Hep C Discussion Forum

Doni · Veteran Member

RE: Confused with my new diagnosis

Huey · Guru

Get out of the newbie section then Doni.....And congrats.

-- Edited by Huey on Sunday 27th of July 2014 12:02:53 PM

Isiscat2011 · Guru

Congrats Doni! As you probably surmised, I'm a fan of the S/L combo, but I would expect the Int/Riba to go easier on a young guy such as yourself. And, as we have all discussed, it is only 12 weeks. As a tx naive, non-cirrhotic, 1a, your odds are very good for beating this thing on the first try.

Hells yes, spend the insurance company's money! That's what you pay premiums for. Well done on your doc's part. He must have advocated well for you.

Do keep us posted. We can't wait to see you SVR. Adorable little boy you have there.

Doni · Veteran Member

Thank God they approved my sovaldi! I'm ready for a ride!

Doni · Veteran Member

Thanks for the advice guys. Somehow I didn't consider the fact that pretty soon the new treatment will be approved, so yes, if I spend my own money then it's much better to wait for Ledipasvir than torturing myself with interferon. Though my doctor never mentioned about it.

Regarding fibrosis progression, I don't drink alcohol if that can be the main risk factor. But I can't help eating food which is not good for liver, though I'm trying my best.

-- Edited by Doni on Friday 25th of July 2014 07:56:33 AM

mallani · Guru

Hi Doni,

Fibrosis progression is not that fast at your age, unless there are other risk factors. It took about 8 years for me to progress from F3-4 to F4, and I'm old and had had the disease for at least 30 years back then.

If I was in your shoes, I'd wait for Sovaldi/ Ledipasvir. It may take a year but I would try to avoid Interferon and Riba. Just my opinion- obviously it's your choice.

Isiscat2011 · Guru

Doni wrote:
Hello Isiscat.
I was planning to wait for months but fibroscan showed F3 advanced fibrosis (and Fibrotest F0). So as I am a pessimist by nature, I assumed that I can progress to cirrhosis in months or already progressing, so that is kind of freaking me out. And that is the reason I am rushing with treatment. Anyways triple combo treatment with Sovaldi wouldn't leave long term traces right? I suppose that if Peginterferon will be taken only for 12 weeks that wouldn't mess up my body too much.

Human nature is funny and we are all human! You are pessimistic about the fibrosis progression (believing that it may progress to cirrhosis in months) but optimistic about the Interferon based tx (believing that 12 weeks couldn't do much harm).

In most cases it takes years to progress to the next fibrosis stage. Also, Interferon based tx has been known to accelerate liver disease although that is unlikely. Interferon absolutely can cause harm in 12 weeks but you are correct that the shorter the duration the better.

There is just no way of knowing how things will turn out, so it comes down to choices, and choices are always filtered by our perspectives and what we want to believe. I think either option--waiting to see if you can access all orals in the near future or starting the Int/Riba/Sovaldi tx asap--is reasonable under the circumstances. Having experienced the down sides to Interferon based tx, and watching others experience the same, my perspective is naturally going to be informed and colored by those experiences. Notably, I've also seen quite a few SVRs from Interferon based tx.

Huey · Guru

If you get the opportunity ,, I would! evileye

We are all in this together Keep you stick on the ice. "Red Green Show"

-- Edited by Huey on Thursday 24th of July 2014 08:28:39 PM

Doni · Veteran Member

My doc just told me Bupa just approved Sovaldi for the same case like mine. So I hope to get approved too. Otherwise, I guess I can start whining to then "hey, why did you approve for him, but not me?!" :D

-- Edited by Doni on Thursday 24th of July 2014 12:17:46 PM

Doni · Veteran Member

Isiscat2011 wrote:
Hi Doni:
I know how difficult this is for you. When I was first diagnosed all I wanted to do was get rid of the virus asap. Back then tx options were limited, and there was nothing better on the horizon, so I rushed into a tx that not only had horrendous short term side effects but also some serious long terms repercussions for my health and my future tx options.
HepC tx is changing rapidly and for the better. I would encourage you to take some time--I'm talking about months not years--to get an idea of what is coming world wide. You will have options you don't know about now and they should start opening up by the end of 2014.
I wish you the best and hope you will keep us posted on how things go for you.

Hello Isiscat.

I was planning to wait for months but fibroscan showed F3 advanced fibrosis (and Fibrotest F0). So as I am a pessimist by nature, I assumed that I can progress to cirrhosis in months or already progressing, so that is kind of freaking me out. And that is the reason I am rushing with treatment. Anyways triple combo treatment with Sovaldi wouldn't leave long term traces right? I suppose that if Peginterferon will be taken only for 12 weeks that wouldn't mess up my body too much.

Isiscat2011 · Guru

Hi Doni:

I know how difficult this is for you. When I was first diagnosed all I wanted to do was get rid of the virus asap. Back then tx options were limited, and there was nothing better on the horizon, so I rushed into a tx that not only had horrendous short term side effects but also some serious long terms repercussions for my health and my future tx options.

HepC tx is changing rapidly and for the better. I would encourage you to take some time--I'm talking about months not years--to get an idea of what is coming world wide. You will have options you don't know about now and they should start opening up by the end of 2014.

I wish you the best and hope you will keep us posted on how things go for you.

Doni · Veteran Member

Thanks a lot for support guys. I thought the Gilead program is limited to US citizen only... Anyways I will give it a try. Otherwise I will sink myself into debt. Being healthy is too important for me at the moment. I just started family, just started progressing in career, lots of stuff to do.

Isiscat2011 · Guru

I'm beginning to wonder how supportive Gilead's financial support system actually is after reading that Gilead has refused to provide any details on how many or how much it has actually helped. These are the current terms and conditions for receiving assistance which are listed at Gilead's US website:

Co-pay Coupon Terms and Conditions

The SOVALDI co-pay coupon program will cover the out-of-pocket costs of your patients' SOVALDI prescriptions after the patient pays the first $5 per prescription fill, up to a maximum of 20% of the catalog price of a 12-week regimen of SOVALDI. The coupon can be applied to up to 6 fills

For residents of the 50 states, District of Columbia, Puerto Rico, Guam and the Virgin Islands. Prescriptions must be filled by a pharmacy in these locations

The coupon is limited to one per person and is not transferable

Coupon is not valid for prescriptions eligible to be reimbursed:in whole or part, by Medicare, Medicaid, or any other federal or state-funded health care benefit programby private plans or other health or pharmacy benefit programs that reimburse a patient for the entire cost of his/her prescription drugs

The SOVALDI co-pay coupon is not prescription drug coverage or insurance and is not intended to substitute for such coverage.

____________________________________

Meanwhile, Gilead's second quarter profits were 3.66 billion and that is before the Sovaldi/Ledipasvir combo has even hit the shelves! One would think they could afford to cover greater than a 20% maximum considering their manufacturing costs are only a couple hundred bucks.

Huey · Guru

Why don't you try a different approach.. Gilead would like to sell the sovaldi, They have a co-pay assistance going on here in the usa, Co-pay is only five us dollars. Why don't you bug and keep bugging Gilead about it, They at least have some motivation to help you,.The sale of the drugs, Everyone else you have gone through has only an interest in doing it cheep. Maybe Greed can work for you instead of against you. Just my thoughts Doni,, I relay feel bad you can't get the help you deserve and need.

We are all in this together Keep your stick on the ice. 'Red Green Show'

Isiscat2011 · Guru

P.S. There is also this, in which Sovaldi is again a recommended tx, but I don't know how (or even if) these guidelines fit into the scheme of things in the UK. Perhaps someone else does.

2014 UK Consensus Guidelines --- Hepatitis C Management and Direct-acting Anti-viral Therapy

http://www.medscape.com/viewarticle/826291_2

Isiscat2011 · Guru

Hi Doni

The WHO published new HepC tx guidelines in April, 2014 and Sovaldi is strongly recommended:

"Strong recommendation, high quality of evidence. This recommendation was made

without taking resource use into consideration, as pricing information was not available

for any country other than the United States at the time this recommendation was

formulated." http://apps.who.int/iris/bitstream/10665/111747/1/9789241548755_eng.pdf?ua=1

The problem is cost and it sounds like the UK is setting the standards your insurance company is following. I'm in the US but from what I can surmise the situation in the UK is something like this: Payment approval for Sovaldi (or other newer DAAs) appears unlikely unless/until the NHS approves Sovaldi. The NHS has approved funding for an all oral Sovaldi combo for 500 of the UK's sickest hepc patients. It looks like a decision (at least an interim decision) could be made by the end of the year for everyone else. The UK has price controls and it could also decide to negotiate with another pharma for all orals. NICE (the National Institute for Health and Care Excellence) is determining whether Sovaldi is cost effective and has requested more information from Gilead.

How this effects you is that unless your doc can persuade your insurance company to pay for Sovaldi it appears unlikely they will. I have no idea how UK appeals work but I assume the process takes some time. If you are unable to wait your options will be either to pay for tx yourself or accept the tx they will pay for.

mallani · Guru

Hi Doni,

BUPA International (or BUPA Global as it is now called) is UK based and closely follows UK guidelines.

My son is working in London and is also covered by them.

Best of luck, but I doubt whether they'd approve Sovaldi as yet. It's a bit different from the USA.

Doni · Veteran Member

My insurance provider (Bupa International) is still reluctant to approve my Sovaldi treatment and there is a lot of back and forth emails going on between my doctor and Bupa. I wonder if I can do anything as a patient in case they finally reject. I mean I am a minority here and insurance guys are backed by huge teams of lawyers right? And if my doc fails to get approval for me, should I just give up and go to the bank or gas station, or should I fight on and appeal to financial ombudsman in UK?

-- Edited by Doni on Wednesday 23rd of July 2014 12:51:29 PM

Huey · Guru

Doni wrote:
Hi Isiscat, My insurance provider, Bupa International, seems to be referring to UK or WHO guidelines, while my doc showed me US guidelines. So yes, I will appeal on several grounds. If things don't work, I will have to call my banker :)

Banks don't carry any money any more,, Go to the Gas station,,, that is where it all is at. smile lol

Doni · Veteran Member

Hi Isiscat, My insurance provider, Bupa International, seems to be referring to UK or WHO guidelines, while my doc showed me US guidelines. So yes, I will appeal on several grounds. If things don't work, I will have to call my banker :)

Isiscat2011 · Guru

Sovaldi is considered a first line tx in the US (used with Interferon/Riba except for those who qualify as Interferon intolerant). However, you are in the UAE, so different tx guidelines may apply. There may be additional grounds for appeal, however. Let us know what your doc says; if he treats hepc regularly he has probably encountered insurance denials before.

Doni · Veteran Member

My insurance company is asking why Sovaldi is chosen as firstline treatment, because it's not firstline treatment. Awaiting for response from my doctor now. I wonder can I fight them back if they reject my treatment based on considering Sovaldi not firstline treatment...

Doni · Veteran Member

Hi Malcolm. They advised me to have biopsy done. I said better let's start treating me. So as soon as my insurance approves I will start treatment. Tired of these inaccurate tests.

(Doni, I removed the double post, Tig)

-- Edited by Tig56 on Monday 21st of July 2014 04:26:45 PM

mallani · Guru

Hi Doni,

IMHO FibroTest or FibroSure is unreliable. I had my first FibroTest just for interest, after a biosy in 2000. The biopsy was F3-4, in keeping with progression from the previous biopsy. At that time the FibroTest came in at F2.

My Fibroscan in 2008 was definite F4, and a FibroTest 3 months later still showed F2. There are too many variables in a FibroTest so go with the Fibroscan. Cheers.

Doni · Veteran Member

I have got my fibrotest results today. My fibroscan showed F3, fibrotest showed f0 and A3. My question is, why is there difference in different tests? What is my true score then?

Doni · Veteran Member

Hi Malcolm. Better f2-f3 :)

mallani · Guru

Hi Doni,

Naturally you need to be guided by your doctor. If it was me, I'd accept the Fibroscan and call myself F3-4. Cheers.

Doni · Veteran Member

mallani wrote:
Hi Doni,
To perform a valid Fibroscan, you need to obtain at least 10 valid measurements . The machine prints out a mean value, and the other measurements need to be +/- 20% of this.
My doc trialled the XL probe, but was not convinced there is any difference, so he only uses an 'M' probe.
I agree fatty liver and acute inflammation can increase the Fibroscan reading. Also, you should fast ( for 2-4 hours) before the exam, as recent food intake increases the reading.
Anyhow, let's assume you have significant fibrosis. Good luck with treatment!

Thanks Mallani. Do you think it's ok not to have biopsy for me at current situation? Actually I expected my doctor would tell me to have biopsy, but he said my blood tests shows my liver is functioning well, and fibroscan shows I have fibrosis. And he said biopsy will not reveal much new at current stage.

mallani · Guru

Hi Doni,

To perform a valid Fibroscan, you need to obtain at least 10 valid measurements . The machine prints out a mean value, and the other measurements need to be +/- 20% of this.

My doc trialled the XL probe, but was not convinced there is any difference, so he only uses an 'M' probe.

I agree fatty liver and acute inflammation can increase the Fibroscan reading. Also, you should fast ( for 2-4 hours) before the exam, as recent food intake increases the reading.

Anyhow, let's assume you have significant fibrosis. Good luck with treatment!

Isiscat2011 · Guru

Doni wrote:
My wife is no more allowing me to drink coke and eat kebab as a result of this fibroscan!

Ha! A silver lining to all of this. Maybe not for your taste buds but for your health! How does some green tea and tofu sound instead? Yummy.

Tig · Admin

Hey Doni,

I was overweight when I started treatment a year ago last May. I did nothing but start treatment and eat right. I actually ate more while I was on treatment that I ever did beforehand, because the old triple therapy protocols demanded we eat properly with each dose of medication. With that said, as I progressed with treatment, the weight started to fall off. In one year, without even trying, I lost 55 pounds and have lost another 5 since June. I'm 6' 1" and weigh in at 195 now. So look forward to the possibility of losing some of that extra weight. Concentrate on eating right and getting in some extra exercise. It not only helps your state of mind, but improves your physical health as well. There are a lot of positive results from taking this treatment and doing it right. Not only will you destroy the virus but can improve many facets of your life you hadn't really considered possible (at the same time)! Good luck...

Tig

Doni · Veteran Member

Isiscat2011 wrote:
Doni wrote:
Probably I will start seeing a head shrinker soon.
LOL. Sooner or later we all need one.
Yeah, your doc just doesn't want to see it get any worse. Sounds like a good plan to me. Get rid of it and get on with your life. Keep us posted, Doni. We are rooting for you!

Thank you!

Isiscat2011 · Guru

Doni wrote:
Probably I will start seeing a head shrinker soon.

LOL. Sooner or later we all need one. biggrin

Yeah, your doc just doesn't want to see it get any worse. Sounds like a good plan to me. Get rid of it and get on with your life. Keep us posted, Doni. We are rooting for you!

Doni · Veteran Member

Tig56 wrote:
Hi Doni,
Here's an article, while dated (2011) still provides you with some explanations of why a high BMI might impact the elasticity measurement obtained by a FS. I believe the answer to your question about the various KPA readings is the test is comprised of many readings and averaged. I'm not positive on that and Malcolm will be better able to explain that. Here's that information:
"Advantages of TE include its simplicity, short performance time, immediate results, patient acceptance, and ease of incorporation into an outpatient clinical setting. A disadvantage of TE is the inability to accurately assess liver stiffness in some patients, predominantly due to obesity. Because subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation, FibroScan failure (i.e., no valid measurements) and unreliable results occur in 3%-5% and 10%-15% of patients, respectively.6, 9-13 Numerous studies have shown that obesity, defined as a body mass index (BMI) 30 kg/m², is the strongest predictor of failed or unreliable liver stiffness measurement (LSM).6, 9, 12, 13Moreover, subcutaneous adipose tissue may lead to overestimation of liver stiffness."
http://onlinelibrary.wiley.com/doi/10.1002/hep.24624/full

Tig

Hi Tig,

Thanks a lot. That is what I thought as well. My bmi ranges from 30 to 32 all the time and I have fat skin. Never been able to go below 30 after I turned 30!

Doni · Veteran Member

Actually doc said my liver is functioning well right now as per my blood tests, even if fibroscan showed stage 3. I was expecting him to say that I'm on my fast track to chirrosis from current stage. Somehow he seemed not to care about this, OR I got too obsessed thinking about this. My wife is no more allowing me to drink coke and eat kebab as a result of this fibroscan!

Yes, I will be on 12 week treatment and will not wait for all orals. Honestly don't have time to wait. I have postponed my MBA because of this disease, and I'm getting distracted from work because of thinking about this disease too much. Probably I will start seeing a head shrinker soon.

Tig · Admin

Hi Doni,

Here's an article, while dated (2011) still provides you with some explanations of why a high BMI might impact the elasticity measurement obtained by a FS. I believe the answer to your question about the various KPA readings is the test is comprised of many readings and averaged. I'm not positive on that and Malcolm will be better able to explain that. Here's that information:

"Advantages of TE include its simplicity, short performance time, immediate results, patient acceptance, and ease of incorporation into an outpatient clinical setting. A disadvantage of TE is the inability to accurately assess liver stiffness in some patients, predominantly due to obesity. Because subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation, FibroScan failure (i.e., no valid measurements) and unreliable results occur in 3%-5% and 10%-15% of patients, respectively.6, 9-13 Numerous studies have shown that obesity, defined as a body mass index (BMI) 30 kg/m², is the strongest predictor of failed or unreliable liver stiffness measurement (LSM).6, 9, 12, 13Moreover, subcutaneous adipose tissue may lead to overestimation of liver stiffness."

http://onlinelibrary.wiley.com/doi/10.1002/hep.24624/full

Tig

Isiscat2011 · Guru

Hi Doni:

My understanding is that the reason for the disparity is that fibroscans take multiple readings of your liver and not all readings are equal. Biopsy readings vary as well but with biopsies the number of readings is smaller, because they actually take tissue samples from your liver, and are limited as to how many samples they can take. Because the liver is a large organ the level of fibrosis is likely to vary depending on where in the liver it was taken from.

There is usually more than one approach to diagnosing and treating, and each may be equally reasonable, so it comes down to choice. Your doc must feel that he has adequate information to adequately diagnose the severity of your liver damage. There can be a fine line between stages and in some cases the line is a bit blurry as well.

Since you don't know when you will have access to the all orals, and it could be a while, treating now seems reasonable too. Your Interferon/Riba exposure will only be for 12 weeks, right? It may not be easy, but at your age, it should be tolerable and safe enough. With a little luck all will go well and you will get rid of this virus on the first try.

Huey · Guru

Got my fingers crossed too

Doni · Veteran Member

Doc said doesn't see necessity in biopsy. Whatever stage it is, I have fibrosis and I need treatment. I didn't object as I really didn't want this procedure done anyway. Sent for approval to my insurance company to start the treatment. Fingers crossed.

Doni · Veteran Member

I have studied my fibroscan report and I am questioning the accuracy of this method. I have read that high BMI (mine is 31), and active inflammation can overestimate the fibroscan reading. And why is there such a dispersion in KPAs? One is 6.8 and another on is above 12?

Doni · Veteran Member

Thanks a lot guys. I have a son who just turned one. So I wanna see him grow up and get me some grandchildren :)

Isiscat2011 · Guru

Hi Doni:

Finding out that you have liver damage is frightening but it isn't the end of the world. The damage can be stopped and often even reversed. Just look at Malcolm's improvements since he reached SVR. Our bodies are pretty amazing; they want to function properly.

Doctors call determining the level of liver damage one has "staging." Staging the degree of fibrosis is not as easy at it sounds and every test, including liver biopsy, has margins of error that can be as great as 1 or in rare cases even 2 stages off. The more information the docs have the closer they can get to accurately "staging" your liver fibrosis. Biopsy can detect a few other important things besides fibrosis and at this point it would be a very reasonable next step. Ultrasound is fairly useless for detecting fibrosis and fibrotest (also called fibrosure) is notoriously inaccurate.

Everything will be okay. At your age your body is a fighting machine. It is designed to recover. smile

Tig · Admin

Hi Doni,

F3 is not considered cirrhosis, that begins at F4. However, an F3 is considered advanced fibrosis. Fibrosis is reversible, how fast that occurs is unknown. SuziQ just posted an article on this, I recommend you take the time to read it. Don't worry about your fibrosis level now, there isn't a thing you can do about it. I would do the biopsy and get a definitive diagnosis. The Fibroscan can be inaccurate at this stage of fibrosis, as Malcolm stated. The standard ultrasound does not accurately diagnose fibrosis at any stage, the only accuracy lies in the fibroscan and it has it's limitations (as explained). Good luck...

Tig

Doni · Veteran Member

Also, in January, when I had ultrasound, everything was normal except for some polyps in my gallbladder. Wouldn't something abnormal show up on ultrasound if i was on F3 stage?

Doni · Veteran Member

Hi Mallani,

You mean I might have chirrosis already? Is stage 3 reversible and if yes how long does it take? And yes, I guess I will go for biopsy now.

mallani · Guru

Hi Doni,

Yep, F3 stiffness has a range of 9.5-12.5 kPa. Forget the Fibrotest.

Personally, I'd want a biopsy for confirmation, as 9.9 could be a Stage higher or lower. I was 30.1 kPa before treatment, but have dropped to 7.8 12 months after SVR.

Huey · Guru

This may still yet recover after treatment,, Don't loose hope!

We are all in this together,Keep your stick on the ice,,(Red Green Show)

Doni · Veteran Member

Dear friends,

I did my fibroscan and my stiffness is 9.9 kpa, which F3 stage fibrosis. Success rate says 76%, don't know what it means. Actually I am shocked. I just turned 33, and now I have no idea what will happen to me. I also did fibrotest to get correlation. Awaiting for results now.

Doni · Veteran Member

Tig56 wrote:
Hey Doni,
I did a bit of research into the Nigella Sativa (Black Cumin Seed) and find it spoken of very highly in supplemental circles. If you're a fan of supplements, you must also be aware that they can be quite harmful and counter effective when combined with prescriptive medications. It's definitely detrimental to any HCV protocol and it's proven that comsumption of them will alter your blood test values. It's not something you want to consider if you're going to go forward with treatment. I understand your brother in law's dislike of Interferon, but it has provided many medical benefits over many years of use. If he was the individual that recommended the "Black Seed" treatment, I wanted to point out one comment about Nigella Sativa. He might want to reconsider his recommendation!
"Hundreds of studies have been conducted on black cumin which have shown that compounds from the seeds help fight diseases by boosting the production of bone marrow, natural interferon, and immune cells."
Learn more: http://www.naturalnews.com/030800_cumin_seeds_health.html##ixzz371vev37A
Tig

Actually I was thinking about taking this supplement in addition to my treatment. But I'd better check with my doctor I guess.

Doni · Veteran Member

mallani wrote:
Hi Doni,
Interesting comments from your brother-in-law. A surgeon!
Interferon is a naturally occurring compound produced by the body. Sure there may be some long-term effects in some people after prolonged use. They are better than the problems of liver failure! I've injected the stuff for a total of 2.75 years from 1996 to 2012. I don't think I have any residual problems and in my case, Interferon helped me clear the virus.
His comments show a lack of knowledge about HCV. Interferon will still be used for many years in many countries.

That's what I thought also, he's a good surgeon but knows nothing about HCV.

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