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

 

 

 

 

 

 

 

 

HEPATITIS C: THE HAPPY-EVER-AFTER ENDING

Happy Ever After, Mostly

Happy Ever After, Mostly

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

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

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

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

Guidance for Insurance Carriers Also

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

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

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

 

 

Hepatitis C: More Affordable Treatment Possible

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

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

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

Good Bye everyone, thanks for your support.

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

www.HCVguidelines.org  Give this to your physician

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

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

 

 

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”)

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 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.