Author Topic: 8 Wk End Of Harvoni Treatment result: Detected (Read 119787 times)

dragonslayer · « **on:** January 28, 2015, 02:01:17 pm »

Just got my EOT result today. I dont even know how this could happen.. What am I.. the most unlucky person in the world? 8 wk End Of Treatment result: Detected HCV RNA (IU/mL) 29. Doctor said redo the test in 12 wks and see him after that. Can it be Detected at EOT and then miraculously disappear in the next 12 wks? The trials for those with my stats given 8 wks were like 95% successful with SVR 12... I assumed that all of those results also showed Undetected at EOT... Wish I had those numbers... Just totally stunned at this result...

Lukey · « **Reply #1 on:** January 28, 2015, 02:43:48 pm »

Sorry to hear this but you could try to see if you can be retested by a different lab to see if you test Und there.

How are your AST and ALT?

Joe

dragonslayer · « **Reply #2 on:** January 28, 2015, 03:01:50 pm »

Quote from: Lukey on January 28, 2015, 02:43:48 pm

Sorry to hear this but you could try to see if you can be retested by a different lab to see if you test Und there.

How are your AST and ALT?

Joe

Both tested normal: ALT 44; AST 25.. Both were slightly above normal prior to treatment. I have to redo the RNA Quant test again in ~12 wks and Ive got an appt with him after that. Im really puzzled though.. Statistically, this should be a no brainer, easy test to pass if you go by the trials. I was exceedingly diligent in taking the pills and living clean, as I do anyway. I took no supplements that were on a reactive list... So I just dont get it. My last liver biopsy was in March of 2013 which was scored stage and grade 0-1. My biopsy prior to that was in 2008 which scored stage and grade 0. With VL at 2.4mil, this 8wk treatment should have been clear sailing. I just dont get it.

Picnic · « **Reply #3 on:** January 28, 2015, 03:36:47 pm »

Dragonslayer,
As Lucinda says ,"Don't freak out yet!". I had a detected after 8 weeks after I had three undetected. I did one 2 days later and it was undetected and has been since. This could be an abberant lab result, meaning it may not be valid for a number of reasons. The next test will tell the story. I have been undetected since the abberent test. I just finished 24 weeks of S/O. I waiting to do the SVR 4 and 12 and 24. Good luck!

dragonslayer · « **Reply #4 on:** January 28, 2015, 03:58:27 pm »

Quote from: Picnic on January 28, 2015, 03:36:47 pm

Dragonslayer,
As Lucinda says ,"Don't freak out yet!". I had a detected after 8 weeks after I had three undetected. I did one 2 days later and it was undetected and has been since. This could be an abberant lab result, meaning it may not be valid for a number of reasons. The next test will tell the story. I have been undetected since the abberent test. I just finished 24 weeks of S/O. I waiting to do the SVR 4 and 12 and 24. Good luck!

Thanks Larry.. I see a major difference here though... You were slightly detected at 8 wks, but that was on a 24 wk treatment program, so the 8 wk results, Id imagine, werent nearly as definitive as being detected at End Of Treatment as I was. Thats what Im freaking out about. If I got these results at wk 8 of a 12 wk treatment plan, the result would be concerning, sure, but not nearly so concerning as when its the end of treatment result...

motor · « **Reply #5 on:** January 28, 2015, 04:43:55 pm »

Bummer dragonslayer. Your treatment is the first I've read about where they didn't test along the way to measure progress. Is this common procedure? Seems negligent to me. Seems they shouldn't stop at 8wks if you're not undetected. Can you find a more involved treatment team?
They want to wait 12wks before testing again and no contact in interim? Excuse me if I'm out of line with comments, I'm just disappointed for you.
motor

Bob V · « **Reply #6 on:** January 28, 2015, 04:52:12 pm »

Sorry Paul that sucks.

I know this won't help you but I don't understand why they can't do labs at week 6 and if you're still positive order 4 more weeks.

Bob V · « **Reply #7 on:** January 28, 2015, 04:57:55 pm »

Bummer dragonslayer. Your treatment is the first I've read about where they didn't test along the way to measure progress. Is this common procedure? Seems negligent to me. Seems they shouldn't stop at 8wks if you're not undetected. Can you find a more involved treatment team?
They want to wait 12wks before testing again and no contact in interim? Excuse me if I'm out of line with comments, I'm just disappointed for you.
--------
I wasn't scheduled to have labs until EOT and see my doc 3 weeks later. But I was on 12 weeks, my doc said he wouldn't alter the course of treatment anyway. I did get labs at week 5 and I was still detected, less then 12.

dragonslayer · « **Reply #8 on:** January 28, 2015, 05:00:50 pm »

Quote from: Bob V on January 28, 2015, 04:52:12 pm

Sorry Paul that sucks.

I know this won't help you but I don't understand why they can't do labs at week 6 and if you're still positive order 4 more weeks.

Bob, Motor: You know, I asked him at the beginning if we can do labs before the 8 wks are over so that we can order up another month if needed, and he simply said NO. I dont get it either. .I dont know if the numbers dont show any benefit or what. I know some doctors will do that, and others will ask for nothing except a 12 wk test after treatment. I have a hard time believing that 4 more wks wouldnt have knocked out the 29 lousy remaining virus particles. Im certainly going to go down that line of questioning with when I see him in April. Nevertheless, I note in the trials documents, On-Treatment Virologic Failure results were 0/215 in the 8 wk cohort, and 0/216 in the 12 wk cohort as shown in Table 6 from the prescribing document from the Ion-3 trial ***... So with odds like that, how can I still be detected at end of treatment?! I just dont get it.. If these trial numbers are to be believed and not prettied up for public consumption, then what happened to me should be an impossibility I would think.

***PS.. Called Gilead Medical Info and spoke to a Pharmacist. I questioned him about the 0/215 (8wk) and 0/216 (12wk) trial stats for On-Treatment virologic failure numbers. One might assume that these represented 100% UND results at end of treatment.. But I found out otherwise.. I was told the criteria for these numbers was not UND but, rather, viral load of 25 or under! If I were showing a VL of 25 instead of 29, Id have been reported as an on treatment success also... Its things like this which should cause us to look at the trial results with a little more scrutiny, seems to me.

Red Hen · « **Reply #9 on:** January 28, 2015, 05:06:15 pm »

Paul, very upsetting! I'm so sorry and wish I knew what you should do next. You will get plenty of advice here. Best to stay calm and maybe re-do labs.

Bob V · « **Reply #10 on:** January 28, 2015, 05:08:42 pm »

I hear you Paul, this is gotta suck for you.

My thinking is like yours, it should be set up PRE tx for people on 8 week to have labs at week 4 or 5 and if positive have enough time to ship the meds to you for another 4 weeks.

My doc asked for 12 hoping to get 8. I got approved for 12 so I'm taking 12.

Maxlaw · « **Reply #11 on:** January 28, 2015, 08:15:10 pm »

Hi Paul, I don't have any brilliant explanation to offer (maybe Lucinda can provide some medical insight for you), but I just wanted to say how sorry I am that you got this news. It's all of our worst fear. And I really, really hope it was a faulty test and that your next test will be UND!

Wow, I really can't believe your doc wouldn't do any VL tests during your treatment, especially at 4 weeks, if nothing else to see if the treatment was working, and especially given that you requested it! I am currently taking the next generation AbbVie drugs in a clinical trial, and in this trial they test everything (and I mean everything!) every 2 weeks, so I am fortunate to have all the information at every appointment. I can't imagine not knowing anything during treatment!

I know you are flabbergasted by this news, as I know I would be, but from what I have learned from being associated with the trial I am in, there are several more drugs in phase III right now that will be approved soon. So there is something to look forward to if it turns out that the Harvoni didn't work for you.

Wishing you the best,
Max

bsmith9876 · « **Reply #12 on:** January 28, 2015, 09:09:17 pm »

I'm sorry too, paul. I feel for you. I'm an eight-weeker myself and just finished my first week....I understand.

Did the doc offer an alternative or say what your next steps would be?

Brenda.

dragonslayer · « **Reply #13 on:** January 28, 2015, 09:14:48 pm »

Quote from: bsmith9876 on January 28, 2015, 09:09:17 pm

I'm sorry too, paul. I feel for you. I'm an eight-weeker myself and just finished my first week....I understand.

Did the doc offer an alternative or say what your next steps would be?

Brenda.

He left notes with the nurses re my result to test again in 3 mos, and make an appt to see him with those results.. Im sure we'll be discussing alternative at that time, ie, maybe Abbvie, or maybe something else as new drugs gain FDA approval. I called Gilead to find out if I can be retreated with Harvoni for a longer duration or, might there be an immunity/resistance issue with retreating.. They said they had no data on that! At least none that they could divulge to me.. But if they really have no data, then good luck to the doctors in making a decision on how to proceed.

Bob V · « **Reply #14 on:** January 28, 2015, 09:41:06 pm »

. I called Gilead to find out if I can be retreated with Harvoni for a longer duration or, might there be an immunity/resistance issue with retreating.. They said they had no data on that! At least none that they could divulge to me.. But if they really have no data, then good luck to the doctors in making a decision on how to proceed.
----------
I've called Gilead several times with drug related questions, sorry to say they've not been much help. To be honest I don't think they know that much, the drug is too new. They'll know more in the next year as we finish our treatments.

Bob V · « **Reply #15 on:** January 28, 2015, 09:47:50 pm »

Paul
I see you're a long timer with Hep C going back to the early 70's, me too. I wonder if this plays a roll or should play a roll in the treatment time. It might take longer to clear if you've had this for 40 years.

dragonslayer · « **Reply #16 on:** January 28, 2015, 10:32:47 pm »

Quote from: Bob V on January 28, 2015, 09:47:50 pm

Paul
I see you're a long timer with Hep C going back to the early 70's, me too. I wonder if this plays a roll or should play a roll in the treatment time. It might take longer to clear if you've had this for 40 years.

Who knows?! I know there are tons of drug interactions they havent studied yet, and I havent read anywhere that they did any data segmenting by length of time infected.. Plus likely a whole lot of other factors. Id imagine time infected would be a really hard one to study because most patients are only vaguely aware of when they were infected. We all have ideas as to when it was most likely, but very few of us can pinpoint the date, etc. I just think there are so many factors they didnt segment by in the trials that real world results may wind up looking a little different from the trials results and will certainly take time to develop.

Bob V · « **Reply #17 on:** January 28, 2015, 11:02:30 pm »

I just think there are so many factors they didnt segment by in the trials that real world results may wind up looking a little different from the trials results and will certainly take time to develop.
------
I agree

Lynn K · « **Reply #18 on:** January 29, 2015, 12:45:04 am »

Hi Paul so sorry to hear this my heart goes out to you.

I was looking at the ION 3 results and am seeing 215 tx naive treated for 8 weeks and 202 made SVR12 so 94%. The thing we all need to remember is these were clinical trials and with limited numbers of participants.

Once the meds get out in the real world with larger numbers being treated the stats never remain the same. Could be better could be worse. But none of the number crunching in the world matters if you fall on the short end of the stats.

sending you a big hug Paul

ma snart · « **Reply #19 on:** January 29, 2015, 10:03:44 am »

Paul, my wife had her 8 week results and still showed detected 22, but is on the 24 week plan, I too was disappointed with the results as we are allowed to have them every two weeks I could track the progress, 8.5 million, 933, 212, 95, 105, and then 22, Dr told us that when cirrhosis is evident that it takes time to flush them out, I would demand to see your doctor immediately and possibly have a biopsy performed to see if this might have developed, and to try to up treatment time without waiting 12 weeks to see him. I would be livid. Make some more noise.
Good luck

dragonslayer · « **Reply #20 on:** January 29, 2015, 10:28:13 am »

Quote from: ma snart on January 29, 2015, 10:03:44 am

Paul, my wife had her 8 week results and still showed detected 22, but is on the 24 week plan, I too was disappointed with the results as we are allowed to have them every two weeks I could track the progress, 8.5 million, 933, 212, 95, 105, and then 22, Dr told us that when cirrhosis is evident that it takes time to flush them out, I would demand to see your doctor immediately and possibly have a biopsy performed to see if this might have developed, and to try to up treatment time without waiting 12 weeks to see him. I would be livid. Make some more noise.
Good luck

My most recent biopsy was in 2013... I apparently show no evidence of cirrhosis, and I think another biopsy now less than 2 yrs after my last one is not advisable.. Maybe Ill request a fibroscan though.. I think he wants to see the 12wk viral load, and then he will recommend alternatives. I completed treatment 1/20, so there's no point in thinking I can add a month to that now.. At any rate, I appreciate your suggestions, and after I get over the shock of this, I may take a more proactive approach. Its not even 24 hrs since I got the result, and my mind is still reeling. I dont know what can be done immediately anyway; 12 wks is not all that long to wait to develop a new plan.

Red Hen · « **Reply #21 on:** January 29, 2015, 10:48:04 am »

I think the idea of a liver scan is a good idea. Non-invasive procedure. Thinking of you and wishing you the best possible treatment in the future.

Bob V · « **Reply #22 on:** January 29, 2015, 11:21:37 am »

With all this I think I'm going to get my 8 week labs done VS waiting until EOT. If I'm still detected, maybe see if my doc can add 12 more weeks. Not sure the insurance will go for it. I was under 15 at week five.

dragonslayer · « **Reply #23 on:** January 29, 2015, 11:35:54 am »

Quote from: Bob V on January 29, 2015, 11:21:37 am

With all this I think I'm going to get my 8 week labs done VS waiting until EOT. If I'm still detected, maybe see if my doc can add 12 more weeks. Not sure the insurance will go for it. I was under 15 at week five.

I checked into that at the time with my specialty pharmacy when I asked if the doctor could order a second refill, ie, third bottle during treatment. I was told that the whole process of getting a brand new prescription written and submitted to the pharmacy, who would then have to submit to insurance for approval would have to be followed.. ie, simply adding a refill on to the existing approval, even if the existing approval went far enough out in time to cover it would not suffice. At that point, i simply capitulated to the existing prescription, assuming, of course, that the trials success numbers would rule.... I was wrong! Problem is, with my benign biopsy and <6mil viral load, I considered myself so lucky to have gotten approved for even the 8 wks, that I did not want to push it, fearing theyd reevaluate even their original approval......

Bob V · « **Reply #24 on:** January 29, 2015, 11:55:49 am »

Paul
I'm sure I wouldn't get approval in time to continue tx. Might just get the labs for piece of mind....or not.

I was only going to do 8wks at first, I'll know if I would of been detected at EOT.

Mike · « **Reply #25 on:** January 29, 2015, 12:41:46 pm »

Hi Paul,

Sorry to hear this. The important think to remember that a 100% cure is close at hand and new combinations are coming out this year.

You'll get this dragon for sure!

Best wishes, Mike

BattleTheBeast · « **Reply #26 on:** January 29, 2015, 08:11:00 pm »

Hey Paul,

This totally sucks, not gonna candy coat here. It sucks and I am so so sorry. If it were me I would be looking for a proactive doctor before I began another treatment. I have had multiple blood tests, had one today in fact. I have insurance and I just deal with the co-pay because if it's not doing what it's suppose to do then I want to know ASAP so we can look at options, my doctor supports me but then again I came in pretty sick in the first place so he is watching a bunch of things on me.

Sending you a big hug over the web. It really is possible there was an error. Isn't it worth a re=test just to make sure? I think that would be my step #1 because Labs do make mistakes and anything is possible. Like Mike said there are more new medications coming really soon and hopefully the next path you choose will be the right one to kick that beasts butt!

Mel

Katie · « **Reply #27 on:** January 29, 2015, 08:42:18 pm »

Oh Paul....You are going through all of our worst nightmare! I am so sorry to hear that. It seems I heard where someone was detected at the end of treatment, but since Harboni is still in your system it continues to work for awhile and they came back cured after 12 weeks. It was on this forum somewhere and like others have said, labs make mistakes...their calibration could be off or the blood sample was affected by something.

I would also ask for another test sooner than 3 months just to know for sure and to help with the anxiety. I am so lucky as my viral load was less than 3 million (although in the past it had spiked to 16 million) and they authorized 12 weeks. That is what my doctor requested and it went through. I was detected at 4 weeks with 59 so we'll see how that goes.

Hoping you are doing OK. Thanks for sharing with us as it is important we hear the reality of this treatment and hoping the Harvoni is still kicking butt and clearing your virus! My thoughts are with you and I send ((((HUGS)))) too!

Katie

dragonslayer · « **Reply #28 on:** January 30, 2015, 12:52:02 am »

A big thanks to each and every one of you! I was reluctant to open this thread here because I didnt want to put doubt and fear into anyone else's mind... I was always fearing reading a thread like mine which kind of takes a small chip out of the Harvoni facade. But I thought it was important to start contributing to real world results, so here it is. This wasnt supposed to happen according to trial data. And yet, it did... Im beyond disappointed in my hepatologist. Hes got mad skills, technically, but he leaves a lot to be desired in his followup and his patient interactions. I wonder if I would ever have gotten a call from his office re the status of this blood test had I not made sure the lab sent me a copy so I wouldnt be dependent on him for results. Its hard to imagine a doctor not making a personal call to his patient upon an apparent treatment failure result... All I got from his nurse, after I called them, was that he left a small note, either on paper or electronically, to have me retest in 3 mos and make an appt to see him after that. Its unconscionable to not get a personal call from him . At the very least, he might have returned the phone msg I left with the receptionist this morning for him to return my call re treatment failure.. Nothing today. Maybe tomorrow.

I was thinking of making an appointment right away to speak with him about the situation and options, and my general displeasure with the lack of contact... But then I thought, listen, more blood tests create more anxiety. Why not just wait for my scheduled April appt and bloodtest then... Hes going to want to see what happens over these 12 wks, anyway, wrt my viral load before we commit to any new treatment plans anyway. And at that time Im going to request he do a fibroscan. I suppose its not out of the realm of possibilities that the reason the treatment failed is that my liver disease progressed beyond what the most recent biopsy showed. I know he doesnt think that would be the case, but we dont have to guess; his office has the machine (one of the only ones in the entire area) so we might as well use it. As for now, Im starting to get over the shock and disappointment of the result. .Its been really rough yesterday and today, trying to keep a positive attitude, but slowly, I feel the veil lifting, and once it does, it will be April before I know it, and Ill be doing the 12 wk post treatment test, and meeting with him to plan a new course of action.

I'll be sure and report back either here, or in the post treatment forum, with any change of status or any updates. Everybody, keep hanging in there.

amy1662 · « **Reply #29 on:** January 30, 2015, 12:55:07 am »

So sorry about your news Paul. Do not worry you will clear this virus and you still may have a chance with Harvoni. It may still be working in your system since you had that blood work. Do not give up. I don't want to rock the boat but I think that anyone who is on the eight week treatment should have blood work at four weeks and if it comes back detected they should at least allow for a twelve week treatment plan. I feel like a lot of these rules that apply to this treatment are not totally fair. The insurance companies have put too many stipulations (hoops) that one has to cross for this treatment. I think your doctor should have at least tested you at four weeks knowing that although the cure rate is high it is not one hundred percent. At least that would have given time to get an authorization for the twelve week treatment. I hope when you test again it is undetected. If by chance your not do not worry there are better medications on the horizon so you will beat this that is a guarantee. Try not to think about your last test it is not a definite result. I am going to be praying that you have cleared this virus and show undetected on your next test. Chin up, Amy

Lynn K · « **Reply #30 on:** January 30, 2015, 02:55:46 am »

Hi Paul

I did see one post on another web site forum where the person was told he was detected but then retested and was found to be clear and that a lab error had been made. We have all heard stories of people enduring chemo only to find out they never had cancer.

Just on the small chance that the was a lab mix up any chance you could be tested again?

How are you liver function tests? When I relapsed on Sovaldi Olysio I got my LFT results before my viral load and saw my ALT had gone above normal range while it had been normal the whole time I was treating the first time in decades. Seeing the elevated ALT gave me a early warning about my viral load.

Just a thought

anniemybaby · « **Reply #31 on:** January 30, 2015, 05:49:20 am »

Hi Paul I also am on the 8 wk treatment of harvoni but I need to go for blood work every 2 wks after starting harvoni so they can monitor if its working I was a candidate for the 8 wk treatment because of low viral load n I never had prior treatment I wish you all the best

kate0b1 · « **Reply #32 on:** January 30, 2015, 06:01:21 am »

Paul, I am in the don't give up hope just yet group, I don't know what harvioni's half life is, but it may still be there working (might be a question for someone with more knowledge than me). i do know that it took forever (at least that what it felt like) to get the riba out go my system). also does any know yet what the re-treatment options even are yet? if you have to retreat (if you even can), at least you already know the drill and the sides so it will be easy going back.

kate

BattleTheBeast · « **Reply #33 on:** January 30, 2015, 07:57:08 am »

I was awake so I thought I would see if I could find anything on this situation our friend Paul is in today and potentially more of us shortly and so far this is all I came up with:

Details below pulled from http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4627-easl-2014-sofosbuvirledipasvir-cures-more-than-90-of-first-time-and-retreated-genotype-1-patients

ION 1 - 12 vs 24 weeks - 865 Patients

"Among participants who did not achieve SVR12, there was 1 on-treatment viral breakthrough -- in an individual with unmeasurable blood drug levels suggesting lack of adherence -- and 2 post-treatment relapses. The rest were lost to follow-up. All 3 people with virological failure had evidence of NS5A resistance variants"

ION2 - Treatment experienced - 440 Patients

There was a single case of on-treatment viral breakthrough, again in a person with undetectable drug levels. Among the 14% who had resistance-associated variants at baseline, 89% still achieved SVR12.

Out of the 11 participants who relapsed, 7 had cirrhosis. Further evaluation of this group did not reveal any specific clinical factors -- such as platelet count or low albumin -- that predicted who would relapse

ION 3 - Treatment-naive 8 vs 12 Weeks - 647 Patients

No virological breakthroughs occurred during treatment. There were 23 relapses, all but 3 of them in the 8-week treatment arms. Afdhal suggested that people who relapse using a short ribavirin-free regimen could either be retreated with a longer duration or add ribavirin, but there is "no signal about which is better."

The good news is we can retreat after relapse with Harvoni (if the insurance Co will approve), I mean they already just saved themselves a 2.5 million by limiting many of the people on treatment to 8 weeks,

IMHO Penny Wise Dollar Foolish - Basically they approve the minimal number of weeks because in the long run the number of people that will need to be retreated is way less than approving 12 or 24 weeks right out of the gate.

Here's how it breaks down (I am going to round the $ for harvoni just to show my example):

100 people for 8 weeks @ 50K per person and 6,250.00 per week per person. and out of that hundred 5 fail and need to be retreated for 12 and possibly add in RibV.

Total for the 100 initial treatment is 5,000.000.00
Total to retreat 5 for 12 weeks 375,000.00 plus the cost of the RibV
Total of 5,375,000.00
2 pt retreat @ 24 weeks 300,000.00plus the cost of the RibV
Grand Total 5,675,000.00
vs.

100 people for 12 weeks @ 75K per person and 6,250 per week per person

Total cost for the 100 people is 7,500.000.00
Maybe 2 would need to retreat 300,000.0024plus the cost of the RibV
Grand Total of 7,800,000.00

It's over a 2 Million dollar savings to the insurance Companies to only approve the 8 weeks instead of the 12 and just retreat the relapsers, Pretty disgusting isn't it? This is the real world and what we are all dealing with it. They save a ton of money by handling it this way. That one little line in the results that some people may only need 8 weeks is what they are running with based on my fancy math above. I do know my numbers are a little low because Harvoni actually costs 1125.00 per pill which is 7875.00 per week not my rounded 6250.

Believe it or not I have rendered myself speechless and slightly sick to my stomach for now but I am going to hang on to the fact being retreated with Harvoni is an option is we relapse.

Mel

Picnic · « **Reply #34 on:** January 30, 2015, 08:35:54 am »

Wow! Are you an accountant? Great analysis!

BattleTheBeast · « **Reply #35 on:** January 30, 2015, 09:12:56 am »

Morning Larry,

Did it make sense? I've barely had any sleep for days and am a bit delirious. It's insane because the more exhausted I am the more my mind continues and I just keep going on and on!

Mel

Red Hen · « **Reply #36 on:** January 30, 2015, 11:31:32 am »

Wow, Mel! Money talks, doesn't it? Paul, I'm thinking of you and hoping that either the labs are wrong or that you can be re-treated with Harvoni for a longer time in the future, since it has very few side effects. I hate it when anyone has a relapse but also know that it can happen, apparently, with all the various drugs. Asked my doctor at one point what they would do if someone relapsed. Re-treat. Please let us know how you're doing.

Bob V · « **Reply #37 on:** January 30, 2015, 11:41:28 am »

Excellent Mel. I had this conversation with my wife last night that it all has to do with $$$. Let's be honest it sounds better to say we have a drug that only requires 8 weeks and saves some $$. I'm sorry but "I feel" this is at least a 12wks thing and maybe should be 24. The answer is going to come from us as the true numbers start to come in.

I called my doc office to have them call in some labs for Mon (8wks). I explained about this thread to them and that I was originally only going for 8wks...I want to know if I would of cleared.
Also, if I'm still detected next week I'll have little hope I'll reach SVR 12 even if I'm undetected at EOT.

Paul I think it's great you posted this. And I'd be pissed that the doc didn't call me too. Good luck.

Katie · « **Reply #38 on:** January 30, 2015, 01:52:05 pm »

Hi Guys! Happy Friday!

When I was first researching Harvoni last spring, to get a grip on it before it came available in October, all I saw for recommended treatment was 12 or 24 weeks. When I met with my doctor to discuss the new treatment as he had been following it closely since the beginning (he said 4 years) he never even mentioned an 8 week treatment. When I heard some of you, who are now my friends, were only being given 8 weeks, my first thought was MONEY! That is one reason I was making comments about it earlier and it confused me. Then the 8 weeks seemed to be the prescribed treatment for so many I figured I should drop it. It's always about money instead of the good of the patient with the insurance companies. It is sick!

They don't consider the mental anguish it puts someone through to get the news of relapse, let alone the physical setback and how that affects the overall health.

I am hoping the Harvoni still in the system is still working and searching out those few alien monsters and squashing them for the parasites they are so the SVR12 is still achieved. It sounds like that may be a good possibility and the percentages of a cure are still high so I am sure most will be OK.

We all need the reality of the situation so we can stand up for ourselves and for each other.

Thanks for you post Mel. It is an eye opener and when you almost double the profits you list it is obvious what they are doing. It's just typical of corporations in this day and age and it is wrong. And thank you Paul for sharing your situation with us. We are all with you!

Katie

anniemybaby · « **Reply #39 on:** January 30, 2015, 02:41:55 pm »

Hi Katie I know with my 8 week treatment the reason being is a low viral load and no cirrhosis

Bob V · « **Reply #40 on:** January 30, 2015, 02:51:49 pm »

My .02
If they wanted to improve patient outcomes with Harvoni: all patients on 12wks and patients should have VL test at 8wks if undetected complete 12wks. If positive test every 2wks until undetectable then add 28 more doses. Yes this is a PIA and labs cost money but long term it would save $$$ and a better SVR rate.

For patients with cirrhosis they might need the full 24wks regardless.

I know, I'm dreaming.

Katie · « **Reply #41 on:** January 30, 2015, 03:04:15 pm »

We also need to remember that even if you are UD during treatment doesn't mean you've cleared the virus as there are limits to the sensitivity and the post tx test at 12 weeks is the one that shows if they are replicating and if you are clear.

I feel they are just using the low VL and no cirrhosis as an excuse to save money and gamble with our health, but then I don't have much faith in their intentions. Just my opinion.

I just hope I am wrong and everyone clears this disease without relapse, but Paul is a disturbing example and the way his doctor treats him is not how it should be.

I don't want to be a downer for anyone as I have faith in this new drug and in the end I know we will all be OK. It is just getting through it, so I'm going back to my positive energy and am grateful to be able to speak freely on this forum.

Thanks to all of you for being here. You make this journey so much better.

Katie

Bob V · « **Reply #42 on:** January 30, 2015, 03:12:53 pm »

Katie
I agree with you and some, I hope I'm wrong too. If my Monday lab comes back detected that means I would of had a failed treatment too.

Lynn K · « **Reply #43 on:** January 30, 2015, 03:43:26 pm »

Great analysis Mel

All I can say is it's all about the Benjamin's

kate0b1 · « **Reply #44 on:** January 30, 2015, 05:32:08 pm »

@mel, wow thats a great post. lots to think about there, thanks for the hard work

kate

Mike · « **Reply #45 on:** January 30, 2015, 06:13:24 pm »

I know I'll get some boos and hisses for writing this. Regardless:

The reason why some folks are on 8 week course of Harvoni is because that is all that is needed to achieve an SVR12 for 95% of this qualified population.

In fact, this is supported by empirical research that demonstrates that the efficacy for those who qualify for an 8 week course of treatment is commensurate with the efficacy of those requiring a 12 or 24 week course.

In medical science, the least invasive treatment which is shown to be effective is always the first choice.

There is also an ethical issue: Would it be appropriate to prescribe a cancer patient a 20 week course of chemotherapy when the research indicates that, for this particular patient's clinical picture, all that is needed is a 10 week course? Absolutely not.

The same is true here.

Having said this, the unfortunate fact is that 90-95% efficacy is not a 100% and some will fail to clear the virus (I failed my first treatment).

The good news is that this population can be retreated and it doesn't appear that the body develops a resistance to the antivirals.

Best wishes, Mike

anniemybaby · « **Reply #46 on:** January 30, 2015, 06:24:14 pm »

OK I'm totally starting to freak out I read these posts everyone that was on the 8 wk treatment couldn't rid the virus so I'm 2 wks into treatment n I'm probably gonna still have the virus at end of 8 wks then what do I do will they prescribe me more medication what will happen omg I'm freaking

anniemybaby · « **Reply #47 on:** January 30, 2015, 06:32:51 pm »

I'm calling my GI Dr Monday I want a back up plan if I'm still infected in 8 wks this &#%# has me scared well my insurance company gave me no problems for the prescription so hopefully if I need 4 more wks I can receive it is there no end to this madness

kate0b1 · « **Reply #48 on:** January 30, 2015, 06:38:40 pm »

@annie, don't freak, as mike said you are on 8 weeks for a reason. I do utilization review for a "for profit" hospital and yep there is a crap ton of money/insurance woes out there, but the bottom line is that you are on 8 weeks for a reason.
1) most if not all us on 12 weeks with or without other meds is because we have failed treatment before.
2) you should be having labs at 4 weeks to see where you are with your VL, if your not cleared, that is the time to have a discussion about weather or not to add more time.
Are you having labs @ 4 weeks? if not thats the question you need answered.
this is scary for all of us but your on the right path for you.

kate

Red Hen · « **Reply #49 on:** January 30, 2015, 06:40:29 pm »

Annie, I think most people who have the 8 week treatment prescribed for them do clear the virus. That's what Mike is saying. What I wonder about is if all doctors are educated enough about HCV to make an informed decision about length of treatment. I guess the drug company or insurance company recommends what they have determined is sufficient. I am, naturally, skeptical about that. However, it doesn't mean that the 8 week course doesn't work. It usually does. Don't freak out.

Katie · « **Reply #50 on:** January 30, 2015, 06:44:12 pm »

Annie you need to read Mike's comments again. Not everyone on 8 weeks is going to fail to clear the virus. The cure rate is still high it just isn't what was originally recommended from the initial trial tests, which were on very small groups.

I think it would be good to discuss this with your doctor for a back up plan, in case you are in that small percentage which is somewhere between 5-10 %, according to what Mike posted. None of us know and won't know until we are tested at least 12 weeks after we stop the medication. This drug is really new and the data isn't all in.

My comments were that I don't always trust the intentions of insurance companies, but I am hoping the doctor stands up for their patients and does the very best for them.

I didn't want to cause you any distress as I was worried some of these comments would upset you. You are being regularly tested so you should see the results. Many of us are only tested at 4 weeks and then 8 weeks later and then again at 12 weeks. That leaves a big gap in knowing what is going on, which other than peace of mind, doesn't really change anything.

Hope this helps in putting your mind at ease.

Katie

anniemybaby · « **Reply #51 on:** January 30, 2015, 07:01:56 pm »

I'm sorry I'm just really scared

Bob V · « **Reply #52 on:** January 30, 2015, 07:24:34 pm »

There is also an ethical issue: Would it be appropriate to prescribe a cancer patient a 20 week course of chemotherapy when the research indicates that, for this particular patient's clinical picture, all that is needed is a 10 week course? Absolutely not.
----
Mike
Read my post, that's why I say do labs and treat accordingly.

Bob V · « **Reply #53 on:** January 30, 2015, 07:30:58 pm »

Annie
Don't freak out, like Katie said talk with your doc. Remember 90-95% will be undetected.

Katie · « **Reply #54 on:** January 30, 2015, 08:02:38 pm »

Quote from: anniemybaby on January 30, 2015, 07:01:56 pm

I'm sorry I'm just really scared

You don't need to be sorry. This is frightening for everyone and we all understand. Most of us have been on this forum for several months so we are used to going back and forth and discussing the different options and remember, we are not doctors or medical research scientists, we are just infected same as you. That's why our support of each other is so important as we totally understand the ups

and downs

and round and rounds!

Just hang in there and keep being proactive!

Katie

Lynn K · « **Reply #55 on:** January 30, 2015, 10:21:54 pm »

Annie

95% cure you will be fine don't worry. Take a deep breath and exhale slowly.

We are all nervous, I am nervous just remember

“It’s OKAY to be scared. Being scared means you’re about to do something really, really brave.” -Mandy Hale

Katie · « **Reply #56 on:** January 30, 2015, 10:45:29 pm »

“It’s OKAY to be scared. Being scared means you’re about to do something really, really brave.” -Mandy Hale
[/quote]

Great quote Lynn!

How are you feeling these days with your new treatment? Hoping all is going well for you. Your common sense posts help keep us grounded. Thank you.

Katie

Lynn K · « **Reply #57 on:** January 30, 2015, 10:47:47 pm »

Just got my 1 week on Ribavirin results looking for changes in hemoglobin:

1/13/15 before Riba
HGB 11.1 - 15.9 g/dL 13.7

1/27/15 after 1 week
HGB 11.1 - 15.9 g/dL 11.9

So still in normal range steady as she goes

Katie · « **Reply #58 on:** January 30, 2015, 10:56:50 pm »

Glad to hear it.

Keep the faith!

Katie

Bob V · « **Reply #59 on:** January 30, 2015, 11:00:58 pm »

Lynn
Good news. When do you get your next HgB?

Lynn K · « **Reply #60 on:** January 30, 2015, 11:02:06 pm »

Hi Bob

next Tuesday 2/3 so end of week 2

Bob V · « **Reply #61 on:** January 30, 2015, 11:55:58 pm »

Lynn
Hoping for a stable HgB for you.

JoeK9999 · « **Reply #62 on:** January 31, 2015, 08:26:04 am »

Quote from: dragonslayer on January 28, 2015, 05:00:50 pm

Bob, Motor: You know, I asked him at the beginning if we can do labs before the 8 wks are over so that we can order up another month if needed, and he simply said NO. I dont get it either. .I dont know if the numbers dont show any benefit or what. I know some doctors will do that, and others will ask for nothing except a 12 wk test after treatment. I have a hard time believing that 4 more wks wouldnt have knocked out the 29 lousy remaining virus particles. Im certainly going to go down that line of questioning with when I see him in April. Nevertheless, I note in the trials documents, On-Treatment Virologic Failure results were 0/215 in the 8 wk cohort, and 0/216 in the 12 wk cohort as shown in Table 6 from the prescribing document from the Ion-3 trial ***... So with odds like that, how can I still be detected at end of treatment?! I just dont get it.. If these trial numbers are to be believed and not prettied up for public consumption, then what happened to me should be an impossibility I would think.

***PS.. Called Gilead Medical Info and spoke to a Pharmacist. I questioned him about the 0/215 (8wk) and 0/216 (12wk) trial stats for On-Treatment virologic failure numbers. One might assume that these represented 100% UND results at end of treatment.. But I found out otherwise.. I was told the criteria for these numbers was not UND but, rather, viral load of 25 or under! If I were showing a VL of 25 instead of 29, Id have been reported as an on treatment success also... Its things like this which should cause us to look at the trial results with a little more scrutiny, seems to me.

Paul - Just keep in mind with these low numbers the majority still reached SVR12.
I read a post on another forum of a detected at EOT and then the woman reached SVR12 and SVR24. Evidently the immune system was able to eradicate the rest. So keep your spirits up. We are all in the unknown boat.

dragonslayer · « **Reply #63 on:** January 31, 2015, 10:35:30 am »

Quote from: JoeK9999 on January 31, 2015, 08:26:04 am

Paul - Just keep in mind with these low numbers the majority still reached SVR12.
I read a post on another forum of a detected at EOT and then the woman reached SVR12 and SVR24. Evidently the immune system was able to eradicate the rest. So keep your spirits up. We are all in the unknown boat.

Thank you guys for giving hope. It surely will make the 12 wks til my next bloodtest and followup appt with hepatologist easier to take. Ive read that even one lowly viral particle is enough to replicate and send the viral load back into the millions, which is often used as an explanation for relapse, ie, the rna quant test shows undetected when below 12 or 15, but it may not be zero, hence, in 12 wks, when svr12 is tested for, it appears as a relapse, when in all likelihood, it never really went away... I mean, this is certainly a possible scenario. So at first glance, its difficult for me to buy into the concept that a vl of 29 on last day of harvoni can go to und at the svr12 test.

A more positive interpretation might be that of those testing UND at end of treatment, probably only a very small number really have a viral load count of zero; seems more likely to me that the real number might be somewhere between 1 and the lowest bound of the test, whether 12 or 15, or whatever it is... If that is a valid interpretation, then that can give people like me more hope also.

Continuing along this line of thought, I mentioned earlier that although the total number of participants in the Ion-3 groups of both 8 and 12 wk recipients showed 0/451 on-treatment viral breakthrough making it appear as though I really am a total outlier, the fact remains, according to the Gilead Medical Info pharmacist I spoke to, the criteria for making it into this group was not UND, but a quant rna value of <=25! In other words, Im close enough to those results that its not inconceivable that, on any given day, I would have tested with that 'no viral breakthrough on treatment' result as well.. So that gives me a little hope too.. Not much, but enough to help me past the next 12 wks.

Thanks all for your continuing comments and well wishes.

Islandgirl · « **Reply #64 on:** January 31, 2015, 10:54:32 am »

First, Paul, I'm so sorry you are going through this!

I remind myself from time to time that just because I was UD at 4 & 6 wks, doesn't mean it will be the same at next test, although I'm hoping/praying it will. I confess it's my attempt to keep from being too overwhelmed if it happens, since I've seen it happen with others in our Forum Family.

Originally, I naively thought if UD it would remain UD, your experience is a BIG reminder to keep hopeful but to keep open to changing direction if the final test turns out to not be what we're all hoping for.

There's a wealth of great information and reassurance in these posts and I hope more people get a chance to read them. Thanks everyone! I'm holding all of us in positive thought - along with a group hug (we never get enough hugs

...Islandgirl

Lynn K · « **Reply #65 on:** January 31, 2015, 01:46:54 pm »

My thinkng is that with the 95% SVR rate that 95% truly were virus free at EOT which was confirmed 12 weeks later and the other 5% had a few below detectable levels.

Also bear in mind say it was 3 IU/mL so 3 units of virus per mL of blood. If memory serves the body has about 4 liters of blood so really that is a lot of virus left over that survived treatment.

dragonslayer · « **Reply #66 on:** January 31, 2015, 02:47:39 pm »

Quote from: Lynn K on January 31, 2015, 01:46:54 pm

My thinkng is that with the 95% SVR rate that 95% truly were virus free at EOT which was confirmed 12 weeks later and the other 5% had a few below detectable levels.

Also bear in mind say it was 3 IU/mL so 3 units of virus per mL of blood. If memory serves the body has about 4 liters of blood so really that is a lot of virus left over that survived treatment.

Lynn, Is this in response to my statement regarding what the Gilead pharmacist told me regarding the criteria used in the trials to establish on-treatment-virologic-failure being a viral load <=25 and not UND or 0?

Katie · « **Reply #67 on:** January 31, 2015, 03:17:43 pm »

[Also bear in mind say it was 3 IU/mL so 3 units of virus per mL of blood. If memory serves the body has about 4 liters of blood so really that is a lot of virus left over that survived treatment.
[/quote]

Oh Dear Lynn, Now you have my head swimming with questions on that statement. I had thought of this when I was first diagnosed but haven't pondered it lately.

Just think how many were in the total blood volume when we were in the millions!!!

So are they uniform throughout the circulatory system?

Are these the ones who escaped the liver, if so how many are left there doing damage?

If blood was tested every day for a week what would the readings be? Would they fluctuate?

How do they get that count? Is it an average or an indication, a sensitivity test or and actual count? They are SO tiny, we can't even comprehend.

I knew they were other worldly parasites!

All I know, is that 59, in my case at 4 weeks, is a heck of a lot better than 3 million, and my body is an incredible machine that fights hard to keep running so I will put these questions aside and just be grateful I am improving and know I will be cured, soon, as we all will.

I believe the drug stays in our system working after the last pill and has diminished them to the point of extinction and the monster will the be defeated. Remember, many people infected with Hep C take care of the virus on their own and never go to the chronic state so when we get to a very low viral load, even after the treatment and even after the medication has flushed out, our immune system is still working and killing the virus. If this doesn't make sense, please let me know.

Good. I talked myself out of the panic mode! HA! It's going to be a good day. Breathe, Relax, Enjoy and Celebrate the day. We are warriors in this battle and our victory is coming!

Katie

bridget · « **Reply #68 on:** January 31, 2015, 10:04:48 pm »

Paul,
I am so sorry that this happened to you! It makes me very angry that your dr. didn't follow up with you directly. Treatment failure definitely merits a phone call! I agree that you deserve a re-test of those labs. 12 weeks is too long to wait. Email your dr. and express your frustration/anxiety & ask for a re-test. It's a reasonable request. It would also be a good test to see how your dr. responds to your request. If you don't like the way you are being cared for, find a better dr.
Best of luck

dragonslayer · « **Reply #69 on:** January 31, 2015, 10:22:46 pm »

Email the doctor? Lolz... wish I could.. The only way I can communicate at all with the doctor aside from an office vist is through his nurse via phone. Hes one of 3 or 4 doctors in a local Comprehensive liver center. These doctors to their own biopsies and transplants... That leaves patient contact aside from office visits to the their nurses.. I have requisitions for blood work from him which his nurse sent me which I can basically do anytime I want. Im gong to follow the orders he left with the nurse for a 12 wk wait and a retest followed by an office visit.. If I want this doctor to go to bat for me regarding retreatment Im going to have to follow his advice.. When I see him in april, Ill let my feelings be known. I dont see what retesting now will do. Ill still have to be retested in 12 wks at which time we'll know either that Im SVR12 or that I need to be retreated.. .Before that, nothing can be determined.. Even if I tested UND now, Id Still have to be retested at 12 wks, so I really dont think this plan is a bad one..More testing, for me, just adds to the anxiety, and accomplishes nothing since the 12 wk retest is mandatory anyway. The only thing I heartily object to is the lack of any ability to speak with him outside the office visit and his failure to contact me personally after the eot bloodtest result. I also would have preferred if I got 12 wks of treatment, but the data, so far, just really doesnt support it for someone with my stats..

Lynn K · « **Reply #70 on:** February 01, 2015, 01:55:30 am »

Hi Paul

I was thinking about this comment you wrote:

"A more positive interpretation might be that of those testing UND at end of treatment, probably only a very small number really have a viral load count of zero;"

When I wrote:
" My thinkng is that with the 95% SVR rate that 95% truly were virus free at EOT which was confirmed 12 weeks later and the other 5% had a few below detectable levels."

That is only my personal opinion and I am not at all a medical professional. Just in my thinking it seems that once off the meds the therapeutic effect has ended so they would have to be zero at that point for those that eventually make SVR or the virus would come back since it was still there just below detectable.

But again it is only my lay persons opinion trying to make sense of the science.

Wishing you only the best

Lynn K · « **Reply #71 on:** February 01, 2015, 02:25:27 am »

Hi Katie

Ok so I am not a scientist so this is all only my opinion ok?:

Just think how many were in the total blood volume when we were in the millions!!!

Yes that is correct like my viral load 2 million /mL lots of them but remember they are very, very small.

So are they uniform throughout the circulatory system?

I would think so that is where we test for them.

Are these the ones who escaped the liver, if so how many are left there doing damage?

I don't think they stay in the liver in a higher quantity but I am very much outside my knowledge here on this. So there is no escape they are freely flowing throughout the circulatory system. Again I am not a scientist.

If blood was tested every day for a week what would the readings be? Would they fluctuate?

When we are not being treated yes there is variation from what I have been told basically sampling variation. So yeah just like all your other blood tests when you are being tested frequently if you compare your liver enzyme tests they change all the time as do others. What they look for is trend.

How do they get that count? Is it an average or an indication, a sensitivity test or and actual count? They are SO tiny, we can't even comprehend. Way out if my league on this one. I think the test is done by a machine and as they draw more than a mL I think it is sample average.

All I know, is that 59, in my case at 4 weeks, is a heck of a lot better than 3 million, and my body is an incredible machine that fights hard to keep running so I will put these questions aside and just be grateful I am improving and know I will be cured, soon, as we all will.

Absolutely I trust the science if they had not been shown to be effective in trials and not dangerous the meds would not have been approved.

I believe the drug stays in our system working after the last pill and has diminished them to the point of extinction and the monster will the be defeated. Remember, many people infected with Hep C take care of the virus on their own and never go to the chronic state so when we get to a very low viral load, even after the treatment and even after the medication has flushed out, our immune system is still working and killing the virus. If this doesn't make sense, please let me know.

Interesting theory never thought about that I did check the hat life of Sovaldi Ledipasvir but I don't recall off hand but I think it is only a day or 2 and the meds are no longer in our systems they have been excreted in our urine and poop.

I just don't see any value in worrying about the end result at this point. Sure it is natural to be concerned as we all want to be rid of this virus or we wouldn't be here, but excess worry or freaking out will not change the final result it only makes today stressful when it does not need to be.

Best to you you will be fine

BattleTheBeast · « **Reply #72 on:** February 01, 2015, 02:44:55 am »

Interesting Lynn,

I wonder if this medication help to build up whatever it is that helps our ability to fight the virus off ourselves when we have completed the course. So the medication kills off what it can find but does it also help us to fight it on our own after that magic Undetected so we would be more like the group who's own bodies fight it off naturally. I mean after TX it will always show HepC yet we no longer have the active virus once we reach SVR24 (I know some people think 12 is the new 24).

Just curious, no matter how much I read or try to understand it's still really confusing to me and I am tying to make some sense out of it.

Mel

Lynn K · « **Reply #73 on:** February 01, 2015, 02:54:57 am »

Yeah me too Mel lol

Yes we will always test positive to antibodies but hopefully never again for the virus.

Just like if you have either been immunized against or had the measles you will have measles antibodies same thing with hep c except hep c antibodies don't protect us from reinfection.

I don't think my system can beat hep c on its own that is why I became chronic like 75% of those exposed do and why even though I was UND after 12 weeks of Sovaldi Olysio I relapsed after treatment stopped.

Who knows maybe that is why some clear and some relapse that your body still needs to get rid of the last few which if that is the case doesn't sound like good news for me. I think I need the meds to take care of the virus 100%

JoeK9999 · « **Reply #74 on:** February 01, 2015, 08:04:17 am »

I agree with Paul that more testing just adds to the anxiety.
When I called Gilead after my 1 month on treatment still detected test,
they told me just finish the medicine and and get the 12 week post treatment test.
I never got another HVC RNA test, just CBC and Liver panel tests. And my doctor was only interested in a post 24 week test, period. He didn't care about any other HCV RNA testing.

After more reading I am not even sure about test results. I am confused because
I have read some of the virus can be stuck in you for a long time, but without the capability of replicating. So does that mean the tests finds those, but they have been cleaved and thus not a problem for us?

We've seen enough on treatment results going
both ways in this forum with Harvoni. The only tests that count are many months post treatment as we have seen in past treatment protocols results. We can only pray for a good outcome for ourselves. We cannot predict it and we certainly don't need anymore stress and anxiety. I am wishing and praying for the final outcome we all want.

bridget · « **Reply #75 on:** February 01, 2015, 09:53:23 am »

Paul,
Sorry to hear that you cannot email your dr. The only way I was approved for treatment and later approved for the correct length of treatment was to write to my dr. with facts from Gilead, AASLD & the ION-3 Trial. It's easier to reference those sources in writing.

If no email, I would write via snail mail & would want to know why you were not tested at 4 or 6 weeks when there would have been time to lengthen treatment to 12 weeks? And, if you are still at 29 at 12 weeks EOT, what is the treatment recommendation? I would also like a re-test now, just to confirm the accuracy.

My reason for writing would be to create a paper trail to document your concern that by not testing you mid-treatment, an opportunity was missed to cure you. This may help your case if you are denied re-treatment. If I was not comfortable with the way the dr. responded, I would rather shop for a new dr. now vs. waiting 12 weeks to start looking. What if he told you after waiting for your 12 week appointment that he does not recommend treating you anytime soon? Why wait 12 weeks for that news?

I'm still puzzled about your finding that Gilead claimed success for anyone <25!
I had never read that!
Good luck, hang in there, you WILL be cured eventually.

bridget · « **Reply #76 on:** February 01, 2015, 09:55:55 am »

Paul,
Who made the decision not to test you mid-treatment? Doctor or Insurance company?
Just curious.

dragonslayer · « **Reply #77 on:** February 01, 2015, 10:13:28 am »

Bridget,

I already knew how he worked prior to receiving my prescription.. In my pre-treatment meeting with him, I learned that the only number he's interested in is the 12 wk post treatment number. I had asked him if hed do a a test prior to end of treatment and he said no. It had nothing to do with insurance so far as I could tell. Doctors have different approaches to how to work with this disease.. He is a transplant hepatologist and far from a novice in the field. At some point, either you trust your doctor or you dont.. The on treatment bloodtests, for instance, while commonplace on trials and with earlier forms of treatment due to the relatively large numbers of null responders, assumes a lesser roll with the new DAAs to some doctors. At the end of the day, the only number that matters is the 12 wk post treatment number. All the rest is a bit of noise in the system.

> What if he told you after waiting for your 12 week appointment that he does not recommend treating you anytime soon? Why wait 12 weeks for that news?<<

Because I presume it takes time for viral loads to return to a more stable value after having been so diminished during treatment.. That and the fact that there is still a chance that svr12 might be achieved.

>>I'm still puzzled about your finding that Gilead claimed success for anyone <25!<<

As I wrote in my post, this was the number Gilead used in the trials to ascertain whether or not there had been any 'on treatment Virologic failure' as reported in the trial tables in the prescribing document (as can be seen in table 6 relative to the Ion-3 trial, for instance) . This was conveyed to me by a Gilead pharmacist who I reached through Gilead Medical Info. He seemed extremely well versed on the data and the result, although was only allowed by FDA guidelines to convey certain info to patients.. He couldnt, for instance, advise me as to whether Harvoni may be retreated and whether there was any resistance or immunity involved.. He did say, however, that they were permitted to divulge this and other info to doctors.

apache · « **Reply #78 on:** February 01, 2015, 02:50:42 pm »

Executive summary: having one EOT result which is > 25 IU/mL is not necessarily an indication of treatment failure.

See the appended for more on this. In particular, look at the bold highlighted section.

---- cut here for more details ----

Quote

>>I'm still puzzled about your finding that Gilead claimed success for anyone <25!<<

As I wrote in my post, this was the number Gilead used in the trials to ascertain whether or not there had been any 'on treatment Virologic failure' as reported in the trial tables in the prescribing document (as can be seen in table 6 relative to the Ion-3 trial, for instance) . This was conveyed to me by a Gilead pharmacist who I reached through Gilead Medical Info.

This "25" threshold (IU/mL) is actually mentioned in the detailed Harvoni product insert:
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

If you search for "25" (in the .pdf viewer), it'll eventually take you to:

Section 14.1: Overview of Clinical Trials

which contains this info:

Quote

All three Phase 3 trials evaluated efficacy of HARVONI (one fixed-dose tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir administered once daily) with or without ribavirin. Treatment duration was fixed in each trial. Serum HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.

Sustained virologic response (SVR) was the primary endpoint and was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment. Relapse was a secondary endpoint, which was defined as HCV RNA greater than or equal to LLOQ with 2 consecutive values or last available post-treatment measurement during the post-treatment period after achieving HCV RNA less than LLOQ at end of treatment
.

The hopeful part is the last sentence (where I've added the bold):

Quote

Relapse was a secondary endpoint, which was defined as HCV RNA greater than or equal to LLOQ with 2 consecutive values or last available post-treatment measurement during the post-treatment period after achieving HCV RNA less than LLOQ at end of treatment.

The fact that they mentioned 2 consecutive values... implies that the RNA measurement test is not 100% accurate. In other words, having one test with a value that is not UND is not necessarily an authoritative determination of treatment failure.

The difference between LLOD (Lower Limit of Detection) and LLOQ (Lower Limit of Quantification) is a bit confusing, but there is a Medscape article which gives a pretty good explanation. Note that the Medscape article is not about Harvoni, but about a different Rx. However their explanations of LLOD, LLOQ are well-done, and will help clarify how things are measured in clinical trials:

Quote

http://www.medscape.com/viewarticle/756591_3
Lower Limit of Detection (LLOD) Versus Lower Limit of Quantification (LLOQ)

The LLOD is the HCV RNA concentration at which less than 5% of the samples that contain a known amount of an RNA standard yield a signal that can be detected. The LLOQ refers to the lowest HCV RNA concentration that is within the validated quantitative range of an assay. An undetectable result indicates that HCV RNA was not detected in the sample. The limit of detection and the limit of quantification vary according to the assay used. Both the boceprevir and telaprevir phase III studies used the COBAS TaqMan HCV RNA assay, version 2.0 (Roche), with a LLOD of 10 IU/mL and a LLOQ of 25 IU/mL. Eligibility for RGT was based on the lower limit of detection (<10 IU/mL) of the assay. There is thus a range in which HCV RNA can be detectable, but falls below the level of quantification. This situation is not uncommon during HCV treatment and is associated with lower SVR rates.

BattleTheBeast · « **Reply #79 on:** February 01, 2015, 02:57:23 pm »

Hi Apache,

Thanks for sharing that but I have to admit I am still lost with this whole thing. Perhaps a bulb with go off in my head for this one but right now it's just not making too much sense to me.

I bet in 2 months I look at this post I made and laugh that I didn't understand it

Mel

dragonslayer · « **Reply #80 on:** February 01, 2015, 02:58:11 pm »

Wow, Apache.. Great Find!!!! That is bound to make those of us with lower limit type detectable amounts during or at End Of Treatment feel considerably Better.. . I think many of us have been focusing on UND as the only measure of on-treatment or EOT success. Perhaps we can now expand this a little to encompass values near the lower bound.. Really good find, corroborating what the Gilead Pharmacist told me.. Thanks much.

Red Hen · « **Reply #81 on:** February 01, 2015, 03:13:16 pm »

I'm like Mel and really don't understand all of this. It does seem like the drugs would continue to work in the body after the last pill and that the 12 week after treatment time frame might have some relationship to that. I'm not a doctor and never wanted to be one. Just hope that all paths lead to successfully getting rid of the virus!

Katie · « **Reply #82 on:** February 01, 2015, 03:40:01 pm »

Thanks Apache. Appreciate you taking the time to share that.

The thing I know about viruses is they are Sci Fi...They aren't alive but these non living parasites are very specific, looking for the right cell to penetrate and use those cells to inject their DNA or RNA which allows them to replicate. Ever since my micro biology class many years ago they have given me the creeps and they cause so much disease and are the most difficult to treat. What is even worse is that there are viruses out there we haven't even discovered yet and may very well be causing other chronic and terminal conditions where the cause is yet unknown. Hep C was only discovered in 1989, and then it took a couple years to perfect the blood screening tests for safe transfusions or other blood products.

This site gives a good history of Hep C up to the pre release of Harvoni and the language is in layman's terms. It doesn't go into the test trials but is a fact sheet on the history and is quite interesting.

http://hcvadvocate.org/hepatitis/factsheets_pdf/Brief_History_HCV.pdf

Enjoy your Sunday, and if you are a football fan, Have a good All American Super Bowl Sunday. I do admit to watching the commercials and half time, but that's about it. Many in Alaska are excited as the Sea Hawks are considered "Our Team". HA!

Katie

Lynn K · « **Reply #83 on:** February 01, 2015, 04:39:06 pm »

I have run across something about virus fragments being in the blood that are not able to replicate.

My testing for the virus is at week 4 on treatment, EOT and 12 weeks post but I am thinking about asking my doctor to skip the EOT and do a 4 week post tx test. To me the EOT virus test means little and since I relapsed on Sovaldi Olysio seeing a 4 week post tx test I think would be more informative.

Bob V · « **Reply #84 on:** February 01, 2015, 04:39:59 pm »

Apache
Great post. Pre tx I really studied that drug info, still do.

Paul,
I think I posted this before but my doc wasn't going to do labs until EOT too. His reasoning was that he's not going to change the treatment so what's the point. I asked and he did order 5 week VL, I was under 15. I'm doing a 8 week tomorrow. Am a nurse and I always had to follow labs so to do it for myself just seems normal. I want to know where I'm at at what point I'm UND or not. Also, I'm want to see if I would of been detected after 8 weeks.

I'm hoping in light of this new info today things turns out well for you, fingers crossed.

Tess1971 · « **Reply #85 on:** February 02, 2015, 12:59:58 pm »

My gastro did not do any VL checks until EOT either. He only checked platelets, LFT, etc due to using ribavirin. He insisted that it was meaningless until treatment is over as he would continue treatment no matter what the results were. Not sure if it was a $$ thing with insurance or truly in his experience. I still have not seen him and will not until after my 12 week blood work. I only communicated with his nurse during treatment.
I agree with many here that it is a question of $$ with the insurance companies as when I read studies they all had 12 and 24 week originally for Harvoni.
I feel fortunate to have been UND so far, but, ribavirin has taken its toll on me. I am still recovering from it. And since I am Geno 2 there are no other options for me at this time.
In my research I have found that all these drugs remain in the system after treatment so b between that and your immune system you can still clear that small amount of virus left especially since the drugs interfere with replication. Be positive that your body will prevail !

anniemybaby · « **Reply #86 on:** February 03, 2015, 04:27:14 pm »

I've been reading this thread Im also on harvoni for 8 wks I go for blood work every 2 wks till finished with treatment but my GI Dr told me she doesn't say I'm cured till a 6 month blood work after treatment I guess all drs are different

Bob V · « **Reply #87 on:** February 03, 2015, 04:35:29 pm »

Annie
I think for people who took Harvoni SVR 12 was almost 99% at 24 weeks. I'll have both for piece of mind.

dragonslayer · « **Reply #88 on:** February 03, 2015, 04:38:21 pm »

Quote from: anniemybaby on February 03, 2015, 04:27:14 pm

I've been reading this thread Im also on harvoni for 8 wks I go for blood work every 2 wks till finished with treatment but my GI Dr told me she doesn't say I'm cured till a 6 month blood work after treatment I guess all drs are different

I think some of the Drs are still using the older Interferon related protocols, where, if Im not mistaken, SVR24 was the name of the game (although, never having been treated with that drug, I could be completely wrong on this one)... The new DAAs which dont include interferon are more likely to include SVR12 as the end measure of success. But as we can see, these measure will likely undergo a period of adjustment as the newer regimens roll out. .. And, at the end of the day, there still will be individual differences among the Drs and how they work.... If SVR4 is something like 99% predictive of SVR12, Im not sure it must go much beyond that even. But one likes to be 100% sure in this arena, if that is even possible.

anniemybaby · « **Reply #89 on:** February 03, 2015, 04:46:24 pm »

Thanks Bob n dragonslayer I just can't wait to b hep c free I guess I'm going to try n lay down I've basically been up 24hrs n I feel like I've been up for days hubby says I look like a zombie he's lucky I love him hahaha

dragonslayer · « **Reply #90 on:** March 18, 2015, 08:58:22 am »

Just heard from my doctor regarding the test I did at 7.5 wks post treatment.. As you may recall, at EOT on 1/20/15 I was singing songs of woe because I tested Detected with a VL of 29... The test I just did 7.5 wks post treatment came back still Detected, but with a level below the LLOQ limit of 12.. Doctor tells me if I were relapsing, or if I still had active virus, at 7.5 wks post treatment, the VL would have gone back into the millions where it was before... He thinks that this is a good indicator toward SVR. Ill test again at 12wks, 24wks, and 48wks. But the fact that over a month after stopping Harvoni, the viral load was still decreasing into the range below Lower Level of Quantification is certainly a very good sign, and that Im most likely in the SVR camp ...

Long_Haul · « **Reply #91 on:** March 18, 2015, 09:05:31 am »

Awesome news Paul! I hope you continue to progress to SVR. I wonder if they need to send the blood test to a different lab to see if the result is the same? At any rate this looks promising and a lot better than dealing with a relapse. Best wishes and keep driving the number down. Be healthy and happy.

AL

JoeK9999 · « **Reply #92 on:** March 18, 2015, 09:34:05 am »

Paul - What a load of great news!
Very encouraging for the rest of us that are playing the waiting game.

apache · « **Reply #93 on:** March 18, 2015, 09:37:08 am »

Quote

He thinks that, this is a good indicator toward SVR. Ill test again at 12wks, 24wks, and 48wks. But the fact that over a month after stopping Harvoni, the viral load was still decreasing into the range below Lower Level of Quantification, Im most likely in the SVR camp is certainly a very good sign...

Congrats Dragonslayer, it sounds like you are definitely headed towards SVR.

Now that you're no longer actively taking Harvoni, perhaps it would be beneficial to try taking some of the non-Rx "liver healthy" supplements (milk thistle, dandelion root, etc) that many of us were taking before Harvoni? Of course the evidence for these is mixed, but there is significant positive anecdotal evidence for these types of supplements.

The big concern with taking supplements while actively taking Harvoni is that the interaction (if any) has not been well studied. Commingled with Harvoni, they could be detrimental. Then again, it seems more likely that it would be beneficial. However given the extreme cost of Harvoni, everyone leans towards the "lets just eliminate all supplements" argument. And that makes sense.

But now that you're no longer on Harvoni, perhaps it might be worthwhile to add these (or other similar) supplements, to improve your chances of SVR?

I'm no MD, but when I asked my MD about how long a Rx remained in one's system after the last dose, he said that it varies (no kidding), but it can actually be accurately calculated by looking up the "half-life" of the particular Rx. The rule they use is that after 5 (five) half-lives, the Rx is effectively no longer active. The reason for 5 half-lives is:
5 half-lives = (0.5 * 0.5 * 0.5* 0.5 * 0.5)
= 0.0313
= 3%

In other words, after 5 half-lives, the effective amount of the Rx still remaining in the body is 3%, which is essentially equal to 0.

For Harvoni, the half-life is actually specified in the 31 page detailed product insert:
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

in section 12.3 Pharmacokinetics, under the "Elimination" subsection.
They analyze the half-live in terms of the components of Harvoni:
Harvoni = sofosbuvir + ledipsavir

and the half-lives of those two are:
ledisavir = 47 hours
sofosburir = 0.5 hours

which implies the half-life of Harvoni is the max of those two: 47 hrs.
Rounding that up to an even 48 hrs (ie, 2 days).
and then multiplying by 5 to get 5 half-lives:
==> 5 half-lives of Harvoni = 10 days.

Thus, after 10 days the amount of Harvoni still present in one's body is essentially zero.

So if one were to start taking supplements after finishing a course of Harvoni, it would seem wise to wait 10 days. Which you have.

Again, I'm no MD, but this is a possible strategy you might want to run by your MD. He'll either say:
a) "Excellent idea, go for it."
b) "Horrible idea, because... <some wise insightful observation>."
c) "I have no idea. It's up to you to decide."

Best wishes for a SVR!

charly8 · « **Reply #94 on:** March 18, 2015, 09:57:57 am »

Quote from: apache on March 18, 2015, 09:37:08 am

and the half-lives of those two are:
ledisavir = 47 hours
sofosburir = 0.5 hours

Great Post Apache. Just one clarification. Sofosbuvir quickly breaks down into GS-331007 (the primary active ingredient) which has a half life of 27 hours. This is why we are able to take one pill a day. If it was .5 hours we would be popping almost 12 pills a day.

dragonslayer · « **Reply #95 on:** March 18, 2015, 10:07:18 am »

Apache.. Great find there in those stats.. Both prior and Post treatment, I take Maximum Milk Thistle from Natural Wellness every day. Ive been doing so ever since I was diagnosed in '08. I have no idea if it works, but I do know that IVe had this disease for over 40 yrs, and Im still F 0-1 on the biopsies, so no reason to stop doing what Ive been doing.

motor · « **Reply #96 on:** March 18, 2015, 10:29:52 am »

Great news DragonSlayer, thanks for posting and to other recent posters for useful info.
The VA had me scheduled for 12wks treatment, but changed it to 8.

apache · « **Reply #97 on:** March 18, 2015, 11:16:59 am »

Quote

Just one clarification. Sofosbuvir quickly breaks down into GS-331007 (the primary active ingredient) which has a half life of 27 hours. This is why we are able to take one pill a day. If it was .5 hours we would be popping almost 12 pills a day.

Thanks for the clarification charly8! Your explanation makes perfect sense.

Picnic · « **Reply #98 on:** March 18, 2015, 02:23:19 pm »

I told you not to freak out!

chino1969 · « **Reply #99 on:** March 18, 2015, 02:52:23 pm »

Lynn,
I had exactly the same experience you did with Solvadi/Olysio. I was SVR at 4 & 12 weeks with ALT & AST in the normal range. I was on it for 12 weeks. Two months after treatment I had the tests repeated and noticed my LFTs were elevated with the SVR coming in later which showed the Hep C to be back. I am now doing 24 weeks of Harvoni with my 4 weel blood work coming up.

I sought another opinion/doctor at The Univ. of PA Hospital; a renowned hepatologist who is handling my treatment as well as my Gastro.. He told me that had I done a 24 week course of Solvadi/Olysio, there is a good chance I would have remained virus free.

Quote from: Lynn K on January 30, 2015, 02:55:46 am

Hi Paul

I did see one post on another web site forum where the person was told he was detected but then retested and was found to be clear and that a lab error had been made. We have all heard stories of people enduring chemo only to find out they never had cancer.

Just on the small chance that the was a lab mix up any chance you could be tested again?

How are you liver function tests? When I relapsed on Sovaldi Olysio I got my LFT results before my viral load and saw my ALT had gone above normal range while it had been normal the whole time I was treating the first time in decades. Seeing the elevated ALT gave me a early warning about my viral load.

Just a thought

Bituman · « **Reply #100 on:** March 18, 2015, 03:16:01 pm »

Congrats DS! Looks like the momentum of treatment continues for you.

Bob

Momof3 · « **Reply #101 on:** March 18, 2015, 03:32:48 pm »

That is very great news!!!! Very uplifting and promising for those who are on the 8 week treatment like myself! I finish my course of treatment on April 7 I should be getting my 4 week viral load results any day and I really hope that 8 weeks is enough!

Bob V · « **Reply #102 on:** March 18, 2015, 04:03:02 pm »

Great news Paul, fingers crossed on your next labs.

Katie · « **Reply #103 on:** March 18, 2015, 07:13:35 pm »

YAY Paul...That is terrific news and you are going to beat this. Don't be worrying about theories out there as those a basically questions and not based on data or results for that specific question.

We'll be both testing at about the same time for our next check! It's nice to have a buddy.

I am so Happy for you and am doing the HAPPY DANCE for your behalf! No panic attacks yet...OK? HA

Katie

PatEquack · « **Reply #104 on:** March 19, 2015, 10:34:30 pm »

I would also caution everyone to get new razors, fingernail clippers and toothbrushes. They say the virus can remain potent for weeks on these tools. Also remember if you drink some of those mineral waters they have lots of metals and Harvoni binds to metals.

Lynn K · « **Reply #105 on:** March 20, 2015, 07:42:04 pm »

Hi Chino

Yup same here did 12 weeks Sov Oly in November the prescribing information sheet for Olysio was changes making Oly Sov an on label usage and the length of treatment was upped to 24 weeks for patients with cirrhosis. But I treated March to June and that was the recommendation at that time so it is what it is.

I have 45 days left of my 24 weeks with Harvoni and Ribavirin added at 9 weeks in.

I was not detected at 4 weeks and 12 weeks on treatment hopefully this will get the job done this time.

Are you treatment naive or previous non responder? Do you have cirrhosis? That make us harder to treat to be sure.

Good luck

spitzbar · « **Reply #106 on:** March 21, 2015, 10:09:13 am »

1) for careful reading and consideration, and maintenance to SVR:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3646144/

2) to obtain appreciable effects on HC viral load:

amazon.com/gp/product/B00IPMSQEW/ref=oh_aui_detailpage_o00_s00?ie=UTF8&psc=1

regards

MEG · « **Reply #107 on:** March 21, 2015, 12:15:18 pm »

Paul!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

I am just getting onto the forum after almost a week offline and yours is the first post I saw...........can't wait to read through others responses because I'm so excited.

I can't tell you how happy I am for you..........so happy...........

God bless and may you continue to lifetime SVRRRRRRRRR!

katheK · « **Reply #108 on:** March 28, 2015, 06:48:15 pm »

It looks like good news after all! Please let us know what happens at 12 weeks and 24.

Best,
Kathie

Tiger · « **Reply #109 on:** April 16, 2015, 05:05:45 pm »

In case you missed this info, here's some great news about dragonslayer - he's finally UND after 11 weeks post EOT:
http://forums.hepmag.com/index.php?topic=2557.msg19072#msg19072
Fantastic news for all of us - gives us all hope!

ponygirl · « **Reply #110 on:** April 21, 2015, 02:44:47 am »

I don't understand why physicians are doing 8 week treatments. My gastroenterologist said that the recommendations are 12 or 24 weeks. And I guess I am fortunate, I have Group Health and was told that they extend treatment if your are responding but not yet clear at 12 weeks

dragonslayer · « **Reply #111 on:** April 21, 2015, 09:21:56 am »

Quote from: ponygirl on April 21, 2015, 02:44:47 am

I don't understand why physicians are doing 8 week treatments. My gastroenterologist said that the recommendations are 12 or 24 weeks. And I guess I am fortunate, I have Group Health and was told that they extend treatment if your are responding but not yet clear at 12 weeks

Quite simply, they are doing it because the Ion-3 trial numbers show it to be just as effective as 12 wks for the recommended group and cost effective, which is never a factor far from the equation... Its the same reason theyre not prescribing Riba with it; in the trials, it did not generally add to effectiveness.

Lynn K · « **Reply #112 on:** April 21, 2015, 10:28:10 am »

And other than the additional cost another goal is to minimize exposure of patients to excessive amounts of medications when they are not needed.

dragonslayer · « **Reply #113 on:** April 21, 2015, 10:35:47 am »

Quote from: Lynn K on April 21, 2015, 10:28:10 am

And other than the additional cost another goal is to minimize exposure of patients to excessive amounts of medications when they are not needed.

Good point; forgot to add that one. Also, what about this:

>>And I guess I am fortunate, I have Group Health and was told that they extend treatment if your are responding but not yet clear at 12 weeks<<

Since we are finding that low level detecteds at EOT are NOT indicative of treatment failure, why are they extending treatment based on EOT results??

apache · « **Reply #114 on:** April 21, 2015, 11:12:04 am »

Quote

Since we are finding that low level detecteds at EOT are NOT indicative of treatment failure, why are they extending treatment based on EOT results??

Why is it that with prior treatment protocols (eg, ribavirin and interferon), detectable at EOT meant treatment failure, yet with Harvoni... detectable at EOT... is not an indication of failure? After all, the active ingredients in Harvoni will be eliminated from one's system in a very short time window (days) after one stops taking Harvoni. So it would seem that the virus response, given similar VL numbers at EOT, would be the same for both protocols. What logical explanation is there for the difference?

While I am happy when I read stories about people who are detectable at EOT and then go on to achieve UND status, something seems to be missing from the story.

Also, it seems to me that the conservative (safe) thing to do would be to extend the treatment if one is detectable at EOT. After all, for all we know, someone who is still detectable at EOT (for 8 week protocol) could be... someone that (had they tried a prior Rx, like interferon & ribavirin) would have failed that prior protocol... and thus fallen into the 12-week Harvoni protocol (not the 8 week protocol). I think I might be one of those candidates, as my Dr. is (attempting to) extend my 8 week Rx to 12 weeks, due to the fact that my 4-week VL is not UND. After all, if one looks at the detailed FDA report, for ION-3, the graph in Fig 2, page 81, of Gilead’s FDA detailed report @ http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000MedR.pdf ) shows that close to 99% of people in ION-3 were UND at week 4. So the fact that one is not UND at week 4 means that one has worse results than 99% of the people in ION-3. Thus, math would indicate that one's chances of achieving UND are not nearly as good as the participants in ION-3.

The above seems to contradict the anecdotal reports we're hearing about people who are still detectable at week 4 (and EOT), however the above ION-3 study is the only rigorous data we have to date.

Rereading the above, it seems quite pessimistic, so I'd love for someone to point out the flaw in the above logic.

Lynn K · « **Reply #115 on:** April 21, 2015, 11:31:39 am »

What I have read is that being detected at week four is no indication of eventual SVR. Weakly detected or not detected at week 4 on treatment has been shown to have no effect on eventual SVR 12.

Interferon based tx and Harvoni based tx have different methods to eridicate the virus. On theory being they are damaged and incapable of replicating virus being found and that interferon did not interfere with the virus replication life cycle as Harvoni does.

That being said if I was on 8 weeks and still detected I would prefer to get the additional 4 weeks no matter what the reports say. But if I was not detected a week 4 and 8 week EOT I would be good with that

MEG · « **Reply #116 on:** April 21, 2015, 01:51:34 pm »

Hi apache,

There is a thread for this conversation re: being detected at various time-points with Harvoni(and other direct acting agents(DAAs).

Lynn's explanation points to what they are saying. It's a completely different way the 2 agents(interferon-based tx vs. DAA therapy) work....

http://forums.hepmag.com/index.php?topic=2597.0

I hope that helps. It's very confusing for those of who, even if untreated, have been following the evolution of HepC therapy.

I think a good analogy re: the DAA's may be the Zithromax for bacterial infections. You take it for only 5 days but it continues to work in your system for a while post finishing.

Meg.

dragonslayer · « **Reply #117 on:** April 21, 2015, 02:06:17 pm »

>> Why is it that with prior treatment protocols (eg, ribavirin and interferon), detectable at EOT meant treatment failure, yet with Harvoni... detectable at EOT... is not an indication of failure? After all, the active ingredients in Harvoni will be eliminated from one's system in a very short time window (days) after one stops taking Harvoni. So it would seem that the virus response, given similar VL numbers at EOT, would be the same for both protocols. What logical explanation is there for the difference?

While I am happy when I read stories about people who are detectable at EOT and then go on to achieve UND status, something seems to be missing from the story. <<

I had asked a similar question with implications not all that different from yours.. I wanted to know why it is that being low level detected at end of Interferon treatments meant relapse for many/most, while being detected at end of Harvoni does not? My reasoning, not unlike yours, was that when the virus attacking drug is out of the system both with Interferon treatments and with Harvoni, relapse should quickly occur with both.. Yet it doesnt... Implicit in that question was, why are relapse rates so much higher with interferon patients who had acheved undetected status at EOT than Harvoni patients who have achieved undetected status at EOT.

The answer to both, from what I read, is the same.. .DAAs in general, and Harvoni in particular work differently than earlier treatments. Harvoni interferes with the virus' ability to replicate, so those virions detected at EOT are often times not vital. As with the case with me, the viral load count went from 29 at EOT, to detected < LLOQ(12) at 7 wks post treatment, to Undetected at 11 wks post treatment.. SVR....

I wish there were more cases to generalize from where patients were detected at EOT, to follow their progress to SVR, however we have some.. .Me, for one... Katie and Dee Dee were also detected at EOT. Katie had her 12 wk post treatment blood draw yesterday and we are looking forward to some good news from her in a few days..

Then, we have this study published in the Oxford Journals which shows all 6 low detecteds achieved SVR12. None of them did not achieve SVR.. .

http://cid.oxfordjournals.org/content/early/2015/03/02/cid.civ170.abstract

The conclusion of this study is:
"Conclusions. Contrary to past experience with interferon-containing treatments, low levels of quantifiable HCV RNA at EOT do not preclude treatment success."

Clearly there is something going on here with Harvoni which renders eot low level detected status much less significant for svr than with past treatments.

Im not wishing eot detected status on anyone; just that I believe it must be viewed quite differently than with past treatments, and I believe, the evidence is mounting.

MEG... thanks for posting that link.. I had forgotten about that article, so its a great inclusion in this thread, and just adds to the mounting evidence about which we've been talking. From the wonderful article to which you refer comes this quote; while Im not sure we know the exact reason that low level detecteds at EOT go on to SVR; only that it often does:

"There must be other reasons to explain the high SVR," Guedj said. "We think most of the [newly produced] virus may be uninfectious...treatment may have the effect of replacing a working replication complex with a defective replication complex, which explains how most patients could clear the virus in 6 weeks."

and:

"Based on these findings, the researcher concluded that direct-acting antivirals may have a "hidden effect [of treatment] not reflected in measured HCV RNA," and that "viral load kinetics, in particular at [end of treatment], may not be a reliable marker of SVR." "

Katie · « **Reply #118 on:** April 21, 2015, 02:26:37 pm »

Dragonslayer: Your logic is good. Thanks for your comment as it helps put some of my fears aside. I am very confident I will clear this, however there are those moments. I am going in for an abdominal ultrasound tomorrow and then will get both results on Monday.

Thanks again to both you and Meg and Apache!

A beautiful sunny day today. Going out to the shop and pull out some wood for a bookshelf. I still have boxes of books to sort through and put away!

Life is good!

Katie

apache · « **Reply #119 on:** April 21, 2015, 03:41:44 pm »

Hi Dragonslayer and Meg,

Thanks for the detailed replies. It's nice to see even more data points for non-UND at EOT progressing to a happy ending (UND).

So taking those scenarios into account, and once again looking at the detailed FDA report, ... perhaps the real question is, what proof do we have that anyone needs more than 8 weeks of Harvoni? The VL charts in the report imply no one needs more than 8 weeks, even treatment-experienced patients!

In particular, take a look at the ION-2 arm of the study, where Gilead tested:

12-week
24 week

protocols, for treatment-experienced, etc. candidates. Logically, it "makes sense" that those candidates would need to take Harvoni for longer.

And yet, if one looks at the week-by-week report for ION-2 results (Fig 3, page 82)
, we see almost identical results as from the ION-3 chart (Fig 2, page 81). The ION-2 chart shows that by Week 4, 99% of the ION-2 (treatment-experienced) had achieved UND status! Which is exactly what the ION-3 chart shows.

So this implies that no one needs more than 8 weeks of Harvoni! In other words, according to the detailed report, all of the candidates (ION-2 and ION-3) achieve (in 99% of the cases) HCV < LLOQ by Week 4. So since we're arguing that low levels of VL at EOT lead to UND, there appears to be zero argument for extending Harvoni beyond week 8. In fact, for 99% of the cases, it would seem there is zero argument for extending Harvoni beyond Week 4!

(As far as the viral load not being an adequate indicator for extending treatment, that of course begs the question of... well, what should be used then to measure whether or not the Harvoni works? AFAICT there is only one diagnostic measure possible, and that is VL.)

Katie · « **Reply #120 on:** April 21, 2015, 03:51:24 pm »

Apache: That's a good argument but it may be a bit premature. It would be prudent to wait for the 24 post treatment tests to come in to make sure there aren't any relapses. We are the true test! The real world treatments are too new to change right now, in my personal opinion, but it would be GREAT for the treatment to be shortened and that may be what the data will show. With so many taking Harvoni who have different conditions I am sure they will fine tune much of the guidelines.

The journey isn't yet over!

Katie

Tiger · « **Reply #121 on:** April 21, 2015, 04:04:06 pm »

Hello everyobody,

I know at least some of you have seen/read this:
http://www.hivandhepatitis.com/hcv-basic-science/5160-croi-2015-hcv-viral-load-and-speed-of-decline-do-not-predict-cure-with-interferon-free-therapy
It was posted here:
http://forums.hepmag.com/index.php?topic=2597.0
and many of your took part in that discussion in which everybody basically agreed that it is a must read and very, very relevant and encouraging.

Anyway, I am expecting my 8-week EOT VL tomorrow and sure hope that it comes back UND, but even if it doesn't, God forbid, judging from the above link and also from experience of others on this forum, there's still should be a good chance that UND can still be achieved at some point later...

Keeping fingers crossed and wishing you all to be done and over with this...

Debula · « **Reply #122 on:** April 21, 2015, 04:27:10 pm »

Good way of thinking about it Tiger, I was reading and preparing for that possibility too
I hope you get UND tomorrow - and so you don't have to worry about it as much
Please post and let us know
Good luck!

dragonslayer · « **Reply #123 on:** April 21, 2015, 04:33:54 pm »

Apache,

>>So this implies that no one needs more than 8 weeks of Harvoni! In other words, according to the detailed report, all of the candidates (ION-2 and ION-3) achieve (in 99% of the cases) HCV < LLOQ by Week 4. So since we're arguing that low levels of VL at EOT lead to UND, there appears to be zero argument for extending Harvoni beyond week 8. In fact, for 99% of the cases, it would seem there is zero argument for extending Harvoni beyond Week 4! <<

Logically, what you say makes sense... However, lets not forget that relapse DOES occur in a small number of patients.. The Gilead stats play pretty much in the 2-5% range. For them, there may be some advantage to extending treatment. Plus, I doubt that 100% of low detecteds at EOT convert to SVR.. We just dont have those numbers yet.. All we can really say is that it occurs. And from that perspective, until the actual number is known, I think your argument of extending treatment may have merit.. My point in responding to you is that folks should not forget that we are seeing low detecteds at EOT convert to SVR.. As to how many, I just dont think it is known yet.

Tiger · « **Reply #124 on:** April 21, 2015, 08:28:00 pm »

He-he-hei!!!

Just went to the online portal of my doc/hospital and they just posted the results -
HCV RNA Not Detected!!! - Yahoooo!!!

Prior to that:
Jan 2010 VL - 2.7 mil
Jan 2015 VL - 0.5 mil

AST - 23 (Prior: mid-treatment: 21, Before treatment: 49, one before that: 33)
ALT - 35 (Prior: mid-treatment: 26, Before treatment: 100, one before that: 65)

So, now I officially transfer to the waiting team - till mid-July.

Thank you all for being absolutely fantastic - and wholeheartedly wishing everybody still not done to follow me to the waiting team and then in 3 month on to join all the others already on the SVR team!!!

Lynn K · « **Reply #125 on:** April 22, 2015, 12:34:26 am »

As far as 8 or even 12 weeks I don't believe either would be appropriate for me as a 3 time null responder to interferon based and a Sov Oly relapser with cirrhosis for 7 years.

Per ION 2 for my cohort the 12 week treatment is more like 86% and if you look at the Solar-1 trial for patients with decompensated cirrhosis Child "B" (I am borderline "B") 12 weeks of Harvoni /Riba 87 % and 24 weeks Harvoni/Riba 89 % So the percentages are not quite as rosy for me. especially when you figure in previous Solvaldi Olysio failure.

I am treating for 24 weeks of Harvoni plus we added ribavirin later so 15 weeks of riba for basically two reasons.

I am obviously difficult to cure and what options do I have if this treatment fails? Do I have enough time to wait for the next, next best thing coming? If I should fail Harvoni what new thing coming would work any better? So basically I feel like this is my last best shot at a cure before I get in line for a liver transplant and hope I get one in time.

Best to all fighting the dragon

Katie · « **Reply #126 on:** April 22, 2015, 12:59:25 am »

You are always on my mind Lynn, and I just know you are going to make it this time! You are always so clear and logical with your information and I admire you!

Keep the strength and courage. This drug is working so much better than anything you've tried before. It is a new game and the Dragon isn't winning!

Katie

Lynn K · « **Reply #127 on:** April 22, 2015, 01:19:32 am »

Yeah I try to be strong but it is hard not to be a little afraid at times....

My test for SVR 12 will be about 27 July so I guess I will know if it is thumbs up or thumbs down in early August.

I have asked my doctor to do a 4 week post EOT viral load just to see how it looks. That would be June 1st with results however many days after that.

ponygirl · « **Reply #128 on:** April 22, 2015, 02:29:23 am »

Thanks everyone. Great responses. I know I was told when I started that because I was a non-responder to Riba-interferon, I was DXed with bridging fibrosis 12 years ago, I have portal hypertension, and I had a viral load of 23million I had to do either the 12 weeks Harvoni with Ribavirin or 24 weeks Harvoni.

My gastro said for reasons of shortening treatment and cost of Harvoni that they were starting me with the two drugs and if I could not handle the anemia and depression sides of Riba, that they would stop the Riba and do the 24 weeks of Harvoni.

At week 4 my Riba was decreased because of side effects. My count was <15 and Gastro said that if my count goes up they will either try to increase the Riba 200mg or extend the Harvoni from 12 to 24 weeks. I was told that the most recent studies indicates that with cirrhosis the recommendation is 24 weeks Harvoni or 12 weeks Harvoni and Riba.

My friend who was a PA in concurrent HIV/HVC studies at UW told me: <15 results ( and sometimes higher) counts does not always mean that the virus is not clear but based on how the viral strands are identified in the testing it could mean that partial/broken or "dead intact strands that cannot replicate" are being counted. She says that, in layman's terms, this is frequently the reason that people "clear" 12 weeks after the end of treatment when they were detectable at the end of treatment.

ponygirl · « **Reply #129 on:** April 22, 2015, 02:44:09 am »

Lynn, The studies you are quoting are the same ones that I read and it made me REALLY sad. I saw a study, and I do not know which one it was, that indicated that odds of clearing were increased with 24 and Riba even for those with cirrhosis...which keeps me a bit more positive.

I am rooting for you, and for myself because I am about to become a 1st time grandmother.

Lynn K · « **Reply #130 on:** April 22, 2015, 02:57:35 am »

Rooting for you too ponygirl grand ma to be!

May you have many years to enjoy your grand children and watch them grow.

Don't forget to give the grand kids loud toys like drums to send them home to mom and dad so they can all enjoy together lol

janne325 · « **Reply #131 on:** May 04, 2015, 10:50:24 pm »

I am new here and was approved today for 8 weeks Harvoni. I am still in shock the procedure was so fast and all paid for. I am 66 female with 1b under 6 million treatment naïve and have been living with this for 11 years.
I am so upset to hear of relapse of others and so very sorry.
I raised concern with my Dr. that there are no guidelines! IF WE CAN INFECT OTHERS WITH OUR TOOTHBRUSHES, RAZORS, ETC., WE CAN CERTAINLY RE-INFECT OURSELVES. My first inclination is to sterilize everything by soaking all personal items in Clorox (1part Clorox to 9 parts water) for 20 minutes and starting over with fresh new washcloths or disposable cloths, toothbrushes, etc, bath sponges, manicure products, makeup, etc. and then keeping everything sterile all throughout treatment. My mouth bleeds sometimes when I brush my teeth, always when I get my teeth cleaned. I work outside in my garden and get scratches on my legs and arms sometimes and sometimes cut my finger a little when I slice food in the kitchen. I live alone and don't cook for anyone on purpose. I am seriously wondering if people are relapsing because they have somehow re-infected themselves??? Maybe a nail clipper that had some blood on it? or a handkerchief? I don't know. It just freaks me out at the possibility. I think it is very real that this is something we all need to pay attention to and sterilize our environment for our own safety. Wipe everything down with Clorox that could possibly have been exposed to our own blood. Also, should we take vitamins and other supplements or not take them to put less work on the liver? It makes sense to eat as healthy as possible and organic and avoid foods like red meat that is hard for the liver to digest. Does anyone know of any detailed guidelines on how NOT to re-infect ourselves? Would like to hear what you all have to say. Thanks, JJ

pappy · « **Reply #132 on:** May 04, 2015, 11:28:24 pm »

I did Harvoni 8 weeks and 3 months after treatment i found out i had a 7867179 viral load so i am going to do re-treatment not sure on what yet . At the end of treatment i had a 0 detected lab result . The dr. said i was only the second person who had a relapse at his office .

Lynn K · « **Reply #133 on:** May 05, 2015, 02:27:14 am »

Hi Pappy

so sorry to read this here is some info I found

When a short course of sofosbuvir/ledipasvir fails, some people can be cured of hepatitis C with a double treatment duration

http://www.aidsmap.com/When-a-short-course-of-sofosbuvirledipasvir-fails-some-people-can-be-cured-of-hepatitis-C-with-a-double-treatment-duration/page/2965963/

Best to you

dragonslayer · « **Reply #134 on:** May 05, 2015, 09:30:45 am »

Lynn, That's encouraging; thanks for the link!

pappy · « **Reply #135 on:** May 09, 2015, 02:42:54 pm »

Just to update those who are interested my dr. has decided to wait for a new drug and delayed any further treatment for me till 11-15 ! I cannot get any satisfactory info about what this new drug is ? This leads me to believe that it is more a ploy by my insurance (Aetna) to wait for price reduction . If someone can enlighten me about what new treatments are in the pipeline i will feel better about my fate .

Quote from: Lynn K on May 05, 2015, 02:27:14 am

Hi Pappy

so sorry to read this here is some info I found

When a short course of sofosbuvir/ledipasvir fails, some people can be cured of hepatitis C with a double treatment duration

http://www.aidsmap.com/When-a-short-course-of-sofosbuvirledipasvir-fails-some-people-can-be-cured-of-hepatitis-C-with-a-double-treatment-duration/page/2965963/

Best to you

DisabledHepcat · « **Reply #136 on:** May 09, 2015, 03:01:30 pm »

pappy , you wrote earlier : I did Harvoni 8 weeks and 3 months after treatment i found out i had a 7867179 viral load

If you were over 6 million IU when you started you should have received 12 weeks of Harvoni. You are 7.9 million after 3 months off the 8 weeks according to what you wrote and I would suspect you were around that number or higher when you started the 8 week therapy. Lawsuit !

badbradley · « **Reply #137 on:** May 09, 2015, 03:06:00 pm »

Pappy Here is a link you may find useful.http://hcvdrugs.com/detailed_ref.html

Brad

anniemybaby · « **Reply #138 on:** May 13, 2015, 03:13:30 pm »

I haven't posted for awhile but thought I'd give n update I was undetected at 2,6 n 8 wks while on my 8 wk treatment next month I go for my 3 month post treatment test I'm very positive feel great will let everyone know my results next month

Katie · « **Reply #139 on:** May 13, 2015, 03:56:17 pm »

Hi Annie! Good hearing from you and am happy you are doing so well. If you have time to post your post treatment test results on this forum: http://forums.hepmag.com/index.php?topic=2665.new;topicseen#new

Charly is compiling the data so we can see the data for all of our fellow Harvoni friends.

Have a great summer!

Katie

bridget · « **Reply #140 on:** May 16, 2015, 09:42:30 pm »

Pappy,
It has to be very frustrating to be put off until November. Some good news; I am in a study at the National Institutes of Health. They have been following my progression for 20+ years but I have never been a good fit for one of their drug studies. The last time I was in there was a couple of months ago. I had just tested "detected" after 8 weeks on Harvoni & was sharing my concern with the dr. He said don't worry, we are doing several studies now & the effectiveness is improving & the duration of treatment is decreasing. He seemed very positive that there will soon be several excellent options. If Harvoni is not the right one for you, there will soon be other great choices.
Hang in there.

LazyRob · « **Reply #141 on:** May 18, 2015, 05:11:55 pm »

Hello all

I joined here to share my lab tests and other experiences with you and to find maybe some additional infos.
Maybe someone is in the same situation like me and I can give some hope in this situation.
I think I'm HCV infected since 1991, diagnosed in the year 2008 because bad conditions comming from my very bad liver blood tests.
From that moment, I stopped drinking alcohol or any other influences which can stress my liver (zero tolerance policy) and my liver values becomes slowly better (but it takes 5 years).
I drank maybe 1-2 bottles of beer per day in the evening during years but I was not alcoholic.

I live in Switzerland (sorry for my english) and waited until March 2015 for Harvoni and the approval process and I'm one in the first line, using Harvoni in my country, so there are not many experiences to share available.

I started as a treatment naive with Harvoni (for 12 weeks) at March 2015 with a F3, HCV GT 1b, Fibroscan 6,6 ... 8,9 at day zero of the treatment.

Day 0 results: VL 1.4M, GGT 62, AST 48, ALT 129
Day 12 results: VL 470. GGT 43, AST 22, ALT 35
Day 27 resluts: VL 217, GGT 41, AST 19, ALT 31

After 4 Weeks (exactly 27 days) my feeling was very very great and everything looks positive, but now I'm very worried, because I was still HCV positive after 4 weeks.
My Doc said, another Prof at the last Vienna Hep conference 2015 told him, after 4 weeks it's usual the virus should NOT be longer detectable in any (of maybe his) cases.
I do not know if I should believe this.

This week I'll recieve the week 8 (day 55) results and inform you. I'm aware, that a serious SVR can be only proofed 3 months after EOT.

Additional.. in this 8 weeks, I had no well known side effects (only on day 1 after 4-5h I got almost unconscious, so take care with you after the fist pill)
So still I have 4 weeks left, lets see what happens. I have no plan B because my health insurance told me, that they will pay only for 12 weeks.

I wish you all the best

Rob

MEG · « **Reply #142 on:** May 18, 2015, 05:49:15 pm »

Hi Rob,

Congratulations on being able to receive Harvoni.

Your lab work looks great. Everything coming down. Indeed, many people who are still detectable at 4 weeks into treatment become negative and some people, even at the end of 12 weeks still have tiny amounts of virus. We got the same information from the Vienna Conference.....the time point(whether it's 4 weeks or 8 weeks or 12 weeks) someone becomes negative, while on treatment, that it makes no difference regarding whether they will achieve SVR. Even those with tiny amounts at end of treatment can go to SVR.

We have 2 members here who fell into that category--tiny amount at EOT. They achieved 12weeks SVR.

Best! Keep doing what you're doing to heal and get healthy.

Meg.

Katie · « **Reply #143 on:** May 18, 2015, 06:59:09 pm »

Quote from: LazyRob on May 18, 2015, 05:11:55 pm

Additional.. in this 8 weeks, I had no well known side effects (only on day 1 after 4-5h I got almost unconscious, so take care with you after the fist pill)
So still I have 4 weeks left, lets see what happens. I have no plan B because my health insurance told me, that they will pay only for 12 weeks.

I wish you all the best

Rob

Hi Rob,

Check these sites out. There have been 3 of who were strong responders but were detected at the end of treatment. Our VL tests consistently dropped and we all cleared, 1 at 12 weeks and 2 including me, at 8 weeks post treatment. Several people who were undetected at end of treatment relapsed at q2 weeks post treatment. Check this thread out:
http://forums.hepmag.com/index.php?topic=2665.new;topicseen#new

So there are many variables and scenarios and the undetected during treatment does not always mean cured. That being said, finish your treatment, eat healthy and drink lots of water and exercise as you can and you will more than likely do just fine. Your numbers are doing good and going down. Let us know how you are doing and good luck!

http://hepatitiscnewdrugs.blogspot.com/2015/03/hcv-rna-does-not-always-mean-treatment.html

http://www.hivandhepatitis.com/hcv-basic-science/5160-croi-2015-hcv-viral-load-and-speed-of-decline-do-not-predict-cure-with-interferon-free-therapy

You might want to print these article off and give to your doctor, as my doctor was not aware of this possibility and appreciated that I shared it with him.

Good luck and I think you will find this forum very beneficial!

I have always wanted to visit Switzerland as my Great Grandparents were from there! I have made my home in Alaska!

Katie

LazyRob · « **Reply #144 on:** May 20, 2015, 03:02:19 pm »

thank you Meg and Katie for your words.

Today I become a short message from the lab, that my day 55 liver results (8 wk) looks very fine, meaning hcv is no longer detectable. Now it looks like much better and my positive thinking will help me to climb the next months until final SVR. I'll post all my lab results in the topic you wrote to become more transparence with this treatment.

finally.. do not trust the words, that after 4 weeks the virus must not be detectable. There are no proof for this statement

with fortunately greetings
Rob

Katie · « **Reply #145 on:** May 20, 2015, 03:09:17 pm »

Great News Rob! I am so happy for you!

MEG · « **Reply #146 on:** May 20, 2015, 05:22:18 pm »

How wonderful Rob. Yes, these positive news pieces while on treatment help our spirits to the next steps...

Those links are excellent Katie...!

Awaiting, as we speak, 4 week EOT labs....Lft's are in the 20s...lower than during the entire course of Harvoni and have not been this low since I was in my 20s.......a few decades ago ;-0 Fingers crossed they are a sign that I'll see UNDETECTABLE on my lab report.

Stay positive and love life, all...Meg

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