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.

The Transplants

I received the call at 8:39 PM

I was expecting a call from my parents when the phone rang. When I saw it was from a restricted number, I started off apologizing saying "Yea, I meant to call you back sooner, sorry about that." A little confused, the man asked my name.

I was playing Sid Meier's Civilization 5 with a friend at the time, a very mellow video game. The man began after he confirmed who I was, "Hello Rick Nash, I'm calling to tell you that you have a liver offer." My eyes became transfixed on the wall as he explained to me the details. I was jarred from my seat standing, as if that would help with understanding. He explained all of my options very clearly, I could take the liver, or not and it would not affect my standing for a transplant. There was one hiccup:

It was a high risk liver with HCV.

I told him that I'd call him back with an answer. I had to act fast, an hour was all the time that could be spared. I spoke with my parents and friends to work it out.

In my present state, my MELD score is in the high teens, which means I'm not in an immediate danger. However given my proclivity for the ER, I seem to find myself in life threatening situations every so often. And if I were to be hospitalized it would likely result in my needing a liver.

With that in mind, taking the liver offer becomes a pre-emptive strike approach. If I take the liver it would take a year for my body to get used to it. By that time I will decompensate and be worse off than I am now. And I may also be unable to take the new treatment(s) in 2016 while I'd recover. This pre-emptive strike is more about risk mitigation than anything else.

Besides the affect of my end stage liver disease, I'm otherwise healthy. I'm young and there is little information on recovery following a treatment for young patients (let alone with MELD scores). I could potentially live for a few more years as I am, before needing a transplant. And there are two upcoming treatments which deal with my scenario and trials I could participate in.

When laid out in front of me, the decision was clear. I'm in it for the long haul.

After weighing the options, I called him back and told him I will pass on the liver offer.

When I signed up for the liver transplant program two years ago, I hadn't yet realized just how suddenly these kinds of things are. 

A liver offer has a very limited amount of time to stay viable,

and I have to be ready at a moment's notice to be at that center when the time comes. Which also means I need to have my phone near me at all times.

In the end it I feel it was a potentially worse short run decision with better long run results.

I'll stop the world and MELD with you

A lot of my friends and family have heard me talk about MELD scores, but I've never really explained what they mean.

A Model for End stage Liver Diseases score is determined by the functionality of the liver, the level of cirrhotic damage, and pressure/clotting factors.

In my case I am at stage 4, decompensated with a low INR (clotting factor). My meld score hangs out in somewhere between fourteen and nineteen.

A MELD score is calculated by a person's INR (normal is .8-1.2)

Bilirubin count (normal(total) is about .3 to 1.9 mg/dl)

and creatine level (it's gender based, but for a guy it's .7 to 1.3 mg/dl)

That's what it's a MELD score, but what does it mean?


If you have one it typically means your liver is in serious trouble. A medical professional can determine the need for a MELD score, there are online calculators, but a doc is best suited to assessing whether or not someone needs one.

It's not a death sentence necessarily. Here's the probability you'll need a transplant in three months. If you can't get that, well... then those really are mortality rates. In the chart below it takes the range of scores that can exist, and says the likelihood that you'll need that transplant. MELD scores are not permanent they shift, constantly.

The blue area is where I generally hang out, so at in any given month I have about a 10% chance I might need a liver transplant within the next few months. It's something I've lived with as a fact for about five years now. But keep that in mind, I've been alive these five years, well to the best of my knowledge I am.

There are two other points on that chart, represent two recent hospital visits. In September 2012 my varicies burst, and I was vomiting blood, I was lucky enough to know and understand what was going on so I caught it just in time.

Key factors you have internal bleeding where the blood is entering your GI: Black tarry stool, light-headedness (from loss of blood), easier to bruise, stomach pain(it can be mild or even unnoticeable), annnnnd blood farts. There is nothing in the world quite like 'em, and they're the first thing I (and unfortunately anyone around me) notice.
I was in seriously bad shape that day, and my MELD shot up, ironically they thought I had C. Diff, but in fact I did not. After a quick transfusion, The trip was so hazy I don't even remember the endoscopy where they banded the bleeding varicies . About a week afterward, my MELD score dropped in half, and kept going down.

Fast forward two years to September 2014, my most recent and longest stay yet, I was jaundice to an almost comic degree. And somehow I actually contracted C. Diff ಠ_ಠ it was making the resurgence of my HCV even worse, and my MELD jumped up due to my INR hitting 1.8 and my bilirubin between 28 and 32, then slowly went down to the teens as the month passed.

I am lucky to have been able to have the resources I had when I needed them.

I am also lucky in another sense, I am the extreme. Most people with HCV will not have had the problems I've had in the time span I've had them. There is variance to the specificity but you can see some general trends:

"After twenty years of infection about 20% of patients develop cirrhosis and after fifty years of infection, about half develop cirrhosis. "

"Most HCV patients, if untreated, are expected to develop cirrhosis at about 65 years, irrespective of the age at infection. Thus, age itself seems even more important than age at infection for predicting the occurrence of liver cirrhosis."

" In an estimated 20 to 30% of patients with hepatitis C infection, chronic viremia results in inflammation followed by fibrosis and cirrhosis. "

And for decompensated patients it's a little more complicated, and even more uncommon so early on.

I was first assigned a MELD score when I was twenty three years old, to this day that hospital visit is one of my most vivid memories. Since I didn't really display any other symptoms prominently, for this brief time I had compensated cirrhosis. But as more symptoms showed up I moved to decompensated status.

If what the studies I've read are accurate I could be looking at a (near) single digit MELD by summer's end for SVR12, for now I've got about two more weeks left until I'm finished with my 24 weeks of Harvoni.

Sometimes you just need a happy song

As i approach the last two weeks of my treatment, the anticipation of my next blood test is one of reserved excitement, as in some ways, I've been here before.

During my last round of treatment (Sovaldi/Olysio) I took my six week blood test, 

On that same day the Yes! Album by Jason Mraz came out. It's not his greatest album, but it's timing, and it's message have become important to me. I quickly became a fan of the song 3 things

It spoke a lot to the struggle, and constant necessity of pushing forward and keeping a positive attitude. The following week I received news that I had my first undetectable viral load.

The excitement I felt, was matched by every illuminated face I told, my every smile I was met with, by every drop of joy that came out of the situation.

But it was premature. Not two months later I received a worrisome report regarding my last lab, shortly afterward the virus came back and hit me so hard my MELD score shot up in the high 20s, hanging out with my bilirubin levels at the time. While I was hospitalized due to my failing liver, I was notified of its resurgence. It was crushing, but it's about moving forward and when my bilirubin began to return to normal, I started Harvoni.

The song followed me throughout all of this, and I hope its lighthearted acoustic Graceland-esque sound speaks to you as it does to me.



This happy song reminds me of the importance of struggle, seeing through the darkness, and of routine when things seem to fall apart.

Hep C and Mary Jane

Medical Marijuana and HCV have a very interesting relationship, in every forum I've ever been involved in, I hear dozens advocating for its use. Some claim it helps the liver, some claim it alleviates side effects, others claim it helps them cope with the psychological effects of treatments and liver stress.

But it's not that simple. So let's talk about some Marijuana myths and facts regarding HCV.


Myth number 1: Smoking doesn't harm the liver.

As i went over in a previous blog, smoking doesn't directly cause an issue, but it can worse effects of fibrosis, and the bottom line here is that HCV will cause the fibrosis while long term smoking will worsen in it.

Short term smoking doesn't necessarily harm the liver in any substantial way.

Myth number 2: Smoking weed has Cannabinoids (CBDs) which can help fight HCV.

Nope. CBDs don't work that way, they can help fight against hepatocellular carcinoma (liver cancer). But it's not substantial enough  to make it beneficial for liver disease, nor is there enough information to say that CBDs have created any positive benefit for liver disease.

Myth number 3: Edibles, because they're not smoked, are ideal for  those with HCV who may already have respiratory and blood pressure issues.

Also false. remember that at the end of the day, your liver still gets to process all of that stuff, and most of the time THC and CBD filled cookies, candies, brownies or whatever else is cool these days aren't necessarily made with the best product.

There is a way to mitigate this, and essentially that' using lab-tested companies like Venice Cookie Company,  or Cheeba Chews, Someone even had the genius to make weed pizza

The dangers that comes normally with stuff somebody made are  usually unknown dosages, and unknown THC agent. (What? yea, depending upon where stony Joe decided to pick up his latest supply he could be buying some Mexican cartel weed with a sketchy past, including the possibility of it being cut with something far more nefarious)

In San Diego there was a huge hullabaloo about dispensaries, a massive crack down a few years ago because these shops were literally taking in garbage bags from completely unverified sources in a don't ask don't tell policy. They also operated in areas illegally zoned... there were lots of problems.

Now, they're coming back and have more transparency than a glass window, it's downright impressive how much detail those dispensaries must fork over to the state (besides patient lists).

But i digress, the point is that edibles from these sources, and from lab-tested companies offer safer products that may be less harmful to your liver. It's a lot like bathtub moonshine Vs. Everclear in many cases. Either way there is harm to the liver, one is just a lot worse.

Edibles overall are the best method of consumption for someone with liver disease because they don't impact the lungs and heart as much. However there have been no comprehensive studies on the effects on the GI tract as it relates to HCV.

FACT: It can help ease symptoms in a less harmful way than most painkillers.

There have been some studies regarding marijuana and HCV.

 But not many, because patients who use it sparingly often don't disclose this fact to their doctor (also a bad idea). If you happen to smoke, and also have HCV, tell your doctor, it's relevant, and they are not allowed to disclose this to anyone else. HIPPA has some interesting regulations and it's key that you mention your frequency of use: sporadically for pain, occasionally to help with sleep, or minimal amounts daily to help with appetite, whatever it may be. There are lots of justifications people have for it, but that doesn't make it better or worse for you in the long run.

Especially since a lot of people with HCV will end up using it to cope with the pain and symptoms. Since any other painkiller is processed through the liver, they see it as an alternative. For a long time, people who failed interferon tried all kinds of natural, homeopathic and alternative medicines to help their HCV, weed is just a common one. Recently thanks to newer treatments many do not turn to weed, since they often can't.

FACT: Marijuana use is not allowed for those on a liver transplant wait list.

If you are stage 4 (like myself) with HCV, don't smoke, don't consume marijuana in any shape. The benefits of the pain it can alleviate do not outweigh the risk of having its use influence your likelihood of transplant negatively. Livers are not plentiful, and HCV is one of the biggest causes for liver transplantation. Smoking before, during(the wait), and after the transplant can and will affect your recovery.

FACT: There is completely legal marijuana, and it's FDA approved.

The big name ones in the US are Marinol and Sativex. So if you're nervous about talking with your doc, Marinol is a drug to ask about. For the Ents reading this: It's also a schedule III.
As for Sativex, it's some pharma scam that doesn't even work properly, but it's legal in the UK.  Sativex is on fast track, but it won't be big time here in the US until the end of 2015, if it even passes FDA approval.

OPINION: If you have Model for End-stage Liver Disease (MELD) score do not smoke.

The repercussions of its physical's effects deal with a lot of unknowns, and transplant lists ban its use. While it can help with the onslaught of symptoms and side effects from the medications one must take: Lactulose,  Diuretics, and to avoid muscle wasting by eating...

Essentially, the balancing act of damage being done, possibly being removed from a transplant list  vs. degree of "normal" life they can maintain  is something some HCV patients have considered.

Want to know more about the medical marijuana industry? Check your Netflix, there's a slew of documentaries on the subject.

I still have yet to see enough evidence either way to push it into one category. Hopefully with so many states having legalized marijuana, we could see more studies and more evidence.