Why no standard of Testing Dates?

[Tpropane]

Ok OK! I get it. The almighty doctor is in charge. Hey GILEAD! Get the testing guidelines for doctors treating us before, during and after in line! Before treatment. Full on on blood work, including whatever it's called AFP? looking for cancer markers Fibrosure, ultrasound, fibroscan, (if cirrhosis evident CAT scan) looking for cancer. Hey.WTF? Lay some ground rules for these doctors who see this as a sideline (They make more money doing 10 colonoscopies a day). OR in fact like HIV see we don't deserve the best because we are X,Y or Z. (You fill in the blanks...)
OK after we have been begging treatment (3 months, denied twice.) How about a standard for testing during TX? Viral load 2 weeks. 4 weeks, 8 weeks, 12 weeks, 24 weeks. Also after treatment. 2, 4, 8, 12, 24. IF cirrhosis. End of treatment ultrasound minimum. If complications or disease persists stay on that and get a ultrasound every 6 months or forever and a CAT scan if still cirrhotic. How hard is it to lay out some guidelines? It seems like everyone here is all over the map with testing pre and post TX. Lightening fast. Is how I describe my descent from NAFLD to stage 4 cirrhosis after the last fiasco with boceprovir, interferon and ribaviron. This time I intend to BE MY OWN ADVOCATE and get the tests I want when I want in spite of the lackadaisical attitude of my GI.
I ask the nurse to fax the blood test order to a local and convenient place to draw blood. Therefore I don't need to make a special trip to Cedars Sinai to just get labs. I go to my local GP and it's 20$ and 2 hours less in the car and no $20 just to park my car.
Sorry I am in a pissy mood and my back hurts today.
TPROPANE.

[BubbaT]

I feel your pain propane, really!


The physical and emotional and mental struggle we face is daily our trial,
I am trying very diligently to eat only good, natural, raw foods, and cut out anything
Fried or processed, and I am seeing a better energy level and less pain and swelling,
I'm reading a lot and finding out that the blood is the main thing we must take care of! 

Salt is a problem for us, sugar is a problem for us, drugs are a problem for us,

Our liver is trying its best to heal, and I'm going to do all I can to help him.

Hope your feel better soon, warrior!

[MEG]

Hear, hear Tpropane. I completely agree. But Gilead cannot make the guidelines. The AASLD folk do. My sense is that they will eventually set them....but you're right, it's all over the place now and it needs to change...keep advocating for yourself.

[MEG]

@Tpropane and Bubba

Indeed the liver experts do have guidelines. Essentially, a full workup pre-treatment. Then viral loads at 4weeks-on-treatment and the next is 12 weeks post treatment labs..More often CBC, etc for those on Riba.

http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have

[Lynn K]

AFP or Alpha-fetoprotein is for testing of patients with cirrhosis that along with ultrasound testing can help identify liver cancer early for those of us with cirrhosis as our risk of liver cancer is higher than the general population or even other patients with hep c but without advanced liver disease.

http://labtestsonline.org/understanding/analytes/afp-tumor/tab/test/

PS I have cirrhosis for 7 years but have never had a cat scan or any other testing to monitor for liver cancer than the AFP test and abdominal ultrasound my doctor is at a liver transplant center in Seattle.

Harvoni 16 weeks down 8 weeks to go. Riba 7 weeks down 8 weeks to go.

[dragonslayer]

@Tpropane and Bubba

Indeed the liver experts do have guidelines. Essentially, a full workup pre-treatment. Then viral loads at 4weeks-on-treatment and the next is 12 weeks post treatment labs..More often CBC, etc for those on Riba.

http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have

Meg, I think those guidelines relative to on-treatment testing pertained more to response-guided-treatment regimens; not to generalized Harvoni treatment.

[Lynn K]

It seems to me it is not speaking to response guided therapy as it specifically states

"The assessment of HCV viral load at week 4 of therapy is useful to determine initial response to therapy and adherence. In phase III clinical trials, almost all patients who did not have cirrhosis had undetectable HCV RNA level at week 4; those with cirrhosis may require more than 4 weeks of treatment before HCV RNA level is undetectable. There are minimal data on how to use HCV RNA level during treatment to determine when to stop treatment for futility. The current recommendation to repeat quantitative HCV RNA testing at week 4 of treatment and to discontinue treatment if the quantitative HCV RNA level increases by more than 10-fold (>1 log10 IU/mL) is based on expert opinion. There are no data to support stopping treatment based on detectable HCV RNA results at weeks 2, 3, or 4 of treatment, or that detectable HCV RNA level at these time points signifies medication nonadherence. Although HCV RNA testing is recommended at week 4 of treatment, the absence of an HCV RNA level at week 4 is not a reason to discontinue treatment. Quantitative HCV RNA level testing at the end of treatment will help to differentiate viral breakthrough from relapse, if necessary. Some may choose to forego end-of-treatment viral load testing, given the high rates of viral response with the newer regimens, and to focus on the week 12 posttreatment viral load. Virologic relapse is rare at 12 or more weeks after completing treatment. Nevertheless, repeat quantitative HCV RNA testing can be considered at 24 or more weeks after discontinuing treatment for selected patients."

It also goes on to discuss interferon based tx

"The availability of IFN-free treatment regimens has simplified hepatitis C therapy by allowing shorter-duration, all-oral therapy for most patients. However, PEG-IFN and RBV–based regimens are beneficial for selected patients, and these require specific monitoring for the toxic effects (eg, anemia or neutropenia) associated with PEG-IFN or RBV use. (RBV prescribing information, 2014a [5]); (PEG-IFN prescribing information, 2014b [6]) In patients with a history of cardiovascular disease, RBV dose reduction to 600 mg per day is recommended for those with hemoglobin (Hgb) level below 10 g/dL and discontinuation is recommended for those with Hgb below 8.5 g/dL. In addition, although the newer all-oral regimens are generally well tolerated, adverse effects do occur. Expansion of therapy into a large population of patients may reveal toxic effects that are not apparent in registration trials. Furthermore, drug-drug interactions are possible."

So even though the recommendations are somewhat generic they are speaking to the new non interferon based tx

This information about monitoring patients on tx was last updated December 19th 2015 the day Viekira Pak was approved specifically in mind to include the latest new meds that had just been approved

[Tpropane]

Dear Paul aka Dragonslayer, Specifically your stats state you did Harvoni for 8 weeks and was detectable >29 at the EOT. If, playing devils advocate, they had tested you at 4 weeks or (the test is 20$) at 6 and saw that you were still detectable wouldn't then you doctor have gone a ahead and prescribed another 4 weeks? So that you didn't have to start over? Or 4 weeks + riba? Or 24 weeks? Just to be done with it? Or perhaps I misunderstood what it says your response was. I'm sorry either way.
It just seems in spite of the responses of there is a standard of testing. Doctors aren't testing at the same intervals??? I'm going at 8 weeks and have my doc call in an order for a HCV VL. I've just got to know. I can't just blindly pop pills and wait until 12 weeks after TX to see if it worked. That just isn't me.
So far it is working. But I saw some 8 week breakthrough VL's here. In my case taking 24 weeks not much could be done but add ribaviron. But I would demand it if I had any vl at 12 weeks.
Thanks fellow warriors,
TPropane.

[MEG]

@Bob/Dragonslayer..it looks like @Lynn answered the question re: the guidelines being for all therapies...

Have you reached the 4 weeks post treatment date yet? I'm wondering whether your doctor or you would be willing to do a VL if so. You'd at least know sooner rather than later that either it was a fluke of a lab test and that you are indeed negative, or confirmation that you're positive.

I'd have such a hard time waiting the full 12 weeks. And I think you deserve to know sooner.

Add: the reason I ask for 4 week levels is because my doctor told me that the majority of people who will relapse will be detectable at this point. Good luck, Bob. I truly hope that you are surprised by some great news.....

[MEG]

@Lynn

Harvoni 16 weeks down 8 weeks to go. Riba 7 weeks down 8 weeks to go.

Yes!!! You are down the homestretch. I'm sending you prayers for a smooth finish and SVR!

[Lynn K]

My doctor was going to test me at 24 weeks EOT which since I was not detected at 4 weeks and 12 weeks on tx the 24 week at EOT just seems kind of a waste of time. I asked if we could do a 4 week post treatment test instead of the EOT.

Seems to me to be a good idea and my doctor agreed.

[MEG]

@Lynn

I agree with you both. A 4 week post-treatment VL, I believe, is an important milestone.  And not just for our "peace of mind," but for clinical reasons. They need to know how soon after EOT people are relapsing---and perhaps once they get a critical mass of data it will guide them re: treatment length..

[dragonslayer]

Dear Paul aka Dragonslayer, Specifically your stats state you did Harvoni for 8 weeks and was detectable >29 at the EOT. If, playing devils advocate, they had tested you at 4 weeks or (the test is 20$) at 6 and saw that you were still detectable wouldn't then you doctor have gone a ahead and prescribed another 4 weeks? So that you didn't have to start over? Or 4 weeks + riba? Or 24 weeks? Just to be done with it? Or perhaps I misunderstood what it says your response was. I'm sorry either way.
It just seems in spite of the responses of there is a standard of testing. Doctors aren't testing at the same intervals??? I'm going at 8 weeks and have my doc call in an order for a HCV VL. I've just got to know. I can't just blindly pop pills and wait until 12 weeks after TX to see if it worked. That just isn't me.
So far it is working. But I saw some 8 week breakthrough VL's here. In my case taking 24 weeks not much could be done but add ribaviron. But I would demand it if I had any vl at 12 weeks.
Thanks fellow warriors,
TPropane.

Hi TProp,  Thanks for conveying your ideas.  While altering Harvoni treatment mid-stream based on on-treatment testing is sometimes done by doctors, its rare.  With Harvoni, the only VL test most modern doctors seem to care about is what happens at 12 wks post treatment.  There is nothing Ive read in either the Gilead prescribing document or the Gilead FDA filing document which indicates that treatment should be adjusted by the results of on-treatment testing.  There may be exceptions for severe cases or other circumstances, but in general, theyre going by what Gilead is telling them.  For a doctor to alter the course of treatment with Harvoni  in mid-treatment by increasing the duration of treatment or in some other way would require, in general, some empirical indicator that this works.. .Without a trial result to go on, it becomes almost an off-label useage which has all of its own sets of issues. 

Listen, I agree with you... I wish that some on treatment testing had been offered, and that my transplant hepatologist would have altered the duration based on such results.. But he wouldnt....  Ill certainly bring this up again when I see him next  month, but when I touched lightly on it in a phone call last week, I got the sense that theyre going by what Gilead is telling them and what the trials show.   I dont know, but its even possible that their hands are tied by the FDA to a degree in deviating even slightly from the script, despite the AASLD guidelines.   Lastly, we have to remember we are basically the first group doing Harvoni in the real world.. Up til now, all the doctors have had to go on are the Gilead trial results, the FDA filing document, Gilead's own recommendations, and the AASLD guidelines.  Once this drug has been around awhile and real world results are logged, its more than likely that treatment regimens will change to reflect the changing landscape.  Til then, the providers are as noob as we are.

[dragonslayer]

@Bob/Dragonslayer..it looks like @Lynn answered the question re: the guidelines being for all therapies...

Have you reached the 4 weeks post treatment date yet? I'm wondering whether your doctor or you would be willing to do a VL if so. You'd at least know sooner rather than later that either it was a fluke of a lab test and that you are indeed negative, or confirmation that you're positive.

I'd have such a hard time waiting the full 12 weeks. And I think you deserve to know sooner.

Add: the reason I ask for 4 week levels is because my doctor told me that the majority of people who will relapse will be detectable at this point. Good luck, Bob. I truly hope that you are surprised by some great news.....

Hi Meg,  I dont know who 'bob' is, but since you mentioned me in your post, Ill take the question. Im around 5.5 wks post treatment now, and while I could do a test now, Ive decided to wait another few wks.. Here's why.. I have a Dr appt scheduled for 4/20.   I will test the week before, at about 11 wks.. Im waiting because I want to have the latest viral load to present to him so that we can plan and possibly even start a new course of treatment, or clinical trial.  So testing will need to be done for that anyway.. Plus, its less stressful to me.  If the lab test was a fluke, Ill find out in a few wks.. I think its more likely that it wasnt, so why get the bad news sooner than I have to since I wont be able to do anything about it until  4/20 anyway when I have my dr appt.... Its just the way my mind works..   

[Lynn K]

Hi Meg

Well for a patient like me I don't really see any options re treatment length already doing 24 weeks of Harvoni with a late start of riba at week 9 so 15 weeks of riba if Harvoni / riba doesn't work for me I doubt increasing tx length would matter.

For those tx for only 8 weeks even if real world results slid a bit for the tx naive low damage group I don't see them changing and allowing all to go for 12 weeks if 8 weeks still cures most even say as low as 75 % I still think they would try the 8 week for those patients initially. Maybe if they add a near EOT test say at 10 weeks and if the result in not virus not detected they could add the extra 4 weeks  that would give them time to get a new prescription added for the additional 4 weeks.

But this is just me talking non medical person

[dragonslayer]

Hi Meg

Well for a patient like me I don't really see any options re treatment length already doing 24 weeks of Harvoni with a late start of riba at week 9 so 15 weeks of riba if Harvoni / riba doesn't work for me I doubt increasing tx length would matter.

For those tx for only 8 weeks even if real world results slid a bit for the tx naive low damage group I don't see them changing and allowing all to go for 12 weeks if 8 weeks still cures most even say as low as 75 % I still think they would try the 8 week for those patients initially. Maybe if they add a near EOT test say at 10 weeks and if the result in not virus not detected they could add the extra 4 weeks  that would give them time to get a new prescription added for the additional 4 weeks.

But this is just me talking non medical person

Thats what Im thinking, but it would sure help if there were some empirical results from trials to recommend this test and then reevaluate during treatment with Harvoni kind of thing... Right now Gilead is apparently telling doctors that they dont even know yet what to do with relapsers or partial responders.. To that end, theyre going to be doing trials comprising these groups to decide just what the best course of retreatment will be.. Right now, its a crap shoot, as much of the treatment protocol seems to be since its clear that trial and real world results are different.   As soon as data from real world patients can be logged and compared to trials, we should have a much better idea of how to treat.

[mario555]

I think most doctors have their own little idea about what to do as follow up... My doctor couldn't care less, good thing I made friends with his nurse/secretary! To top it off, I can't really have someone else because I am in Canada and here you take who's available...
Also, Harvoni was literally "rushed through" with a minimum of testing. I think it was because of the revolutionary level of cure and the fact many of us were dying (or getting there). The FDA had no real choice and agreed to rush the product...
I'm in week 17 of a 24 weeks treatment and I am hurting! I have more side effects now than during the week 5 to 12!! Who am I gonna talk to? My doctor knows less about Harvoni than the group here! What can he do about my side effects which are not mentioned in Gilead's littérature?
As for advocating for oneself, I think it is the best idea!
Finally as for the 8 weeks treatment. It pisses me off to see that gilead littérature mentioned that 8 weeks "MIGHT" be considered in specific cases and that insurance companies started assigning a short treatment based on specific  numbers (ie; less than 6 millions, etc...). It doesn't make sense! Mainly for people who didn't clear the virus after 4 weeks!! That VL 4 should be a stronger indicator than the "consideration for a shorter treatment" discussed by Gilead!!
Anyway, good luck to everyone with their SVR12.

[dragonslayer]

Mario, I agree..    That Gilead statement that '8 wks may be considered' for the indicated groups has got to be one of the most misleading and inconclusive statements Ive ever read..

So does 'May be considered' mean 'Should be considered', or 'May be considered as a last resort', or 'May be considered but read the Ion-3 data and form your own conclusions',  or   'May be considered but only as an enticement to get the insurers to cover', etc...   I hate that statement...

[Lynn K]

All my on tx follow up is through my doctors nurse they run the tx and consult with doctor as needed. Mostly in contact through my chart messages and occasion calls when my hemoglobin was crashing from the Ribavirin

[mario555]

I would think that 8 weeks should be considered when you have someone who has ultra low viral infection and never treated and with no liver damage.  Anything more than that should require at least 12 weeks! In other words, 8 weeks should be used in an exceptional cases only! Also, the 8 weeks was done on a minimal number of people and was almost an afterthought, not a rule to follow! Finally, it is a sad state of affairs when insurance agents/management decides on the proper course of treatment and decides on lengths of treatments. I was a ''management person'' for most of my life and I wouldn't know shit about length of treatment! I was only good at saving money! At least, I wasn't working with sick people!

[dragonslayer]

Mario,

>>, 8 weeks should be used in an exceptional cases only! Also, the 8 weeks was done on a minimal number of people and was almost an afterthought, not a rule to follow! <<

I think  thats really going too far... Theyve estimated that the 8 wk treatment protocol would apply to roughly 40% of all those on Harvoni treatment, so clearly its more than an 'afterthought' on an 'exceptional' group.  . Moreover, its clearly supported by the trials data.. And lastly, in the Ion-3 trial which was designed to test the 8 wk treatment, the same number, ~215 was used in the 8 wk arm as the 12 wk arm.   I really think its the real world results which may topple the 8 wk treatment, but certainly the trial data supports it.. The rest remains to be seen.

This may sound strange from the only one here Ive read about that looks like he probably failed the 8 wk treatment, especially since I think Im really the ideal type to have been given that treatment.. But Im trying to be objective here.   The trial data is so good for my group, ie, every bit as good as the 12 wk group, that I can only be so disillusioned with my doctor. I was the ideal candidate for the 8 wk regimen, and I probably failed, or rather, it probably failed me!   Theyve got to get to the reason why a tiny minority fails this treatment, what specifically accounts for the discrepancy between real world and trial results, what supplements and meds in common use diminish the potency of Harvoni, and how exactly to retreat it.

[mario555]

Hi again Paul. Sorry if I depress some people here, I'm definitely not in the best of moods with my ever increasing side effects; my wife will throw me out soon! I guess I would need Katie the builder (I think she's the one doing renovation...) to build me a larger dog house (ha! ha!).
I did talk about the 8 weeks treatment because although I agree to the general 40% mentioned, I find the time elapsed (8 weeks) doesn't allow for any type of screw ups whatsoever! Also, statistics are a weird game; as an example, 97.5% of the time, the variation in the results will be within 2-3% of the official results. The other 2.5% of the time, the actual results will be 'outside' the 2-3% range!! So, the little testing Gilead did is far from exact, it is an ''experiment'' they did that came out like that.  The only way to decrease those variations are to ''increase'' the population (ie; test 2-3-4,000 people). You would then reduce the variability.
If someone has a choice, I would go for extra pills everytime! This is from me, the guy who can't stand the f..ing treatment anymore! I initially wanted only to do 12 weeks because of my borderline status at the start of the treatment. If an insurance company would have decided, I might have ended with 12 weeks and I don't think it would have worked (based on a multitude of personal clues...). With the extra pills since then (I'm in my 5th bottle), I ''feel'' every little sucker has died by now but, despite my increasing unease with the treatment, I carry on with the help of a valium with my Harvoni     
I only give my opinion here but I'd be really uneasy if I'd still be detected at week 4 and be on an 8 weeks treatment. When you are already 8 weeks into it, the extra expense to ''make more sure ()'' would be worth it.
Finally, I agree that most people on 8 weeks will clear the virus but,,,, the ones not clearing it are up the proverbial creek with no paddles for the next couple of year until something super new comes along. Some of us do not have those extra couple of years so, this has to work!!! I'm almost at Lynn K level where I would consider taking extra insurance (riba) to make sure I clear this demon in me.  Anyway, once again sorry for depressing people here....

[dragonslayer]

Thanks for your thoughts, Mario.  Question:  Why add Ribavirin?  Didnt the Gilead trials feature both With and Without ribavirin, ultimately coming to the conclusion that it made no net SVR difference?  Btw, from what Ive read of the studies, I dont agree that it will take 2 more years for more effective drugs to become approved. 

[mario555]

I agree that statically it doesn't matter if you add Riba. But after falling previous treatments, you don't want it to happen again so, even if imprecise results give you a sliver of an extra chance, some will take it.
As for the 2 years. Gilead would need a minimum of 1 year for a formal approval after submission and they have not finished testing the next generation which is also based on Sovaldi, their champion! So, 2 years... Other companies that such as Achillion are 5 years away but have what appears to be revolutionary approach..
I've read that if you fail a short treatment, you could be retreated for a longer period.

[dragonslayer]

Doesnt Merck have a combo scheduled for this year?  Of course, there's also Viekira Pak.  I hope the Achillion pkg works out; a 6 wk cure that is 100% effective would be hard to beat!  Maybe Ill wait for that.

>>I've read that if you fail a short treatment, you could be retreated for a longer period.<<

Doctor mentioned Gilead is soon going to trial to test this.  Id be happy to give a longer Harvoni treatment a shot, but Im not sure the insurers and doctors will go along until the trials prove that it works for prior failures.  If you come across a link to what you read regarding this, please link me..

Thanks!

[kate0b1]

I have a lab question i want to run by everyone, I am done treatment on thursday and am supposed to get labs on friday (EOT) and then again on june 5th (12 week), i am stewing about fridays labs, I'm pretty sure they will be und and am wondering if maybe i should ask to do them at 4 weeks instead of friday.  thoughts anyone??

kate

[Lynn K]

Hi all

About the folks like me with added riba well with my treatment history and cirrhosis the extra tiny percentage maybe needed I was also looking at treatment for folks with decompensated cirrhosis and the recommendation is to add riba for a fighting chance as we are basically at end game here. 

Hi Kate0b1

From my understanding if you become not detected while on treatment you will remain so while on treatment. There are no breakthrough failures on Harvoni only relapse failures. So the EOT viral load test to me seems like a waste of time because we know what the result will be if you were not detected on treatment.

I have asked my doctors office to forgo the EOT viral load test and to do a 4 week post treatment test instead as from what I have read most patients who relapse will do so in the first 4 weeks after tx and if still not detected at the 4 week post point odds are good I think like 98% that you will make SVR 12 as well.

As I already relapsed on Sovaldi  Olysio last year I would like to know sooner where I stand. But my situation is different from yours so see if your doctor is willing to go with it but for you your odds of being cured are very good.

Good luck all

[Islandgirl]

Lynne,

My doc must be of the same mindset.  My EOT with Harvoni was Feb 25 and she has my labs set for March 25, with the final set for September 25.  I was UND at 6 wks and praying I stay that way.  Praying for all of us.  Hugs,  ...Islandgirl

[charly8]

My doc has me doing a VL at the following:

2 weeks
4 weeks
8 weeks
12 weeks

I agree its a bit much.  I was undetected at 2 weeks and Lynn is correct that there are no on tx breakthroughs so I am not sure why they want the VL?  I think its just habit from the old interferon days.

I plan to ask for a 6 week post tx blood work.  From the data about 15% of the people that relapsed did so after 4 weeks.  I am betting that most of them relapsed in the next two weeks.  I don't think I could wait the whole 12 weeks before getting a EOT VL test, the anticipation would be too high for me.

[Lynn K]

I wouldn't mind the wait if I was confident of final result. But given my history I am less confident of an SVR 12 than I was last year on Sov Oly.

So call it cautiously optomistic but also trying to be realistic that this too may not work. Hoping for the best and trying to be prepared for the worst.

[dragonslayer]

Lynn,

>>From my understanding if you become not detected while on treatment you will remain so while on treatment. There are no breakthrough failures on Harvoni only relapse failures<<

Is 'breakthrough failure' the same thing as 'On-Treatment Virologic Failure '?  Because, with the latter, there were zero accounts of those during trial, and yet we know, in the real world, that doesnt hold true.

[charly8]

I think that there is way too much speculation still with Harvoni.  Unfortunately there is not enough data to know what would be best as far as treatment duration, adding riba, and most importantly if the Harvoni limits re treatment outcomes.

If you look at the data, there were ZERO relapses on the 24 week duration.  Some people were lost to followup and one person stopped tx due to ineffectiveness as a result of not following protocol.

So if 24 weeks is a 100% cure, then is 20 weeks a 100% cure?  what about 16 weeks?  It may be as well or very close to it.

The big question in my mind is the re treatment after Harvoni relapse.  Specifically if the Harvoni creates a mutant HEP C virus that is resistant than I think longer durations should be a priority. 

 If it turns out that if you relapse and retreat for a longer duration without any issues than shorter duration should be a priority, because if you fail just retreat for longer.  Harvoni is well tolerated so it should not be an issue. If you look at the odds, this will cure the most people with the least amount of medicine. 

[Lynn K]

Hi Dragon

In my understanding is a "breakthrough" failure would be a patient was virus not detected while on treatment and becoming detectable again while still treating. As opposed to having a result of say less than 15 detected. As we sadly do know there have been a few who were not able to acheive not detected status while on tx

Much in this link is from the old tx but some of the terms still apply

http://www.hcvadvocate.org/hcsp/articles/Keeffe-3.html

And I found this about on treatment virologic failure

[PDF]Hepatitis C Clinical Trials Program Overview - AbbVie
www.abbvie.com/.../ClinicalTrialsFactshe...
ON-TREATMENT VIROLOGIC FAILURE was defined as confirmed HCV RNA :25 IU/mL after HCV RNA <25 IU/mL ...


I am thinking they are different things but obviously I could be wrong were you at one point virus not detected and at EOT virus was again detected? Or was the virus always detected?

I have just read several sites there thy said in trials there were no on tx virologic failure but we already know studies and real world differ.

But in any event for my situation if I had to choose between an EOT test followed by a 12 week post test. Or no EOT and instead a 4 week post tx followed by the 12 week that is how I would prefer to be tested.

I have always prevoiously heard that once Not detected on treatment the only failure was relapse. But that were some who never made it to not detected. Please remind me of your situation and again so sorry you are still having to be in the fight

[Lynn K]

Hi charly8

Actually if you drill down not all groups made SVR 12 after 24 weeks for tx experienced with cirrhosis ION 2 was 99 and 100 but we are only talking about 111 patients in that trial

And in the SOLAR study with patients with more advanced cirrhosis 24 weeks of Harvoni with Ribavirin only made 89% SVR 12 for Child score B and 90% for Child score C and that was only about 50 patients in the Child B group and 30 in the Child C group

Which pretty much sums up why some of us are treating with 24 weeks of Harvoni and Ribavirin

[charly8]

Hi charly8

Actually if you drill down not all groups made SVR 12 after 24 weeks for tx experienced with cirrhosis ION 2 was 99 and 100 but we are only talking about 111 patients in that trial

And in the SOLAR study with patients with more advanced cirrhosis 24 weeks of Harvoni with Ribavirin only made 89% SVR 12 for Child score B and 90% for Child score C and that was only about 50 patients in the Child B group and 30 in the Child C group

Which pretty much sums up why some of us are treating with 24 weeks of Harvoni and Ribavirin

ION-2 had 1 patient with loss of efficacy and one patient never completed the therapy.  Maybe I am reading it wrong but according to this study it appears that nobody that completed 24 weeks with undetected status went on to relapse. 

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000MedR.pdf

I have not read the SOLAR study, can you post the link?  never mind found it here:

http://depts.washington.edu/hepstudy/presentations/uploads/143/solar1_post_transplant_ledipasvir_sofosbuvir.pdf

[mario555]

Hi Lynn K. Do you know anyone who is well advanced in his 24 weeks treatment and who doesn't take Riba? I'm finishing week 17 and I have had worsening side effects and I wanted to compare notes... Maybe you're having the same but it's hard to tell Harvoni problems with Riba problems...
My situation is worse than at the beginning of treatment and I am becoming worried I won't be able to finish treatment! Please let me know when you have a chance..

[Lynn K]

Well I don't know who is just on Harvoni 24. I can say the only sides I am ha I g are from the riba as my hemoglobin is at the min they like to see for a female 10.0 so I get out of breath and I guess am even more tired but other than the riba I feel fine. Just starting week 17.

What day is your last dose? Mine is May 4th.

What kind of sides are you having? Best I can tell you is hang in there you have just under 8 weeks to go. Also I would ask my doctor they may have some ideas to help with the sides

[charly8]

Hi Lynn K. Do you know anyone who is well advanced in his 24 weeks treatment and who doesn't take Riba? I'm finishing week 17 and I have had worsening side effects and I wanted to compare notes... Maybe you're having the same but it's hard to tell Harvoni problems with Riba problems...
My situation is worse than at the beginning of treatment and I am becoming worried I won't be able to finish treatment! Please let me know when you have a chance..

I started Riba about 3 weeks ago.  No symptoms on the Harvoni but definately with the Riba, it is most likely from the Riba.  You should ask you doc about a booster (procrit). 

I did 72 weeks of peg-int with Riba and needed a booster.  That was the only way I was able to finish tx.

[mario555]

My last pill is on April 29th (I lost a pill..) My worsening side effects are the same as at the beginning but much stronger; intense but short lived headaches, almost constant ringing in one ear, short lived panic attacks, short temper, impatience, lack of 'get up and go, etc...
My panic attacks are not what I experienced before treatment, they are like if my mind would want to' leave me' and I'd be left with a mindless body! Really strange shit... As for my doctor, what could he do? My symptoms are not in the information booklet...

[charly8]

mario,

other than the ringing in the ear, the symptom could be from stress. 

At the end of my 72 week treatment, I had to go to the emergency room because I had pretty much the same symptoms you did.  But I also had chest pains.  They monitored me for about 24 hours and was all clear.  They told me it could be from stress which made me feel better.  I started meditating and it helped, took of work and relaxed in a week I was much much better.

You should definitely talk to your doc.  but in the meantime I would try to releave any stress to see if it will help.

[Lynn K]

We are not doing epocrit only dose reduction I was taking 1200 mg and got down to 9.3 so we dose reduced and I am holding steady at 10.0 with 1000 mg of riba. My doctor is ok with 10.0 me not so much. Almost wishing I would test below 10.0 so I could change to 800 mg but like I said to you just under 8 weeks to go hanging tough.

[charly8]

We are not doing epocrit only dose reduction I was taking 1200 mg and got down to 9.3 so we dose reduced and I am holding steady at 10.0 with 1000 mg of riba. My doctor is ok with 10.0 me not so much. Almost wishing I would test below 10.0 so I could change to 800 mg but like I said to you just under 8 weeks to go hanging tough.

Lynn is there a reason you don't want the procrit? 

[Lynn K]

Because my doctor says no procrit

Heck I am taking 1000 mg and the trials with advanced cirrhosis they were only taking 600 mg

[dragonslayer]

Hi Lynn,

>>I am thinking they are different things but obviously I could be wrong were you at one point virus not detected and at EOT virus was again detected? Or was the virus always detected?<<

I might have been UND at some point during treatment, but we'd never have known since my Doctor wasnt intererested in doing any on-treatment testing... Even my EOT test he wasnt going to do until I called the nurse and asked her to send me a lab req for it... His feeling was that, since SVR12, at the end of the day, is what really matters, he wasnt interested in anything else.. I had the nurse send me the lab req because I wanted to know, even if  he didnt, if I were to show up Not und at the SVR12 check, if it was because I failed to clear during treatment, or if it was due to a relapse after clearing... I figured that info might be useful in case we have to retreat, as now seems the case.... I dont know for sure, but I definitely get the sense that with all the research Ive done, and what Ive learned on this board, etc, Im more familiar with how to treat this disease than he is, even though hes an experienced transplant hepatologist.   Id probably switch doctors if it werent for the fact that the spec. pharmacy he uses was really incredible, and they got me approved without any appeals despite my lack of liver fibrosis.  In addition, starting anew with someone else, when there's no guarantee hed be any more responsive is taking quite a gamble.   So Ill just see what hes got to say when I see him next month. I know hes going to want to enroll me in a Gilead trial in the area that is dealing with how to treat Harvoni relapsers.   That might be something to seriously consider, providing  I dont get put on a placebo arm.  But I hear even then, if thats the case, they will treat you afterward, so that doesnt sound like a bad deal..

If I have go make a decision of doing Viekira Pak with Ribavirin, or doing a Gilead trial for Harvoni relapsers, which do you think would be preferable?

[MEG]

That might be something to seriously consider, providing  I dont get put on a placebo arm.  But I hear even then, if thats the case, they will treat you afterward, so that doesnt sound like a bad deal..

If I have go make a decision of doing Viekira Pak with Ribavirin, or doing a Gilead trial for Harvoni relapsers, which do you think would be preferable?

Hi Bob..I think I'd wait to see what Gilead's trial for relapsers is about before jumping into Viekira Pak and see which arm you are assigned. You're well taken care of in a clinical trial. Blood work is done often and with lots of other support all along the way.  Insurance approval won't be an issue, etc. Keep us posted....best luck. I'm still rooting for you to test negative..

[dragonslayer]

Thanks Meg.. For the sake of clarity though, Im Paul, not Bob!

[MEG]

So sorry Paul.!

[kate0b1]

@lynn, morning, i called and asked to change my EOT labs to april 9th (4 weeks out). I kinda agree EOT labs don't mean much to me, last time i was still clear at that time but relapsed at 8 weeks. Im liking doing it this way, a little stressful waiting now until april for labs but ill feel better about it then 

PS just took the last pill 

kate

[Lynn K]

Congrats on completing tx Kate!

Wishing you SVR 4, 12, 24 to infinity and beyond!!! 

[BubbaT]

Hi everyone,

@Lynn, what have you read about the outcome of cases similar like mine and yours?

If I'm at f4, and I clear the virus is there trials or data that says the liver will heal once the virus is gone?

What evidence is there?

Also Mario555, if I were you I would stop taking the Valium and see if my condition improves...  It's worth a shot, you don't know the results of using these together?

[MEG]

Congratulations, Kate! Wishing you all the best.

[Lynn K]

Hi bubba

Yes I have read it is possible that once clear of the virus our livers may begin hi improve basically a lot depends on the extent of damage but even if the liver was so far gone still needed a transplant at least new liver will never be  infected

One battle at a time right?