in the ASSLD conference and is on breakthrough status, but they just had 98 people in the earlier part of this trial.  As Matt stated in another thread--the effects of these clinical trials still have a way to go in understanding how they affect larger groups of us. I am hopeful it is a good combo while remaining aware that it has been so far a very small trial. 

I'll have more info after my appointment Tuesday Dec 3rd.

Thanks to all who post on their trials--I read them all.

SuziQ

Hi.

I'm into my 10th week of the latest Merck Study with MK-5172 and MK-8742, now called the C-Worthy trial.  Is anyone else here doing that trial??? Or did the same trial earlier this year??  I was <25 weeks 1 and 2 and UND weeks 4 and 8. I am on the arm for cirrhosis with ribavirin.

I would love to hear from anyone doing this trial. The data from the earlier trial published at the ASSLD conference was excellent.  A "Study Buddy" would be great.

SuziQ