Null Responders in a horse race

Null Responders:   Poor Bastards and Horse Racing

Being a null responders is kinda like paying for your horse to run in the Kentucky Derby, going to the first turn, watching all the other horses go by and realizing that your horse never left the gate.  You put all your money and resources on that horse and ….he is a fizzle.  This is one opportunity I missed!  When you enter a treatment or a study, that is the horse you pick.  Put some research into picking your horse. At the end of the day, everyone else tears up their ticket.  You gotta load up that horse and take it home.

Note on the graph below by Vertex is an example of full, partial, breakthrough and null responder

http://www.vrtx.com/assets/pdfs/VRTXHCVTreatmentResponse.pdf

Liver and Onions

My favorite joke:Two cannibals are eating a clown.  One pauses and says “Does this taste funny to you?”     I think this is hilarious!

You know when your liver is being treated, it seems almost cannibalistic to cook  and eat someone else’s liver.  Fellow livers and all.

When I was in treatment for Hep C, My Red Blood Cells (RBCs) and hemoglobin  (HgB) were low.  My friend Trish came from the bay area armed with her Cooking for Cancer Patients cookbook.   She wanted me to eat  chicken liver.  She promised that it wouldn’t taste like liver.   She covered it in curry and stuff.  The flavor wasn’t as horrible as regular liver, but the look and texture felt like a soap dried loofah in my mouth.   Deb, don’t gag.  Eat one and push the others around your plate.  Tried and true techniques.  I did eat three.   I think she left the recipe. The curry rice was good.

When I was a kid, we only had one ghost story.  The whole story was built around “I’m on the first step, I want your liver.  I’m on the second step, I want your liver.  I’m on the third step”…Then you grab kids and scare the shit out of them.  It worked on me every time.  This Halloween classic went along with the dark spook house where you always touched beef liver and screamed.  Those days of course I went home to a big skillet of cows liver, onions and gravy and ate it up.  Or on Sunday, Mom fried a chicken.  The liver and gizzard finished before the rest of the chicken.    I hung around like a little bird.  Mom blew on them and popped them in my mouth.  That was before I had anatomy and physiology.  I still don’t want to think about a gizzard’s function.

Anyway, as soon as I stopped taking Ribavirin, my blood cells began reproducing.  I feel more energy  every day and it is awesome. I will pass on the liver.

Things not to say to a person with Hepatitis C

Things to not say to a person with Hepatitis C

 You understand this medical stuff. Explain it to me like I am an insensitive idiot

 What did you do to get Hep C?  Insensitive Idiot again. If I want you to know, I’ll tell you

What is your endpoint?  Death?  Transplant?  Winter Olympics?

Would you like concealer for your eyes?  Here just keep it.

Are you okay in that chair?  You are listing about 20 degrees

Maybe we should wait to clean your teeth after your treatment is finished

You got crazy eyes

You don’t seem like yourself.  No shit

When will you get back to normal? Normal is a setting on a washing machine

Hey I’m getting a carload of friends and we are coming to spend the day with you!

So now you are healed?

I didn’t recognize you.

What happened to your hair?  You might think about Rogaine

You look like shit!

What is that disease you got?  I want to tell everyone at the family reunion.   You have never met these people but they care

We are all praying for you.  A lot of people with Hep C have no friends/family due to previous what ever.  Surely God doesn’t go by share of voice

Didn’t your ex husband die after a liver transplant?  Yes

So when is your transplant?

Didn’t David Crosby have a couple of transplants?

Wow, you have really lost some weight.  Good for you

Wow this time you didn’t shed the extra pounds

There is a blood drive today in the lobby.

Partial Responders with Hepatitis C

All Hepatitis C studies are not created equal. Duh

I used to see myself as smarter than the average bear.  Not so much now.

Being me, I was not passive when searching for a Hep C study.  But I was mistaken.   I assumed. Don’t make an assumption.  I knew better.   My mom taught me this.  Every time some of us kids got in trouble, she pulled me aside and said, “You know better”.  It was years before it dawned on me that other kids knew better too.  My mom was once a kid.  In fact she was still a kid when she had me.  In 1951 it was not cool to have a baby out-of-wedlock.  My biological father passed on marriage and she had to go back home to Harlan County, Ky.   This is where I was born.  Papaw told me to say I was from “Bloody Harlan” because of the bloody mine strikes.   So that is what I told my teacher.  Papaw and all Moms’ brothers were coal miners.  We didn’t make moonshine (the other career path)

I learned that the TV show Justified   is about Harlan County.  I don’t watch it myself.  Makes me jumpy.

fig 1.Me, Mom in the white car coat, dad that raised me, Mamaw, Papaw, and aunts. Harlan County, KY. My mom has the big nose like Papaw.  She waited to get a nose job after Papaw died

Coal tipple loads rail road cars 1

When I was a curly headed baby
My daddy sat me down upon his knee
He said, “Boy, you go to school and learn your letters
Don’t you be a dirty miner like me”

I used to think my daddy was a black man
With script enough to buy the company store
Now he goes downtown with empty pockets
And his face is white as a February snow

I was born and raised in the mouth of the Hazard Hollow
Coal cars rambled past my door
Now they’re standin’ in a rusty row all empty
And the L & N
Don’t stop here anymore

http://www.sing365.com/music/lyric.nsf/The-L-amp-N-Don’t-Stop-Here-Anymore-lyrics-Johnny-Cash/6B378501111ECA5D48256DEA000A5308

I love this song but never heard it until I moved to Texas

Where was I?    Okay brain get back on track.  Let me recommend that you do not have your driver’s license photo taken while on treatment. Very scary.

I chose to participate in a Multi Centered, Randomized, Placebo Controlled, Double Blinded study, evaluating Standard of Care (SOC) Interferon and Ribavirin (which had been my only choice all these years) vs. SOC and telaprevir for round one.  In fact I sought out this study. There were three arms, two with study drug.  I had a 66.7% chance of receiving study drug.  As I learned later, I was not randomized to study drug (telaprevir).  I assumed SOC included addressing anemia and other life threatening events.  In this case, SOC did not include blood transfusions or red blood cell (RBC) stimulant injections such as Procrit.  Standards of care have not caught up to current practices. Step one was to reduce the Ribavirin dose.  .  My hemoglobin (HgB) was 8.9 and the guideline minimum for taking Ribavirin is 10.0. Normal HgB range for females is 11.5-15.8 mg/dL.   My Ribavirin dose was decreased. Hemoglobin got slightly better but I paid for it later by not clearing the virus. In order to treat the anemia I would have to walk away from the study.  Dang it!   I quickly lost the ability to walk down a hallway, climb stairs or lift baggage without major shortness of breath (SOB) and the ability to complete a thought, all necessary for my job (oops, career). More about that later.

After treatment completion, an individual is assessed for response to measure viral load. If there is virus remaining but a reduction of disease by 30% or more  – it is called a partial response.   Partial response (PR) implies further treatment  required.  www.about.com   I moved from treatment naïve to partial responder.  Here I had saved myself for newer treatments but still got the same treatment that was available years ago.  Plus no treatment for the anemia.  How did a smart girl like me get in a dumb box like this?  I hung in there and finished the (long) 48 week trial.  Not only did I not have red blood cells (RBCs) or white blood cells (WBCs), but then the virus that was left was a stronger warrior.   Not good.  Here is the part where my education went out the window.  I was so depressed that I couldn’t function.  Every little thing was monumental.  I should have quit the study when my blood chemistry went to hell.  But I couldn’t think clearly enough to look at the situation logically.  All my decisions were made by a scared little girl.  See fig 1

You know I wanted to blame insurance companies.  It is so easy to blame insurance companies.  I wanted to blame pharmaceutical companies and the FDA.  They are easy targets too.  In reality, I, more than most, understand the study requirements and commitments. Sort of. I have been a research pharmacist for a couple of decades.  The data must be unsullied from outside forces like blood transfusions that will make it impossible to evaluate the toxicity.  That is the point of the study, not patient care.  Don’t misunderstand me.  Patients are well cared for. A patient can get treated without a study but a study cannot evaluate a treatment without patients

FYI, HgB is the molecule in the blood that carries oxygen, (O2) from your lungs to your blood and carbon dioxide (CO2) to your lungs so you can exhale this gas.  Speaking of HgB, it is a bucket brigade that carries water to a fire.  Even if you have plenty of water, if you don’t have enough buckets, the barn burns down.  Wait, that wasn’t a great example.  It wasn’t completely accurate either.  Never mind.  It’s just that I spent all these years learning this stuff; I want to get my money’s worth.  Kurt Vonnegut said only hermaphrodites use a semi colon; .Sort of.  While metaphorically I don’t relate to that, he did say it.   I didn’t pay Kurt Vonnegut, God rest your soul Mr. Rosewater.  Anyway my WORD grammar check said uses it.  I think I paid for that.  Yes of course I did.

Telaprevir (Incivek) and boceprevir (Victrelis) are now available to add to Standard of Care (SOC).  In fact by now they may be a part of SOC.  Glad I contributed to the body of knowledge that is clinical research.  Really I am.  But I wouldn’t repeat round one for nothing, not no way, not no how. It was two years before I was well enough to go for round two of treatment.  My career never recovered.

Why do you think they call it a LIVEr?

HepLikeMe: recovering from hepatitis treatment

If we didn’t need our livers to live, why are they named LIVEr?

If you have Hepatitis C and are reading this blog, I assume you have a working knowledge of this disease.  If not, there are great sites such as

http://www.cdc.gov/hepatitis/C/index.htm

and crap sites where lay people talk out their irresponsible asses.  If a statement starts with “I feel”, “I think” or “This herb won’t hurt, it is organic/ natural” run away.

My daughter tells me I have always been a bit ahead of the curve.  She says I am hep. I moved to the country and painted my mailbox blue before it was hep.   I got sober before it was hep. You get the idea. BTW hep is better than hip because Cab Calloway said it.

I like to type BTW.  You have been warned.

Indeed, Hepatitis C has now become main stream

http://www.chron.com/default/article/CDC-mulls-hepatitis-C-testing-for-boomers-3550384.php

I have just completed round two of treatment for Hepatitis C genotype 1.  Is the treatment worse than the disease?  No, but  that is difficult to grasp when you are asymptomatic.  Or at least you are ignoring symptoms.  This round sucked less of my life out of me, only because I brought the experience of round one.  Sounds like a prize fight. TKO I was technically knocked out by round one. I didn’t care after a while.  A new experience for me.

In order to survive, one must care.  The treatment says fuck it.  Don’t fuck it

In 2007 I began my first, and what I thought was my only, round of treatment for Hepatitis C.  The treatment, Pegylated Interferon and Ribavirin, did not clear the virus (we don’t say cure.  That is for hams).  What it did do was kick my ass to the curb.  The recovery was longer than the treatment and I never did get back to where I was.  All of my depression and insecurities bubbled up.  Depression is so depressing, insecurities so insecure.

In 2011 I began treatment with Interferon, Ribavirin, and two antiviral study drugs from Gilead Pharmaceuticals. Each drug attacks a different site in the virus life cycle. Early on there was no detectable virus.  Still not.  My treatment ended after a short (wink wink) 24 weeks.

Background:

In 1992 I donated blood and got a letter in the mail from the blood bank saying “you’re a winner.  You have Hepatitis C.  Please don’t give us your blood again.”  I was a winner.  No further information.  I went on with my life but didn’t donate blood and made it clear that my organs are not a gift to the living.  There was no proactive information regarding this disease and I had not exposed my liver to toxins in years.   I went underground with my secret.  Ironies abound. Forward a few years. I worked in Medical Affairs for a large pharmaceutical company, and my field of expertise was gastroenterology.  So, having access to the top research hepatologists, I had a liver biopsy performed for base line.  Marvelous results, you are great, minimal inflammation, no scarring or activity.  Go away and check back if things change.  Whatever that means.  I saved myself for new therapies.  I was treatment naive in the lingo. I love it when I can say words like naive.  There are web sites to define phase and staging of liver biopsies.  Bottom line,  Inconsistent

In 2007 during an annual physical, (which the AMA is now discouraging) my liver enzymes were elevated.  My internist wanted to send me to the local gastroenterologist, but me being Dr Science, I said no way.  And I pursued another research hepatologist.  Had another biopsy, phase one grade one activity.  Options, ignore or don’t. By then there was a minute amount of data indicating that maybe older patients (> 50) should go ahead and get treated.  That would be me.  Amazingly, there were no new available treatments.  So, I went to the government site www.clinicaltrials.gov , and entered my disease and city. Voila, there was a site with a randomized trial comparing Standard of Care (SOC) to SOC plus telaprevir.  This site was affiliated with a gastroenterology department at a medical school where I had a relationship (not relations) with the head of Gastroenterology/Hepatology. This DID NOT influence my ability to enter the trial.  But because of that relationship, I had confidence in and respect for the quality of research.

Enough for today.  This is a lot of work.

Deb