Hepatitis Forums
Hepatitis C Main Forums => Living with Hepatitis C => Topic started by: Terry1947 on July 04, 2015, 12:04:50 pm
-
I hesitated 3 weeks to post this since I was told I failed Harvoni treatment…I didn’t want to discourage anyone who is in treatment. But I need help from anyone who has had my experience. I am apparently now one of the 1 to 4% that failed Harvoni treatment. Here’s my story. I got a blood transfusion in 1964. I was 15 years old and hemorrhaging. The doctors had to get fresh blood from a donor and spin it to get just the platelets to transfuse me as well as days of blood transfusions. That was 52 years ago. I knew as early as 1985 I had a liver problem. It was classified as non-A non-B hepatitis. I was told then never drink alcohol and only take prescription drugs when I had to. In 1992 they identified my problem as Chronic Hep-C. I have kept records of blood test ever since then. Through good health care I was able to kept my liver enzymes to slightly elevated to normal. Also had a viral load over a million once, but brought that down, on my own, to 122,376 at start of Harvoni treatment. My doctor felt I would beat this in 4 weeks and wanted me to have 8 weeks of Harvoni. I ask for 12 weeks just to be sure I killed this virus. Only missed 1 pill in my 11th week.
I am F2-F3, genotype 1a-1b. No cirrhosis and have not had any other treatment for Hep-C in past.
I have no other health issues and take no prescription drugs, just vitamins and clean eating.
Week 4
HCV RNA QUANT INTRP DETECTED
HCV RNA PCR IU/ML 34
Week 8
HCV RNA QUANT INTRP DETECTED
HCV RNA PCR IU/ML <12
Week 12
HCV RNA QUANT INTRP DETECTED
HCV RNA PCR IU/ML <12
I asked my doctor and the RN nurse at Gilead to move me to 24 weeks till the virus is undetected. I was so close. They said no. FDA only recommends 12 weeks.
I know Gilead Sciences are not going to invest in research for the 1-4 percenters who failed treatment. Really not profitable for them. My doctor said, “Well I don’t know why the 1 to 4 percent failed, not enough information out there on failures”.
So my point is, I’ve been left on my own for now. I have followed this forum all through my treatment and it helped me through that journey. Now I have to find a new path and need your help again.
Is there a research center that collects medical history information on people who failed treatment to study and see what links me and others in virus resistance? Is there a test to identify types of HCV that have resistance? Has anyone had this virus for over 50 years. Is there any scientific evidence that the virus hides in your brain during treatment. I know I sound like I’m throwing wet spaghetti at the wall to see what sticks, but hopefully some researcher will collect the spaghetti that stuck to the wall and study it. Or maybe I just need to know mentally or emotionally that I’m not alone and I'm making a positive forward movement so I can stand back up and walk that path to continue to fight the fight to beat this virus. Please let me know. Thank you for letting me vent. God Bless.
-
There are new treatments coming out. Get in a study!!
-
Thank you for your reply TexasC+…I just need to find out how to get involved in study. Maybe I’ll find something on line. again thank you.
-
Hi Terry. The numbers you have posted here for your viral load readings - are those post-treatment numbers? i.e., 4, 8 and 12 weeks AFTER end of treatment? Or are those your Viral load numbers DURING treatment, at weeks 4, 8, and 12? Because if those numbers are from DURING your treatment, you don't yet know if you are cured or not. And in all likelihood you are. You need to see what your viral load is 12 weeks after EOT (End of Treatment) to know whether you have been cured or not.
There are certainly cases right here on these forums, and other cases documented in the literature, of people on the new drugs still being detected at EOT, but then going on to be cured (i.e., they become undetected at 12 weeks after EOT). Those detection numbers you have posted are so low at < 12 that it is probably just some pieces of dead virus in your blood.
So my question to you is what makes you think you were not cured?
Clinical Trials
Now, if it is true that you have not been cured, then I would agree that getting enrolled in a study (a clinical trial) can be a very good option. That is how I am getting my Harvoni right now, and I expect to be cured by it.
The 2 ways I know of for getting your name on lists for clinical trials relevant to you are:
1. Have your liver doctor (or in my case it was a nurse) submit your name to various clinics in your state or province that will likely be involved in clinical trials that may be relevant to you. In my case, the nurse gave my name to 3 clinics in my region, and one of them had this Harvoni trial starting a few months later.
2. You can search for trials yourself at this website: https://clinicaltrials.gov
You will need to look not just for a trial that you qualify for, but one that is close enough to you and that has not started yet or is still recruiting. So in my case, I would put "Genotype 3" in the search box, and that will show me all clinical trials in the world for new Hep C drugs for Geno 3 people. But it is possible to go through them pretty quickly and find the ones in Canada (in my case). And then winnow them further from there to see which have not start and fit my profile.
Best of luck to you Terry. There will always be other options for getting cured. We have reached that point in history where Hep C is curable. So know that you will be cured.
And do let me know what evidence makes you think you have not been cured already. I don't see any in what you have posted.
best,
kim :)
-
hi Terry , the tests you show say "quant" which is the quantitative test , there is also the "qualitative" test that actually shows pos. or neg./ dect/undet.
were you on ribavirin also ?.........sometimes they add riba. to the treatment when the tests aren't going so well during treatment .......i would hold your doctors feet to the fire and ask some questions , find out more about the different rna test's .
as Kim said , you might very well be neg./undetected hcv .
re. test's:
http://www.hepatitiscentral.com/news/how_to_better_u/
God bless Terry...finger's crossed !
-
KimInTheForest
Wow Kim…you are amazing! to take the time to write all that.
In answer to your question, 4,8 and 12 weeks results were during my treatment on Harvoni. My liver functions were normal all the way through treatment. So at the EOT, my Doctor said although the numbers are low the virus is still detected. She had no answer except lets check in 12 weeks to see were your viral load is then. She explained ‘detected is’ …I still have virus and the Harvoni recommended 12 week course was not able to bring me to “undetected”. In fairness to my doctor, I am the 1st and only patient on Harvoni she has treated. And when I called Gilead Sciences and spoke to their nurse, she just quote, ‘there is only a 96% cure rate” and a “1% relapse after 12 weeks EOT”. I will search the site again and hopefully be able to find the post on: ‘detected EOT’ and then went on to have an ‘undetected’ at the end of 12 week Post treatment. That is encouraging news.
Your help with Clinical trials was fantastic. Thank you Kim .. You took the time to show me the way out of ‘The Forest’. Best wishes for your cure.
Terry
-
Well that explains a lot Terry. I would say you have no reason whatsoever to believe you have not been cured by the Harvoni. But you won't know until your blood test for viral load that comes 12 weeks AFTER end of treatment. That is the only viral load count you need to care about. In all likelihood you have been cured.
If you are the 1st and only Harvoni patient your doctor has ever treated I guess she would not know. But this is yet another example of why it is really important to be treated by qualified liver professionals who have done all the reading about the latest hepatitis C drugs.
I think you will find that you have good news when you go to get your viral load checked 12 weeks after EOT. And if if not, there is a lot of good stuff in the drug pipeline right now. You will have other options.
best,
kim :)
-
Terry, I agree with Kim. Odds are you did not fail treatment. I'm an example who tested detected 29 at EOT, detected < 12 (LLOQ) a few wks later, and Undetected (svr) at 11 wks post treatment.. There are others..
Gilead in their trials considered any value < 25 (LLOQ for the test they used) as being SVR for the trial results they posted..
So, Im thinking youre going to be ok.
Check this quote from the study link below:
"Utility of Hepatitis C Viral Load Monitoring On Directly Acting Antiviral Therapy
Notably, six patients with HCV RNA ≥LLOQ at EOT (range: 14-64 IU/mL) achieved SVR12 (NPV: 0%)....Conclusions. Contrary to past experience with interferon-containing treatments, low levels of quantifiable HCV RNA at EOT do not preclude treatment success."
http://cid.oxfordjournals.org/content/early/2015/03/02/cid.civ170.abstract
-
dragonslayer, kiminthewoods and KAL
Thank you so much. I can finally get a mental and emotional break from all the worry because of your input. I have been following dragonslayer for months. I just didn’t pick up on your 11th week ‘undectected’. I realize now it was Post test. KAL … there was never any conversation with my Doctor about ribavirin. I will be sure to mention that to to my Doctor. And kininthewoods, ….I will be reading those cid.oxfordjournals tonight.
I will keep you updated, I should know the 3rd week in September with my post 12 week test results. Now I feel that I will have options if it doesn’t go my way and that I’m not alone in this thanks to your words of encouragement .
God Bless and I look forward to your good health and paying it forward.
Terry1947
-
Hi Terry,
It's not over until it's over.
Have your doctor run a 12 week post-treatment viral load. There have been may folks in a similar situation and found out they achieved an SVR12 (cure).
If there is still active virus in your system, a 12 week post treatment VL will surly be higher than your 12 week EOT result.
Hang in there and stay positive!
Best, best wishes, Mike
-
Thanks for the input Mike. I'm hoping for the best but bracing for the worse.
Terry