Author Topic: Length of treatment (Read 21832 times)

mikelhc · « **on:** December 25, 2014, 10:25:45 pm »

Hello, still fighting insurance (Medicare D plan) for approval. Retirement medigap type program seems to follow Medicare restrictive rules, Medicare Generation Rx sent me my denial. I found out the my M.D. only wrote Harvoni for 8 weeks, due to their (insurance) guidelines. Gilead's prescription guidelines, FDA approved, say that with a low viral load and no prior treatment, 8 weeks CAN be considered. But I had failed interferon Mono-therapy 20 yrs ago, and seems that I am being considered treatment naive, not treatment experienced, due to not having had ribaviron. When I called Gilead, a nurse said that Gilead thought I was experienced ( but couldn't sent MD a letter regarding it). After 30 yrs with HCV, failed mono-therapy, prior higher viral load, kidney disease, and Diabetes, you would think I wouldn't be even considered for the shorter treatment. AASLD new guidelines says the 8 weeks should only be done with caution.

I think its a good idea to get the M.D.'s prescription for the 12 weeks now, not getting him hopefully to change it later. I've heard of some people being denied a third month of Harvoni. Does anyone have any info on this length of treatment issue? Thanks and Happy Holidays and Peace to all....Mike

lporterrn · « **Reply #1 on:** December 26, 2014, 12:59:03 am »

Hi - Twelve weeks makes sense. The new guidelines are so new, coupled with the end of the year, that it may be that you will need to have your doc pursue this in January with fresh determination.

mikelhc · « **Reply #2 on:** January 12, 2015, 04:09:52 pm »

Hi Lucinda-thanks a lot for your reply. I got approved, took my 3rd dose of Harvoni this am!!! However, approval was for only 8 weeks, Dr (or rather his nurse practitioner, who does all the HCV treatments for the Univ) still will not put in for 12 weeks, not considering interferon mono-therapy as "prior treatment". Any advise on changing their minds? thanks...Mike

Mugwump · « **Reply #3 on:** January 13, 2015, 04:34:23 am »

Quote from: mikelhc on January 12, 2015, 04:09:52 pm

Hi Lucinda-thanks a lot for your reply. I got approved, took my 3rd dose of Harvoni this am!!! However, approval was for only 8 weeks, Dr (or rather his nurse practitioner, who does all the HCV treatments for the Univ) still will not put in for 12 weeks, not considering interferon mono-therapy as "prior treatment". Any advise on changing their minds? thanks...Mike

Greetings. I too am rather unsure as to how long my treatment will proceed. I am currently informed that I am a 24 week because of cirrhosis, am responding quite well and the 4 week VL test came back at <15 not UD.

Pay careful attention to whether or not you are UD at 4 weeks and make certain that the option of extending is possible. In my situation the specialist has reduced the number of blood tests to once every 4 weeks and will at 12 weeks determine by my liver panel if another VL is called for.

There was some talk of adding ribavirin which did knock the cell counts down to low for me when I was first treated 11 years ago, but only if absolutely necessary to boost the treatment if the virus does not completely clear at 12 weeks. I will find out exactly what is going on Feb 2 after 8 weeks of pills is up.

You can call Gilead and find out if there is the possibility of getting help with the longer treatment costs over and above the insurance coverage, your doctor should know this.

Keep your stick on the ice!
Eric

mikelhc · « **Reply #4 on:** January 13, 2015, 02:17:16 pm »

University nurse wants me tested for VL at 2 weeks (!) and 4 weeks. Per insurance,4 weeks test must be under 25 IU/ml for final approval renewal to 8 weeks. When I told Gilead Support Path this, they were surprised and said do not stop, they would "help" pay, at least for the 8 weeks.

Of course, I am hoping to be clear at 4 weeks, and think my overall profile callls for 12 weeks...Mike

yag1064 · « **Reply #5 on:** January 13, 2015, 05:59:05 pm »

Eric,
I didn't know you are currently in treatment. My best to you on your Feb 2 test. May it be U/D!! The only thing I have noticed after 6 months without the virus, is the reduction of the fog and less fatigue. My platelets are back to normal. Maybe there will be a day when no one has gone through the treatments during the dark age of HEP C.

To all brave warriors, Keep up the fight.

lporterrn · « **Reply #6 on:** January 14, 2015, 12:04:12 am »

hi Mike,
Sorry but I don't have any great ideas on this. Let's hope for the best.

Katie · « **Reply #7 on:** January 15, 2015, 07:27:52 pm »

Quote from: mikelhc on January 13, 2015, 02:17:16 pm

University nurse wants me tested for VL at 2 weeks (!) and 4 weeks. Per insurance,4 weeks test must be under 25 IU/ml for final approval renewal to 8 weeks. When I told Gilead Support Path this, they were surprised and said do not stop, they would "help" pay, at least for the 8 weeks.

Of course, I am hoping to be clear at 4 weeks, and think my overall profile callls for 12 weeks...Mike

Mike, I would be very proactive in getting the full 12 weeks and you can challenge the insurance company. Just because you show as UD you can still have the virus which is not concentrated enough to be detected with the test and without Harvoni will start to replicate again. This seems to be the basis of the entire treatment. My 4 week test came back at 59. Do you mean to tell me if you have that at 4 weeks they would not continue your treatment? That is just crazy!

My take on how Harvoni works it is that Sofosbuvir actually kills the virus and Ledipasvir inhibits the replication. The previous treatment did not inhibit the replication fast enough so even though the virus was being taken down, it was still replicating faster than it was being killed, thereby not clearing it. An UD test could be seen but there were still some hiding out and the concentration wasn't enough to be detected. That too is why it is so important to continue Harvoni, even if you are UD at 4 or 8 and sometimes 12 weeks (for those on a 24 week schedule) Harvoni came up with a new inhibitor and I think that is what is making it so effective, but you have to take it long enough to be totally cleared.

Many times the doctor will fight for you. Maybe it is time to make an appointment with the doctor rather than the nurse practitioner to have a review of your case and explain your concerns.

Let us know how that goes.

Katie

mikelhc · « **Reply #8 on:** January 16, 2015, 10:14:32 pm »

Thanks for your excellent reply. The MD is head of the liver dept, and refuses to see anyone after he has turned them over to the nurse practitioner, who handles all HCV cases. Can't seem to convince her (and she's nicer than the MD) that 12 weeks is a good idea. Support path nurse told me orally I could be considered as treatment experienced, but Pharmacist at Gilead only sent me another copy of prescribing info. Support Path did say that if for some reason my 4 week test was over 25 IU NOT to discontinue, that they did not want me to stop at 4 weeks, and would help to pay for additional 4 weeks. (Maybe a total of 12 weeks, but I need the perscription)....

AASLD says that 8 weeks should only be done "with caution" and that 8 weeks CAN BE, not MUST BE, considered in some cases. I just can't see how it would apply for someone who had interferon mono-tx, Diabetes, Kidney disease, and over 35 years with the virus. Current VL is 1.8 million, but several years ago it was 7.8....Mike

lporterrn · « **Reply #9 on:** January 16, 2015, 11:12:31 pm »

Mike,
I think that your rationale is solid, but perhaps that is not the issue here. If you are right but your doc/NP won't write the script, then being right is not going to help matters. Any chance you can find a new doc at this late stage? If not, then fight for yourself until it doesn't make sense to fight any longer.

The bottom line is that the monotherapy experience is unlikely to mean you were treatment-experienced, and your chances are darn good. So if in the end you just end up with 8 weeks, I hope we can do everything we can to keep your spirits up while we wait for what I hope is good news.

Katie · « **Reply #10 on:** January 16, 2015, 11:46:28 pm »

[. quote author=mikelhc link=topic=1922.msg11595#msg11595 date=1421464472]
he MD is head of the liver dept, and refuses to see anyone after he has turned them over to the nurse practitioner, who handles all HCV cases.

[/quote]
Mike I am curious if the nurse is making this decision with or without the doctor's input. I can't believe the head of a liver Department wouldn't follow the guidelines for this treatment after all of the years of his patients suffering and living with this disease without any hope for a cure. If so, perhaps he is in the wrong field. I agree with Lucinda and would check on a new doctor as well as your time could run out quickly.

If the nurse is in control of this I would print off some information and go through it with her step by step highlighting everything that points to a 12 week treatment. Let her know you are resolved to get the best possible chance of beating this thing and you have done your research. Maybe you have already done that. I am curious what kind of reason is given to you for shortening this treatment to a mere 4 weeks or even 8. I have a feeling those reasons are not valid.

If you need some links for information, I have some easily available and I am sure there are some on this forum as well.

Katie

mikelhc · « **Reply #11 on:** January 19, 2015, 03:13:20 pm »

I believe the nurse practitioner works with the MD, but she is writing the scripts now and seems mostly in charge of tx. The MD is known for having a major God complex. It would be hard to find a new MD at this stage as I am taking (one week now) Harvoni currently and approved thru insurance and University Pharmacy for total of 8 weeks. Univ has 25 years of records with me. Nurse practitioner and doc seem on the same page however, go by the insurance guideline.

Any info of help you or others could send with be apprciated...thanks...Mike

Katie · « **Reply #12 on:** January 19, 2015, 03:39:34 pm »

Hi Mike, I am giving you this site as there is lots of valuable information on all aspects of Hep C. Search on the different links as it covers just about everything and has helped my understanding.

Good thoughts for you on this journey!

Katie

http://hepatitiscnewdrugresearch.com/hcv-newly-diagnosed.html

mikelhc · « **Reply #13 on:** January 20, 2015, 04:03:17 pm »

Hi Katie, thanks for the website. It looks great...Mike

bridget · « **Reply #14 on:** January 22, 2015, 05:50:12 pm »

Hi Mike,
The letter I used to convince my dr. & insurance co. that I am not treatment-naive is posted on the thread, "Definition of Treatment Naive."

The bottom line is, if you had any form of interferon treatment, you are not treatment-naive & that means 8 weeks may NOT be considered in your case.

AASLD Guidelines:
Initial Treatment of HCV Infection includes patients with chronic hepatitis C infection who have not been previously treated with IFN, PEG-IFN, RBV, or any HCV direct-acting antiviral (DAA) agent, whether experimental, investigational, or US Food and Drug Administration (FDA) approved.

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment

Please see other thread for details, good luck!

mikelhc · « **Reply #15 on:** January 23, 2015, 03:35:03 pm »

This link worked, seen it before, full prescribing info:
Table 1 Recommended Treatment Duration for HARVONI in Patients with CHC Genotype 1
Patient Population
Recommended Treatment Duration
Treatment-naïve with or without cirrhosis
12 weeks*
Treatment-experienced** without cirrhosis
12 weeks
Treatment-experienced** with cirrhosis
24 weeks
* HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pretreatment
HCV RNA less than 6 million IU/mL [see Clinical Studies (14)].
**Treatment-experienced patients who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin.

It does say peg-interferon + riba, I took only interferon mono-therapy. The link to AASLD didn't work. Have accessed their site several times, tho.
It seems that insurance likes to stick to the more restricted definitions. Will attempt to look at the ION 3 studies again.

Did write to MD yesterday. Thanks for your post, good luck to you...Mike

bridget · « **Reply #16 on:** January 23, 2015, 10:03:18 pm »

Mike, I should have used the link insertion button, here is the link with that newly revised statement at the very top of the page saying, that "Initial Treatment" means the patient has not previously been treated with any interferon. It did previously specify PEG-IFN, but now includes plain old IFN.

LINK: http://www.hcvguidelines.org/node/71

hope that works

dragonkiller · « **Reply #17 on:** January 26, 2015, 12:32:36 pm »

I will be starting my 12 week treatment tomorrow. I hope I don't have any side effects. Does anyone know if you can take your meds at night? I hear Harvoni makes some people tired and I have to work during the day no matter how I feel.
I am the only bread winner in the house. anyway I wish everyone a smooth treatment and to get well soon!

Mugwump · « **Reply #18 on:** January 26, 2015, 03:19:31 pm »

Quote from: dragonkiller on January 26, 2015, 12:32:36 pm

I will be starting my 12 week treatment tomorrow. I hope I don't have any side effects. Does anyone know if you can take your meds at night? I hear Harvoni makes some people tired and I have to work during the day no matter how I feel.
I am the only bread winner in the house. anyway I wish everyone a smooth treatment and to get well soon!

I am sure you will do just fine.

It really does not matter when you take your meds. The main thing is not to miss a pill or double up by mistake. There is a big sheet with the details that is usually attached to the pill bottle.

Here is the info available online. http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_patient_pi.pdf

And the more detailed product info http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

I see that their recommendations about antacids is not to take them close to the same time as Harvoni. This makes sense as most likely an antacid will absorb a portion of the meds and cause them not to be metabolized. Some people do seem to have nausea and I have had a little but not enough to write home about.

Because you are on the twelve week treatment you should not experience dead liver cell exchange as much people who have more advanced damage to the liver. But you will need to drink more water to aid in the removal of dead virus particles as they are excreted by the liver in the natural process of the creation of bilirubin.

Think of it this way, Harvoni works because the virus is killed inside the liver cells because it can no longer replicate and the liver needs to discharge the cells that have been killed by the virus. This happens as a natural process but over time the rate at which the virus kills off liver cells exceeds the livers ability to replace the cells, or if the immune system suddenly becomes weak then the virus runs amok and causes rapid damage to the liver.

So essentially every HCV infected individual will naturally discharge encapsulated fully reproduced HCV in the blood or other body fluids. By blocking the virus from replicating the body and the immune system is given the chance to clear the infection and discharge the now inert virus RNA to the point where the body removes the virus faster than it can reproduce. So Harvoni accelerates the removal of the virus because it blocks the reproduction of the virus directly in the liver which is the only place that HCV can replicate.

For me at week 8 the need to urinate has slowed but I still drink more water and pass more urine than I normally do as I am on the 24 week treatment because I have cirrhosis and am treatment experienced.

Even though my viral load was only just over 2 million at the start of treatment this did not mean that the level of active virus in my liver was low. It only meant that my immune system was keeping the virus in check for the time being but the level of damage it has done over the years to my liver is much greater than some who currently might have a much higher viral load detectable in the blood.

Many have found that at first if you do not drink enough water then headaches happen but they quickly dissipate if you keep yourself well hydrated.

Glad to hear you have the chance to clear the virus,

Best wishes for a trouble free treatment

Eric

Katie · « **Reply #19 on:** January 26, 2015, 05:24:43 pm »

Hi Dragon Killer! I take my Harvoniu about 2 hours before bedtime and am sleeping better than I have in years. Some say they get energy from it and take it in the morning and afternoon so what Eric wrote is probably correct. I just figured I wanted the meds to work while I rested. For someone having insomnia for so many years, this treatment is a blessing and I haven't experienced any problematic negative affects.

An increase in hair shedding, but not much, just noticeable, dry mouth which tells me I am falling behind on water consumption (1/2 gal per day), an unusual craving for sweets especially in the evening, and mentally a lack of motivation (which is really weird for me). I am very happy and content and am feeling so much better that I just can't even describe the difference even if my projects aren't getting done. My brain is clear of the fog and confusion I experienced for YEARS along with the severe fatigue and nervousness I suffered.

I was diagnosed over 9 years ago, do not have cirrhosis and the viral load fluctuated from about 2,500,000 to 16,000,000, where it bounced back and forth over the years. You'd think it would just raise consistently but that wasn't the case.

Congratulations and Good luck with your treatment! Be good to yourself, eating healthy, drinking lots of water and getting your rest.

You're on your road to recovery and it is a great thing. Praises to Michael Sofia for discovering Solvadi and Gilead for coming up with Harvoni to give us all this chance to be rid of the alien dragon.

Katie

dragonkiller · « **Reply #20 on:** January 29, 2015, 06:32:14 pm »

Thank you Eric and Katie for all the great info. it's nice having others that have been through all this, I wish you both a full recovery and live an awesome life Hep C free! Thanks,
Dragonkiller

mikelhc · « **Reply #21 on:** January 30, 2015, 12:14:32 am »

Just got my 2 week lab test results. Viral Load = UNDETECTABLE !!...Mike

Katie · « **Reply #22 on:** January 30, 2015, 12:26:18 am »

WhooooHoooooo! YAY Mike

That was quick! Good for you so now you have 6 more weeks to go? You have it Nailed and your cure is on it's way.

I am so happy for you and here we were all so worried. Whatever you are doing, keep it up as it is working!

Katie

mikelhc · « **Reply #23 on:** January 30, 2015, 04:04:52 pm »

Thanks. I credit my healthy diet to keeping my immune system going: Lo-fat, Whole Food (unprocessed) Plant based Diet. The authorities are Dr John McDougall (drmcdougall.com), Dr Caldwell Esselstyn, Rip Esselstyn, Dr Colin Campbell, Dr Pam Popper, Dr Neal Barnard, Jeff Novick....Mike

lporterrn · « **Reply #24 on:** February 03, 2015, 09:05:15 pm »

Oh Mike, I am so happy!!!!!!!!!!

Mike2 · « **Reply #25 on:** February 21, 2015, 02:03:30 pm »

I'm treatment naive and was approved for 8wks of Harvoni therapy however I really want 12wks just to make sure the virus is gone for good. I'm just worried that if the 4wks results show the virus undetected they won't give me the 12wks

charly8 · « **Reply #26 on:** February 24, 2015, 12:24:24 pm »

Quote from: Mike2 on February 21, 2015, 02:03:30 pm

I'm treatment naive and was approved for 8wks of Harvoni therapy however I really want 12wks just to make sure the virus is gone for good. I'm just worried that if the 4wks results show the virus undetected they won't give me the 12wks

Try Mysupportpath and ask them if they will give you a discount to extend to 12 weeks.

I plan to do the same. Only approved for 12 weeks. I would like to have at least 16 weeks to insure the little buggers are finally dead.

mikelhc · « **Reply #27 on:** February 24, 2015, 03:37:01 pm »

I just got approved for extending my 8 weeks up to 12 weeks. When I called insurance previously, they said this shouldn't be a problem. Less worry now about relapse, considering my overall profile. Had to write a lot a letters to Physician and Nurse practitioner, but seems I finally wore them down. Didn't ask to many questions yesterday as to what changed their mind, when asked if I still wanted the 12 weeks, I said "yes" and then "thank you". Quit while you're ahead. Onward to 12 weeks SFR! Had to fight for the first 8 weeks tx and now the 12 weeks, but perseverance does pay. To all my friends, never give up, and good luck to you all...Mike

Katie · « **Reply #28 on:** February 24, 2015, 04:18:40 pm »

Good Job Mike! I am happy for you it is just too bad it takes so much energy to get what's needed.

Onward towards the cure and Thanks for the advice & encouragement!

Katie

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Author Topic: Length of treatment (Read 21832 times)