Zepatier Part Ugh

I have spent the better part of this past month re-writing this post, and on March 11, i will find out much more.

Because I legitimately don't know how to properly convey my despair and disappointment and fear at what will soon unfold.

I had been eagerly awaiting the release of Zepatier,  the announcement last month was terribly exciting.

Zepatier is a Hep C drug that deals with NS5A resistance,has a very high success rate, and is almost half the price of the leading treatments Harvoni and Sovaldi.

It's amazing, and it has shown to work very well in other harder to treat cases.


The drug has one small hitch.

Well, i think it kinda sucks like... a lot.

The FDA/Merck released a contraindication for the drug for use with patients who with child pugh score B or C

"ZEPATIER is contraindicated in patients with moderate or severe hepaticimpairment (ChildPugh·B or C) due to the expected significantly increased grazoprevir plasmaconcentration and the increased risk of alanine aminotransferase (ALT)elevations" - 

The contraindication does have a rationale beneath it.

In 1% of cases ALT levels raised 5X within in the first 8 weeks, Clearly, an indicative factor of a problem.

Unless it isn't.

Which it isn't.

Most instances self corrected soon after:

" During clinical trials with ZEPATIER with or without ribavirin, regardless of treatment duration, 1% (12/1599) of subjects experienced elevations of ALT from normal levels to greater than 5 times the ULN, generally at or after treatment week 8 (mean onset time 10 weeks, range 6-12 weeks). These late ALT elevations were typically asymptomatic. Most late ALT elevations resolved with ongoing therapy with ZEPATIER or after completion of therapy [see Warnings and Precautions (5.1)]. The frequency of late ALT elevations was higher in subjects with higher grazoprevir plasma concentrations [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. The incidence of late ALT elevations was not affected by treatment duration. Cirrhosis was not a risk factor for late ALT elevations."

In fact the contraindication seems odd considering the big new DAAs carried no such contraindication:
 Sovaldi 
Harvoni 
Daklinza 

Olysio 

"Initial analysis of Zepatier’s label showed comparatively fewer AE(Adverse Effects)s (29 vs 41 for Sovaldi). Liver cirrhosis, the only ImportantMedical Event (IME) listed on the label, is largely associated with HCV and notwith the drug. "

So... Now it's time to figure out how the hell I get this drug, because I suspect this will be my last treatment. success or failure.
Further research should show it's true efficacy, which i feel will reflect poorly on Zepatier if the drug is prioritized because of its price-point rather than it's efficacy.

And So It Is.

This will probably be my most personal blog to date.

I have been lost in exploration lately.

Rather, I should say I wander, not simply that I am lost.

This blog has been an unforeseen gift to me, allowing me to look back at my thoughts years ago, and understand where I've come from. To better understand my mistakes, and to live better than I have. I have learned to strengthen the bonds near me, and now I should seek the same connection with others. I value every bond I share, and if I am to truly know myself I must share more personal moments with friends.

If I have not extended a hand to you yet, I implore you to seek me out. Because I appreciate you as a friend and I want to experience something you truly love with you. A place or thing that represents who you are, your happy place, if you will.

In the same spirit, I have a few weeks remaining on my Disneyland pass, (basically the 15th of December), and I want to share my happy place with you. So that I may know and experience my favorite place with you. I realize I may never go again after this. There are a lot of factors involved with this reality, the price increase is part of it, but there is another hurdle.

For the last 4 years, I have had a steadily rising cumulative probably of death. To say I'm beating the odds isn't entirely true, I'm simply very fortunate. As I presently stand, without any treatment my probability of death reaches about 94% by this time next year. 

Including the odds of a successful treatment my outlook improves dramatically. Even if the treatment fails it could extend my gambling habit for another two years, as previous treatments have extended my stay. There's a lot I cannot account for but with the odds I can see, there is about a 9% chance that I become terminally ill this next year and will not make it past 2017. It is something I have taken months to really accept, but I have to learn to let go, and accept what I cannot change. I would rather focus on the hope of success, but I cannot ignore the parts I dislike, I must understand them, and accept them.

This isn't some weird dying request or whatever, the odds of me living and getting cured are pretty great as far as I'm concerned. I simply have reached a point in my life, where I cannot abide weak bonds. If I am to grow, I must humble myself to learn from and better understand every soul around me.

On another incredibly personal subject, I am a Deistic Religious Scientist. And the last few months have affected me deeply on a spiritual level. I don't talk about my faith, mostly because there isn't a lot to talk about. Religion has always fascinated me, the tenants, mysteries and what amounts to articles of faith. My faith compels me to understand all forms of belief, and to understand my friends through their faith. It's an aspect of my faith I regrettably stopped paying attention to after my first treatment.

I will also take a small bit of time to explain my faith, so that you may know me better. Most people do not know of either aspect of my faith, since they are incredibly obscure and I so rarely talk about them.

In essence it is a "belief" in a unity of all things through God. That God is within everything and everything is God's will. Good is infinite and an inherent quality that can be understood and accomplished with prayer, meditation, and/or acceptance. There is a universal harmony, a balance, that every moment is complete and perfect within itself and the law of cause and effect is always in motion. That immortality is achieved through our very existence, because life moves in perpetuity. I believe in the mystic concept of a Cosmic Christ, not a person, rather a universal presence, an image of God present in all creation. That it is a God-like consciousness that was and is present in all Prophets and enlightened people who use this in a positive evolution of society, mankind and/or personally.

As a Deist, I find the form of religious science to be my truth. I am compelled to understand the bonds of faith that exist within my friends, so that I may better understand them and my own faith.

As a Deist, I find validity and wonder within all forms of faith. Because the core understanding within Deism is simply a belief in God, the personal relationship of a religion is up to the Deist as an individual.

It is ever present in my life, I don't usually talk about it because I'm actually always talking about it. It is my way of life. I do not invoke the name of God when it's implied so frequently. As a gesture of gratitude to my faith, the symbol of my will bears resemblance to the symbol of Religious Science. 

Left: Symbol of unity from Religious Science.
Right: V of Acceptance and Struggle: HCVME

HCVME is the manifestation of my will to become more than I am, to better connect with others and to be open about my challenges so that I may better understand theirs. So that through the power of empathy and perspective we can overcome the social hurdles that face Invisible Disabilities. 

The name HC<ME (HCVME) is also intended to evoke the iconic HE>i, which is a shorthand for John 3:30 "He must become greater and greater.  I must become less and less." But instead flipping the idea on its head implying  1 John 5:4 "Because everyone who is born from God conquers the universe; and this is the victory that conquers the universe - our faith."

If you are a new friend, or someone I've yet to meet Email me: Canythingbutaverage@gmail.com

And of course, if you need to talk to someone about Hepatitis C(HCV) and you're not sure where to turn I'll do everything I can to help.

Wait, what? This was supposed to be a sequel, not a trilogy!

In five days, I will be finished with the Harvoni treatment. Much to the relief of my friends, I will no longer wait for my alarms of Taylor Swift's" Trouble When You Walked In" everyday at 6:50-7:05 PM.

I will no longer wait for weekly results on my blood tests. In five days I will have my end of treatment blood test.
Whose results rest my future. Will I have ten years left? Twenty? Fifty? Will I wait in line for a liver transplant, only to re-infect the organ and return to my level of damage within a few years?

And what happens when I reach the coveted SVR12 (Sustained Viral Response, the point of "cured")? If I can clear it, if in this game of life-or-death tic tac toe I manage to avoid a fifth cat's game...what does that mean for my liver? What does recovery look like?

I am the extreme, What happened to me at the age of twenty is more likely to happen to someone after forty to fifty years of infection. I am lucky, I came from a tiny likelihood of vertical transfer, and at less than 5% I beat the odds, and live with a decompensated liver so early in life... I have been in study after study since I was sixteen. Most studies bulk young people in an under 40 bracket. Inherently, a twenty year-old and a forty year old have wholly different recovery abilities, which only makes data harder to find/interpret.

What research can I find to help me understand what my future looks like?

Almost none. As most of the F4 and decomp patients are considerably older there is simply not enough data to provide more than a strong inference.
Even the classifications (F0-F4) themselves have been recently been looked at.


Where I sit now, the majority of my liver is...well... to say garbage would be an improvement. How my body chooses to handle the different parts of my liver is the subject of debate.


Whatever parts are near healthy will recover in around a year, the early stage fibrosis areas will recover within a few years. But the worse off the fibrosis is, the less likely it will recover. The last chunk of my liver, is the cirrhotic bit, which probably isn't going anywhere.


While there are some RXs for helping the fibrosis, the level of damage to the remainder of my liver has already been done. It is, most likely irreversible.

This is why I'm so insistent on testing, on looking at your options early. Early detection can prevent situations like mine.

I say a lot of probablys and likelys in this situation, because as I said before, I am the extreme.


So true to my nature, I hope to be the extreme here too, and recover in the dramatic flair that has engulfed my treatments.

Know More Hepatitis

Be #hepaware

If this title were a pattern it would be damask.

There is a long list of terrible health issues most doctors will tell you regarding the health factors of smoking cigarettes.

If the varieties of cancer, lung, heart, and throat problems sound terrible, there is one other organ that is constantly affected by smoke.

The liver. Smoking with liver disease isn't a good idea and dramatically raises your chances for liver cancer, but what about it's affects on other liver related issues?

For a time, i smoked cigars, not really realizing the full extent of the damage it was causing.
It's not hard to see that the liver would be adversely affected by smoking, as it filters your blood.

Assumptions are great, but it's better with facts.

The study looks at Cigarette smoking's affect on the liver, as well at its affect on a compromised liver (NAFLD/NASH)

Cigarette smoking, in the short term:

"...these results indicate that smoking does not cause acute effects on the liver."

Short exposure to cigarette smoke doesn't have a huge impact on the liver, which can imply that occasional/short exposure, to second hand smoke will have a similar result.

But what about the long run? 

"...These results show that (cigarette smoking) induces profibrogenic gene expression in the liver, yet does not induce liver fibrosis per se."

What the shit does this mean.

Well it means that cigarette smoking doesn't cause the fibrosis, but it can help fibrosis along if it already exists. So while i do not advocate smoking, and encourage quitting ASAP...

If you aren't cirrhotic( AKA are at F0 coming up on F1) you can slowly ease off smoking and it won't have much impact as if you were to cut it off cold turkey.

The F0-4(6 in some countries) indicates the level of liver fibrosis/cirrhosis in a liver.

F0 .	No fibrosis	You should probably stop smoking.
F1 .	Portal fibrosis without septa (mild)	You need to stop smoking.
F2 .	Portal fibrosis with rare septa (moderate)	If you haven't already, stop smoking, as you're now hindering your liver, and will result in faster liver damage.
F3 .	Numerous septa without cirrhosis (severe)	Don't smoke. see that shit up there^^ it's worse down here.
F4 .	Cirrhosis.	Don't smoke, risk not getting a transplant, smoking and alcohol can decrease your likelihood of getting a liver in time.

Additionally, as cigarette smoking is not typically accounted for in FDA approval(On page 5 are drug interactions for Harvoni) for liver RXs, there is no telling what odd side effects you may encounter.

ASIDE:
If you've recently had a physical, blood work, or check up, i recommend this handy chart. (Usually blood work has normal ranges written in, but if you ever want clarification.)

Why would it's title be damask? because it's smokin'