Author Topic: What is the "Correct" Length of Time for Harvoni Tx? (Read 28085 times)

Roger · « **on:** November 21, 2014, 03:17:49 pm »

My first bottle of Harvoni arrived this morning.
I'm going to go eat an $1125.00 lunch after I write this...

I need some educated help understanding What is the "Correct" Length of Time for Harvoni Tx is.

I called my doc's office and asked them if they have any leads on a good Medicare Plan D company - one that would cover my 3rd bottle of Harvoni since I am being booted off my current plan January 1st and my 3 bottle will be ordered January 20th or so...

The nurse told me that since I am only stage 3, Viral load under 6 million and never been treated before, that it's ok for me to take only 2 months (8 weeks). Not to worry about the 3rd bottle.

Does this sound ok? Is 8 weeks enough or is 12 weeks a safer bet to kill the virus once and for all? My prescription is written for 12 weeks.

Sweetie1 · « **Reply #1 on:** November 21, 2014, 04:28:12 pm »

Hi, I think it is 8 weeks if you are without cirrhosis and have never been treated before. Karen

BattleTheBeast · « **Reply #2 on:** November 21, 2014, 04:48:24 pm »

Hi Roger,

I can't believe the nurse said "You are only Stage 3". God forbid this horrible infection ever hits closer to her home. So not cool!

Hope all works out for you but keep fighting for your 12 weeks, Maybe you can ask if you can get the last bottle ordered on 12/31 so it's covered.

~Mel~

Roger · « **Reply #3 on:** November 21, 2014, 05:01:12 pm »

Hi Mel,
Thanks for your note. I tried the Dec 31 thing... no go! I would have had to have the first bottle the last part of October.

I have a script for 12 weeks, so I can use it "if" I can figure out the Part D plan to buy.
Thank God I know how to ask questions and dig, but it is very difficult dealing with these bloody insurance types!

BattleTheBeast · « **Reply #4 on:** November 21, 2014, 05:04:44 pm »

Hi Roger,

Did you sign up for the copay coupons? They could help with whatever happens with your Medicare

~Mel~

Rubye · « **Reply #5 on:** November 21, 2014, 05:21:00 pm »

The problem is a particular insurance may pay now and then take the drug off their formulary in January.

The answer to your question is --

12 weeks without cirrhosis
24 weeks with cirrhosis

Check out AASLD, if you haven't already, hcv guidelines for treatment -

http://www.hcvguidelines.org/

Roger · « **Reply #6 on:** November 21, 2014, 05:24:35 pm »

Mel,
Yes I did. That was great - it took care of the rest of my annual deductible so I'm home free for this year. Gilead does not have any support for Medicare people though, so it all ends for me Jan 1 (3rd bottle)...

They did, however, give me the name of an Non Profit Foundation that can help Medicare co=pays - which is great.

Roger · « **Reply #7 on:** November 21, 2014, 05:28:15 pm »

Rubye,
The bigger problem for me is - so far, non of the Part D plans I have found even cover Harvoni on their formulary! Sovaldi yes...

There is a possible savings grave available called "Transition of Coverage". I am reading about it now. As far as I have read (there's lots more to read) it says that a new Part D drug plan must cover a drug for the first month on the plan, while they work out future details and commitments. It might help!

RichardEll · « **Reply #8 on:** November 26, 2014, 02:26:00 am »

I know that my Drs. would like to see you on it for at LEAST 12 weeks. I'm very ill and cirrhotic, so they've got me down for 24 weeks.

When dealing with insurance companies: Take all you can get. Try to stay on it at least 12 weeks. Call Squibb directly, explain your situation, and apply for special RX Assistance program, to finish your RX. Chances are, they will ship it FREE. But, DON'T WAIT - do it NOW. Their processes take a month or two.

Bottom Line: Once you've done a full course of Harvoni, any insurance company will deny a 2nd attempt, based on the fact that "it didn't work for you". So, grab for as much as you can, right now.....gouge the eyes, knee the groin, whatever it takes. You probably won't get a 2nd chance.

Best wishes. My Drs. are seeing Undetectable in 4 weeks, even for the most stubborn 1A, cirrhotic, sicker than dogs. So, your chances are good. But, don't sit down. I say: Shoot for 12 weeks. Best wishes - RL

Roger · « **Reply #9 on:** November 26, 2014, 02:07:04 pm »

I agree with everyone here that says go for 12 weeks. I called Gilead, and also read on the paperwork that came with the bottle of pills - 12 weeks. I'm not sure what to do, as my doc is very busy and I have to rely on his assistant/nurse - who keeps saying 8 weeks!

I told her that Gilead said 12 weeks for my stage and viral load... she said "8 weeks"!

To get an appointment with the doc is difficult - and he doesn't answer my emails. She will answer an email (very good about it actually), but not him.

It's another frustration... If taking the full 12 weeks won't hurt me - it seems that it can only be good!

I am still trying to figure out how to "pick a Medicare Plan D" that will cover that last 4 weeks of Harvoni, as I have to transition onto Medicare during this Tx. Bummer...
They do have a law called 'transition of coverage', that might work - if all else fails.

mario555 · « **Reply #10 on:** November 26, 2014, 02:17:50 pm »

IN support with the statement from Richardell, I would also suggest you take more than 8 weeks with whatever money you can raise! Although it appears expensive, the cost of an extra 4-8 weeks of treatment will seem terribly small when the side effects of your Hep C increase!
I'm F4 with a high viral load. I took a 24 weeks treatment to make sure (or almost) I get rid of the disease the first time around. I could have stayed with 12 weeks but I was determined to do 4-8 weeks more just to make sure!!!
Although I live in Canada and do not understand much about your insurability, I had my private insurance ready to pay a max of $50,000. With that information, I called the Millenium Foundation (Gilead in Canada) and discussed my case. They were willing to make up for some of the missing money and my cost will be bearable (approx. 25% of the total cost). So, see what you can do money wise and show Millenium that you're willing to bear some of the cost and they should come through!!!!

lporterrn · « **Reply #11 on:** November 26, 2014, 02:48:43 pm »

Roger - technically you need 8 weeks of treatment because stage 3 is not cirrhosis and your viral load is less than 6 mil. Honestly, I think I'd be asking the same question if I was in your shoes. However, I am very nervous about insurance plans, and they usually play strictly by the book, so getting coverage for a 3rd month is unlikely to be approved. What I would do is take the 2 months, but if I was not approved for a 3rd, I'd start the process with https://www.harvoni.com/support?evo_source=MYSUPPORTPATH and see if I could get a 3rd month. I think you will be OK with 8 weeks, but that slight doubt is hard to relieve.

Rubye · « **Reply #12 on:** November 26, 2014, 02:58:05 pm »

That's interesting about the 8 weeks Lucinda. You would think insurance would want to make sure a person is cured when they are putting out such a huge amount of money so that the person does not need to come back to them again if tx doesn't work. But, I do kind of understand that insurance only invests in the now because of reasons like in the future you may have a different carrier or move or die. Kind of a glum business.

Roger · « **Reply #13 on:** November 26, 2014, 04:18:00 pm »

Lucinda - the prescription was approved for 12 weeks. It's not the insurance people saying don't take it - it's my nurse... unless what you are saying is, 'even though it was preapproved for 12 weeks, the insurance company will follow my chart and then come in and deny the last 4 weeks of coverage'?

Roger · « **Reply #14 on:** November 26, 2014, 04:19:49 pm »

Quote from: Rubye on November 26, 2014, 02:58:05 pm

That's interesting about the 8 weeks Lucinda. You would think insurance would want to make sure a person is cured when they are putting out such a huge amount of money so that the person does not need to come back to them again if tx doesn't work. But, I do kind of understand that insurance only invests in the now because of reasons like in the future you may have a different carrier or move or die. Kind of a glum business.

Rubye - BINGO! You are exactly correct, that the insurance companies hope you either move on to a different company (job related, etc, etc), or die.

RichardEll · « **Reply #15 on:** November 26, 2014, 09:29:56 pm »

That's exactly what Blue Cross tried to do with me. I was refused Olysio/Sovaldi in January of this year, all my Drs. appeals were denied. I was invited to send my own letter, which I did - and no answer.

Their previous 'rationale' for refusal was that it was TWO oral drugs. BC/BS said I could have ONE (success rate, about 50% for a case like mine), plus Interferon - but Interferon is severely contraindicated for me - I would likely die from liver failure quick and soon.

So when they attempted to "sit down" on my Harvoni request, I called them and (businesslike but persistent) took them down the entire List, of their own Justification and Criterion documents, explaining how I filled every criterion necessary. Long session of Chin Music, ended with them confirming my address for delivery. Hallelujah!

But, it was obvious - I am VERY sick now, and BC/BS were hoping I'd die first. A shame, but that's Big Business in America. Incidentally, Harvoni is to be made available in foreign countries, at a much lower price - 12 to 24 week courses will be priced "In the hundreds" to "low thousands" of dollars, for the entire course. This was on the drug Manufacturers' own website. Tough rocks, for Americans.

lporterrn · « **Reply #16 on:** November 26, 2014, 10:33:04 pm »

Yes Roger - I am saying that is a possibility. And your MD trumps the RNs feedback, albeit neither is wrong.

dragonslayer · « **Reply #17 on:** November 28, 2014, 09:35:19 am »

Maybe Im not understanding, but if you read the prescribing notes from Gilead that accompany the prescription, not only is 8 wks considered positively for non cirrhotics who are treatment naive and have viral load < 6mil, but the included study statistics show there is no benefit to be gained by going the extra month. Specifically, in this cohort in the ION-3 trial, the number of responders after 8 wks and 12 wks was essentially identical, and the relapse rate was the same 2% after 8wks as well as 12, So why are you all recommending 12 wks to Roger who appears to fit this criteria?

Rubye · « **Reply #18 on:** November 28, 2014, 11:49:14 am »

Hi Paul, I said 12 weeks because that's what I've heard so many others say on these forums. I've never seen Gilead's prescribing notes, only press releases and comments from lots of people who give the impression of being knowledgeable in the latest in tx. I guess Gilead should know and it's interesting how we get caught up in believing what people are saying without researching it ourselves. I think this is true even with doctors. So, thank you.

I like to think that if it were me doing the Harvoni I would have read Gilead's note but do patients have access to this info? I know I got an enclosure with my Sovaldi but not with the Olysio.

dragonslayer · « **Reply #19 on:** November 28, 2014, 11:54:28 am »

Here you go:

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

Go to Table 1 for treatment duration notes, and table 7 for responders and relapse rates. This is a pdf of the same enclosure that comes with Harvoni.

lporterrn · « **Reply #20 on:** November 28, 2014, 05:58:06 pm »

Dragonslayer - You wrote,

Quote

Maybe Im not understanding, but if you read the prescribing notes from Gilead that accompany the prescription, not only is 8 wks considered positively for non cirrhotics who are treatment naive and have viral load < 6mil, but the included study statistics show there is no benefit to be gained by going the extra month. Specifically, in this cohort in the ION-3 trial, the number of responders after 8 wks and 12 wks was essentially identical, and the relapse rate was the same 2% after 8 wks as well as 12, So why are you all recommending 12 wks to Roger who appears to fit this criteria?

Roger is at stage 3- which is closer to cirrhotic than non-cirrhotic. There is a huge difference between stage 2 and stage 3, but less between 3 and 4 then one might realize. Liver biopsies are not 100% accurate, and although the lack of accuracy works both ways, if Roger was more stage 4 than 3, then 12 weeks is a must. (I didn't ask if he had done prior treatment - if so, then 24 weeks is the correct time.)

What we have is an easy to tolerate drug, and his doc prescribed 12 weeks. Other than the fact that is expensive, the extra time on the drug is low risk but potential beneficial. I've watched many people who have failed treatment, have failed it twice myself, and the uncertainty of "did I do everything right" is a burden. Doubt can dog you - "If I only had done 12 weeks" is a harmful, but understandable mantra. So, all these factors are why I made the comment I did.

Roger · « **Reply #21 on:** November 28, 2014, 06:28:10 pm »

Quote from: lporterrn on November 28, 2014, 05:58:06 pm

Roger is at stage 3- which is closer to cirrhotic than non-cirrhotic. There is a huge difference between stage 2 and stage 3, but less between 3 and 4 then one might realize. Liver biopsies are not 100% accurate, and although the lack of accuracy works both ways, if Roger was more stage 4 than 3, then 12 weeks is a must. (I didn't ask if he had done prior treatment - if so, then 24 weeks is the correct time.)

I've watched many people who have failed treatment, have failed it twice myself, and the uncertainty of "did I do everything right" is a burden. Doubt can dog you - "If I only had done 12 weeks" is a harmful, but understandable mantra.

Lucinda, Right you are - 'If I only had done 12 weeks is a harmful, but understandable mantra.'.. and I don't want to be doing it (Which I know I would!).

I have never had a prior treatment, and my staging went from 2 to 3 in a year. I have read that HCV can hover at Stage 2 for a l-o-n-g time - then zoom into Stage 3 & 4 quickly. My FibroSure blood test gave me a "Fibrosis Score" of .61, with a "Fibrosis Stage" of F3 - Bridging Fibrosis with many septa.

If Stage 4 would be 1.00, then I am 61% closer to stage 4, than not (if I am reading this correctly)... hence, I'd like the full meal deal and take the drug for 12 weeks not 8.

All too many times we fall into "categories" at the doc's office. They are busy and only want to deal with those categories all too often. ...Then there is "real life".

Why gamble?!

dragonslayer · « **Reply #22 on:** November 28, 2014, 08:22:18 pm »

Good discussion. I think we all tend to process information according to where we sit.. In this case i was relating Rogers situation to my own. I also have a viral load < 6mil at 2.4 and like Roger I'm also treatment naive. What i didn't realize until i read Lucinda's post was that the biopsies can be a grade off and that that can effect treatment length if a 3 can really be a 4 .. And in Roger's case it wasn't even 3 biopsies; it was 1 biopsy, then a fibroscan , and then a fibrosure, giving even less assurance of producing s consistent grading/staging. In my case I've had 2 biopsies; 1 in 2008 and again in 2013... Both scored between 0 and 1. So I guess I should be ok with my 8 weeks of current treatment with no need to push for another 4 wks. For my situation the trial cohort showed zero benefit to adding another month. For those on the cusp i can see how the decision might not be so simple. Id normally think that for those near my biopsy numbers it might still be prudent to go with the longer treatment. But the trial numbers don't seem to bear that out. Roger, I hope you you get that extra month and if you don't, that 8 weeks works out for you.

dragonslayer · « **Reply #23 on:** November 29, 2014, 10:57:04 am »

Quote from: lporterrn on November 28, 2014, 05:58:06 pm

Dragonslayer - You wrote,

Roger is at stage 3- which is closer to cirrhotic than non-cirrhotic. There is a huge difference between stage 2 and stage 3, but less between 3 and 4 then one might realize. Liver biopsies are not 100% accurate, and although the lack of accuracy works both ways, if Roger was more stage 4 than 3, then 12 weeks is a must. (I didn't ask if he had done prior treatment - if so, then 24 weeks is the correct time.)

What we have is an easy to tolerate drug, and his doc prescribed 12 weeks. Other than the fact that is expensive, the extra time on the drug is low risk but potential beneficial. I've watched many people who have failed treatment, have failed it twice myself, and the uncertainty of "did I do everything right" is a burden. Doubt can dog you - "If I only had done 12 weeks" is a harmful, but understandable mantra. So, all these factors are why I made the comment I did.

Lucinda, when you talk here about failed treatment, you're not talking about Harvoni, are you?

lporterrn · « **Reply #24 on:** November 29, 2014, 11:56:12 am »

No Dragonslayer - I failed 2 interferon-based therapies

dragonslayer · « **Reply #25 on:** November 29, 2014, 12:19:21 pm »

Quote from: lporterrn on November 29, 2014, 11:56:12 am

No Dragonslayer - I failed 2 interferon-based therapies

Yea, thats such a bummer.. I can hardly conceive of going through that nearly year long treatment torture only to find it didnt work.... Its really unthinkable to me how horrible that must have been. I kind of figured its too soon to have gone through harvoni twice... And besides, if someone had actually failed Harvoni twice, that would truly be a statistical anomaly! Thank goodness that hasn't happened yet... Failing once is a true long shot in itself, but twice would be a real rarity.

UndetectableC · « **Reply #26 on:** November 29, 2014, 01:26:28 pm »

I'm on an 8 week course of treatment because I meet the criteria. I must have faith that it will work. I have a better chance of clearing on this regimen than I was offered 6 months ago. Other good signs are that my VL was very low <400,000 and I have had rapid response within 2 weeks. No time for regrets now. This is it!

Best wishes to everyone in treatment, and especially to those awaiting treatment.

Roger · « **Reply #27 on:** November 29, 2014, 03:03:34 pm »

To be on an interferon treatment once would be hard - but twice?
Yes, Harvoni seems like a miracle. Hopefully it will not have any
bad side effects down the road.

lporterrn · « **Reply #28 on:** November 30, 2014, 11:59:37 am »

I love the cartoon Roger and Undetectable's words! As for Dragonslayer's compassionate reply, it may sound odd, but I took it well. In many ways, not responding helped me - I wasn't ready to commit to a healthy lifestyle, and hep C hanging over my head kept me on a healthier path. Also, I got 2 books out of the experience, so I really didn't suffer.

dragonslayer · « **Reply #29 on:** November 30, 2014, 12:09:57 pm »

Lucinda, I definitely hear you re the healthy lifestyle thing! Nothing tends to keep us clean and sober like Hcv. Although, I must confess, Im counting the days til my last Harvoni pill in mid January to sit down and have a beer with friends...

Bucky · « **Reply #30 on:** November 30, 2014, 12:51:51 pm »

I can understand the discussion and concern about the correct length of treatment. Those of us who were treated with S&O off label before the FDA guidelines came out only did 12 weeks where now 24 weeks is the recommended time. Will the treatment time for Harvoni change in the future? It is certainly a possibility as more data is collected in the future.
Bucky

dragonslayer · « **Reply #31 on:** November 30, 2014, 01:08:51 pm »

I haven't seen the trial results for SO, but the SVR12 results on both the ION3 8wk vl<6m and 12 week vl>6m cohorts look fantastic. Relapse rate holds firm at 2%. Not sure why this would change radically. That would truly be bad news.

Could it be that SO was off label for gt 1 for a reason?

Bucky · « **Reply #32 on:** November 30, 2014, 01:29:48 pm »

Quote from: dragonslayer on November 30, 2014, 01:08:51 pm

I haven't seen the trial results for SO, but the SVR12 results on both the 8wk vl<6m and 12 week vl>6m cohorts look fantastic. Relapse rate holds firm at 2%. Not sure why this would change radically. That would truly be bad news.

Could it be that SO was off label for gt 1 for a reason?

It was off label at the time for all including hard to treat like me. The approved treatments at the time included one of the backbone meds, either S or O but you had to use Riba or interferon with either one. If you have the Q80k gene then O was out. By going with S&O there was no I or R involved. Getting approved by an insurance company for off label use of a drug combination was challenging. As real world numbers started coming in the cure rate was lowered for S&O 12 weeks. 24 weeks provided a better SVR for the hard to treat. Granted the cure rate for S&O 12 weeks is still quite good so I am hopeful. I would have done another 12 weeks for a 10% better chance of SVR but it does not matter now.
Bucky

dragonslayer · « **Reply #33 on:** November 30, 2014, 01:42:46 pm »

Quote from: Bucky on November 30, 2014, 01:29:48 pm

It was off label at the time for all including hard to treat like me. The approved treatments at the time included one of the backbone meds, either S or O but you had to use Riba or interferon with either one. If you have the Q80k gene then O was out. By going with S&O there was no I or R involved. Getting approved by an insurance company for off label use of a drug combination was challenging. As real world numbers started coming in the cure rate was lowered for S&O 12 weeks. 24 weeks provided a better SVR for the hard to treat. Granted the cure rate for S&O 12 weeks is still quite good so I am hopeful. I would have done another 12 weeks for a 10% better chance of SVR but it does not matter now.
Bucky

Since SO alone was off label for gt1, were there any trial results for this group , or were efficacy/duration numbers dependant on real world results? One thing i thought we had going for us with Harvoni was great trials numbers

Bucky · « **Reply #34 on:** November 30, 2014, 01:55:39 pm »

Quote from: dragonslayer on November 30, 2014, 01:42:46 pm

Since SO alone was off label for gt1, were there any trial results for this group , or were efficacy/duration numbers dependant on real world results? One thing i thought we had going for us with Harvoni was great trials numbers to go by.

Yes, there were trials for S&O but it was with a small group of people and in trials the controls are more stringent. S&O was off label for all. When I started on the meds the first group of people at my hospital had not even reach EOT so my IDS had no real world data only the trials. When you have a large number of people on meds you have more variables to deal with so naturally the % drops.
Harvoni appears to have better cure rates than S&O and I would have used it had I had access to it but at the time it wasn't approved. I needed treatment! Since it is an all in one pill the off label combining was not available as with S&O.
Bucky

BattleTheBeast · « **Reply #35 on:** December 02, 2014, 02:02:07 am »

Even when I started S/O on 10/11 it was not FDA approved and even crazier Harvoni was approved the day after I started S/O; should I have waited? my itchy skin says yes but honestly I just wanted to get started and the approval happened so fast I didn't want to take a chance on a battle for treatment. Now 7 weeks and 2 days into treatment we are trying to move me to Harvoni anyway due to my allergic reaction to the Olysio. So I guess I will get the best of both worlds.

If that doesn't work well then I will try AbbieV or whatever is next. We will all be cured, just a matter of time. Some of our roads will be and have been easier than others. My itch is nothing compared to what so many of the warriors of interferon for almost a year went through!

~Mel~

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Author Topic: What is the "Correct" Length of Time for Harvoni Tx? (Read 28085 times)