Simeprevir deaths?

[Sarah1949]

Have you all heard about the three deaths in Japan attributed to Simeprevir Sodium? Do you think this is the same as the Simeprevir (Olysio) here in the States?

"According to the Ministry of Health, Labor and Welfare, taking the drug will increase "bilirubin" by decomposing hemoglobin in the blood and may aggravate dysfunction of the liver and kidney."

http://www.globalpost.com/dispatch/news/kyodo-news-international/141024/3-die-after-being-administered-hepatitis-c-drug

[picolax]

having read through the chemical formulation they are as near as dammit the same drug. maybe there was some dropping of some of the esters due to asian genetic intolerance of ethyl alcohol (which in itself may bring up questions about genetic intolerability e.g il28b differences, simeprevir doesn't do 40% of G1a, etc ) but they are generally there for absorbtion. the question raised is is it due to racial genetics or problems with the drug. Dosage wise they generally build a prescribed dose based on average population weight.
as someone said earlier, monitor, monitor, monitor.
these drugs are good but they are not the easy treatment the companies are selling them as to justify their extortionate prices

[Dee1956]

I love that! :)

We stand on the shoulders of giants!

So inspirational

[hepcandme]

One final thought from me

Though the numbers may sound optimistic, it's a whole different ballgame once a person becomes ill. It's not the Hep C that kills, it's the cirrhosis and the cancer and so many other complications that are caused by Chronic HCV.

On a very personal level, I have known 5 people who died from complications caused by Hep C in the last 2 years!

These people were very dear to me. They died much too young. Even if one decides not to treat, wouldn't you want to live the rest of your life (however long or short) feeling well, being active, lucid and enjoying your life without pain? Maybe enjoying a good night's sleep? Not feeling like you have run a marathon every single day?

Do some research about what it is like to die of ESLD. It's not pretty, it's not painless. I'm ready for a cure and I feel so fortunate that so many people took a chance on treatments that were simply awful and had very limited success rates so that new regimens could be developed

We stand on the shoulders of giants!

[Livelife777]

Just adding my 2 cents to this discussion.
Yes, it takes years and even decades for the virus to do its damage.
The issue with that is once you reach a certain degree in the disease process, there is a period of acceleration in which the virus rapidly destroys our liver and decompensation leaves little choice other then a transplant.
No, don't believe we should panic and not thoroughly investigate our plan of action,  but we should rationally do our research and make informed decisions based on whats right for our individual situation.   That's the only thing any of us can do.

What other options do we have at the moment?
.....Kim

[flyinlynn]

Oh sure they have the luxury of time absolutely. I just think they should be treated as some point before they possible develop complications.

If I was still healthy sure wait a year. But I would still want to get rid of hep c to make sure I don't have troubles down the road.

My thought is if you have hep c you should try to get rid of it. But for people with only F0 F1 yeah they can wait a little while. Early hep c is not an emergency.

[Sarah1949]

I don't think it will hurt a healthy young person diagnosed with HCV with no symptoms to wait a year in order to see if there are any serious repercussions from these new drugs. However, I am very cautious when it comes to any new treatment.

[flyinlynn]

Good info there about the FDA

Yes they can only try their best. Especially as we keep cutting down their staffing.

The FDA has a huge mission if you think about it. Check new drugs. Invettigate both over the counter reported problems and well as prescription drugs to ensure medical consumer safety. Tylenol excedrin etc?

Also the have inspectors checking food processing facilites and having recalls of food products from salmonella concerns to products accidently contaminated with nuts and not labeled posing a danger to the allergic people out there. To I am sure humdreds of other problems.

So I have a great respect for those FDA workers out there but they are only human as well and there are only so many mant hours a day to get the missions they are tasked with done.

Just my thoughts
Lynn

[flyinlynn]

Hi
Your question to me

"In your search did run accross that eastern Asians require a different medication because thier body requires a different treatment of the same thing?"

My search was a farily simple on just Olysio Sovriad. The first hit is the jnj press release. I did not try to see about the different doses for Japan vs US and Canada but that is a curious thing indeed.

I dunno I am not a research scientist I guess. Just a blue collar kid.

Lynn

[flyinlynn]

Just to chime in

I have had hep c probable since 1977 and was diagnosed with cirrhosis in Jan 2008. So my odds of HCC are about 20% every year.

Basically ever since I was DX with cirrhosis I have had new symptoms come around every year it seems.

So yeah hep c has take it slow course but I am now at risk of early death or transplant if I am lucky enough to get one and survive if I do get to the point of total failure or HCC.

Personally I think 56 is a little too young to die and if these new drugs can save my live I will be indescribably grateful to the scientists who found these new drugs.

Not being gullible to corporate advertising in the least.

About the newly diagnosed folks who have no liver disease are you suggesting they should walk around with a potentially live altering virus that has you thinking about the dangers of infecting your family and if single wondering if you are safe to even start a relationship? Also how would a person you would like to get to know romantically react to a person with the virus?

Why carry that load on your shoulders when you can be cured and put hep c behind you and go on with your life?

What wouild be an informed reason to not be treated especially as a very tolerable cure for most is at hand? Because we shouldn't be afraid of hep c because it takes a long time to harm us? Once you do have liver damage we are harder to cure even with these new medicines.

Personally for me I can see no reason to not be treated early so you never will have to deal with these issues.

Best of luck to all
Lynn

[hrsepwrguy]

Wow, I didn't mean to get that started, just to be clear, I was borderline cirrhotic, treated with incivek, inf and riba for 48 wks and would do it again in a heartbeat to beat this nasty virus

[AWorriedMom]

Five percent of 5 million is a huge number. Just sayin'.

[AWorriedMom]

Fasting in people with liver disease (and just because the virus is gone does not mean the liver is healthy) can be dangerous. Please DO NOT fast without the guidance of your gastro or hepatologist. None of us here are doctors, including myself, but it is always prudent to be safe rather than sorry.

[HopeInPA]

scottie24, but have you tried fasting? I believe, fasting 24-36h once a week, every week if possible, will help a post-treatment syndrome like you have been experiencing. This situation has to do with epigenetic changes that strong drugs like interferon and rivavirin can induce, especially if they are taken long term --- and for the rest of us, on the newer SOC, it's worth remembering that, even though they significantly cut the length of treatment, drugs like Sovaldi or Olysio are known to mess up mitochondria; and mitochondria toxicity can leave an array of lingering problems of its own.

After adopting this sort of weekly 24-36h fasts and becoming comfortable with them, one can try a longer fast. Long-term fasting, when done right, will reboot the immune system, get rid of autoimmune issues, clean up the cells from junk, fix mitochondria -- in short, rejuvenate.

However, those who have not yet achieved their SVR should NOT fast more than 24-36h once weekly, because HCV exploits the cell repair mechanisms that are activated during a long-term fast for its own replication (this leads to increase in viral load).


Now that I have completed the treatment and got my SVR 12 weeks EOT,  I'm planning to fast to get rid of the lingering issues left by the treatment. You may want to consider doing it, too. If so, make sure to start with once-weekly short fasts and proceed very slowly.  

[Sarah1949]

Scott, actually I was only speaking for myself. I've had hcv for around 40 years and cirrhosis for a few, at least 2-3. I never seriously considered tx until this year. I never have, and still don't, trust these drugs but I'm out of waiting time.

[hepcandme]

Well, that depends on how sick you are Scott

Most of us Did live with HCV for many years - decades even. And then HCV took over our health and our lives

We are here because we are sick and some are quite ill. It's not like thinking about getting a nose job. For us, it really is a matter of life and death.

Many of us feel sick all the time. HCV has affected our lives immeasurably and for those whose livers have been severely damaged by Hep C, there are no options but a liver transplant

And for those lucky enough to receive a transplant, unless they are also cleared of HCV, the virus attacks their new livers!

http://www.liverfoundation.org/patients/organdonor/about/

So, for those whose lives and the lives of those who love us, this is critical and we feel overjoyed that finally there are treatments that will cure us

We're not gullible, we are looking for a cure

[scottie24]

"…  to me unless I get rid of the hcv then I will die from the hcv."

The corporate marketing teams get an A+!!!!


In reality, the odds of dying from untreated Hep C are very low, especially if you maintain proper body weight and live a healthy lifestyle.   Read even the marketing materials for Sovaldi - they now disclose CDC estimates of 1 - 5% max death rate. Other retrospective studies disclose less than 4% rates of cirrhosis in normal body mass index women 35 years after exposure, about 24% in obese women.  These are women who never knew they had it, who drank, partied, etc.  for 35 years.

Cirrhosis does not instantly mean death.  If you're 70 when you finally get cirrhotic, so what?  It doesn't mean your liver is dead. 10 - 15 year life expectancy.  Diabetes or stroke or heart attack or Alzheimers or car wreck or something else gets you first.

I had Hep C and was never scared of it.  Was strong as an ox, healthy, living life, full of stamina.  Got the (now proven false) 70% cure rate pitch for INF / RVN for Genotype 2, and "six months of fatigue."  Pressure fro family. Treated.

I have literally been fighting for my life ever since treatment.  My platelets were 150,000 3 months before treatment.  They have been below 100,000 since, and usually around 80,000.  I have been in the hospital twice and wracked up $125,000 in hospital bills from bizarre septic infections (platelets at 20,000 then - blood oozing from my mouth).  I have had one autoimmune disorder after another, and the latest one (vasculitis) appears that it will either take my leg or my life.  I am praying for remission.  It is terrifying.  All the while trying to keep shelter over my head and food in my belly and not getting despondent.  And I omit a whole slew of terrible other things that I went through between then and now.

I don't where people get this idea that HCV means death.  It's simply not  true  I know you prefaced it with "to me,"  but the statement that "Hep C means death" is used to convince people to treat and it is simply not a true statement and should not ever be taken at face value.

You know, you can go look at Genentech and their job postings and they seek PhD psychologists to help them create marketing campaigns for their drugs.  They have legions of really smart, talented people figuring out how to scare us, and the doctors.

[scottie24]

From the amicus curie brief of former FDA Commissioners Dr. Donald Kennedy and Dr. David Kessler, in the 2013 US Supreme Court case of Mutual Pharmaceutical v. Bartlett:

"In recent years, study after study has documented severe limitations in FDA’s ability to ensure drug safety, as this Court recognized in Wyeth v. Levine, 555 U.S. 555, 578 n.11 (2009). The studies include:

• The Institute of Medicine of the National Academies, Ethical and Scientific Issues in Studying the Safety of Approved Drugs (May 2012);

• Institute of Medicine of the National Academies, The Future of Drug Safety: Promoting and Protecting, the Health of the Public (2007) (“IOM 2007 Report”);

• FDA Science Board, FDA Science and Mission at Risk: A Report of the Subcommittee on Science and Technology (2007) (“FDA Science and Mission at Risk”);

• GAO, Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process 5 (GAO–06–402, 2006), http:// www. gao. gov/ new. items/ d 06402. Pdf."

[dontworry_behappy1]

In your search did run accross that eastern Asians require a different medication because thier body requires a different treatment of the same thing?   It has to be different because they don't have the same chemical make up.   Just like 40% have a intolerance for alcohol.   Unlike thier western brothers.  

[hrsepwrguy]

They do but they don't seem to do anything in a hurry, it took them over a year to change the on box warning for incivek

After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

    unexpected and undesirable side effects
    quality problems, such as a drug with an unusual odor or color, or a device with defective parts
    unclear or confusing instructions
    failure to deliver the expected benefit.

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

    Online
    Regular Mail: Use postage-paid, pre-addressed FDA form 3500
    Fax: 800-FDA-0178
    Phone: [phone]

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.

Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm335899.htm

[Sarah1949]

This is all such a puzzle to me. It seems like everyone assumes the FDA keeps track but I really do not think so. How could they? I guess it's the kind of thing that if something goes seriously wrong it comes out in the wash. Ah well...

[hepcandme]

Hey Ruby

I found at a support group meeting that insurance companies do not even share their data with one another!

That is so crazy to me. In the same city, the same drugs, similar patients and they are keeping the data to themselves?

That's not good science

[Sarah1949]

I suppose the bottom line for me is that even IF the two should be the very same drug and it did indeed cause three deaths, would I still treat with it. Yes, I would because to me unless I get rid of the hcv then I will die from the hcv. I just don't understand why people want to take these drugs without seeing how they affect people over the long haul, or at least a year or two, unless they already have cirrhosis. If I were healthy and newly diagnosed with the virus, really, what would waiting a year or two matter?

[flyinlynn]

The thing I am having trouble with is from what others have found Sovariad and Olysio apprer to me different chemically but yet I have found on Johnson & Johnsons / Janssen press release

http://www.jnj.com/news/all/OLYSIO-simeprevir-Receives-FDA-Approval-for-Combination-Treatment-of-Chronic-Hepatitis-C

"Janssen is responsible for the global clinical development of OLYSIO™ and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for OLYSIO™ in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved in September 2013 in Japan under the trade name SOVRIAD™ and in November 2013 in Canada under the trade name GALEXOS™ for the treatment of genotype 1 hepatitis C"

and that originally Janssen asked for approval of Olysio under the name Sovriad but were not approved by the FDA due to concerns Sovriad might be confused with Sovaldi

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000NameR.pdf

So I am confused from what I have read at the FDA site and Janssen ir seems like only a name change and that for what wver reason the went with a lower dose in Japan. But then some of the chemical information folks are bring up do seem to be in conflict with Janssens press release.

So I have given up trying to figure out this one and just go with be careful out there folks. These are potent meds no matter what they are called and we should all be aware of that when treating.

Hope we all get to say we are free of hep c one day
Lynn

[dontworry_behappy1]

Great answer Dee.   Makes it easy for everyone to understand.  Very direct and to the point.  

Best to you