Not Negative at 4 weeks on O/S

[AugustineMama]

Wondering is anyone did not become UND at 4 weeks. Went from 143,000 to 44 in 2 weeks and at 4 weeks now 20. Is this good or bad

[heart_in_the_keyes]

To whoever said I was knowledgably thanks but am not....I am just living it...and I am a preverbal miss sunshine...have been put in my place several times so I stick to what I know.  I may not be clinical like some but I value this website.  There are quite a few knowledgeable posters.

Hector, Advocate and Orphanhawk were the first to response to me and then others. So many more...and I appreciate it.   At first I just read, then I started posting, but now am too tired to post all the time.

You can always make friends with a person and the go to their board and read their posts.  Since information changes with the results and time I try to read the posts a couple of times a week to stay current and have the emails sent to me.

Next week is my last week on sovaldi / riba.  We'll see. I had been having signs for years before being diagnoised but doctors always said it's stress, it's depression, etc   My bottom line is just keep trying ... they gave me 30 days to live and for me to put my affairs in order when officially diagnoised in 95.  I said bull s...... !!!!!!  Get me another doctor and they did and he was so progressive then he went into HCV research and turned me over to a doctor who I have gone to since and obviously trust with my life.

I am knowledgeable in nutriention but don't get into the discussions much any more.....no red or processed meats...also no sugar substitute  ...could use agrava but if you just stop with the sugar altogether soon you wouldn't miss it...if a recipe necessities it, use brown sugar.... no sodium, caffeine, or carbonation, .....drink fruit and vegetable ....just and follow a vegetarian diet as best as I can.  I learned to cook in the South and it is hard to give up that bacon, sugar and  butter.  I was shocked that I could kick the butter and sugar.

I try to drink a lot of water, very important...also drink or try to, 4-6 cups of oolong tea, cold or hot and a couple of cups of coffee a day.  But water is the key.  As your liver get is worse ...like in decompensation...it is better to eat small mini meals or snack through out the day....puts less stress on your liver...remember everything you intake filters through your liver....

I start my day with pineapple juice, yogurt and fruit...a mid morning snack if I need it of a tablespoon of peanut butter with a half a apple..then lunch a salad or I have a weakness for grilled cheese but cook it with miracle whip not butter.......etc., etc.  I use a lot of spices, beans, eggs, legumes.  You can get protein many ways on a vegetarian diet.   Think you get the idea.  I still struggle with other foods but I just don't purchase them...

You can make changes.  A good diet won't cure you ... but it will give you the energy you need.

Think positive......read....research....ask questions....find out what works for you.  Each of us are individuals...what works for me might not work for you.
Whatever do you do....but please use common sense....and this is to others...if you are smoking...drinking alcohol...taking non-prescribed drugs....stop.  

Good luck to you................

[patra_]

My Dr uses 3, 7, 11, etc w/ visits a wk later.  However I am now also being tested every 2 wks to monitor my Hmg, next Lab w/b drawn on completion of 13 wks exactly, and will include CBC, LFTs and another Viral Load test.

I agree w/why Mayo is monitoring you so regularly.

Good luck and hang in there, every UND is a win for your liver as even w/ cirrhosis, the liver CAN improve while the virus is not attacking it!

On to Battle, warriors, lets kill this dragon forever!  Pat

[AugustineMama]

I have a direct set of orders from my doc at Mayo as follows:

2 weeks
4 weeks
6 weeks
8 weeks
12 weeks
SVR week 4
SVR week 8
SVR week 12

They may be doing this as I have stage IV cirrhosis, but this is my outlined order which I have.

[patra_]

Thanks for the update and clarification.  I missed the part about whether to do it @EOT or EOT Wk4.  I am learning everyday, but appreciate the correct information when I do it wrong or misunderstand.  I don't ever want to give some one wrong info or respond inappropriately because I didn't have it right myself.  

Again, thanks, can.  Appreciate it!

Be well.  Pat

[can-do-man]

I think you misunderstood my answer in that thread and the OP's question as she asked if she should have one done now at EOT or wait. Please read my answer. Thanks

[patra_]

Can:  See Hector's answer as od 3 hours ago under the thread 'EOT, finally'.

Basically he said that the EOT4 is 98.5 predictive of SVR 12, so that is a good reason to check it, AND that if someone is going to fail, since usually it is within that first 4 weeks, knowing that early, allows the patient and his/her Dr go ahead and begin planning for the next step.  But look at his entry.  He spells it out much better than I can.

Hope this helps!  Hang in there.  Pat

[can-do-man]

While I'm not disagreeing  that an RVR is not important and trial results seem to show everyone goes UND during treatment. The question is then WHY do they even do a four week viral load if it has no meaning?

[Ekkiemom]

You aren't being too pollyannish just speaking from experience and from the heart and since I'm unable to give you a real hug here goes a GREAT BIG HUG VIA THE SUPER HIGHWAY!!  I have to keep moving forward and be thankful that I ...we...have much stronger meds than ever before with min side fx.... Thanks for being our cheerleader and thx to Hector for all of his help...for that matter thx everyone!  Good Health
Deb

[patra_]

My carefully thought out program, before I started treatment, is the more positive I can be about everything, including my chances - and I am Gt 3 hardest to cure, Allele TT, the hardest to beat, F-3 Not helping anything.  My rationale is that while it may not change/ improve my chance of SVR, it will most certainly improve my health - stress is a killer - and THAT can help me do the things that MAY improve my chances. Maybe not, but I am ready to face what comes along, a little stronger and better equipped to handle the next step and I am not fooling myself, I am very aware there may be a next step.  HOWEVER, there is also a chance that there MAY NOT be a next step.  People ARE getting cured - just not everyone - and the number and explanations from the trials showed that up front.

Hang in there, remember, we are warriors and do not give up when we lose a battle - we are fighting to win the war!  

If that sound too PollyAnnaish, sorry.  It is a wisdom distilled from 73 years of living through the good times AND the bad - and I have found it truly works - especially with the help of God, my family and friends and sooo soooo many strangers - or at least used-to-be- strangers..

We are all stronger than we think, and, banded together,as we are on the Forum, we make each other stronger.

Please do NOT give up, keep on keeping on.  Hugs to all.  Pat

[Ekkiemom]

Hi Hector.......thanks for encouraging words. I see so many things about Ilieles(sp) host factors, etc. should I be asking my gastro these questions?

[HectorSF]

I am glad you feel better.
We all have enough stress from "life". No need to add things that are of no concern.

Be well.
Good luck with your treatment!

Hector

[Sovaldi13Newbie]

I didn't get completely negative until week 6 of S & O treatment (or thereabouts). At my week 6th week of End of Treatment, I'm still negative. (Undetectable) and my doc says I have a "good" chance of staying negative, but we'll see...on my 3rd month Viral load.

[AugustineMama]

I Bow down to the all knowledgable Hector. You just said exactly what I needed to hear. I shall carry on and quit my worrying. Thanks everyone.

[HectorSF]

Thanks marivirginia  and heart_in_the_keyes for posting the actual data from the COSMOS trials.

We repeatedly see postings of worry, disappointment, feeling of failure, depression from people believing that not being undetectable by week 4 has any meaning. The fact is that RVR has no meaning with this treatment.

Treatment success is based on a person's host factors BEFORE starting treatment. NOT what happens on treatment. Whether a person has cirrhosis or not, is genotype 1a or 1b, whether they are treatment naive or treatment experienced. Did they fail a PI treatment? Which we have no data on because these people were excluded from the trials.
Not what happens with the viral load on treatment.

Worrying about something that has no association with treatment or its success is creating a problem when there is none. Which IMHO seems like a waste of time and energy to me. I am on the same treatment myself coming up on week two. Based on my subtype, post transplant, etc. I know roughly what the chances of cure are ....and hope for the best. Time will tell.

Hector

[Ekkiemom]

I think I want to cry right now....such a deep sadness has come over me....I've been so positive but sometimes you just get weary....

[marivirginia]

just to be clear my last post was Hector's post copied..

[AugustineMama]

I really appreciate this, but unfortunately this like many others have been in the rodeo a long time. I think it is time to slay the beast.

[AugustineMama]

They tell us we are not supposed to have this, but I have had it bad for 10 years. It feels like a rock is sitting under my ribs. I guess partly because my liver has turned mostly into dead tissue. Anyway, I have neuropathy in my feet and have now developed contractions in my hand which mostly alcoholics develop or impaired liver function. I try to stay positive, but it is hard after failure and failure, but I try. I just want my life back.

[Ekkiemom]

Been reading the posts this morning and you seem so knowledgeable . I am 59 yo f gt1a  SOT 9.1.14  VL 11 mil  stage 3-4 fibrosis compensated, first lab VL 17 @ 3 wks. Dr drew lab early because of past tx side fx. I see dr today for 2nd set of labs I am assuming.  I'm on Sov/rib and it's been relatively a breeze.  I have noticed how much better I have been feeling energy I forgot I had etc. then last I had this horrible pain where my liver is.  I haven't had this pain since before I started tx.  I'm now worried that this tx isn't working for me.  Do you have any thoughts
Thank you
Deb

[AugustineMama]

I am exactly where you are pre-transplant. I have had tx 4 times, the last I was relapse on Incivek. My hepatologist is at Mayo JAX. I have had the dragon since 1990. I did all the right things, no alcohol, no drugs, no Tylenol, lived by the book. I got it from a transfusion. When they asked me to be tested I actually laughed because I had no risk factors. I thought the blood was being tested, well it was for HIV. I did the treatments, worked right on and then my mind wouldn't work. I knew something was wrong. Ammonia was thru the roof and had full-blown cirrhosis. Now here I am again. I was so fixated on it for years I had to quit and back away. Now for the last 5 years I have been in real trouble.

[heart_in_the_keyes]

what I meant to say above in # 2 was they "can't" read you viral load status while on treatment.  

marivirginia's post says it well.  

I have been on so many treatments in the last 24 years.  Non-responder on all.  Am on sovaldi / riba right now and doing well.  I am stage 4 decompensated cirrhosis, geno 1, MELD 15 and on the pre-transplant list.  While curing the HCV will not stop the necessity of still having to have a transplant.  

So like I said above one thing does one thing, not necessarily another.  
And to you newbies out there....read, read, read....go to a  qualified hepatologist...take one day at a time....if something doesn't work that is just how it is ... maybe the next thing will.  There are so many better drugs now and will be more soon then were available 20 years ago,  Read all the recent posts on here.....if you are new you will soon learn who the most learned of the posters are and watch for their posts.  And I read all daily posts.  The information is on here...  

[heart_in_the_keyes]

1:  Read other posts.  Especially read anything HectorSF has posted on.

2:  If you are taking meds to eradicate HCV you will be UND status.
3:  UND means undetectable.  They can really read your HCV status
     while you are on a treatment. They don't do a viral load count in the
     middle of treatment.
4:  SVR...this is the status your goal should be set for through treatment.
     Your HCV will either be UNDectable, DETectabe, or SVR in remission

5.  Even if you reach SVR you will still have to have a full panel of blood
     tests between 3 and 6 months to make sure your HCV is eliminated
6. I am always concerned when I see people celebrating UND...I am on
    a 24 week program....first tests showed me UND...the a month later I
    was DET....a month later back to UND.  My drug regimen stops end
    of September and even if I am SVR I will not celebrate under I have
    those 3 and 6 month bloods tests telling me that the HCV is eradicated.

7.  Be hopeful.  Be realistic.  Start reading other posts even if you think
     the topic might not pertain to you. Someone always mentions some
     thing of interest.

[marivirginia]

When you become undetectable has no correlation to whether you will achieve SVR.

"Rapid virologic response (RVR, defined as undetectable HCV RNA at Week 4 of treatment) was not found to be predictive of achieving SVR.
In patients receiving simeprevir and sofosbuvir alone for 12 weeks, 93 percent achieved SVR, while 57 percent achieved RVR. "

"85% of participants in the ribavirin-containing 12-week arm and 57% in the ribavirin-sparing 12-week arm achieved rapid virological response (RVR) at week 4."

Once a person on this treatment becomes undetectable they stay undetectable for as long as they are treating. There are no viral breakthroughs during treatment as can happen with peg-interferon based treatments.

What determines your chances of SVR is whether or not you have cirrhosis, Genotype subtype, Q80k mutation, etc. Not anything measurable during treatment.

Note: People that have been treated with a PI either Incivek or Victrelis were excluded from the COSMOS clinical trials. So any resistance issues caused by previously treating with those drugs is unknown.

"The most common side effects were fatigue (22%), headache (20%), insomnia (18%), and nausea (14%)."

[marivirginia]

the graph didn't copy correctly . Here is the link.


http://www.jnj.com/news/all/Final-Data-from-the-Phase-2-COSMOS-Study-of-Janssens-Once-Daily-Simeprevir-in-Combination-with-Sofosbuvir-Presented-at-The-International-Liver-Congress-2014-of-the-European-Association-for-the-Study-of-the-Liver-EASL