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

 

 

 

 

 

 

 

 

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.

 

 

My Teeth? The Least Of My Hepatitis C Problems…

RottenTeeth

Face it, a lot of my peeps with Hepatitis C have bad teeth. If you have a drinking or drug problem, hygiene may be low on the  daily living list.  Yet before treatment for HEP C, the medical team encourages you to catch up all systems.  So, maintenance for eyes, lungs, naughty bits, you get the idea.  I didn’t have big concerns because I was current on all systems, having been clean and sober a quarter of a century.  Treatment HO!

Well, Hep C treatment affected my priorities.  I was so sick.  Daily I was just trying to stay on the planet,  hoping gravity didn’t take a holiday. I didn’t care at all about my grooming, cleanliness, appearance, or anything that healthy people care about.

And my teeth? I have been a nut about dental hygiene since discovering dental floss at age twenty-one. I come from a long line of false teeth people cleaning between teeth with match book covers. Yuck. I never saw a dentist until I was fifteen. Dr. Ache, yes that was his name, removed an important molar (aren’t they all?)

In treatment I tried to keep up dental grooming but sometimes it was days between flossing. Since I rarely ate, it wasn’t a big deal. But, one thing I didn’t consider was that my mouth was always dry even when I drank liquids. So here I am one year after treatment and my dentist is having expensive talks with me about teeth and gum line issues. Not gingivitis, existing dental implants (from lack of pediatric dentistry).

HEPATITIS C AND DRY MOUTH:

Many drugs cause dry mouth including Hep C drugs and antidepressants.  So what?  Saliva is essential for keeping your mouth clean and lubricated.  Saliva contains enzymes that flush away food and odor-causing bacteria.  So what? A dry mouth is a marvelous arena for bad breath, cavities and mouth infections. Symptoms include:

  • Dry mouth (duh)                                           
  • Cracked lips
  • Difficulty swallowing
  • Difficulty eating dry food
  • Altered sense of taste
  • Plaque, decay, gum disease
  • Sores or cracks at corners of mouth
  • Sore throat
  • Oh yes, increased risk of head and neck cancer

Harsh terrain

Remembering to sip water every fifteen minutes was out of the question, so I sucked on sugar-free hard candy and chewed sugar-free gum.  Obviously this didn’t save my oral cavity.  My dentist says I have a geographic tongue.  I will leave that statement alone.

Okay I have created a new entry for your list of “Shit that doesn’t work“.  Now what?

GlaxoSmithKline claims to have the elixir for all your dry mouth angst.  Biotene is a triad of gel, mouthwash and toothpaste.  My dentist gave me a sample of the triple threat. My experience has been short-term relief, maybe that is the best Biotene can do.

BTW, it has been over a year since treatment but I am still on antidepressants and still have a dry mouth.  Dang.

http://www.biotene.com

http://www.nuvorainc.com/salese

http://www.medscape.com/viewarticle/813283

http://www.hcvadvocate.org/hepatitis/hepC/hepatitis_coordinators.html

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

For You New Guys: Now What?

I wrote this article for www.hepatitiscnews.com.  Visit their site for more information.

You have hepatitis C (HCV) and have only heard scary things. Your best friend is knowledge, not just facts. It is no good to just bring your liver to treatment. You must bring your mind as well.

Quit drinking or taking drugs? If not, come back when you do.

What to learn:

Doctors: Your insurance will pay the same amount for a hepatologist or a gastroenterologist. Go for a hepatologist. All he thinks about is the liver.

Treatment Lingo: Learn it. This language is the only way you have to talk with your treatment team.

  • VR: Viral load - number of viruses per ml of blood is written      in logs
  • Log: simply a way to not write all the zeros in a number. 1,000,000 is 1 million viruses per ml of blood, is 6 logs
  • RVR: Rapid Virologic Response - hep C undetectable at week 4 of  treatment
  • NR: Null Response – no decrease in virus at week 12 of treatment
  • PR: Partial Response – small decline in virus at week 12 but still detectable at week 24
  • SVR: Sustained Virologic Response – undetectable virus 6 months after treatment completed. The goal!
  • Genotype: Most people in the US are Genotype I. Learn yours. Treatment choices are based on genotype

Depression: If you are like me and inclined toward depression, ask your doctor if you can start antidepressants before treatment. It’s easier to get ahead of depression than try to catch up to it. This can make the difference between completing treatment and not.

Available Treatments: Currently the standard of care (SOC) includes Interferon, which is harsh. Soon treatments will be available without Interferon. Can you wait? Talk to your doctor. All treatments include at least 2 drugs to attack the virus at two different sites in the life cycle (think of killing fleas on your pet).

flea life cycle

Another approach: I am a scientist as well as a treatment success. Here is what I did and why: I looked up clinical trials in my city at clinicaltrials.gov. I found a research site and participated in trials there.

The advantage: Newest treatments and a team focused on my health with close monitoring of my whole body, not just my liver. All treatment is free and you can opt out if you don’t feel comfortable.

The disadvantage: You must commit to follow the protocol. My first treatment drugs were SOC and didn’t work so I went through treatment again. But, this was successful and I am cured!

One note of warning: They are researchers and so they don’t know all the answers to treatment outcomes. Phase III means that many patients have experienced this drug and more is known about safety. Phase II means the drug has only been in a few humans, so less is known about safety. I suggest only participating in a Phase III trial if you aren’t comfortable with the unknown.

I wish you the best and suggest taking it one day at a time.

on the farm

on the farm