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Peginterferon-Ribavirin, Failed it twice. Incivek, Failed it. Sovaldi Olysio, failed it. Harvoni, failed it... Transplant Patient Zepatier and Sovaldi...we'll find out!
Showing posts with label DAA. Show all posts
Showing posts with label DAA. Show all posts

Friday, January 26, 2018

Mario is free to use the now empty Hep C pipeline

Although, based on his history of drug use he's more inclined to die from eating the wrong mushroom than from Hep C, but I digress.

Since 2011, DAAs have been coming down the Hep C pipeline, until now. 2017 marked the year where announcements of new meds not only slowed its pace, but many were cancelled. Janssen, as of Sept. 2017 discontinued use of Olysio, a DAA which acted as part of a combination therapy, the only lone NS3/4 Protease inhibitor. Without a unique NS3/4 inhibitor, combination therapies will be more likely to include combination meds like Harvoni. Most meds target the NS5a or NS5b cleavage point, which means when a patient has RAVs which prevent that protease inhibitor from working at that cleavage point, it becomes harder to target the virus.

As Gilead and AbbVie continued to push on with newer iterations of their Hep C treatment meds, Merck abandoned two drugs which were currently in the Hep C Pipeline. At an 8 week price point of $26,400, Mavyret is dragging Gilead's Vosevi and Epclusa to push not for lower prices but shorter treatment durations to lower the price point to insurers. Merck's treatment is still standing at its 12 week price point of around $54,000 making competition with the Pan-genomic Mavyret almost impossible. Mavyret contains an NS 3/4 and an NS5a inhibitor, whereas Epclusa targets NS5a and NS5b cleavage points. These subtle differences have an impact on patient efficacy due to RAVs which affect these cleavage points.

The empty pipeline means that if a cure cannot be found within these combinations insurers decide, then patients may die. As with more 2 in 1 pills like Epclusa and Mavyret, it will become harder for patients to find individualized therapies.

Monday, February 22, 2016

Zepatier Part Ugh

Olysio, Sovaldi, and Harvoni


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 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:

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


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.

Monday, October 5, 2015

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/