Author Topic: On harvoni for 12 weeks but wanting to go 24 weeks. (Read 19521 times)

charly8 · « **on:** February 18, 2015, 02:13:21 pm »

Hello everybody. I am on Harvoni for about 4 weeks now. I am scheduled or approved for 12 weeks of treatment. My stats are below:

F3
had HCV since transfusion at birth over 40 years ago
failed interferion & riba in 1996 48 weeks (non responder)
failed peg interferion & riba in 2006 72 weeks (relapsed, slow responder)

My doctor says they would prefer me to go 24 weeks but my insurance CVS caremark has currently only approved 12. They are still trying to get 24.

Looking at the test data, if you are cirrotic and tx experience you only have a 86% chance of svr if you go 12 weeks. Given that I am close to that being F3 vs F4, I give my self a 12% to 15% chance of relapse.

I really really don't want that. I know the FDA protocol recommends 12 weeks for me, but if my doctor requests 24, do the insurance companies have to comply?

And if they don't approve, would I be able to get the extra 12 weeks thru "mysupportpath"? Any opinions.

At last resort, I could manage to pay for some of the drug, not the full amount, but maybe a 1/3rd. Does Gilead give discounts for extending treatment?

Tpropane · « **Reply #1 on:** February 18, 2015, 08:57:33 pm »

It's up to your doctor to recommend...beg them to fight the fight and help you.
I said, "What would you do if I was your,(wife, mother, sister, daughter [insert here]) what would you recommend that they do? It helped to reach out for the empathy gene.

lporterrn · « **Reply #2 on:** February 19, 2015, 03:00:52 pm »

The problem with your analysis is that F3 is not cirrhosis. As Shakespeare would say, "There's the rub." However, there may be another option that perhaps is worth considering - In the SIRIUS study, cirrhotic pts who took ribavirin with Harvoni for 12 weeks did nearly as well as those on Harvoni for 24 weeks. 8 weeks of Harvoni might not be too awful - the first 4 are fairly easy, the last 4 are awful, so a total of 8 might be worth discussing with your doc.

mario555 · « **Reply #3 on:** February 21, 2015, 02:08:07 pm »

12 versus 24? I wanted 12 and my doctor recommended 24. I am now at week 15 in my treatment and I am thankful to go for the extra time! I would bet 12 wasn't enough because my enzymes were still elevated at week 12. My VL was UND after 4 weeks. Why do I say 24? My elevated enzymes and the fact it's like if I'd be at week 2!! Thist and smelly pee are back and my side effects were more pronounced at week 14 than the previous 5-6 weeks.
I don't think everyone needs 24! You might need 16?20? Nobody knows but I would suggest you do the most you can afford to kick that f... virus. Beg, borrow, plead to get an extra bottle or two... Good luck!

charly8 · « **Reply #4 on:** February 23, 2015, 01:41:10 pm »

Well I talked to my doc and we are adding RBV to the Harvoni. I am on the low end of the F3 and my starting viral load is 1 Million so he does not think the Insurance will pay for the extra Harvoni.

I did 72 weeks of Peg and RBV and survived. I think 8 weeks of RBV will be a walk in the park.

My 2 week blood work came back Undetected, so that helps too. ALT now at 25 was 47 before meds. So that helps as well.

lporterrn · « **Reply #5 on:** February 23, 2015, 06:56:42 pm »

Congratulations. I like your spunk - hope it kicks hep C out of your life for good. Keep in touch.

cate · « **Reply #6 on:** February 25, 2015, 12:00:35 am »

Hello Everyone,

I'm Cate. This is my first post. Thank you for this great forum and sharing your situations.

I've been reading your comments and have a couple questions about the 24-week Harvoni protocol, which I just found out I have to do. But first, I'd like to introduce my specs.

I'm 60
Geno 1a
Never treated
Ultrasound showed very early cirrhosis / CT scan clear and normal
Started Harvoni mid December
Starting VL 2 million
Week 4 - 180
Week 8 - 17
Doctors requested additional 12 weeks. Haven't had approval yet from my insurance company. I go in for my 12-week VL March 9.

I've known I've had Hep C for about 9 years, and managed it well. I was actually shocked when the last ultrasound showed progression. My ultrasounds had been fine and I was feeling well. That's why this thing we have is so sneaky!

It was my understanding that a 24-week treatment course would result in 96-100% SVR. I read that someone posted 86% SVR. Would like to hear your comments.

My best to all of you!

Cate

Lynn K · « **Reply #7 on:** February 25, 2015, 03:53:05 am »

Hi Cate

Welcome

Not sure where you saw 86% maybe for tx experienced with cirrhosis taking Sovaldi and Olysio?

Ref the ION 1 clinical trial for treatment naive 20 % who had cirrhosis

SVR rates for 12 weeks treatment without ribavirin tx naive with cirrhosis was 97%

see link
http://depts.washington.edu/hepstudy/presentations/uploads/120/ion1ledipasvir_sofosbuvir.pdf

Good luck on treatment

Rexray · « **Reply #8 on:** February 25, 2015, 02:48:52 pm »

Quote from: lporterrn on February 19, 2015, 03:00:52 pm

.... 8 weeks of Harvoni might not be too awful - the first 4 are fairly easy, the last 4 are awful,...

Just curious Iporterrn, do you mean Harvoni by itself or combined with another drug?
I feel great this first week, hope I don't feel like crap in a month or so...
(forgive me if OT)

charly8 · « **Reply #9 on:** February 25, 2015, 03:02:10 pm »

CATE,

I would definitely be pushing for 24 weeks if your still detected at 8 weeks.

Take a look at this document: Pages 54 to 85

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

The 24 week arm had no relapsers. One person did not respond and I think 2 were lost during followup.

cate · « **Reply #10 on:** February 25, 2015, 07:49:12 pm »

Hi guys - thanks for posting info about Harvoni @ 24 weeks. I read in the research reports that the Harvoni patients were getting between 96 and 100% SVR after 24 weeks - that's why I was confused. My hepatogist's Fellow was the one who said 84% - she was not available to speak with me at the time. Anyway, I've this all sorted out now. Thank you!

My doctor did prepare me for the possibility that we may need to extend treatment once she saw I was still detectable at week 4, and then of course when I was still detectable by a smidgen at week 8, that was the deciding factor.

I must say, my brain fog has cleared since I started treatment. I hope it stays that way for the next 12 weeks! I've been taking Benadryl at night for 7-8 hours/night good sleep. Anyone else taking Benadryl? According to the pharmacist and my doctor, one tab of Benadryl at night is fine.

My very best to all of you. I love reading your comments.
Cate

atomic dog · « **Reply #11 on:** February 28, 2015, 01:07:47 am »

Hey Iporterrn, you wrote that 8 weeks of Harvoni might not be too awful - the first 4 are fairly easy, the last 4 are awful, what's so awful about that last four weeks?

Sam1224 · « **Reply #12 on:** February 28, 2015, 09:45:45 am »

Cate

There is a possible drug interaction between Harvoni and Benadryl (diphenhydramine). Check the link below.
http://www.hep-druginteractions.org/interactions.aspx
I would contact Gilead and your Dr. for more info.
That is the active ingredient in unisom which I don't take anymore because it's on the "the list". It's not a flashing red light STOP but more of a yellow proceed with caution and guidance warning. Let us know what you find out.

lporterrn · « **Reply #13 on:** February 28, 2015, 10:47:03 pm »

AtomicDog - The hard part about ribavirin is that it slowly drives down your red blood count, so you get tired. It starts off gradually, but by the last 4 weeks, you get a bit tired of being tired.

atomic dog · « **Reply #14 on:** March 01, 2015, 07:28:30 pm »

Quote from: lporterrn on February 28, 2015, 10:47:03 pm

AtomicDog - The hard part about ribavirin is that it slowly drives down your red blood count, so you get tired. It starts off gradually, but by the last 4 weeks, you get a bit tired of being tired.

Sorry, I missed the ribaviran part of your initial comment. Fortunately, I'm on just Harvoni.

cate · « **Reply #15 on:** March 02, 2015, 12:31:21 am »

Sam:

Thank you for the post about a possible interaction between Harvoni and Benadryl. I did send an email to my clinic about a month ago asking about Benadryl since I take it for my seasonal allergies, and they responded by saying 25 mg/day was fine. But now you've got me thinking! I will call Gilead Monday morning, March. 2. I'll let you know what I find out. Thanks again for bringing this to my attention.

Cate

Lynn K · « **Reply #16 on:** March 02, 2015, 01:58:05 am »

Humm
I am not seeing anything about Diphenhydramine aka Benadryl and Harvoni on the prescribing information sheet.

I did generate a report from the link you shared very hand tool by the way

It says for Ledipasvir/Sofosbuvir coadministered with Diphenhydramine

"Coadministration has not been studied but based on metabolism and clearance a clinically significant interaction is unlikely. Diphenhydramine is a substrate and inhibitor of CYP2D6 and ledipasvir/sofosbuvir does not affect this pathway. However, Diphenhydramine should be used with caution in patients with moderate to severe hepatic impairment"

The only adverse thing I have seen is that Diphenhydramine is not a good idea for patients with advanced cirrhosis who have hepatic encephalopathy which is what the concern is in patients with moderate to severe hepatic impairment or advanced liver cirrhosis is about.

From what I found it does not appear to be a concern in an otherwise healthy hep c patient treating with Harvoni.

But always a good idea to ask your doctor or Gilead

cj · « **Reply #17 on:** March 02, 2015, 03:39:37 am »

I would ride on the side of caution and avoid all other meds ...just to be safe ...if at all possible

cj · « **Reply #18 on:** March 02, 2015, 03:53:24 am »

I would ride on the side of caution and avoid all other meds ...just to be safe ...if at all possible

Lynn K · « **Reply #19 on:** March 02, 2015, 04:17:53 am »

Yes I do agree both times :-) when in doubt don't take the meds but if you do need the meds then check with you doctor what is safe on treatment.

For some suffering from rashes Diphenhydramine is what is often recommended for patients on treatment.

If you need help for a symptom and your doctor has a safe treatment they recommend why suffer needlessly

Sam1224 · « **Reply #20 on:** March 02, 2015, 07:23:08 pm »

I saw the gold square (or was that blue lol) and stopped reading. Thanks for the rest of the story Lynn K.

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Author Topic: On harvoni for 12 weeks but wanting to go 24 weeks. (Read 19521 times)