Hepatitis C: The Post Interferon World has Five Scoops of Good News

Hep C:  The Post Interferon World is Five Scoops of Good News

  1.  Increased number of patients screened and identified
  2.  Increased options for those who failed previous therapies
  3.  Improved patient compliance
  4.  Possibilities of patient-guided treatment
  5.  Decreased need for liver transplantation
Donna Reed on Laundry day.  Now her modern day peers can get tested.

Donna Reed on Laundry day. Now her modern day peers can get tested.

  •   I quit writing my blog when I saw the first ad for Hepatitis C treatment on television. The representative people were not parrot heads or crack heads. They were typical ad people like Crestor or Nexium. These ads will bring people in for testing and treatment.  The early treatment decreases transplantation demands. But there is still a lot of Hepatitis C news, so I am back.

A friend of mine started round four of treatment three days ago and she is scared.  Because of Interferon and depression, she could not complete previous treatments. No pledge from me or her physician made a dent in her fear but time will show her. Her new protocol doesn’t call for Interferon, and she is on preventive anti-depression medication. The three drug cocktail for her is one of many not available six months ago, a bygone era.

I recall Fridays during treatment, Interferon injection days. Bathing and grooming started on Wednesdays. I could schedule most work meetings (via telephone) for Thursday and Friday. There is much compliance built around Interferon day. For me, there came the day I could not  work and Friday no longer mattered. Unfortunately leaving work isn’t always an available solution. I lost my career when I returned and I was still sick from drugs. Luckily I retired with benefits.  When I went through treatment # 2, I wasn’t working and could get all the rest required. In the post Interferon world of (mostly) no Interferon and ribavirin this may not be an issue, thus better patient compliance, and cure.

 

And now about patient-guided therapy and no you do not get to select from a menu. For those of you following genotyping using IL2b.  Researchers predict (I love that phrase) which treatments will work best in your body.  That will partially determine the treatment drugs for you, thus ruling out waste-of-time and money treatments.

Be sure to visit my friends at http://www.hepatitiscnews.com  They have great usable info and practical application.  They carry my blog too.

https://us-mg4.mail.yahoo.com/neo/launch?.rand=084ro4ia0h0pr#1

Kentaro Matsuura, Tsunamasa Watanabe, Yasuhito Tanaka

Disclosures

J Gastroenterol Hepatol. 2014;29(2):241-249. 

The Depression Road Goes On Forever and The Party Never Ends *

Hepatitis C and Depression: I should be weary of this subject, but I’m only weary of depression. Thirteen months ago I completed a clinical trial for Hepatitis C. I was cured, c-u-r-e-d.

 GS-US-256-0124-A Phase 2B, Trial Evaluating Using Combinations of Oral Antivirals (GS-5885, GS-9451), PegInterferon Α and Ribavirin In Treatment Experienced Subjects  With Chronic Genotype 1 Hepatitis C Virus Infection

Last month I went in for my one-year follow-up visit where it was confirmed “No Virus After One Year!”.  Okay, maybe it’s true.  Maybe. I answered questions about my mental well-being.  I felt great and said so.  Later I remembered that I felt great because I was on two anti-depressant drugs, Lexapro (escitalopram)  and Wellbutrin (bupropion XL) with a splash of trazodone at bedtime.

BTW, I think everyone should speak about their antidepressants. I know there’s a bunch of us out there.  Just look at the sales $$$.     I worked for Lilly when they launched Prozac.  Rather than get it for free, I paid at the retail pharmacy because I didn’t want anyone to know.  That’s Bull Corn.  Bull Corn?  Where did that come from?

Where was I?  So two weeks ago, my psychiatrist,  (who treats Hep C patients) began to decrease the Lexapro with the goal of decreasing my antidepressant load.  My scaffolding crumbled under me and I spiraled into an anxiety-ridden, weeping insomniac in just a few days and nights.

I've come undone
I’ve come undone

.So,  I am miserable and looking at increasing drugs.  My first thought was that I am FUBAR (Fucked Up Beyond All Reason/Recognition/Repair  military slang) and that’s that.  My second thought was to work closely with Dr _ who assures me that this is a minor setback. Minor to someone else maybe. How quickly I become self-absorbed.

Now, after 400 words, the reason for this blog.  Today I received this article from  Medscape.

 Psychiatric Treatment Considerations With Direct Acting Antivirals in Hepatitis C   Sanjeev Sockalingam, Alice Tseng, Pierre Giguere, David Wong
BMC Gastroenterol. 2013;13(86)

(Newly published articles in my areas of interest for August 9, 2013: Medscape)

Can’t resist the title can you?  I know I can’t.

Being a Doctor of Pharmacy and a scientist, I love articles like this. It takes my entire nineteen years of schooling to follow the data dump. Gastroenterologists and Psychiatrists won’t read this article. It falls into a discrete category that gets filtered out during literature searches. DAAs means previrs ( boceprevir / telaprevir).

Abstract

Background Despite recent advances in hepatitis C (HCV) treatment, specifically the addition of direct acting antivirals (DAAs), pegylated interferon-alpha remains the backbone of HCV therapy. Therefore, the impact of DAAs on the management of co-morbid psychiatric illness and neuropsychiatric sequelae remains an ongoing concern during HCV therapy. This paper provides a review of the neuropsychiatric adverse effects of DAAs and drug-drug interactions (DDIs) between DAAs and psychiatric medications.

Methods We conducted a PubMed search using relevant search terms and hand searched reference lists of related review articles. In addition, we searched abstracts for major hepatology conferences and contacted respective pharmaceutical companies for additional studies.

Results Limited data is available on the neuropsychiatric adverse effects of DAAs; however, data from major clinical trials suggest that DAAs have minimal neuropsychiatric risk. DAAs can potentially interact with a variety of psychotropic agents via cytochrome P450 and p-glycoprotein interactions. Triazolam, oral midazolam, St. John’s Wort, carbamazepine and pimozide, are contraindicated with DAAs. DDIs between DAAs and antidepressants, anxiolytics, hypnotics, mood stabilizers, antipsychotics and treatments for opioid dependence are summarized.

Conclusions Although DAAs do not add significant neuropsychiatric risk, the potential for DDIs is high. Consideration of DDIs is paramount to improving medication adherence and mitigating adverse effects during HCV therapy.

So the abstract  (I saved you from the entire article)  kinda says: We don’t know enough to draw any conclusions so we caution you when using any drugs metabolized by the liver, including antidepressants. Terms: pharmacokinetics (where the drug goes in your body and how your body changes it to water-soluble (pee), or fat-soluble (poop) to get rid of the drug:  pharmacodynamics , what the drug does to your body to heal you and how it does it. This is for one drug. Think about a bunch of drugs where the liver and maybe kidneys do not work well.  There is a traffic jam and a couple of fights at the entry to your liver and the drugs build up in your blood.   Crash.

This is a year of my life

CPY 450 System, took me years

And so I say to you what any good or bad pharmacist would say:  “Caveat Emptor”.  Actually,  the pharmacist will put warning stickers all over the bottle and give you a packet of small print information.  Then she will make you sign that you have been counseled.

Beware the Jabberwok

Caveat Emptor

* A nod to the awesome Robert Earl Keen Jr. http://www.metrolyrics.com/the-road-goes-on-forever-lyrics-robert-earl-keen.html

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/HCV_Neg.pdf  This is awesome for those like me.

http://www.medscape.com/viewarticle/807927?src=wnl_edit_tpal&uac=190805DY

Hepatitis C Treatment: The Big Sleep In The Rabbit Hole

Going through treatment of Hepatitis C, I suspended reality. 

My world became a rabbit hole.  More like a depressed Bugs Bunny than Alice.

The first on-screen appearance of Bugs Bunny, ...
The first on-screen appearance of Bugs Bunny, from an unrestored version of the cartoon. (Photo credit: Wikipedia)

Only my husband Spanky, the psychiatrist and the research nurse could check on me.  But frequently I pulled the hole in on myself and stayed there.  It was kinda weird.   I felt safe from others but not my crazy mind.  I couldn’t close the rabbit hole fast enough to keep out my mind.   Sometimes I felt like I was watching the world through a window but  I couldn’t remember what happened that day.

Memories of coming out of a bar when the sun is still bright, eewww.

Twice stolen from Edvard Munch

Twice stolen from Edvard Munch

malavula.blogspot.com

I used to wonder if other study patients felt the same as me.  I would watch in the waiting room.  But they weren’t giving up their secrets.  Each traveling with his own rabbit hole.

Rabbit Hole Urban Dictionary
Alice in…Metaphor for the conceptual path which is thought to lead to the true nature of reality. Infinitesimally deep and complex, venturing too far down is probably not that great of an idea.
An allusion to Lewis Carroll’s Alice in Wonderland. To go “down the rabbithole” is to enter a period of chaos or confusion.
Or to take acid, Deb
…….
Then the study ended.  As drugs began to leach out of my body, I felt like I took a year-long nap.  Only I wasn’t asleep.  I was waking from a little tiny world.  Like a newly released guest of the penal system or someone from the space station, I heard about stuff while in my pseudo-sleep but hadn’t really grasped it.  Politics, friends, life skills, I had to catch up on it all. This is more difficult than you think, trying to get past all the celebrity crap. Who “gets” celebrity crap?  I don’t but somebody must or it wouldn’t be ubiquitous.
Sometimes I want to crawl back down the rabbit hole.  During those times, I hang out in our guest room, my home during treatment.  It’s comforting in a psychiatric kind of way.  It took months to feel free of that need,  about four half-lives*  When I can’t sleep I still go in there.  It is normal to lie awake all night in the rabbit hole.
 I’m thinking of painting the rabbit hole room lavender (I don’t like lavender) or getting a new bed (I like the existing bed).  Dismantle the tangible rabbit hole.
*A half-life, t1/2, is the time it takes to remove 1/2 of a drug from your system.  To approach 100% drug removal takes about six half-lives.

A biological half-life or elimination half-life is the time it takes for a substance (drug, radioactive nuclide, or other) to lose one-half of its pharmacologic, physiologic, or radiological activity. In a medical context, the half-life may also describe the time that it takes for the concentration in blood plasma of a substance to reach one-half of its steady-state value (the “plasma half-life”)

Things Not To Say to Someone Who Just Completed Hepatitis C Treatment

Now What?

Now What?

  • You were in treatment?  I just thought you were aging badly.
  • Now make sure you don’t get it again (my personal favorite)
  • How do you celebrate without alcohol?
  • How can you be sure you are cured? I’ve heard it comes back.
  • I heard of a guy that went two years then his liver blew up.
  • Some guy finished treatment then killed himself.
  • Can you talk to my husband?  He won’t quit drinking and drugging.
  • I saw a website that says St John’s Wort works better.
  • Want to volunteer at the hospice?
  • Too bad you have to give up your handicap placard.
  • Glad you finished.  Maybe you won’t be such a moody A Hole now.
  • You should have waited for newer treatments.  They are better.
  • Now, shut up about your symptoms.
  • Good, now get off your butt and do something.
  • Now what?

Hepatitis C Treatment Management: What would Mamaw Do? WWMD?

Mamaw and Papaw’s Wedding Day 1916 Livingston KY

The world of Hepatitis C treatment  is more than taking drugs as scheduled and hoping for virus death.  The bigger part is keeping  your body, mind and soul with you.

  • Diarrhea?  Water and Lomotil I guess, that was never my problem
  • Nausea?  Water, saltines and Phenergan
  • Constipation?  Water and stool softener.  Even the name is too gross.  Kinda like mud-butt
  • Mouth Sores?  Water then swish and spit Mylanta.  Happy to spit
  • Food taste like pennies? Water and floss, floss, floss, brush, brush, brush.  Still doesn’t help
  • Flu symptoms for six months?  Water then alternate Tylenol and Advil for six months.  Exercise: yeah, right
  • Rash? Benadryl oral and topical.  Maybe hydrocortisone/vaseline
  • Insomnia?  Ambien if you are lucky.  Benadryl if you are unlucky, it adds to constipation and taste of pennies.  Don’t drink water before bed
  • Depression? Water and SSRIs/SNRIs/antipsychotics/and on-and-on in couplets
  • Too tired to work?   Adderall if  the shaking won’t vibrate your loose screws
  • Can’t go on?  Cry really hard, take Advil, drink water and go on.

My Mamaw had eleven children in Eastern Kentucky  starting in 1917.  There was no doctor, drug store or money.  She lost two baby boys, one to the Spanish Flu.  When she came out of delirium, baby Bentley was already buried.

If an artery spurted, she applied coal soot.  Got a burn?  First well water (cold) then let egg white dry on burn or apply a slice of onion.  Step on a nail?  Clean and soak with turpentine.   Pneumonia?  Inhale kerosene (dosing was tough) through a moist cloth and put a mustard plaster on your chest.  It will kill you or cure you.  I never witnessed this  one.  Croup?  Make a sheet tent over the steam kettle, put in Vick’s and then hold the child under the tent.  If that treatment doesn’t work, sugar with a drop of kerosene. Give a few drops of whiskey if you got it.

a dose of pee

Here’s what applied to us grandkids. Pinworms?  Check rectum at night with a flashlight then give all the kids a stinky medicine that I think had tobacco in it.   Earache?  Warm up pee in a teaspoon a little more than body temp  and pour it in your ear. Stick in a plug of quilting. I would hide in the cedar closet  as long as I could before telling Mamaw.  I made her use my pee.  Here is the thing: it worked. Pee is sterile upon leaving the urinary tract.  Of course I knew nothing of a “clean catch”.  Collection was easier when we got an indoor bathroom.  You figure it out.  When I checked the internet for possible mechanisms of action (MOA) of the pee, there was a claim that urine is an antifungal.  Of course on the internet you can probably find a claim that golf balls extract is good for an earache too.  I made that up.

Mamaw’s rocker and sock monkey

What would Mamaw do about Hepatitis C treatment management?  Probably just rock me and say “Doggone it.  It’ll get better.”    I have her rocker in my house.  It sure is smaller than I remember.  Anyway,  it doesn’t really work without her.

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

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

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

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