Hope is not a four letter word

Merck.

We've been seeing DAAs like Sovaldi come out lots of labs, but we're about to witness the rest of the big companies throw their hat into the ring. Gilead's use of the Warehouse of Hep C (HCV) patients has led to historic profits for Gilead. Johnson and Johnson's Olysio tapped into the market, and Bristol Myers Squibb's new Daklinza (daclatasvir) are filling the gaps Gilead's Sovaldi left.

And soon Merck is about to throw down one of the most virally specific DAAs around. The new combination treatment will be able to cure even cases previously failed due to RAVs (mutations).

Why am i stoked?
Because it may be my sixth treatment.
So what makes it different?

Well first off two/three phases have been done with higher efficacy than Harvoni.
C-Edge and C-Salvage.
C-Edge is similar to most DAA studies, it's efficacy is unsurprisingly high.
C-Salvage as the name implies is specific not only to people who failed interfereon/ribavirin, but also failed a DAA like Sovaldi/Harvoni/V-Pak. It's going after people with NS3 and NS5A variants like myself.

The C-Salvage study has the best results i have seen for someone in my situation.

Previous treatments I've been on had an 84-86% success rate when it came down to my genotype, and cirrhosis. Usually being even lower for decompensated liver patients, however it still positively impacts MELD, so it's not all a waste.

The C-Salvage boasts an unbelievably high success rate: 96.2%

The new drugs names: grazoprevir and elbasvir.

So damn catchy, aren't they?

Annnd it's slotted to be FDA approved during the early first quarter of 2016.
Annnd the new grazoprevir and elbasvir treatments could be as low as 16 weeks instead of 24.

Troubles: The study doesn't specifically mention which variations, as those may/may not have an impact on success. So in this aspect it's kinda a crapshoot, because until later this year we won't have clear enough data to say that it will or will not be successful for my specific variations.

Troubles: Price, with the way Hep C meds are presently being marketed it would not be surprising to see a hundred thousand dollar price tag. Merck will also probably offer a massive discount program similar to Gilead's MySupportPath.

And this thing... keep an eye on the TPP...

The Trans Pacific Partnership. As i highlighted in a series of blog posts regarding why Medicaid is waiting until people are dying to cure them, the TPP will play a large role in how insurance agencies, Managed Care Organizations, Pharmaceutical costs(and carve outs) are going to be set over the next few years. 

With the TPP disclosure coming out soon, and congress to debate it, this will undoubtedly play a role in access to Merck's new meds, and the prices it offers consumers and insurance agencies.

C-Edge Study:
http://www.natap.org/2015/EASL/EASL_04.htm

C-Salvage Study:

http://hepcblog.amjmed.com/hep-c-treatment/c-salvage-final-24-week-follow-up-results/

Inertia and Inhibitors

In the last year a great deal has changed for patients with Hep C. Multiple treatment options with minimal symptoms which take half as long or even less, a renewed focus on testing, and a healthcare overhaul have all been at the forefront.

We're also seeing a trend of high cost medication, with a round of treatment costing twice as much as the poverty rate for a family of four.

Medicaid clamped down to only approve the sickest of patients, many states requiring permanent liver damage before treatment can be an option.
States will begin to get better pricing when election season is done, but depending upon how the TPP goes, it could be better or worse.

Private insurers have similar policies, taking advantage of the discounts offered to patients and often denying coverage.

Cure rates for most treatments remain 90+% and more treatments which use Protease and Polymerase inhibitors are on their way. (Protease and Polymerase are two different approaches in destroying the virus, they combine to be far more effective than alone/with Ribavirin)
So what happens when you're not part of the 90+%?

When you've spent years of your life becoming familiar with health insurance, FDA studies, and in hospitals/clinics. When you grow up memorizing hallways, bizarre wallpaper, medical pamphlets and illustrated guides, all of this seems pretty normal.

I've pressed on past each failure, and usually each time they've found a more specific reason why it didn't work.

I have failed five different treatments, and recently I found out why.

I have three mutations which combine to prevent protease inhibitors from working properly.

Originally I was under the impression that I had the q80k polymorphism (it's a weird mutation that can prevent protease inhibitors from working without a combo of meds) which was an accurate assumption until better tests were able to pinpoint why Harvoni did not work.

While failing one protease inhibitor does not mean another may fail, it does reduce the chance of success significantly.

The combination of mutations I have prevents Ledipasvir (the protease part of Harvoni) and most NS3/4a inhibitors from working as intended.

NS3/4a inhibitors = protease inhibitors= Olysio/Simeprevir, Daclatasvir, Ledipasvir, etc...

So what happens now?

Nothing. Now that I know which drugs I cannot take, it means searching the web for any potential studies which are for Treatment experienced, f4 decompensated patients who cannot take protease inhibitors.

Why I say nothing, is because that's presently what I've found. I'm certain that at some point they'll find a new way to attack the virus but until then my life waits.

I'm uncertain how long I'll live. Depending on my luck, I could have a few years still until transplant.

Transplant is an extension, the likelihood that my liver will decompensate within a year is about 50%, as I will re-infect it. I could push a few more years past that, but it's hard to say.

To say that this isn't depressing would be absurd.

When a chilling reality like this hits i accept it, i embrace it, i understand it, and i forget it.

I accept that my health outlook is grim and will ultimately defeat me.

I embrace the problem and refuse to define myself by it.

I understand the precautions and limitations I face are guidelines, not rules (but seriously though, some are still rules).

I forget it, because the focus isn't on it, my focus is on me.

To move forward i must turn inward and find small bits of motivation to get me moving.

An object in motion will stay in motion.

The Locked Warehouse Doors

Before Viekira Pak, Sovaldi, and Harvoni...

There was Incivek (telaprevir) the $83,509 Drug

When it came out it was heralded as a wonder drug, because it nearly doubled the (SVR)cure rate of HCV meds at the time.

It cured my mother, but while she was on it she had multiple transfusions and her anemia was controlled by ProCrit (a red-blood cell boosting drug). It was later found out to have been a direct contributor to several deaths, and thousands who took it were left with permanent skin damage regardless of success of treatment or not.


When the drug was pulled from the market, there was a feeling in the HCV community. When a cure with rates that good is pulled, even if it carries a black-box(may cause death) label from the FDA, some would risk it.

I nearly died while on it due to my anemia and bursting esophageal varices. From that point on, like many F4 patients I was barred from using Interferon for new treatments.

The term warehousing became popularized with HCV patients. In 2013 Sovaldi and Viekira Pak were undergoing trials and it was believed by many that there would be a host of new drugs being released within a few years (referring to 2014/2015)


The existing treatments' side effects were troublesome, and the results were poor in late 2012 after Incivek became taboo. Patients who could have taken those treatments opted not to because when your options are to feel terrible for 48 weeks and 50% chance, or wait a year or two for a 12-24 week treatment with a 90%+ chance...it's not hard to see the appeal. Especially when you consider that majority of the deferring patients would have been in the F0-F2 category, which has minimal symptoms.



Now, back to 2015. Sovaldi, Harvoni, Viekira Pak and other partner medications like Olysio and Daclatasvir have been released. Every Pharmaceutical is throwing in their hat. Merck is even entering the all oral ring early next year with a grazoprevir elbasvir combo similar to Harvoni. Drug makers are ensuring that each of the drugs targets specific genotypes, and it's not purely scientific. In doing so it allows them to rush the FDA approval process for what's called "Breakthrough therapy" designation. The result is a whole lot of new HCV drugs that treat lots of genotypes of HCV.

Which means that all of those HCV patients can get treatment, right?
Not quite. Because at it would turn out these companies are using Incivek's pricing model.

Let's talk business for a second what makes that price point? The price won't always be as high as it is now. In a few years the drugs will lose their patent's exclusivity 

Usually this means that the drug needs to profit as much as it can within the first five years before generics can start being licensed. Patents still protect a drug from copycats for 20 years from date of filing. So they'll still make large profits until the patent expires.


The Research and Development (RnD), litigation from patent trolling, and acquisitions are also costs to bear in mind. Acquisitions can cost hundreds of millions to billions of dollars. Most Manufacturers acquire smaller labs who are/were producing HCV meds. After that, it's direct injections of capital for RnD expansion until its market ready. Then the lab gets to use the distribution methods, sales channels and brand recognition of a major name. Make no mistake, they're making billions off these deals, but they're also billion dollar risks.

With lots of high priced drugs on the market, both AbbVie (Viekira Pak maker) and Gilead(Sovaldi/Harvoni maker) offered direct to discounts to consumers. AbbVie started to patent troll Gilead in attempt to slow down the impending juggernaut Harvoni. Insurers and Medicaid/Medicare had to figure out a way to handle the tidal wave of some of the largest groups of HCV patients warehoused. The restrictions are now at such a point where those patients still warehoused now find the door locked by health insurance restrictions.

This is the Locked Warehouse Door.

The reality of new HCV patients is one of the locked warehouse door. For those who await treatment, either existing or pending treatments, they must wait for the bureaucracy of the key. Hopefully by then the price of that key becomes affordable.

In an effort to help categorize the different Tweets regarding HCV, consider using the hashtag: #LockedWarehouseDoor when tweeting about health insurance or Medicaid restrictions and high-cost HCV Meds. Help remind pharmaceutical companies, insurance companies and lawmakers that the "warehouse" of HCV patients are dying to get out.

if you were denied Sovaldi, Harvoni, Viekira Pak, or any other new HCV med, if you had to go through lots of hurdles for treatment; I urge you to tweet about them with the hashtag: #LockedWarehouseDoor.

We need slacktivists

These are most of the barriers to treatment.

• Awareness of the illness
• Financial costs
• Occupational difficulties
• Social stigma
• Psychiatric illness
• MISCONCEPTION: Asymptomatic disease vs. symptomatic treatment contrast

Remember when people got irritated and the idea of raising awareness not doing shit?

Well here with Hep C (HCV), raising awareness through testing is the biggest barrier.

Raising awareness about how HCV works and treating others with compassion can lower the stigma.

Raising awareness for the financial costs has create a surge of lawsuits and governments demanding fair prices for over a hundred million people worldwide.

Raising awareness is prompting the US government to start to critically look beyond costs.

This is the area where YOU CAN make a difference with awareness.

We need slacktivism, we need clicktivists.

#hepaware

Bad news for people who like good news

With my present degree of liver damage, my cirrhosis is beyond repair. What's left of my liver is riddled with an ever voracious virus. My body writhes in pain from the ever-worsening side effects. The referred pain in my shoulder has become a now constant reminder as I attempt to sleep.

With each failure I come to new introspection.

To count I have failed:

Interferon and Ribavirin twice.

Interferon, Ribavirin and Incivek (the triple cocktail which cured my mother).

Sovaldi and Olysio.

And now, I have failed Harvoni.

As an aside, I want to explain that I am not typical. If you have Hep C, do not expect these results, know that I am the extreme.

I have struggled to find the words to truly encapsulate the fear, dread, and ultimately sadness that have overcome me. So please forgive my brevity.

While on Sovaldi and Olysio, I cleared the virus, but it came back with a vengeance. Harvoni allowed me to clear the virus faster, and for longer, however it too failed me.

I have escaped death a handful of times from complications as a result of my decompensated liver.

But here I am. I shall not die so easily. We are all endowed with the insatiable human spirit, whose passion shall not be relinquished to something so small.



And now I must pause, before I look forward.
So that I may know my bearing, to find a suitable course.

More blood tests are coming to closer analyze my virus.
For what is a patient without patience?

I found out the results yesterday, and as I've slowly told people I am glad to say I am truly blessed to have such great friends and family.

I am exceptional.

To quote the late John Paul Jones:


"I have not yet begun to fight."

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.