Hepatitis C Now Godzillaprevir and KingKongViracide: Yes but is Interferon Still in the Mix?

GodzillaPrevir

KingkongViracide

No matter how powerful add-on drugs are, if Interferon is still part of the mix, many patients will not be able to finish the treatment.  If I was in early stages of Hepatitis C with minimal liver scarring, I would wait 12-24 months for new treatments sans Interferon.  If my Hepatitis C were more advanced, I would go to www.clinicaltrials.gov and type in my disease and city. (Note disclaimer at end of blog)

Below are “press releases” from companies and are mostly targeted to investors, e.g. The market for treating hepatitis C has burgeoned  (My spellchecker doesn’t recognize this as a word) in the last year.

Always look at the source of medical information, if it is Kiss Your Assets Good-Bye or Liver Heard on the Street, run away. If it is the New England Journal of Medicine, or Gastroenterology proceed with caution and a jaundiced eye.  Oops a hepatitis pun.

Dec 1, 2011 – Novel Hep C Treatment Excludes Peginterferon Alfa By: DENISE NAPOLI, Internal Medicine News Digital Network Therapy with a novel

But then if I didn’t read the business news, I wouldn’t know about this for another couple of days:

Bristol-Myers Drops Hepatitis C Drug After Patient Death

Daniel Acker/Bloomberg

Bristol-Myers Squibb Co. has abandoned an experimental hepatitis C pill it bought for $2.5 billion earlier this year after one patient died and others were hospitalized while taking the drug in a study.

                    

Bristol-Myers will take a charge of $1.8 billion in the third quarter related to research and development of the therapy, the New York-based company said in a regulatory filing today. The drugmaker suspended testing the medicine, known as BMS-986094, on Aug. 1 after a patient developed heart failure.

Bristol-Myers said yesterday it has discontinued development of the drug, part of a class of medicines called nucleotide polymerase inhibitors, and was consulting with U.S. regulators to assess the treatment’s effects. Along with the death, eight patients suffered from heart and kidney toxicity, the company said in a statement.

“Bristol-Myers paid a fortune for a pearl that turns out to be fake,” said Erik Gordon, a University of Michigan businessprofessor who follows the health industry, in an e-mail today, referring to the company’s “string of pearls” name for its acquisition strategy. “The Inhibitex acquisition shows the dangers of paying huge premiums for late-stage drug candidates in hot areas. They still can fail.”

I love it:  The dangers of paying huge premiums…Not the dangers of participating in clinical trials. No disrespect to business people, just a different perspective.  I should know, I worked in Big Pharma for twenty-five years.  First make money for share holders, then do no harm to patients.

dictionary.reference.com/browse/inherent existing in someone or something as a permanent and inseparable element, quality, or attribute:

There is inherent risk for patients in clinical trials.  You can quote me on that.

The Hepatitis C Screen Door Swings Two Ways

My father-in-law wanted Viagra.  He wouldn’t shut up about it.  My mother-in-law finally said “Then what?  You’re not getting on me”  eewww, the visual for me….

So we screen for Hepatitis C, then what?

Attention Baby Boomers: The Centers For Disease Control (CDC), the group that tracks bird and swine flu, is thinking about screening you for Hepatitis C.

Hepatitis C is particularly dangerous because it is a silent killer. It can live for decades in a person’s body, slowly destroying the liver, while causing few symptoms,” said Dr. John Ward, director of the CDC’s division of viral hepatitis.

The new guidelines are expected to identify more than 800,000 infections, prevent 100,000 cases of cirrhosis, prevent more than 50,000 cases of liver cancer, and save more than 120,000 lives. Hepatitis C is the leading cause of liver transplants in the United States.

The relatively inexpensive blood test is “a small investment now for a big benefit later,” Ward said.

The CDC believes routine blood tests will address the largely preventable consequences of the disease, especially in light of newly available therapies that can cure around 75 percent of infections.

The field has attracted broad interest with two new hepatitis C drugs, Incivek from Vertex Pharmaceuticals Inc and Merck & Co’s Victrelis, reaching the U.S. market in the past year.

Sorry about the blur, link at bottom if you are interested

Should we screen for Hepatitis C in patients over 50?  There is no vaccine, the standard treatment of Interferon/Ribavirin is about  $60,000 and the eradication rate about 40-50% in the most common genotype (1).  Adding  Boceprevir (Victrelis) is $1,000 a week (x 24 weeks = $24,000). Telaprevir (Incivik) is $4,100 per week (x 24 weeks = $98,000).  So treatment =  $80,000 to $158,000.  They must be really proud of Telaprevir.  At that price they may have to keep it.  All of this assumes 24 week treatment but it is common practice for those on Interferon/Ribavirin to go 48 weeks ($120,000 for dual therapy)

 

These are all rounded numbers and this does not include anything but the drug.  Side effects are horrible.  A few are nausea/vomiting/diarrhea/depression/suicidal and homicidal thoughts/hair loss/anemia/insomnia . The new drugs add full body rash, rectal itching and/or rectal bleeding.  (This reminds me of the old treatments for syphilis: mercury and arsenic).   Many patients cannot hang and drop out. Jobs are lost, families strained and the patients overwhelmed. And then there is that pesky liver transplant for those beyond pharmacologic help (drugs).

But there are currently over 4 million people infected in the US and the largest group are over 50 with long-term damage.  And there are new tests and treatments.  For instance, researchers recently identified a specific DNA sequence in the gene that codes an immune response regulator, called IL28b. Different IL28b sequences predict whether treatment will successfully clear the virus.

With that in mind Goldhaber-Fiebert and Liu of Stanford created a computer model looking for the line at where it makes sense to go through treatment.  Remember that these people think in terms of how many patients out of 1,00 people, not what YOU should do.

After intense statistical and simulation analysis, the model showed that the new triple therapies were indeed cost-effective for chronic hepatitis C patients with advanced liver disease. Despite the large price tag and side effects, the new treatments help these patients avoid costly cancers and liver transplants — as well as allowing them to live longer, higher-quality lives.

For those patients with mild disease, the model indicated that determining their IL-28B genotype is the best next step, before prescribing a treatment.  The closer the threat of severe disease, the more justified treatment costs and risks become, said Goldhaber-Fiebert. “That would be the bottom line.”

Though these new drugs may offer relatively desirable options now, both Goldhaber-Fiebert and Liu noted that additional, and perhaps more effective, drugs are already in clinical trials.”

So in the “State-The-Obvious” department  they conclude: “As more and better treatments become available, the decision will continue to evolve, requiring further analysis, patients and health systems could also benefit from price competition with multiple treatment options available. But ultimately, treatment decisions will remain a private conversation between a doctor and a patient. “

A bit chicken shit but common in the academic world.  All studies end in “Further research is needed”.  Which is academic speak for “See you at the next medical conference where I will have more data”.  Note the reference to “health systems”.  This includes the insurance company.

Now, as a taxpayer, I wonder where the money is coming from. You can see one reason a clinical trial is an attractive option.  I didn’t pay a nickel.  In fact they paid my gas and parking.  BTW my results from 12 week post treatment just came back “No detectable virus”.  So why do I have a trace of cynicism about drug companies pushing for testing?

My mom used to yell, “close the screen door, you are letting the flies out”.  I always thought that was funny. Regarding screening and insurance that may be true but not so funny.

http://www.nlm.nih.gov/medlineplus/news/fullstory_125350.html

http://health.yahoo.net/news/s/nm/all-baby-boomers-should-get-tested-for-hepatitis-c-cdc

http://med.stanford.edu/ism/2012/february/hepatitis.html

Ungrateful Bastard that I am…Hepatitis C

You Bastard, you killed Kenny

Hepatitis C treatment ended five weeks ago.  All is going well (~ nothing is wrong).  Went to Costa Rica with grand kids, hiked (slowly) up mountain sides.  Thank you Symbicort and red blood cells.  Now home.  I want to lay in guest bedroom (my sick room), watch recorded TV shows and eat sugar.  What’s up with that?  Fighting some mental and physical depression.  Back up.  Not necessarily so…anytime things are caddy wampass I frighten myself with the depression (DEBression) stick.  Kinda like a boogie man under the bed.

Ungrateful bastard that I am, I want to just “be okay”.  WTF does that mean?  Everyone who is “okay” raise your something.  Last time I re-uped for life post-treatment, I slowly weeded the front garden to demonstrate focus and progress to myself.  It took a week.  Currently it is 108 F heat index…so the hell with that.  I go to bed and get up the same time everyday.  Learning how to fall asleep naturally.  Not true…trying to learn how to fall asleep.  I’ve always had some distressing insomnia.  Maybe that contributed to my drinking a quarter century ago.  Maybe not. Currently I’m on two non sedating antidepressants and one sedating, slowly weaning off.  I can hear AA people judging.  Ta hell with ’em. Note to self:   What other people think of me is of no consequence.

You’d think I’d be more sensitive to the term bastard.  I’m not.  One thing I’m clear about, being born out-of-wedlock is not my burden.  Not sure I knew that 30-40 years ago.  And views change.

“Now more than half of all births to American women under 30 are born out of wedlock, and the trend in marriage-less birth is becoming an accepted reality of American life.” Don’t you love marriage-less over out of wedlock?  I wonder which group with an axe to grind is funding this.

“According to an analysis of government data, conducted by the research group Child Trends and reported by The New York Times, the last 20 years have seen illegitimacy among white women in their 20s with some college — but not a full four-year degree — rise more quickly than in other groups.”  …gotta love the internet.

Ah, yet another chapter in “Me-Me-Me”  My favorite subject, I am afraid.  Better keep dancing with the psychiatrist a bit longer. 

http://www.mysymbicort.com/

“You bastard, you killed Kenny”http://www.youtube.com/watch?feature=player_detailpage&v=1A6f3jHTC-Y

http://articles.businessinsider.com/2012-02-21/home/31081751_1_illegitimacy-black-children-unmarried-women

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

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.