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

Hepatitis C: Beware the Jabberwok

 Hepatitis C:  Beware the Jabberwok

Through the Looking Glass

‘Twas brillig, and the slithy toves
Did gyre and gimble in the wabe:
All mimsy were the borogoves,
And the mome raths outgrabe.

‘Beware the Jabberwock, my son!
The jaws that bite, the claws that catch!
Beware the Jubjub bird, and shun
The frumious Bandersnatch!’

He took his vorpal sword in hand:
Long time the manxome foe he sought 
So rested he by the Tumtum tree,
And stood a while in thought.

And, as in uffish thought he stood,
The Jabberwock, with eyes of flame,
Came whiffling through the tulgey wood,
And burbled as it came!

One two! One two! And through and through
The vorpal blade went snicker-snack!
He left it dead, and with its head
He went galumphing back.

‘And hast thou slain the Jabberwock?
Come to my arms, my beamish boy!
Oh frabjous day! Callooh! Callay!’
He chortled in his joy.

‘Twas brillig, and the slithy toves
Did gyre and gimble in the wabe:
All mimsy were the borogoves,
And the mome raths outgrabe.    

  

If you listen to a scientific lecture for an hour, you can begin to believe nonsense is science, but don’t.

I believe that the average Hep C patient (whoever that is) has a triple cross to bear.     1. You feel like shit on a stick  2. You have to go to unimaginable places like a liver biopsy suite and 3.You are thrown into a parallel universe where the language is almost understandable, but not really. It’s Jabberwok.

I was listening to a lecture yesterday on Hepatitis A through E. I was reading the slides as Dr. Nice Lady from pharmacy was talking.  And then I heard it:Hepatitis B and C are predominately associated with percutaneous and permucosal transmission”.  Translation:  Hep B and C can be caught through blood and through sexual contact.  Permucosal  is medical lingo for via mucous membranes.  The problem was that fifty pharmacists were about to  leave the lecture and tell their worlds that you can catch Hep C through sex.  I couldn’t let that happen so I said through the chat box “Hep C can be caught through sexual contact?  Is this new information?”  She said no, you are right to point that out, it is not transmitted that way.  So why did she say it?  The slide looked better that way.

In reality, the way one gets Hep C through sex is through rough sex and I mean rough.  Percutaneous means blood transmission.  I will pause here so that you create your own image.

Now I was willing to let it slide when she said that Hepatitis A and E were transmitted through the oral-fecal route.  In reality it is fecal-oral route.  Think about that for a moment.  But my point is that there is a lot of slightly non-true information out there.  What can you do about it?  Ask questions wherever you go.  Even if you have asked the same question before.  Remember how your doctor’s office always has that sign in English and Spanish that says Questions/Pregunta?  They really want you to ask.

Boy, did spellcheck light up Jabberwok!

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

Lewis Carroll Through the Looking Glass

Viral Hepatitis:  Keeping Your Patients Safe www.freece.com

Where Is Reset? Life After Hepatitis C Treatment

 After four  years and two rounds of Hepatitis C treatment, how do I reset my life?

In 2009 I enrolled in treatment round #1 for Hepatitis C.  I was a subject in a drug trial.  As it turns out, I received standard of care: Interferon and Ribavirin.  This didn’t wipe out the virus, but did wipe out my career.  Between the emotional, psychological and physical melt down, my performance at work  never recovered.  In fact my performance began to slip a couple of years before that.  Depression coupled with anxiety along with tiredness from hep C, career and  school  left me mildly catatonic.  Oxymoron?

After round one, from which my career never recovered, I retired early.  I was that rare bird, a person with a retirement package, and I wanted to keep it.  This was in 2010-11 when pharmaceutical companies were reducing employee numbers by 30-60 %.  If sales aren’t up, expenses must come down.  Employees are expensive, especially when you think quarter to quarter. Human Resources (Man Power in my early days) would never say it, but a disproportionate number of older/higher paid employee positions went away.  A vague yet popular term was “you are not on board”  meaning you are not 110% aligned with new management thinking. Your resistance to any part of process is slowing us down.  Younger business/science professionals with a great deal of ambition and no scientific historical perspective are cheaper and quick to get “on board“.

I agree, I was not on board.  The new direction was not science. The new direction was “scientific marketing”.  WTF is that?  BTW, I used to love my job, absolutely love it.  I had the good fortune to work with  AZT, the first HIV drug and with Ritonavir the first antiretroviral for HIV.  I saw people begin to live with HIV. Ritonavir is now being studied for hepatitis C. I worked with the first oral anticoagulant that didn’t require blood monitoring ( this drug didn’t make it to launch after millions of dollars in research) and the first proton pump inhibitor for GERD.  I put teams of field scientists together in both Hemostasis and Infection.  I developed their individual and group skills.  I was good at it.  I wasn’t as good at managing up the ladder once science got squeezed by sales.  So why can’t I just get on board elsewhere?  Because I have to live with myself.  Whew, too many I’s in that paragraph.  I am trying to learn to relax and live with the debt bomb that will gobble up my little anti wolf money.

English: AZT (zidovudine), the first medicatio...

English: AZT (zidovudine), the first medication shown to be effective against HIV. From the National Institutes of Health website (http://www.history.nih.gov/NIHInOwnWords/docs/page_05c.html). (Photo credit: Wikipedia)

When I was nine, Dad would drive 70 miles to Indianapolis  at 3 AM and pick up fresh produce, then back to  Al Monger’s fruit market.  I  remembered that name because Dad called my dog a mangy mongrel.  I pictured Al Monger as a hound dog  (Mom lost my dog later while drunk.  I cried about that dog for years).  Dad’s pay in part was produce.  He and I would drive through “rich” neighborhoods in an old pick-up truck and peddle watermelon from the back.  We cut plugs from a melon for house wives.  When one turned up her nose, he would say “That woman doesn’t know what trouble is”  And I thought yeah, be poor like us, then turn up your nose at a watermelon.  At day’s end we took the rest home.  It was July and Mom was pregnant with my brother.  She ate watermelon all night long.  We lived in an apartment upstairs with pink  lace plastic curtains and no screens. I knew we hit a low.  She always looked down on plastic curtains and she even had them tied in a knot.

On really bad broke hang-over days, Dad would get a pint of aluminum paint and a pair of cheap gloves.  He made a handle from a coat hanger and ran it through his belt.  We drove through rich neighborhoods and picked out a rusty TV antenna.  We parked on the curb, not the drive. I sat in the truck looking out the window.  He always had a smoke on him while talking to the homeowner. He told the lady of the house he could save that antenna.  After the first one, he convinced neighbor ladies.  For $5 he climbed the wobbly three-sided antennae and painted  up and down streets.  That night we would be “rich” and he would look like the Tin Man from the shiny paint.  One time he said “I sure am thirsty, you want a root beer?”  Are you kidding, heck yeah.  We got ice-cold mugs at the A&W.  I had to gulp it down.

Laughing, he said  he had places to go and people to see.  We’d stop by the store for bread, bologna, milk and Camels.  Maybe Hellman’s too.  A little jar.  Everything we  bought was in the little jar,tube, bottle, box or scoop.  I suggested to Mom once that we could save money by purchasing bigger quantities.  She straightened me out on that thinking.  Only rich people could afford to buy big tubes she said.  I figured out later that her “rich people” were the middle class.  I watched “Leave It To Beaver”  and wished I was in that smiling rich family.  The hedges were trim, mom vacuumed and dad came home on time every night sober.  It was like we lived in a place called Pooristan.

I still love saddle oxfords

If bill collectors came to the door, Mom would push me to tell them she wasn’t home while she hid in the hall.  They looked straight at me with eyes that said “You are lying little girl”.  We shared that moment.  I swore that I would never have the wolf at my door.  I determined to get a good job, maybe teaching, and get a used station wagon, maybe red.  That’s why I am on my 3rd red Volvo. Maybe.  Never did get a station wagon.  Still love watermelon.  Grew my own this year.

From about age six, I collected pop bottles for pennies.  I went to Cozad’s Grocery and anguished over what candy to purchase, favoring slow treats like a Sugar Daddy. If other kids collected bottles, I would cash them and take a cut of the money. I had the corner on the market. Other kids weren’t even allowed to leave our street. From age ten, I took in ironing, babysat brat kids while parents worked second shift, cleaned houses, anything to get money for school clothes and saddle oxfords. Of course in my house I washed dishes, cleaned house, did laundry, then hung it out.  There was nothing wrong with that, my mom worked in a factory everyday.

I still love saddle oxfords

I babysat my brother every summer from age 11 when he was two. In exchange Mom would  get me “something nice” at the end. Once it was my cousin’s used record player.  I couldn’t believe my good fortune.  I went downtown on Saturdays and spent the afternoon choosing a 45 rpm record.  It was 45 cents.  I played Motown non-stop. When I was fourteen I got a blue Princess Phone,  which was good because Dad always pulled the house phone out of the wall when Mom tried to call the police on him.  Phones didn’t plug in those days, the phone man had to come and repair it.After a lifetime of pushing myself to do better, the wind stopped blowing. Now that I spent my life getting out of Pooristan, can I enjoy retirement or will I fear the wolf at the door?  I have been thinking a lot about that.  And I’m only 4 months past treatment number two for hep c.

I did the craziest thing today, in response to a head hunter’s call, I sent in my resume  for a position as a Medical Affairs Director (managing a team of liaisons and of course managing up).  It is a small biopharm company that focuses on orphan drugs (rare diseases).  What was I thinking?  I don’t want to work that hard or long.   IF I talk with them, I’ll price myself out of the market.  A former colleague contacted me last week about some part-time project work.  After talking with him, my skin crawled from all the business bullshit slang.

How would I give back to the world if I could do anything?  I got all this education and pretty good team management skills, but low tolerance for bullshit.  That rules out about everything. I would like to help kids in difficult circumstances, but I remember the church ladies trying to help. No thanks.  My childhood stuff isn’t completely in the closed file.   I wouldn’t mind making a little money but that isn’t the “it”. Suggestions?

Hepatitis C: Does “No Detectable Virus” Equal Cure Or Is It Smoke?

Am I cured or is it just smoke?

Hepatitis C cure?

 If my hepatitis C virus test shows non-detectable virus 6 months after the end of treatment, am I negative?  Will I  stay negative?  Am I cured?  In the recent past only “non-detectable virus” was declared. Now doctors are adding “cure” to the jargon.  This is with the addition of Incivek and Victrelis, and depending on the discussion.  No two clinical trials are alike and so Hepatitis C researchers use (they say utilize) sustained viralogical response (SVR) to compare outcomes.  Most trial design is by the company developing the drug.  One goal is to ask the study questions just right to get scientific and marketable answers.  “GodZillapravir had a non-detectable  SVR at weeks 12 and 24 in 85% of patients including those with mild to moderate cirrhosis”. “KingKongViracide cleared Hepatitis C virus in 94% of patients at 24 weeks including children 12 to 18 years of age”.  Which is the better drug?  You can’t tell by the claims because two different patient populations and time lines .  But they have  SVR in common.  That is why researchers use SVR.  BTW I made up the examples.  Now don’t get down on industry just yet.  Academics are accountable to department heads and medical journals.  That can be as powerful as a stockholder.

Industry is different: Stock holders in towers

When it comes to patients , the word “Cure” has emerged because research shows that if you have no detectable virus after six months, the chances of Hep C returning is about 1-2%.  And the argument is that it was never cleared, just so low that it was undetectable.

So with Hepatitis what does this mean?

Successful treatment for Hepatitis C hasn’t been available for long, so doctors are just starting to understand the long-term outcomes.  Do cancer survivors say cured?  I think they say  cancer-free for 2 years, 5 years, etc.  Am I a Hepatitis C survivor or am I cured?  Is it still a pre-existing condition?   A research site, not insurance, paid for my treatments.  But my medical records say Hepatitis C.

So at 24 weeks can I tell the insurance company that I no longer have Hepatitis C?  I can’t find the answer to that question without talking to them directly. I will wait until 2014 (I think that is the year) when they cannot cancel me for pre-existing conditions.  Insurance politics are so confusing, I am not clear if that stipulation is on the potential chopping block.  In speaking with my mental  Dr, I realize that I do not have confidence in my treatment and I am waiting for it to come back.  I am at 4 1/2 months post treatment.   I have been Hep C positive for so long, I don’t know how to have a future in which chronic debilitating illness isn’t a key player.  What is the world like with only mild hypertension and chronic but manageable depression?

Below is a good article for defining end-of-treatment terms, although it is a bit dated.  Newer drugs are not addressed but the terms are the same.

 Hepatitis C: What Is a Sustained Virologic Response or “SVR”? (From Charles  Daniel, former About.com GuideSVR) 

SVR is the closest you’ll get to “a cure” for hepatitis C.
 Sustained virologic response, or SVR, is the goal of hepatitis C treatment.  Conventional treatment (a combination of interferon and ribavirin) doesn’t  necessarily eliminate the hepatitis C virus from your liver. It can, however,  suppress the virus to undetectable levels for an extended period of time. In clinical language, this is called a “sustained virologic response,” or sustained  response. It means that during the six months after you complete treatment,  there is no detectable hepatitis C virus in your blood.                                         SVR is a good thing.
Studies have shown that with a six-month SVR (which means no detectable virus in your blood for six months after finishing treatment), relapse occurred in only 1-2% of patients. So, for every 100 people who finished treatment and attained SVR, the virus will return in only 2 of them. However, for these people, the
virus never really left. The medicine was able to eliminate most of the virus (so much that medical tests couldn’t detect it), but after treatment ended, for whatever reason the virus was able to continue replicating itself.

Early SVR is beneficial
Since the liver has incredible regenerative ability, achieving SVR
 as quickly as possible is important. This is important because some liver damage can be reversed if the cause of the damage is removed. After SVR is reached and depending on the degree of damage from the virus, the risk of hepatocellular cancer is reduced and about 25% of people see an improvement in fibrosis.

SVR compares one treatment to another. For those in treatment, SVR is the goal. However, for physicians and scientists researching new hepatitis treatments, SVR is also used to evaluate new medicines and compare them with proven therapies.
 For example, depending on the genotype, treatment with interferon alone usually achieves SVR in 15% of the patients. When interferon is combined with ribavirin in the same genotype, SVR is increased to 70% in some people.

Jana L. Lee, R.N., CCRC Clinical Research Nurse St. Luke’s Episcopal Hospital Advanced Liver Therapies, my practical answer source and demon fighter.

http://www.hepcadvocacy.org/factsheets/HepatitisC.pdf

http://hepatitis.about.com/bio/Charles-Daniel-37713.htm