HEPATITIS C: THE HAPPY-EVER-AFTER ENDING

Happy Ever After, Mostly

Happy Ever After, Mostly

I witnessed a marker for Hepatitis C yesterday that three years ago was impossible. On CBS, Gilead was advertising treatment/cure for Hepatitis C. Consider that three years ago admission of having Hep C was admission of a dark past, even when none existed. Consider that only 20% Hep C positive people even knew their status. Consider that three years ago treatment success was 40-50% even with forty-eight weeks, multiple drugs that were disabling and exacerbated long-term crippling depression. The latest treatment recommendations for hepatitis C virus (HCV) infection are now available on www.HCVguidelines.org, the result of a collaboration between the American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA. These are the few that know what is happening. http://hcvguidelines.org/sites/default/files/AASLD-IDSA_PressRelease.pdf   

Drug development for HCV is progressing rapidly, with new direct-acting antiviral medications capable of essentially curing HCV. Eugene Schiff, MD, director, Schiff Center for Liver Disease at the University of Miami Miller School of Medicine in Florida, commented on the development of the Web site in an interview with Medscape Medical News. “The reason [for the development of the Web site] is that the field is moving so rapidly…the [US Food and Drug Administration] is trying to advance some of these [medications] faster than they have traditionally in the past, which is wonderful for the patients,” Dr. Schiff said. “Because of all this, the average clinician can’t keep up with it, and they’re trying to be more in sync with the advances,” he added. “In just the past 3 months, 2 new medications became available for treating HCV that hold a great deal of promise for patients living with this disease, and more are expected. HCVguidelines.org provides physicians with the latest information and informed guidance on the available treatment options based on a rigorous review of data,” Barbara Murray, MD, president of IDSA, explained in the statement. “[The development of newer drugs is] of historical significance. We are quickly approaching 100% cure rates of this disease with treatment,” Dr. Schiff explained. “The presence of a readily available, frequently updated guidance document is a great service to providers and their patients, who will benefit from modern treatments that result in cure of HCV up to 95% of the time,” Michael Saag, MD, a member of the board of directors of the International Antiviral Society-USA and a cochair of the guidance panel, said in the statement. “The site will be updated regularly to keep pace with improved diagnostic tools and new drug options as they meet [US Food and Drug Administration] approval,” according to the statement. The Web site will include an ongoing summary of recent changes. Guidance for Insurance Carriers.   Also The rapid development of medications has made insurance companies as well as clinicians unsure of the best treatment options

The newer drugs are expensive, and not all insurance carriers are willing to pay for them. The guidelines may help insurance carriers evaluate the appropriateness of these drugs for patients with HCV. As the drugs become more available to patients, the cost may go down, Dr. Schiff said.

Even though the newer drugs are expensive, they may still be cost-effective if they are curing patients, he added.

Guidance for Insurance Carriers Also

The rapid development of medications has made insurance companies as well as clinicians unsure of the best treatment options, the statement explains.

The newer drugs are expensive, and not all insurance carriers are willing to pay for them. The guidelines may help insurance carriers evaluate the appropriateness of these drugs for patients with HCV. As the drugs become more available to patients, the cost may go down, Dr. Schiff said.

Even though the newer drugs are expensive, they may still be cost-effective if they are curing patients, he added.

 

 

Hepatitis C: More Affordable Treatment Possible

http://www.medscape.com/viewarticle/819086

This attached link presents interesting models for lowering treatment drug costs.  Not necessarily doable, but interesting.  Remember I worked for drug companies for decades.

Thank You Gilead for GS 5885 /  Solvaldi.  Saved my liver!

Good Bye everyone, thanks for your support.

Special thanks to Jana Lee RN and Advanced Liver Therapies.  Time for you to tackle something else like Non-Alcoholic Fatty Liver Disease or decrease liver transplants rejections; and do something awesome again.

www.HCVguidelines.org  Give this to your physician

http://hcvguidelines.org/sites/default/files/AASLD-IDSA_PressRelease.pdf

http://www.gilead.com/medicines/product-approval-timeline.

 

 

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Hepatitis C: Is that a Real Poncho or is that a Sears Poncho?

Mothers of invention, Theatre de Clichy, Paris...

Mothers of invention, Theatre de Clichy, Paris, 1970-1972 (Photo credit: Wikipedia)

“Look here brother,
Who you jivin’ with that Cosmik Debris?
Now is that a  real poncho or is that a Sears poncho?  Hmmm, no foolin’?”

Frank Zappa and the Mothers of Invention

Do you have a liver doctor (hepatologist) or a gastroenterologist?  Many people start out with a liver doc then over to a local gastro for long-term treatment management.  Kinda like selling your mortgage to a broker that does home mortgaging on the side but commercial financing is his bag.  I know, lame example.

Now a gastroenterologist is trained on the liver but probably hasn’t thought much about it since his fellowship at school.  Why?  Because his specialty is the GI tract (esophagus to anus).  In fact many gastroenterologists spend so much time with endoscopy or colonoscopy, they are refered to as “Scope Monkeys”.   The liver is not part of the GI tube.  No foolin’

Follow the GI tract from esophagus to anus. Then look at the liver.

Members of the two GI national associations, the American Society of Gastroenterology and Endoscopy (ASGE) plus the American College of Gastroenterology (ACG), do not attend meetings with the American  Association of the Study of Liver Disease (AASLD) and visa versa, unless presenting new research data.  But they don’t attend each other’s lectures. I know. For decades I attended the joint meetings of ASGE and ACG. It is difficult for a gastroenterologist to stay current on evolving treatments for Hepatitis C.  And these days the treatment (r)evolution is on.

Two weeks ago the AASLD and the EASL (European Association of the Study of the Liver) met in Prague to discuss Hepatitis C and:

  • Global scale intervention and control of HCV – OK
  • Prospects for a preventive HCV vaccine – OK
  • Review of new drug treatments in development such as Nonnucleoside inhibitors of HCV RNA polymerase, NS5A inhibitors, and Cyclophylin inhibitors – Important to you
  • Effectiveness of triple combinations in cirrhotics Important to a lot of you

Why do I mention this?  Here is an example of why.  Treatment of Hepatitis C is complicated and lasts a long time. The ribavirin induced anemia is treated by dose reductions based on your weight.  If your red blood cells (RBCs) drop below 10 mg/dl, Ribavirin is reduced by 20%.  If the RBC number does not increase in a few weeks, dosing must decrease another 20%.  But the dose cannot drop below 600 mg.  Now adding the protease inhibitors telaprevir and boceprevir,who knows what happens to RBCs in you?  Does the gastroenterologist know that?  Doubtful.  Does he know about the new drugs that work at different sites on the virus?  No.

Your insurance co-pay is probably the same regardless of which specialist  you visit.  Why not go with the real poncho?  BTW I couldn’t find a real poncho, only a Sears type poncho.  No foolin’

References

http://www.songmeanings.net/songs/view/78854/#mjbJdWKO6aRwIzk0.99

http://www2.kenes.com/PRAGUE2012/SCIENTIFIC/Pages/ScientificProgramme.aspx

http://www.natap.org/2012/APASL/APASL_08.htm

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/SEM_anemia.pdf

In The Waiting Room With The Losers: They Don’t Look Like Losers, Do We?

Tuesday Girl

When in a clinical trial for hepatitis C, there is no place to hide in the waiting room.  We are all there with our livers and our coolers full of injectable poisons.  You can tell what trial each person is in by the cooler they carry.  And watching the progress of a person, you can evaluate the side effect profile of the drugs.  Sort of. Do they bother combing hair? Coloring lips? Putting on lace up shoes?   Is that insider trading?  No, studies are blinded.  But we are not.  Clinicians would learn a lot observing us before we go on stage with the white coats.

I’m a Tuesday girl, I come on Tuesdays.  I recognize the Tuesday people.

You can clearly see the transplant candidates.  They look like Cecil without a smile.  A  yellow-green snot color with a gaunt face and an ascitic belly.  The post transplants look less yellow but more waxy, and kinda more dead.   High doses of steroids and immunosuppressives  will do that.  I look around thinking “These are not my people”  but they are.  If I look beyond the medical realities, they show up in a shirt and tie, uniform, sweat suit. But they don’t look like, I don’t know, losers.

I want so badly to change the TV to CNBC or CNN. But I am too short to change channels and everyone is staring at Good Day Houston.  I want to scream.  I breathe in and try to focus on questions I have and remember to request a copy of my lab work.  Don’t forget, don’t forget, don’t forget (Brain Fog).

I am sitting where I can’t see the TV, and listening to a book on my phone.  But then I watch everyone watch Good Day Houston and try to guess their faces.  Ugh, the only thing worse than a national daytime talk show is a local daytime talk show.  I remember Girl Talk with Virginia Graham out of Cincinnati when I was a kid home ill. I’ d never seen anyone so made up in my life.  And at 9 AM.  She had her hair combed into cotton candy, and four shades of lip color.  I don’t know about her feet.  She motioned for guests to join her at the coffee table.  Her jewelry jingled but her hair never moved. .  She was not my people.

Virginia Graham (the early 60s) way before The View…
Woah!  I Googled Girl Talk and got something completely different.

The Butcher Knife Solution

When I went through treatment #1 for Hepatitis C, I discovered that there is crazy in me, lots of crazy.  I get overwhelmed when I am overwhelmed.  Nature/nurture who gives a shit? I have, in my life, gone through self-help jibber jabber, 12 steps, journaling (which I hate-hate), therapy,week-end retreats, working with women in jail that want to stay sober once released without becoming a Baptist,  blah blah blah. I dealt with the demons of my childhood. I put all that little kid stuff in storage somewhere. Interferon drug out the box.

I read a book review that says most horrible childhood memories  published today are fabricated for greed.  The critic says the odds are against finding a person who has an intense childhood memory, wants to share it and is a good writer.  Misery Lit, what a category.  Where is Oprah when a bad critic should be exposed?  BTW, I never watched Oprah.  Too folksy. Makes me think of me.  Does my folksy bug others? Does it seem insincere? See, we all think about ourselves.

When I was a kid, my dad regularly came home drunk after bedtime, wanting money and the car keys.  Nobody slept until he got them or he passed out.  If it got really bad (poorly defined), Mom would grab up my little brother in the bed sheet and tell me to get her pocketbook and run to the car. Winter or summer. Scared me to death.   We got in, Mom started the car while I locked the doors.  Dad came flying after us “You’re not going anywhere”. I was shaking, maybe crying.  He yanked up the hood and pulled out the distributer cap.  Over and over we had no choice but to return to hell. One dawn found me with a butcher knife standing over his passed out body.   I was the grown up on duty (GOD).  It was my job to come up with solutions.  At least my mom and brother could get some peace. I said to myself “Just do it.  It’s okay if you have to go to prison.”   I couldn’t do it.  Mom was asleep on his shoulder. We didn’t talk about it later. We never did. Dad sang Hank Williams “Hey good lookin’, what you got cookin’?”  while Mom cooked breakfast, like the night before didn’t happen.

My good grades started to slip.  My teacher, Mr Kitchen,  asked if there were any problems at home.  My skin blistered red and I muttered no, everything is fine.  I still remember the moment.  I stared at my white gym shoes with broken strings. I was so ashamed.  He could tell my secret. (Therapy says it isn’t my shame.  Damn Interferon says yes it is).  I couldn’t look him in the eye ever again.  After that I got pulled out of class to see a visiting somebody. I went way up the winding steps to the nurse’s office.  The stone stairs had metal flicks.  There were multiple visits. The kids that went up there had some kinda broken something, like a learning disability or speech impediment.  They were outcasts.  I don’t remember who I saw or what I said. I was about eleven.

One time when we didn’t have any money,  Dad took the sewing machine my mom traded for.  He was sneaky, but I saw him. The cord caught in the door as he left.  I hated him.  I also hated sewing.  My Home Economics teacher, Mrs Lodge, said that I was the worst sewing student she had except for Alice Johnson.  Alice Johnson was the retarded girl in our class (that was how we spoke then). I never finished the baby blue robe I was making in class for my mom. So  Mrs Lodge took it home and finished it for herself over Christmas.  I pictured her in Mom’s robe.  In retrospect that was a bit shitty of her.

Dad would go out for bread and not come back for weeks.  Home was quiet.  I preferred that.  Then Mom got a collect call from Florida or somewhere.  Why am I telling these stories?  Interferon drug out the box..

After my parents sobered up and became adults, it was my turn.  I traveled a similar path but in a nicer neighborhood.  Isn’t that incredible??  I would be visited for a decade by active alcoholism and drugism and to this day intermittent depression. Less intermittent, more depression. One doctor called me a high functioning depressive. I was so proud. It is important to me to do well in all things.

Dad, my daughter and my brother. Dad was about 3 years sober there

BTW my dad and I built a loving effortless bridge when he sobered up.  He was the kindest most humble man.   My daughter spent summers with him and Mom.  They were best friends.  Unconditional love.  Who knew?  I’m just glad we had the second life too.

When Dad died, in lieu of flowers, 100 AA books were distributed in jails. He always helped the down-and-out drunk

Why am I telling you all this shit you either don’t care about or are horrified by?  Interferon drug out the box.  It is the stuff that leaked out of me during treatment.  Remember my suggestion for a therapist that knows about Hepatitis C?  These memories are why.

http://www.cowboylyrics.com/lyrics/classic-country/hey-good-lookin—hank-williams-14934.html

http://en.wikipedia.org/wiki/Misery_lit

I Pooped Today, Things to Track with Hepatitis C Treatment

“I Pooped Today”  Important information to track while on Hepatitis C treatment

If you choose to participate in a drug study while being treated for Hepatitis C, be prepared to keep a diary.  Most of these examples are from round one.  You know what they say about experience:  There are those that got it and those that are going to get it.  I’ve been both.  During round two, I knew a lot of holes were out there and walked around them.  Or paved them in advanced.  I did find new ones.

Dear Diary:

How many bowel movements have you had since your last visit? What color is it? I think this is a test to see if I am fixated on poop.  BTW Your family doesn’t want to know about your poop even if they pretend to.  Most people on treatment have frequent stools but not me.  See, don’t you wish you didn’t know?

Get comfortable discussing your bodily functions with everyone in a white coat. You haven’t had dignity for a while. How dark is your urine? I don’t know, it’s diluted when it hits the toilet bowl. Does it smell? I really want to make a nose joke here.

How’s your eating? Food smells and tastes like pennies and my stomach burns. Have you tried not eating spicy foods? I am only eating buttered noodles and Little Debbie Oatmeal Cakes.  Oh.

Brain fog “Loss of ability to concentrate. Memory loss”   How has your memory been?Huh?    Non-participative.  Try to write everything down in one place.  I can’t seem to find my notebook, so I start another. Kinda makes it worse.Try to hold a job let alone a career with that side effect.

Did I take my medicine? When did I take my medicine? Did I take it in lemon duck? Did I take it with a eunuch?  Did I take it on my death-bed?  Did it make me see a dragon’s head?  Write it all down, you won’t remember.  (ref Brain Fog)

Try to get as much sleep as you can. Brilliant. Now I lay me down to sleep, to lie awake with Lil Bo Peep.  Okay, a bit too much rhyming.  But today my brain wants to rhyme. 

Avoid undue excitement. You mean like my brain running The Fifth Element  Flossing Paradise 24/7? We can prescribe sleep medications. Why didn’t you tell me that 6 months ago?

We recommend aerobic exercise 15-20 minutes/day. Are you shitting me? Do I keep track if you are shitting me?

How many times did you have a blinding H/A this week? How many not so blinding?  Let me see, I cry a couple of times a day.  Crying results in a blinding headache.  So I hold in the crying.  The result, “not blinding” headache.  I’m not sure if I am crying on the inside or outside.

Rashes and skin changes. Is that because of medications or just old spots?  What about the ones that are 3-D?

My skin itches. Take an antihistamine. I did. Take Benadryl 50 mg. Spit will fall out of my mouth if I have any secretions Can I see a dermatologist about this?  Sure but it will be weeks before we can get you in.  WTF is a dermatologist so busy doing?

How has your mental health been since your last visit? Can you draw a line on this form to show the change? I can’t give you any more instructions, even if you don’t understand this (silly) form.  The -Y axis is not long enough to document  the rate of my decline.

Do you think we should put you on antidepressants? I don’t know who I am much less what I need. Have you had suicidal or homicidal thoughts? I can’t remember. With or without headaches?

It is Tuesday, time for my weekly injection. Just when I was feeling up line dancing in a circle (props go Dos XX commercial). Where was your injection site last week? In my forehead with a silver bullet.

Because my Hemoglobin (HgB) is so low, I can’t walk  from the parking structure to my work appointments. Can I get a Handicap Placard? No one has ever asked for one before. So can I get one? Bring us the form. The Dr. will have to sign it.

License branch information booth: Do I have to stand in the long line with the masses? If I could stand that long I wouldn’t need a Handicap placard. Then bring someone to stand in line for you. Next

Adverse Events in Treatment: If it’s you, it’s minor. If it’s me, it’s major

Adverse Events and Reactions

There are conflicting definitions here because there are conflicting definitions in science and medicine.

A Side Effect (SE) is when a drug does something besides what you are treating. Rogaine was initially a drug for hypertension that had a side effect (SE) causing hair to grow on your head.  It was predictable.  Talk about a marketing turn-around. That  pharmaceutical guy is probably still hailed as a hero. What? Me judge? 

Minoxidil is an antihypertensive vasodilator medication which also slows or stops hair loss and promotes hair regrowth.

Ooh ah, chemistry structure. 

Why is it that I can understand how this crosses the epidermis but I cannot understand how house plans will look as a house?

An Adverse Drug Event (ADE) is something that is dose independent and causes harm.  Wow, the definitions are wide open.

I went to the Veterans Administration (VA) website:   No clear definition  from their panel of experts

I went to the NIH:  The National Institutes of Health (NIH) Blah Blah Blah ”  WTF? I stopped there.  These people had no intention of helping me get  a clear definition. 

 Wikipedia, that bastion of scientific rigor says:

http://en.wikipedia.org/wiki/Adverse_drug_reactions

An adverse drug reaction (abbreviated ADR) is an expression that describes harm associated with the use of given medications at a normal dosage during normal use. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this expression differs from the meaning of “side effect“, as this last expression might also imply that the effects can be beneficial.[1] The study of ADRs is the concern of the field known as pharmacovigilanceNo shit.  Just what we need, splitting more ill-defined hairs.

An adverse drug event (abbreviated ADE) refers to any injury caused by the drug (at normal dosage and/or due to overdose) and any harm associated with the use of drug (e.g. discontinuation of drug therapy).[2] ADRs are a special type of ADEs.

  • Type A: Augmented pharmacologic effects – dose dependent and predictable
    • Intolerance: Severe decrease in red blood cells (RBCs) with ribavirin.  Decrease dose of ribavirin.
    • Side Effects. Immobilizing depression .  Anti-depression agents can help.

     My question to you and your doctor is “Why not start antidepressants in advance of hepatitis C therapy?”  I did the 2nd time around and I wasn’t on another planet every day.  Only sometimes.

  • Type B: Bizarre effects (or idiosyncratic) – dose independent and unpredictable.

Congratulations!  You are 1 in 100,000 whose teeth fall out.  It is a rare occurrence, 1 in 100,000.  But if you are the one, it is 1 in 1 (100%).  I apologize, I do not remember where I got this mask rendering.  Please don’t sue me.

  • Type C: Chronic effects: You keep taking that boy ,and you will go blind.
  • Type D: Delayed effects:  We didn’t realize that three weeks into treatment your butt hole would fail to shut.  Awkward!
  • Type E: End-of-treatment effects: Seriously, , Ribavirin stays in red blood cells (RBCs) for 6 months after treatment causing teratogenic effects (birth defects)  in non mammals.  Even if only the sire is taking the drug.
  • Type F: Failure of therapy The operation was a success but the patient died.
  • Type G: Genetic reactions OOPs,  you went deaf because you don’t have the enzyme to pee out that drug. Are your parents from Lapland?

My two favorite terms are Bizarre and Idiosyncratic. Bizarre we recognize. Sort of. Idiosyncratic means we have no effing clue. Idiosyncratic is more palatable than ” no effing clue”. 

The Food and Drug Administration (FDA to their friends) says An ADR should not be labeled as ‘certain’ unless the ADR abates with a challenge-dechallenge-rechallenge protocol (stopping and starting the drug). Now, I don’t know about you, but I am probably not going to volunteer to restart a drug that I had to stop because of  a bad experience.  At least not any more.

Both Interferon and Ribavirin warn about severe depression, suicide, homicide, and  crazy thinking.  I got the D and CT.  These are predictable SEs

  From the Interferon (Pegasys) package Insert

http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm#cont

BOXED WARNING 

 Alpha interferons, including PEGASYS, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see WARNINGS and ADVERSE REACTIONS).

Neuropsychiatric

Life-threatening neuropsychiatric reactions may manifest in patients receiving therapy with PEGASYS. Depression, suicidal ideation, and suicidal attempt may occur in patients with and without previous psychiatric illness.

PEGASYS should be used with extreme caution in patients who report a history of depression. Neuropsychiatric adverse events observed with alpha interferon treatment include relapse of drug addiction, drug overdose, aggressive behavior, psychoses, hallucinations, bipolar disorders and mania.   Almost all patients with hepatitis c have a history of depression.  It goes with the territory. 

ADVERSE REACTIONS

Nearly all patients in clinical trials experienced one or more adverse events. The most commonly reported adverse reactions were psychiatric reactions, including depression, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache and rigors. The most common reason for dose modification or withdrawal from studies was hematologic abnormalities.

Ribavirin  http://en.wikipedia.org/wiki/Ribavirin  It is more difficult to get a straight package insert regarding Ribavirin as there are multiple manufacturers.  Of note, Ribavirin has shown teratogenicity in non mammals.  You will have to sign many forms to document that you grasp this.

 I am not the suicide type.  As a kid, I stumbled on my mom trying to kill herself.  Pills, cut wrists, head in gaseous oven.  I would call an ambulance then my Aunt Sudie.   Aunt Sudie kept  my brother and me during hospital stays.  I packed our school stuff in a  cardboard box and waited for her.  We stayed there till Mom promised the psych doctors that she’s better and wouldn’t try suicide again.  Back then you would whisper “She’s had a nervous breakdown”.  You don’t hear that anymore.

It was weird at Aunt Sudie’s house.  It was quiet , clean and ran on a schedule.  They had ice cream all the time  and a freezer that kept it frozen.   My cousins  Gary and Randy would have to room together so my brother  and I could have a bed.  I put every effort into making sure Tim and I were no trouble. Little Orphan Annie has come to our house to stay.  To wash the cups and saucers up and brush the crumbs away…  J W Riley.  This thinking came from me.  Aunt Sudie didn’t expect me to work for my keep.

 When my period  started, Randy’s dog , Lady, shredded my Kotex all over the dining room floor and they saw it.   I died quietly.  At home no one shredded my Kotex stuff.   No matter how bad it is at home, there are some plusses.

Back then there was no Valium or Prozac.  Only Thorazine.  Which Mom used to for suicide attempts. See a pattern?    Mom later found an alternative.  She began drinking with my dad.  I became grown up on duty (GOD) when I was about eleven.

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.