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/

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.