Hep C Discussion Forum

Cheddy · Moderator

RE: My husband starts Epclusa today

Tig · Admin

OUTSTANDING!!

I couldn't be happier, Candace! You're both well on your way to a successful finish. This is the first sign of all the good things coming your way.... count on it!

JimmyK · Guru

YES!

This sure beats waiting around and wondering! Y'all got this now. Kepp on doing what you are doing! This Train is headed for SVR-Ville for sure!

JimmyK

Ruby Red · Senior Member

Wonderful news Candace!

Cinnamon Girl · Guru

Fantastic result, Candace, and just as we expected! I`m sure this must be a huge relief!

Your perseverance in pushing for another viral load test has really paid off, full marks to you for initiative!!

Congrats to you both! biggrin

Phoenix17 · Senior Member

YAY!!!! That is awesome Candice! A big congratulations to you and your husband!

CandaceV · Senior Member

Collected:

09/16/2016 8:44 AM

Resulted:

09/18/2016 8:06 AM

HCV RNA not detected by PCR.
Reference Range: Negative for HCV RNA
The Linear Range of this assay is 15 IU/mL to 100,000,000
IU/mL.
Test Performed by
CLEVELAND CLINIC LABORATORIES
9500 Euclid Avenue
Cleveland, Ohio 44195

SO HAPPY! THANK YOU FOR YOUR HELP & SUPPORT FROM ME & MY HUSBAND! I will update as needed.

CandaceV · Senior Member

Thanks for the kind replies. Sometimes, common sense needs to be pointed out, and sometimes loudly. As I said earlier, I'm like a pit bull, I don't give up easily, I have OCD.

Sydhanrahan · Guru

Candace - you go girl. I like your style. Hanging on the phone for four hours is a feat in itself and then the a or b money question was perfect.

Well done.

Syd

Canuck · Guru

Candace!

Good going!! As you say (or someone did) persistence really IS ever so helpful at times. Attention to detail, very important. Your hubby is so lucky to have you acting on his behalf and lucky for the good advice and care of Tig and Jimmy too helping at the steering wheel. All the folk here want to see you two finally get some relief after all you have been through.

Really impressed you took the bull by the horn on this one and made it work!

You will likely be und. If not, just remember Pablo was still <15 late into the game, and he was cured at end of treatment. I am convinced epclusa is working for you, just based on your profound response.

You two are doing a good job. smile C.

Tig · Admin

That's simply outstanding! Your status around those offices just gained points. In most cases, unless you're dealing with some particularly stubborn staff, will now see them respond with earned respect. It's hard to understand the system anymore and difficult to navigate most of the time. When we can help each other through the maze, we do our best to help.

CandaceV · Senior Member

Other than the 4 hour wait on the phone, it was easy. I simply asked a Medicare supervisor whether they would want to pay $900 for a blood test or another $25,000 for a month of pills that won't work. She put me on hold for about 10 more minutes and then said it was approved. I called the gastro, got the nurse on the phone and said it was approved, issue the order. NOW, LOL

Tig · Admin

Hi Candace,

That's stickng to it and not taking no for an answer. Good job, Jimmy, for sharing that set of guidelines on testing. That's good info to have.

I think you'll be pleased with the 6 week test. We'll be waiting for the news... smile

JimmyK · Guru

Candace that is great news. I full well expect to hear the 6 week test returns UND. This will make the rest of the treatment far less worrisome for both of you. That is what I want to see happen.

This Forum provides support and information to properly prepare the friends to do battle. Sometimes it is with Medical Professionals and sometimes Insurance folks. When they see you know what you are talking about, things tend to go better. ;)

All my best!

JimmyK

-- Edited by JimmyK on Wednesday 14th of September 2016 08:13:03 AM

CandaceV · Senior Member

I was thinking about this before going to sleep last night...after reading the protocols from Jimmy, it would only make sense to do a 6-week test because the protocols says if it's not zero at 4 weeks, and goes up by a factor of 10 at 6 weeks, then it's pretty much a failure. Wouldn't Medicare want to save $25,000 on the last month of treatment? Of course they would!

So I called Medicare myself and spent nearly 4 hours on hold, but it was worth it. Medicare WILL pay for another test at 6 weeks IF not at zero. A call to the gastro with this information and they changed their tune. There's paperwork waiting for him at the lab on Friday, which is 6 weeks.

I swear, is there anything we don't have to babysit anymore?

So we should have results next week - thank you!!! We fully expect the results to be zero or a lot closer to zero than 33.

CandaceV · Senior Member

Jimmy, I have OCD so you don't have anything on me :) LOL Anal doesn't even begin to describe it. It's truly obsession.

There is just no reason to not follow protocol that I can think of. I appreciate the information more than I can tell you. We didn't hear back from the doctor today, but he's doing colonoscopies all day, so maybe tomorrow.

What a story you have! In the interest of full disclosure, I lost faith in doctors and the entire medical community a long time ago. I have my own story as well. I need doctors for one reason, and that is for testing. I'm not a doctor either, but I have a high level of reading comprehension and I will make my own decisions about my health care. It seems like doctors graduate and then they get no further information, or they get the new information way after it's available to people like you and me.

I am diabetic with normal blood sugars and my current doctor told me I know more about it than he does. Well, he doesn't spend his life on the internet learning, like I do. Diabetics can no longer digest carbohydrates, so I don't eat them. Viola! Normal blood sugars. The high blood pressure, high cholesterol, numb feet and blurry vision went away. A doctor would have suggested the approved ADA diet and I would have been dead a long time ago from a heart attack, they recommend a diet of 30% carbs. What I did was just common sense - stop eating what you can't digest!

I'll be thinking about you on the 29th! Good luck, my dear.

JimmyK · Guru

Candace,

Hello again. First and foremost I want to make sure you understand that my thoughts are that therapy is going well and that your husband will in fact be cured.

My purpose is not to alarm you or anyone else. It is simply to arm you with data that may assist in dealing with Doctors and Insurance.

Many folks are still detected at week four and go on to SVR 12 without a hitch. We have seen folks at EOT, still detected, then on to SVR 12. Amazing things are happening across the board.

I am simply one who is a stickler for protocol. I had to be when dealing with myself and my wife as we are both on Omeprazol and so being extremely anal on our routine was the way we approached things. We did not allow for a variance of one single minute with regard to when we took our meds. Keep that in mind when you interpret what I have to say. LOL.

My first protocol had me at 115 at week four. They were in that case also going to let things go and I had to fight like a madman to get them to finally agree to retesting. That took 4 weeks and at that time the look on their face when they realized I had a breakthrough was a Kodak moment for sure. By the time I finally had gotten them to listen to me I had gone from 115 at 4 weeks to 345306 four weeks later.

I read them the riot act because they had ignored me regarding the two week protocol and it allowed for an extra two weeks of treatment that in my case should have been stopped to protect against adding to the RAV count.

I was in fact a true odd case and I am not in any way suggesting that is what is happening here, but it is important to stay with protocol and sometimes you have to fight them to do so.

I have so far been extremely fortunate and blessed. The re-treatment thus-far has worked and SVR 12 is a mere 17 days away if I am to remain blessed.

The folks here, including myself all believe your husband is in fact UND by now. I am one who simply feels you have the right to know that via the protocols and that Medicare should honor the request. You have to first establish their need to and that is all I am trying to help you with.

None of us are Doctors, but ALL of us are advocates for each other and I take great pride in helping if and where I can.

Your Brother

JimmyK

Canuck · Guru

Candace,

The updated American recommendations for treatment protocols Tig posted the other day, and the their testing protocols Jimmy drew your attention to here are excellent reference (for everyone!) alas, some countries differ.

I read some ambivalence in how a doc may interpret the recommended testing protocols though.

Regardless, although everyone WANTS to be 0 at 4 weeks, it does not happen for everyone. But what you DO have, is EVERY indication, that it has worked perfectly for you. I am so glad your husband has you at his side to encourage, protect and advocate for him, and with him - we all need a good buddy through daunting times. But, as you will see, you are already beyond the scary bit of it NOT working - it IS, indeed!

Nice, that AnnieB has posted her reassurance and story as well.

My trial doc was kind of the same as Annie's - pleased with a profound response. I spent a lot of time hanging on my docs every word looking for clues as to my worrying outcome - (thank God he was a man of few words!) - reading between the lines of his silence and the few things he DID say, he had already decided (knew) that sof/vel vox would work well for me, I believe, even before i started! When I got my first on-treatment VL of 237 back, the great silent one was ecstatic for me, but not suprized, to him it was a "done deal" - he knew it had worked, with a crash like that, he never looked back (although I did) of course! I think, being an experienced trail doc, he knows what key info he and his pts. need to concentrate on, he rarely offered much extraneous" info for me to chew on, when I pressed him for informational things, his words were purposefully limited and extremely well chosen, as he just" knew" I would labour over and dwell on them! At one point in my relentless worry wrestling he almost cupped his hands (like a megaphone) to re-direct the loudest key message to me - "97%!!" he yelled. That got me back on track! I read into every subtle word and nuance he offered, so appreciated the unintentional "self-satisfying scoffing" mumbling between him and his nurse, when they reviewed my first labs that showed how well sof/vel/vox had just decimated my load to 237!

Hey AnnieB,

Thank you for posting here! Very glad to meet you! Kind of you to offer up more evidence that sof/vel is an extremely powerful and effective regime. Please, could you share more of your story? What State are you in? Was your epclusa by prescription or did you get it by "trial"? If by trial, did you do 12 weeks sof/vel or did you do 8 weeks sof/vel/vox? Fellow epclusians like visiting with their kin! Welcome to the family! C.

CandaceV · Senior Member

Thanks, Annie. I'm just not sure why they aren't following the protocols, see the link in JimmyK's post further down. I sent them to my husband's gastro for comment.

AnnieB · Newbie

Hi Candace,

Thank you for sharing your story.

My husband (G2b) started Epclusa July 22nd, VL just over 3 million. His VL at 4 wks was 37. My husband who had no, IMO, ill-advised expectation of undetected at 4 wks, was amazed and thrilled by the result. He's had hep c for nearly 50 years. A VL test last year was 7.6 million.

At our appt. when we got the VL result, his doctor, a hepatologist at a major liver transplant center that ran sof/vel - sof/vel/vox trials, seemed well pleased.

The next labs/VL are scheduled for EOT + 4 weeks, doctor appt. following week. If patients are responding well to Tx with no/minimal Sx, doctor said no additional labs/appts. with him are necessary.

Hope this info is of help in some way.

CandaceV · Senior Member

Jimmy, I didn't see your post! Thanks for the guidelines, that's the ammunition we need. You guys are the BEST.

CandaceV · Senior Member

Tig, this is Toledo, Ohio we're talking about here...not exactly medical treatment heaven :), even though we did a thorough investigation before picking a doctor. He's the best there is here. Cleveland Clinic is only a few hours away, but my husband had a knee replacement last year and sitting that long bothers him. So we went local.

This particular doctor slams Medicare every chance he gets, I think he's upset that Medicare's pay rates are so low. He gets $64 for an office visit that is billed at $200.

There's only a 5% chance that he won't be cured and that's great. The only negativity we feel now is from the waiting. Thanks to everyone here for being more informed than the doctors. We couldn't have done this without all of you.

Anyone here have the new protocols in writing? I'd like to send them to the doctor and Medicare, just because I can :)

Tig · Admin

I believe the doctor is the one that isn't up on the newest guidelines. At least that's my impression. A phone call for authorization from him/her would've clarified that right away. Besides, a multi log drop in the viral load is obviously a sign of efficacy. I wouldn't be the least bit concerned, it's working!

JimmyK · Guru

CandaceV wrote:
Jimmy, I'm sorry I didn't mention this...
I did ask for another test for Monday, which would be 6 weeks, but doctor said Medicare won't pay for it, he had the billing person come in and confirm. It's around $900, and that would be out of pocket and my husband said absolutely not.
So we'll wait...thanks

Greetings,

While I do believe your husband is doing great, I am also thinking if a request is made, per the guidelines, then Medicare may be more inclined to honor the request.

AASLD Monitoring Guidelines

The guidelines themselves are quite extensive so I have clipped out the portion I was speaking of and attached it below. Keep in mind also that the guidelines were recently updated (July 2016) so Medicare may not be up on the recommendation.

I can see them not wanting to needlessly spend the money, but that is where the proper justification comes in. They should follow the guidelines and in this case pay to retest at week 6.

All my best.

JimmyK

Had to shorten the URL.

-- Edited by Tig56 on Monday 12th of September 2016 10:38:07 AM

Tig · Admin

Hi Candace,

I see where they wanted you to pay for an additional VL test. The price of $900 bucks is outrageous. The cost used to be $1500+ at some labs here, but they have come down significantly in recent years. Shopping around can save a lot for those wanting to do it on their own. There are some options available if you're interested. I'm including a link to a lab service that allows you to schedule and pay for any lab test you might want. The test required is the HCV RNA PCR - Quantitative. They offer two, the Abbott Real Time and the Taqman. The Taqman (first one) prices at $329 and the Abbott at $775 (still high). The Taqman is a good choice and the test I have done in the past. (Not with this service though) It is more than sensitive enough to determine an individuals viral load or lack of it.

VL RNA PCR Options

Walk-In Lab Homepage

No endorsement implied, just an option. smile

CandaceV · Senior Member

Thanks, Pablo. I think the doctor was surprised he wasn't at zero, but 95 out of 100 will be sooner or later, so his chances are GREAT.

Pablito · Senior Member

He's definitely not relapsed...that was a silly hypothesis to put forward by his gastro. He would probably test UND at week 5 if a VL could have been done then, and almost certainly at week 6. I tested UND at week 8 and since no VLs were done at weeks 5,6 or 7 I can't say which week I went UND. And I only had 8 weeks so your husband has an extra 4 weeks to go UND.

Going UND at week 4 is called a rapid virological response and the positive predictive value of SVR is close to 100% if one achieves this. On the other hand the negative predictive value of not being UND is something like 5%, i.e. only 5 out of 100 people who aren't UND at week 4 fail to achieve SVR. So, yes, it's reassuring to go UND at week 4, not achieving it still gives him the same chances he had before treatment started, i.e. 95% chance of SVR.

CandaceV · Senior Member

I couldn't agree more, Cheddy! It's just the waiting that's frustrating...

Cheddy · Moderator

I'd go with the 8 Ball. It's operator is well informed.

CandaceV · Senior Member

Jimmy, I'm sorry I didn't mention this...

I did ask for another test for Monday, which would be 6 weeks, but doctor said Medicare won't pay for it, he had the billing person come in and confirm. It's around $900, and that would be out of pocket and my husband said absolutely not.

So we'll wait...thanks

JimmyK · Guru

CandaceV wrote:
Gastro said:
Yes, they like to see undetected after 30 days, but since it's not, there could be 3 answers as to why...
1. It will take another month of treatment to clear
2. Might be non-responder
3. Might be relapser
He just doesn't know, my husband is the first and only patient on Epclusa. All that being said, the fact that it dropped from 2.2 million to 33 and the normalization of liver enzymes is a very good indication of being non-detectable soon. Only time will tell.
He has no more appointments with him, he said he's done all he can do. More blood work in October, January and April which will be discussed via email. Call with questions and concerns.
More waiting...

Greetings,

Your Gastro does not sound well informed.

If one is detected at 4 weeks it warrants another HCV RNA at 6 weeks. They should be looking for a 10x increase week 4 over week 6. That would be the only red flag. In other words a reading at 6 weeks of say 333 or higher would be a concern. Anything lower would simply point to a bit slower response that may warrant continued and extended treatment.

2.2m to 33 is a huge drop and indicative of a good response to the drugs.

Ask for a follow up HCV RNA per proper protocol.

Hang in there, lot's of needless worries on these treatments and we all have them. That too is normal. wink

JimmyK

CandaceV · Senior Member

Magic 8 Balls are never wrong! :) Thanks.

Tig · Admin

You should definitely remain positive, Candace. We have been watching the effectiveness of different protocols for years around here. I have yet to see a drop in VL like that, accompanied by the normalization of the enzymes, that didn't go on to an undetected status.

Be confident and don't allow uncertainty to rule the day. It will work, my Magic 8 Ball says so!

CandaceV · Senior Member

Hi Canuck, we're trying to stay positive. I told my husband what you said about no one failing during trials. He said to thank you.

His next blood work will be at 12 weeks...October 28th, the day of his final dose. Results 5 days after that.

CandaceV · Senior Member

Thank you Cinnamon Girl. We are trying to stay positive.

Canuck · Guru

Do not focus on 1., 2., or 3.

Your stupendously crashed decimated VL along with your Alt tells the story at 4 weeks.

It IS the "telling" response, as to what your outcome will be.

The doc is just trying to "educate" you with the other info, just as he did with telling you many people go "0" early on these drugs.

You ARE extremely close to 0 right now! In fact, you probably already ARE 0 by now!

Pablo was a good example, he remained with some stragglers to kill off at week 4, he killed those few off (likely within days), and he still had 4 weeks of drugs to go on his 8 week course!!

My doc (who performed these trials on quite a few people) ignored my concerns about my 237 and then my <15, he already knew based on my early profound response it was a "done deal". I asked ... later - no one on his trials failed. These are effective drugs.

You HAVE had an early profound response.

I know you two still will fret, it is only natural, we all do it, but try to concentrate on the reality of your VERY crashed load.

At what week is your next PCR? Week 12 at EOT? smile C.

Cinnamon Girl · Guru

Hi Candace,

In my opinion it seems very unlikely that your husband has relapsed or that he`s a non-responder, in fact I would say he`s responding very well with such a huge drop in viral load by 4 wks, and his excellent liver enzyme results say the same!

It`s much more likely that it`s just going to take a little more time, probably not even as long as another month, so I really don`t think you need to be worried.

I think your doctor is being a little over cautious and actually quite negative in what he`s telling you, so please don`t be downhearted about this, your husband is doing very well!

CandaceV · Senior Member

Gastro said:

Yes, they like to see undetected after 30 days, but since it's not, there could be 3 answers as to why...

1. It will take another month of treatment to clear

2. Might be non-responder

3. Might be relapser

He just doesn't know, my husband is the first and only patient on Epclusa. All that being said, the fact that it dropped from 2.2 million to 33 and the normalization of liver enzymes is a very good indication of being non-detectable soon. Only time will tell.

He has no more appointments with him, he said he's done all he can do. More blood work in October, January and April which will be discussed via email. Call with questions and concerns.

More waiting...

CandaceV · Senior Member

Thanks, appt. with Gastro today, I'll update.

Phoenix17 · Senior Member

Awesome numbers! Congratulations.

CandaceV · Senior Member

Thanks Canuck...Yes, the Gastro said he should be at zero at 4 weeks, but I didn't think to ask, what if he's not? Now I see that others also weren't at zero, but were after treatment. That's a game-changer for him, he's back to being positive again.

His virus count when he was diagnosed was 4.7 million. So he's 33 now, that's a drop of 99.9999999999999999% or something like that.

Canuck wrote:
Agree RC! They should be celebrating!! Too bad your doc gave you that "0" expectation, he spoiled your party!!, you HAVE crashed - beautifully! - within 4 weeks, just like almost everyone tends to do on these powerful drugs.
What you see ... the crashed ALT, and VL ... is EXACTLY what you want to see! - you now KNOW, it is working perfectly for you! Be happy!. (Listen to what tig, pablo and RC are saying!)
I am glad to know you did your homework/selection for treatment so carefully, (i.e. looking for the fibroscan, etc.) - I did the exact same sort of things, to align myself to the best possible place(s), people and equipment, and it was not an easy feat to sleuth it all out either, but, was so worth it in the end. C.
RC, Are you on the road tomorrow?? Safe journey for you and CC dear.

CandaceV · Senior Member

Thank you Robert, now I see others weren't clear at 4 weeks but were after treatment. That tells me it's going to work.

robertsamx wrote:
Candacev, Don't be disappointed. 2.2 to just 33 in 4 weeks really is stellar,really I'm not just saying that. My first treatment it took me 8-9 weeks to go UND and that was with just one DAA and RIBA, your husband is on 2 DAA's, that's two spokes knocked out of the HCV wheel, the virus doesn't stand a chance. Stay up-beat. RC

Canuck · Guru

Agree RC! They should be celebrating!! Too bad your doc gave you that "0" expectation, he spoiled your party!!, you HAVE crashed - beautifully! - within 4 weeks, just like almost everyone tends to do on these powerful drugs.

What you see ... the crashed ALT, and VL ... is EXACTLY what you want to see! - you now KNOW, it is working perfectly for you! Be happy! biggrin . (Listen to what tig, pablo and RC are saying!)

I am glad to know you did your homework/selection for treatment so carefully, (i.e. looking for the fibroscan, etc.) - I did the exact same sort of things, to align myself to the best possible place(s), people and equipment, and it was not an easy feat to sleuth it all out either, but, was so worth it in the end. C.

RC, Are you on the road tomorrow?? Safe journey for you and CC dear.

robertsamx · Guru

Candacev, Don't be disappointed. 2.2 to just 33 in 4 weeks really is stellar,really I'm not just saying that. My first treatment it took me 8-9 weeks to go UND and that was with just one DAA and RIBA, your husband is on 2 DAA's, that's two spokes knocked out of the HCV wheel, the virus doesn't stand a chance. Stay up-beat. RC

CandaceV · Senior Member

Thanks, Pablo, we were both depressed about it.

Pablito · Senior Member

33 is great at 4 weeks. I was 247 at week 4.

Pablo

CandaceV · Senior Member

Thanks, Canuck, all good points. Sent an email to the Gastro to see what he thinks. My husband is his first patient on Epclusa. We picked him because he's got 1 of only 5 Fibroscan machines in the entire state of Ohio.

Canuck · Guru

VL 33 is stellar, a dramatic and a telling crashing drop!, along with ALT crashing and everything else crashing! Beauties! Be happy, it's working fer sure, just based on your prior ALT alone, we could have guessed your load had crashed too! Just a case of mopping up the last drop of dragon gore off the bar floor after you beat the X out of it - you still got 8 weeks to do that!! Tig's right, 33 can be gone in the blink of an eye, what will you do tomorrow with all that epclusa still course in your veins for weeks to come. Enjoy it!! I was ecstatic when my first PCR showed 237 - I KNEW it was going to work - I was SO relieved!! Amazing stuff this sof/vel. biggrin C.

CandaceV · Senior Member

Thanks, Tig, I'll let you know what the gastro says later this week.

I read your response to my husband, he was extremely disappointed, but you made him feel a lot better, me too. Thank you!

Tig · Admin

Hi Candace,

That's fabulous! Listen, there was a multi log drop in viral load within 4 weeks, that's a great indication of treatment response. Lots of people go 6, 8 or more weeks and are still detected. With the VL that low when he tested, I'm betting he's undetected by now, so don't sweat this at all.

Hep C Discussion Forum

Legal Disclaimer: