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

[marivirginia]

At the start I had 1.7 million. At 4 weeks I had 40. I don't know what to say about going from 44 to 20 in 2 weeks. Do you know what allele you are,,CC,CT or TT? Were you tested for Q80Kpolymorphism? Hector, our hepc expert says it doesn't matter at 4 weeks if you have the virus still. Maybe others have thoughts about your situation. Hang  in there!

[ChrisDDD]

I started with VL 3.88 million.  Week 2 531.  Week 4 122.  I was tested for Q80K polymorphism and was negative.  Going in for 8-week blood draw today.  Hard to make others who support me and mean well that 122 at week 4 is not a good sign.  It should be zero.

[marivirginia]

SVR12 Among Patients with Genotype 1 HCV and Advanced Liver Fibrosis in Cohort 2 of the COSMOS Study*


12 Weeks of Treatment


Regimen

Simeprevir/Sofosbuvir (%)

Simeprevir/Sofosbuvir + Ribavirin (%)


Overall

93

93


Genotype 1a HCV without the Q80K polymorphism

88

93


Genotype 1a HCV with the Q80K polymorphism

100

88


Genotype 1b HCV

100

100


IL28B CT

100

93


IL28B TT

100

88


METAVIR F4

86

91

[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

[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%)."

[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.

[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...  

[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.

[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]

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.

[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.

[marivirginia]

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

[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....

[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

[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.

[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.

[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

[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?

[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]

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

[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?

[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]

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_]

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