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Avatar universal

Undetected at 12 wk EOT!

I had my bloods drawn yesterday for my 12 week EOT test after sofosbuvir/simeprevir/ribavirin. I am lucky to continue to be undetected!!  Of course I'm very pleased with these results, and will next follow up with the test in another 12 weeks to make it official at 24.  I hope many more here have good test results, too!!
27 Responses
Avatar universal
Mark that's wonderful news, and imagine you are so relieved.   I'm kinda in the same boat with Riba/Sovaldi.   Was also UND at EOT12, but honestly not jumping up and down for joy just yet as these new meds are in my opinion to new to say for sure.   Please keep us posted as your status hopefully remains unchanged.   Again, congratulations to you and to all whom treated with or without reaching SVR.  The future is bright, and will give a toast (sparkling juice) when everyone around our world, will no longer fall victim to this horrible disease.  
446474 tn?1446347682
Hi Mark.
I am not saying this about only your treatment but their have been countless posts about people being undetectable at one point or another during treatment and themselves and others encouraging the mistaken notion that being undetectable has some meaning as far as treatment outcome (SVR)....
While it is great to be undetectable and have not viral load for maybe the first time in 40 years (YES!)
Being undetectable unfortunately has NO correlation to outcome (SRV) with current Sovaldi based treatments and the mentions of it as though it indicated successful treatment gives people a false impression that being undetectable is an achievement relating to treatment success (SVR) as it did with old peg-interferon based treatments.

Sadly, now we are starting to see folks who felt encourage by being undetectable throughout their treatment and who have now ended their treatment and are experiencing relapse after stopping treatment. Usually within a month after stopping the treatment. Many of them seem devastated after believing that their being undetectable meant they had a very high likelihood of success. Which is not the cause.

Failing treatment is and has always been difficult no matter if we treated for 12, 24, 48 or longer. We invested a lot of time, hope and energy into our treatments. Many times having to deal with side effect during our treatments which we endured as part of the price we paid for being cured.

We rightly are optimistic during treatment and hope that this time we will finally be cured of this virus after many decades of infection and sometimes many failed treatments.

We all know logically that these treatments are not 100% and depending on different factors such as cirrhosis that at least 1 or 2 out of 10 are going to fail current treatments. Yet it is so sad for those who are now starting to fail these treatments. We are starting to see people truly devastated by the virus returning.  I feel sad for those who now may feel so alone being the minority of those who treated and unfortunately weren't successful.

It seems the big picture is getting lost.
Treatment is more effective than it ever has been and will continue to improve in the near future with more options for all patients.The vast majority of folks (those without cirrhosis) fortunately can wait for more effective treatments that will be available at the end of this year or soon there after.

Treatment failure is not a personal failure and absolutely NOT the end of the story by any means. As in the past, if we fail a treatment then we mourn the lost and disappointment and then in our own time... move on to renewed hope that a newer/better treatment option will cure us once and for all time of this virus.

So to repeat the basic facts as published in all of the clinical studies about these current, 1st generation of Sovaldi treatments...
Please understand that once a person becomes undetectable on Sovaldi based treatment they ALWAYS stay undetectable as long as they continue the treatment and will be undetectable when they stop treatment. Whether it is week 12 or 24 or any other time. This is what happens to ALL people and is how these treatments work. These new treatments are different than peg-interferon based treatments in how they work and how people respond. As different as we normally only treat now for 12 weeks instead of 24 or 48 weeks and ""EVR", null-responders, partial responders, breakthrough  meant something. They are as obsolete as the weekly injections are for those treating with all oral meds.

All people that fail Sovaldi based treatments only fail treatment by "relapsing" AFTER the stop the treatment. Most people relapse within 4 weeks after stopping treatment. Others between 4-8 weeks after treatment and a very few relapse between weeks 8-12. The is why we use SVR12 and the point of cure. Make it past week 12 after stopping treatment and you are cured.

Understanding these basic facts will prevent folks from having false assumptions about the ability to achieve SVR which with current treatment not based on response to treatment (undetectable), as all people become undetectable during treatment but upon a person's host factors (F0-F2 vs F3 or F4, genotype, etc.). We are starting to see folks unfortunately failing treatment (relapse) and seemed to have been under the impression that being undetectable during treatment, whether by week 4 or at some other time assured treatment success,  which sadly they falsely believed to be the case.

We know the following about the new Sovaldi based treatments:
* All people that treat become undetectable and stay undetectable as long as they are treating.
* I.E. There is no viral "breakthrough" during treatment as could happen with peg- interferon + ribavirin treatment.
* When taking Sovaldi + Olysio particularly, when a person becomes undetectable makes NO DIFFERENCE as far as the chances of SVR. In fact those that are not undetectable by week 4 (most of the people in the COSMOS trials were NOT undetectable by week 4) have a greater chance of SVR than those who do become undetectable by week 4.

Best of luck with your treatment!
Avatar universal
I don't know if I'm misunderstanding something, or am I incorrect in the data that I've read.   Mark and I have both completed treatment and have had our EOT12 results which were UND.  Isn't that considered cured?  
Thanks in advance for your reply.
Avatar universal
Not Hector but to clear up any confusion which there seems to be. If one is UND after doing 12 weeks of treatment and THAT PCR says your UND at the EOT then yes it is possible you might relapse. Now if one is post 12 weeks EOT and their PCR shows they are still UND 12 weeks after ending treatment then yes they are considered cured with these new meds.

Hope this helps
Avatar universal
Just want to add it would make it clear if the title of the thread read.

Undetected at 12 wk post EOT!
Avatar universal
Can-do-man, you are correct.  My post was meant to reflect the fact that now, 12 weeks AFTER the completion of treatment (EOT, completion of therapy), my HCV RNA remains "not detected".  This follows being <15 at two weeks during treatment, and not detected at 4 weeks and 12 weeks during treatment.  My 4 weeks post EOT was not detected, and now the 12 weeks post EOT is the same.  Looking good, but I will believe I am "cured" when I do the 24 week post EOT HCV DNA quantitative test.  After all, I remember relapsing at some point weeks or months after completing my multiple various older treatment attempts in past years.  So thanks again Livelife777 and can-do-man: Undetected at 12 wks post EOT!  Will post again at 24.  Hoping that all those who finished more or less at the same I did will also be undetected on THEIR 12-week post EOT.
Avatar universal
Gotcha ....Thanks guys for clearing that up!
Avatar universal
Awesome news. Congratulations! Jo
1815939 tn?1377991799
Wonderful news! Congratulations!
Avatar universal
FANTASTIC news Mark!!!  Yeah!  Congratulations to a life Hep C free.

How did you find out the results so quickly?  I thought it takes a week for results to come back for viral load.
Avatar universal
It came back the next day. I was very surprised (although usually it comes back within two days: this is a major medical center in NYC, and they do their own testing). Not complaining!
446474 tn?1446347682
One the the reasons I brought up the issue of being "undetectable" is that here in San Francisco at the UCSF hepatitis clinic which is treating scores of people with the new oral treatment we have seen some lab results showing "detectable but unquantifiable" with patients during treatment. Since it is known from trial data that once a patient becomes undetectable they stay undetectable as long as they are treating (this is assuming the patient is taking their meds properly) these labs result are an error of the test. In fact we has seen one lab the result as "undetectable" while at another lab the result can be "detectable but unquantifiable" (<15 IU/ml) HCV. Note we haven't seen actual viral load numbers only results that are below the level of quantification.

By understanding how these new treatments work, which is very different than past peg-interferon treatments we realize there is little purpose in performing viral load testing during treatment once a patient is undetectable and I would imagine soon many of these test will be eliminated as part of treatment protocol because they serve no useful purpose related to the treatment. But for now we can be sure that any lab test indicating a detectable viral load during treatment (after becoming undetectable) is only a lab error and that a repeat of the viral load test perhaps at another lab would indicate the proper "undetectable" result. One less thing to have to worry about during treatment.

My main point was the outcome of treatment is dependent not on what happens during treatment but what host factors (genotype, subtype, cirrhosis,etc.) exist prior to treatment and what treatment best addresses these factors which will result in the best outcome. This is why in the future we will see treatments the are for special populations of those infected with HCV. The treatments will be based on these host factors. We are already starting to see some of these early approaches. In the genotype 1, treatment naive people who have a 93% SVR rate with only need 8 weeks of Sovaldi/Ledipasvir. In the simple case of cirrhotics we know that interferon based treatments can be detrimental to the person's liver disease and can cause decompensation or liver failure in some patients. In post transplant patients there are the drug-to-drug issues of the past which are not an issue with the new Sovaldi based treatments. We now are beginning to see which treatments in trials are most effective in co-infected people, in people with genotype 3 and genotype 1b vs 1a.

Avatar universal
Wonderful!  Happy to hear this wonderful result!  We all share this journey- the good, the bad and the yet to come!  Enjoy your report!  :)
215858 tn?1420171556
Congrats on your EOT-UND12!  I'm superstitious and won't be celebrating myself unless its SVR24.   Until then, take stock, you're on your way.
Avatar universal
Great news, Mark.  Kind of ironic that you get this news just as another poster learns he has relapsed.  Goes to show you how each patient is unique with their own particular medical issues and circumstances all of which can impact on their ability to reach SVR.

My husband has three weeks left of 24 weeks total on treatment. He has had to keep his dose of ribavirin at the minimum dosage due to post transplant anemia. Yet his platelets have always remained in the lower normal range since transplant. Though we remain hopeful, because of the low ribavirin dosage, we know that reaching SVR12 is probably unlikely.Nevertheless, as difficult as this treatment has been for him, we believe that the treatment has helped to prevent him from decompensating further.  (He has portal hypertension and bouts of hepatic encephalopathy). The HE has recently  improved a great deal.

There is something I just can't wrap my head around. Maybe someone can explain it to me. How can a virus that is "undetectable" for 24 weeks return?
So is it that the term "undetectable" actually means ""below the level of quanitification"? Shouldn't they just say that in the results instead of using a term that is misleading test after test?

Personally,  I think something that is "undetectable" should be reserved for something that is gone for good, not a virus that can return as soon as you stop the treatment.


Avatar universal
I had the same question regarding UND prior to treatment and this is the answer I came up with.  When you become UND, there are still trace amounts of the virus still present in the blood.  If in fact you remain UND for
6 months, you are then considered cleared or cured.  With the new treatment that we are on, they say if your are UND for a period of 3 months, then you are SVR12, or cured.  Lets hope that's true!
Happy to hear that your husband is doing well with HE, and only has a few more weeks to go.  You are so right that either if he clears or not, his liver has had at least a chance to regroup and heal, until newer meds are available.
Be well and hope for continued wellness
Avatar universal

See that's my problem - the fact that they know that there are likely trace amounts of the virus in the blood at Week 4, 8 and 12, etc. tests, that can cause a resurgence of the virus at EOT and yet still call it "undetectable".
Hearing you are undetectable at each of these weeks only makes it harder on the patient should they relapse. If they just stated LLOQ (lower level of quantification), I think the patient would be better mentally prepared for the possibility of relapse. Not everyone is as well educated about this as most on this site. It just seems to me that they should be more careful about getting
the patient's hopes up for SVR from practically the beginning of treatment.

Avatar universal
I totally agree with you as we are now seeing the virus becoming detectable for some, and its emotionally devastating for them.  It's heartbreaking to see.
As you mentioned, it's setting everyone up to feel as tho they have failed themselves and others.
Perhaps when advice is asked, it may be a good idea to include that the new meds are not a sure thing, and UND simply means a reduced or lower viral load.
Take care.  ...Kim..
276146 tn?1453921024
Congrats Mark!  Gives the rest of us hope!
Avatar universal
Great news , congratulations Mark!
I will be doing my 12 week post treatment test in about 3 weeks.
Your news is encouraging.
Avatar universal
I hope for the best test results for all of us.
The disease is rough; treatment has gotten easier but is still a challenge to get through, and is expensive. We all deserve some good news!
Avatar universal
congrats to you!
Avatar universal
Congrats Mark and wishing you SVR!

6708370 tn?1471490210
That is such wonderful news, Mark!
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