Fibrosis Testing; New Options On The Way

There is a lot of jargon in here, hang with me.

Now about Cirrhosis: You have Hepatitis C and your doctor wants to check your liver for damage

The gold standard for diagnosis is a liver biopsy. This procedure takes place in the hospital. While you are under a local anesthetic, a physician uses a needle with grabbers to remove a tiny sample from your liver. Once the biopsy is completed the patient must lay flat for 6-8 hours to confirm a lack of bleeding, then go home and do nothing strenuous for days.

The sample is studied by a pathologist to assess liver scarring (fibrosis). While liver biopsies are invasive and do have inherent dangers (excessive bleeding, infection, hypotension), they also have variable results, depending on who is reading the results. It is better to have two pathologists study the specimen but this isn’t always practical.

There are promising alternative tests. New tests can assess the severity of the fibrosis in individuals at high risk of developing liver cirrhosis (e.g., chronic alcoholism, chronic viral hepatitis). These tests include breath testing, blood tests, and imaging techniques.

  • Ultrasound initially showed 94% accuracy, but that score has been downgraded. But in the US it is cheap and widely available
  • Ultrasound with contrast media is about 79% accurate but contrast media is expensive and not always used in compromised livers
  • Doppler checks the blood flow through the hepatic vein. This shows overlap of staging cirrhosis and therefore not a good choice
  • CT Scans look at the whole abdomen so subtleties can be missed
  • MRI has an accuracy of 80-89% but requires a high level of technique which is not always available clinically and is expensive
  • Biomarkers can establish cirrhosis and non-cirrhosis but not grades of scarring
  • Biomarkers: Indirect
    • Fibrotest is useful in diagnosing and grading fibrosis. This test has established measurements and may be used in place of a liver biopsy for patients with Hepatitis C
    • FIB4 uses a panel of biomarkers and can also be used instead of liver biopsy.
  • Biomarkers: Direct
    • HA (hyaluronic acid) normally occurs outside the circulatory system but can be evaluated by update in scarred vs normal livers. Scarred livers leave more HA behind while normal livers convert more to remove it from the blood.
    • PIIINP and PIINP
    • TIMP-1
    • YKL-40

All the tests listed above have varying degrees of accuracy but liver biopsy is still the standard for staging of scaring (fibrosis).1

Symptoms

The early stages of cirrhosis often produce no symptoms. As scar tissue replaces healthy cells, the liver begins to fail, and symptoms may become evident. The severity of symptoms depends on the extent of liver damage.

Because the liver is crucial for many metabolic activities, cirrhosis impacts a wide range of the body’s functions, including nutrient and hormone metabolism, blood clotting, and processing of ammonia and other toxic wastes. Many of the symptoms of cirrhosis are directly related to disruption of these functions. However, most of these symptoms can also be caused by other conditions, so it is important to consult with your doctor if you experience any of these symptoms, particularly if you have risk factors that increase your likelihood of developing cirrhosis.

Early symptoms of cirrhosis include:

  • Fatigue and weakness (related to anemia and altered nutrient metabolism)
  • Poor appetite
  • Depression
  • Nausea
  • Weight loss
  • In men: A decrease in liver metabolism can contribute to: Impotence; Reduced testicle size; Enlarged, tender breasts; and/or Loss of interest in sex—due to altered liver metabolism of sex hormones
  • Small, red spider-like blood vessels under the skin—caused by increased pressure in the tiny blood vessels due to liver congestion
  • Increased sensitivity to drugs—due to reduced ability of the liver to inactivate them

Symptoms become more pronounced as cirrhosis progresses. Later symptoms, some of which are due to complications, include:

  • Reddened or blotchy palms
  • Sleep disturbances
  • Ulcers
  • Fever and other signs of infection—due to altered immune function
  • Peripheral neuropathy
  • Frequent nosebleeds, skin bruising, or bleeding gums—resulting from decreased liver synthesis of clotting factors
  • Ascites —water retention and swelling abdomen caused by obstructed blood flow through the liver and reduced synthesis of the protein albumin
  • Bacterial peritonitis—infection of ascites causing abdominal pain and fever
  • Itching—caused by deposition of bile products in the skin
  • Jaundice —yellowing of the skin or eyes due to build-up of bile pigments (bilirubin)
  • Vomiting blood—due to swollen veins in the esophagus that burst
  • Encephalopathy and coma—mental changes, including forgetfulness, trouble concentrating, confusion, and agitation, caused by the build-up of ammonia in the blood
  • Decreased urine output and dark urine—caused by kidney dysfunction or failure
  • Liver cancer

This is an extensive list of symptoms but not complete. Each person is different. Remember that by taking care of your liver, some damage is reversible.2,3

  1. World Journal of Gastroenterol. 2014 Dec 7: 20 (45).
  2. American Liver Foundation.
  3. National Library of Medicine.

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. 

Hep C Treatment: Do We Or Don’t We? And Who the Hell Does Egypt Know That We Don’t?

I’m going to  ask you to hang with me on this one.  It is a lesson in pharmaceutical pricing and what your insurance will/can pay. Medicaid can’t! 

I worked in Big Pharma Research and Medical Affairs for a quarter century.  So? I see pricing strategies for Hepatitis C treatment compounds and they will affect you.  Let’s look at:

  1. Pricing Strategies for Big Pharma, and they DO have one for who, how much, and how long
  2. How some get to bypass this pricing strategy entirely
  3. Why patients will unnecessarily suffer with this curable Hep C

These days you can’t swing a cat without uncovering a new treatment on the horizon!  Good! Right?  Mostly.  Big Pharma competitors have a short time on top and intend to make  as much profit for stakeholders (stock holders)as possible.  It is the job.

Remember when Vertex launched Incivek (telaprevir) fourteen months ago?  First new drug in forever.  All new patients were given Incivek along with the standard cocktail of Interferon/Ribavirin.  Vertex was the new darling in hepatology, for a year. Sales went from $76.1 Million Q 1 2013 to $44.3 Million Q 4 2013. Now they have dropped out of Hep C research because there is a new rock star launch; Gilead Sciences with Sovaldi (sofusbuvir).

“Record sales of a new hepatitis C drug, Sovaldi, pushed the first-quarter earnings of Gilead Sciences far beyond expectations, the company reported on Tuesday, Sovaldi (sofusbuvir), the company’s $1,000-a-pill medicine to treat hepatitis C, had sales of $2.27 billion in the first quarter, the company said in a statement. That beat an average of analyst estimates by more than $1 billion. The Foster City, California-based company also reported profit excluding certain items of $1.48 a share, beating by 56 cents the analysts’ average estimate (GILD:US). (Yes that is Billion not Million.) The hepatitis C sales are “above even the high end of buy-side expectations,” Mark Schoenebaum, an analyst with ISI Group LLC in New York, said in a note to clients. He called it the best drug introduction in history. Gilead, the world’s biggest makers of HIV drugs, yesterday reported total first-quarter revenue of $5 billion.

Gilead is awaiting U.S. regulatory approval of a two-drug combination with Sovaldi that does away with shots that boost the immune system, yet produce side effects. Company executives said they are aware of the price criticism and the sustainability of spending on the drug. “There are natural limits on what I think is appropriate for next generation products,” Chief Operating Officer John Milligan said yesterday on a conference call.”

 

“If cost were not a factor, we would want to treat the entire population,” said Dr. Rena Fox, a professor of medicine at the University of California, San Francisco. She said it was frustrating that “we finally get this great treatment and then we withhold it.” 

Ah,  my point exactly.

And then there is Egypt. Yes that Egypt.

On March 12 the Egyptians declared  that negotiations between the ministry and the American company were successful and Egypt will obtain the drug for only 1 percent of its price internationally, according to Al-Masry Al-Youm. Adawy, Minister.  The price of a one-month prescription in Egypt will cost $300 while in the U.S. it costs $28,000 a month. (Yes that is Hundred, not Thousand).  The full course will cost $13,000 instead of the $168,000 it costs in the U.S.. They agreed to support making hepatitis c a top priority and to intensify efforts to provide the required medicine at “affordable prices”. According to Reuters, Gilead said on March 22 that it was “pleased to have finalized an agreement” to provide the cure to Egypt, one of the countries with the highest rate of hepatitis C patients.

 

 

May 6, 2014:  Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir) for Once-Daily Use in Combination with Sofosbuvir for 12 Weeks for the Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C. AbbVie, Merck, Bristol-Meyers-Squibb and Johnson & Johnson have potential treatments on the horizon. This is why Gilead is gouging now.  Big Pharma calls it recouping research money. Some is profit too.   It’s all perspective.  Which a Hep C patient is sorely missing.

I shit you not. Thanks for hanging with me on Big Pharma Pricing.  Now you can teach MBA students.  I am feeling powerless though.  Maybe you know someone in Egypt.

One last thought:  I am clear of Hep C Virus after two years and I wish this for you.

Go see my friends at http://www.hepatitiscnews.com  They have great helpful news all the time!

hcvnewdrugs@gmail.com

 

http://www.businessweek.com/news/2014-04-22/gilead-beats-hepatitis-c-sales-estimates-by-1-billion

 

http://www.fiercepharma.com/story/vertex-profits-one-time-gain-despite-plummeting-incivek-sales/2014-01-29

 

 

 

 

 

 

 

 

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 Research: What’s a Phase and How Can We Get through it Faster?

Hepatitis C:  Current Research Drugs

Picture your liver at the center of the Milky Way. Now, the swirling stars are treatments, some closer than others.  Drug studies are in orbit like this.  Work with me here.

Your Liver = Center of your universe.

Illustration of the Milky Way by Dianna Marquee

Illustration of the Milky Way by Dianna Marquee

Filed = Closest stars, drugs waiting on FDA approval.  The red tape wheels grind on.

Phase III = Next out, drugs being tested large-scale for safety and efficacy.  Will the virus die before you do?

Phase II = Further away from your liver, drugs shown not to kill  people when tested on a small group of sick patients. Cohort is the word.  This was me during round two of treatment.  Kind of risky here.

Phase I =  Compounds (drugs) that don’t kill healthy people crazy enough to volunteer (broke students and new parolees)

Preclinical =A blur of solar dust = test tube, computer chemical structuring, animal studies. Yep, animal testing.

When I was first diagnosed in 1991 with Hepatitis C, there was only one binary star, Interferon and Ribavirin.  Finally in 2011  came Telaprevir  and Boceprevir. That’s a long time between hits, 20 years.  Now the Hep C universe is almost getting crowded, but not yet.  The issue is safety and timelines.  The barbaric days of Interferon could be phased out (pun intended).

Phases of  Current Drug Research:  Thanks go to Dr Paul Kwo for this slide

Paul Y. Kwo, MD, is Associate Professor of Medicine and Medical Director of Liver Transplantation in the Gastroenterology/Hepatology Division of Indiana University School of Medicine in Indianapolis

Paul Y. Kwo, MD, is Associate Professor of Medicine and Medical Director of Liver Transplantation in the Gastroenterology/Hepatology Division of Indiana University School of Medicine in Indianapolis

So, this slide represents current studies, phases  and the mechanism of action (MOA).  Remember that we want at least two drugs with different MOAs in our bodies to avoid virus mutation and resistance.  The good news is that there are multiple drug candidates in each category.  For further information on any study, go to www.clinicaltrials.gov and enter the drug/compound name.  This site will also tell you if the study is enrolling patients and if there is a location close to you.  This website rocks.  Thank you federal government.

The US research system is business-based, where competition for the patent drives the process.  I’m not completely opposed to this system.  But it does have drawbacks.

Remember when AIDS researchers were competing to isolate the culprit?  France and the US,  it was crazy.  The two groups still argue about whom was first with what.

The HBO movie And The Band Played On documents government and cultural barriers to a disease connected with a cohort that isn’t mainstream, i.e. HIV and homosexual men.  I’m glad the barriers came down a bit faster with Hep C.  Initially the cohort was alcoholics and drug addicts.  But then the target audience became baby boomers.  This was 1. More acceptable and 2. A bigger pool of patients and potential profit.

Obviously the slide above is the star of this blog.    Drug companies race to be first with a new drug(s).  So why am I speaking of other things?  Because I think the days of working in a research vacuum are limited.  American drug companies say this is bad.  They claim without financial incentive, research will dry up.

But, wouldn’t it be great if companies worked together and combined research efforts?  I know, that is a big but.  I like big buts…There are novel initiatives include partnering between governmental organizations and industry. The world’s largest such initiative is the Innovative Medicines Initiative (IMI), and examples of major national initiatives are Top Institute Pharma in the Netherlands and Biopeople in Denmark.  In the USA it could be the National Institutes of Health (NIH).  We used to joke that NIH meant “Not Investigated Here”  meaning that the USA insists on its own research.  Only science types would joke about such topics. No wonder we have a reputation.

Paul Y. Kwo, MD, is Associate Professor of Medicine

Paul Y. Kwo, MD, is Associate Professor of Medicine

Now picture these studies sharing data.  Think of all the time and patient suffering saved by quickly identifying drug-drug and drug-disease interactions.  Think about how the winners would rise to the top.  I don’t care about the political/social overtones.  I am just thinking about patients. This is already happening with cancer research.

I have worked on this blog for a week and still can’t get it right.

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

http://www.chronicliverdisease.org/COEE/index.cfm?id=PKwo

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

http://voices.yahoo.com/a-summary-film-band-played-on-127287.html

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

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

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

Snoop Dog, Come On Down!

Don't forget to spay and neuter your petsBeing in bed 24/7 without the ability to lift your head will cause your brain to accept the unacceptable…Reality TV Shows.  I began to watch them as though watching a poorly rehearsed train wreck.  In horror, I couldn’t look away.  At first it was a Project Runway  seven-hour marathon which I slobbered and dozed through.  Then Yard Crashers/Bath Crashers/House Crashers/Income Property/Dear Genevieve/Run My Renovation (RMR).  I even submitted to RMR on line…But they don’t really send out cute Joni.  In fact they don’t do anything and that is good.  I can’t imagine a reality show at my house with me on hepatitis c treatment. ” Hello, pretend the camera’s not in your face and tell us how happy you are with your new environment friendly parrot poop kitchen.  The newspaper floor’s recyclable”.

Going through hepatitis c treatment is sort of like going through labor.  There would be zero population growth if women could remember the first one.  I have one child.  She was born full breech.  I remember.  So why go through a second round of hep c treatment?  Fear of the pain of a cirrhotic death.  Again pain avoidance.  I can’t believe I used the old “going through labor”  analogy.  I hate it when women do that.  I won’t even have lunch with those women.  Shut the Fuck Up!

I had lofty dreams for this down time: learn Spanish, keep a diary, write a book, plan a big trip, read a couple of classics, walk every day, meditate.  What was I thinking?  That I was just gonna have a fractured spine?  I’ve had that and got back on the horse, no shit.

DIY: I couldn’t do shit but got it in my head that my bedroom needed french doors, the living room color was too dark (Osso Buco) and the dining area needed a skylight.  I hated the bed sconces, was sick of the plaster patch on the ceiling and the thumping ceiling fan.  All must be fixed right now (I know, redundant).  Even in the best of health, I cannot do anything myself. My dad told me years ago, when I was trying to help him remodel my house “Good thing you went to school”  Truer words were never spoken.   Poor Spanky tried to explain the error of my crazy thinking process without me going straight to sobbing.  I have no  explanation for the sobbing.  Except to say that my every emotion could and would leap tall logic in a single bound.

Cooking shows:  I watched them and it looked so easy.  Giada, Ina, Nadia G’s Bitchin’ Kitchen (my favorite because it is a comedy too), Top Chef, Chef Roble, Chopped, Chopped Champions.  I couldn’t watch Iron Chef, too many moving parts.  Why would I watch cooking shows when I couldn’t stand the taste or smell of food? I don’t know.  I dropped 20 pounds and never moved.  Basal metabolic rate.

I couldn’t watch my favorite game show,  Jeopardy.  I felt like I stroked and couldn’t find my answers.   Couldn’t watch  The Daily Show with Jon Stewart.  It required knowledge of current events to get the jokes.    Couldn’t watch movies with a story line.  The Marx brothers were good but again too many moving parts.  I found myself watching Ice Loves Coco with Ice T (my personal bottom)  and The Price Is Right with Drew Carey. I shit you not.   Drew Effing Carey!  Snoop Dog was on for his charity.  That man knew the price of everything from Zesta saltines to a Harley.  He won $75K for an old lady.  I think she shit herself on stage.

How did I get from “I don’t watch TV” to “The Price is Right”?

Yep, Snoop Dog on Price is Right. I thought it was the drugs

How did Drew Carey get from here to The Price Is Right???

 

 

 

 

 

I couldn’t read, the books were too heavy and my concentration too light.  During the second treatment I listened to books on tape.  The important issue was the sound of the reader’s voice.

At the kids section of the library I got books  on how to draw.  I sat in bed and drew dinosaurs, flying squirrels and bunny rabbits.  I drew the two trees in the pasture through our three seasons.  Then with the drought last year, I drew them dead.   My art work was terrible,  but that wasn’t the point. Since my analytical brain was pithed, I went to my dormant-since-five-year-old creative brain. I now have a closet full of art stuff/supplies and I like it. I never show my stuff to anyone but Spanky.  He never judges.  He calls me an artist. It makes me squirm. I hung one painting on the wall (on a push-pin) but not where folks would notice.  I still listen to books on tape a lot.  Still can’t sleep.

Don’t forget to spay and neuter your pets Bob Barker.  BTW, turns out Drew Carey has a blog.  Don’t we all?

en.wikipedia.org/wiki/Ice_Loves_Coco

http://bitchinlifestyle.tv/

http://www.drewfromtv.blogspot.com/