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

[flyinlynn]

I did find this info don't know it it is the same you are referencing

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371623.pdf

Deaths:

Four deaths were reported in subjects receiving simeprevir in the pooled Phase 2b and Phase 3 analysis (including the C205, C206, C208, C216, and HPC3007 trials). The reported causes of death included the following: 1) bacterial meningitis and brain hemorrhage; 2) colon cancer; 3) presumed cardiopulmonary event; 4) bilateral pneumonia and septic shock. No deaths were reported in the Control arms. In each of these cases, the subject’s death was judged unrelated to simeprevir by the investigator. The Division concurs with the judgment of the investigators in these cases.

So although these people dies it looks like it had nothing to do with Olysio

[Dee1956]

Hi there, I did some searching and found that for people of Aisian-Pacific descent the does of simeprevir should be reduced.  It is in this article though I had to read most of it to find it.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371623.pdf

[hrsepwrguy]

They are not the same drug, follow the links

http://www.medhelp.org/user_photos/show/510276?personal_page_id=2257209

http://www.medhelp.org/user_photos/show/510275?personal_page_id=2257209

[Dee1956]

I'm sorry it is made by the same manufacturer I just assumed that it was the same but made for that specific population. You know what happens when you assume :)
I am sorry I did not see your post before I replied.
In my zeal to help my foot is often in my mouth
In fact I often say "my heart is on my sleeve, foot in mouth"
Thank you
Dee

[AugustineMama]

I will just add this. My t.bilirubin went to 2 from 0.9, then down to 1.7, then 1.4, and now back up again. They told me it was normal, but thank god I only have a few days left.

[flyinlynn]

OK I did find something on J & J (Janssen) site

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

excerpt

"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. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of OLYSIO™ for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with OLYSIO™ in clinical trials."

So it does look to me that OLYSIO = GALEXOS = SOVRIAD

I also found on the FDA site Janssen applied under the name SOVRIAD but the name was not approved due to potential confusion with other drugs. See paragraph 1.1

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

[Sarah1949]

I was thinking they may have tweaked it for Asians but I do wonder if anyone in the states has died due to Olysio. I doubt that we would ever know unless there was a suit.
That's why I was asking the other day if anyone is keeping a database of things like sides and cures.

[flyinlynn]

I am confident the FDA is tracking our medications that is one of the agencies functions.

I am sure you remember medicines being pulled for use by the FDA when unexpected serious complications were discovered once a medicine was released to the general public.

They even track OTC medicines and have them recalled.

There is also this notice on the full prescribing information that comes with your medicine.

This is from Harvoni but it is on all medicines

To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

[hrsepwrguy]

Generic Name: simeprevir (sim E pre vir)

Brand Names: Olysio

http://www.drugs.com/olysio.html

Trade Name: SOVRIAD™

Generic Name: Simeprevir Sodium

http://www.jnj.com/news/all/Japanese-Health-Authority-Approves-SOVRIAD-For-The-Treatment-Of-Genotype-1-Chronic-HCV-Infection\

So can anyone tell me why one generic is called simeprevir and the other is called simeprevir sodium then

[hrsepwrguy]

DESCRIPTION
OLYSIO (simeprevir) is an inhibitor of the HCV NS3/4A protease.
The chemical name for simeprevir is (2R3aR,10Z,11aS,12aR,14aR)‑N‑(cyclopropylsulfonyl)‑2‑[[2‑(4‑isopropyl‑1,3‑thiazol‑2‑yl)‑7‑methoxy‑8‑methyl‑4‑quinolinyl]oxy]‑5‑methyl‑4,14‑dioxo‑
2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a‑tetradecahydrocyclopenta[c]cycloproa
[g][1,6]diazacyclotetradecine‑12a(1H)‑carboxamide

http://www.olysio.com/shared/product/olysio/prescribing-information.pdf

Simeprevir Sodium Chemical name
Monosodium (cyclopropylsulfonyl)[(2R,3aR,10Z,11aS,12aR,14aR)-2-({7-methoxy-8-methyl-2-[4-(1-methylethyl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-5-methyl-4,14-dioxo-1,2,3,3a,4,5,6,7,8,9,11a,12,12a,13,14,14a-hexadecahydrocyclopenta[c]cyclopropa[g][1,6]diazacyclotetradecine-12a-carbonyl]azanide

http://www.oneyao.net/article/2014/0219/33814.html

[Dee1956]

Great job.as always! :)
Dee

[keepingOnkeepingOn]

It's my understanding they are one and the same. (Olysio)
"Simeprevir Sodium? Do you think this is the same as the Simeprevir (Olysio)"

[hrsepwrguy]

You know what they say, close only counts in horse shoe's and hand grenades and apparently there is enough of a difference in the chemical formulation between simeprevir and simeprevir sodium that one is killing people and one isn't, as I pointed out above, they are different

[Livelife777]

Hrsepwrguy is right.  They have different components.

[Sarah1949]

If no one is keeping track of who cures and who relapses, how would we know if anyone died from it. Maybe if the treating person wasyoung and healthy there would be a link. I'm not real worried about it but am curious.

[flyinlynn]

That is one of the jobs of the FDA to keep track of drugs after release. There is even a phone number to contact the FDA if you experience side effects that is included on the full prescribing information sheet given to the patient with their prescription.

I am sure you can think of drugs that have been recalled when it turned out they had serious side effects.

Lynn

[NYCMark]

Lynn is correct, as far as I can see. "So it does look to me that OLYSIO = GALEXOS = SOVRIAD"  

This is the same drug sold under different brand names in different countries.

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

You may recall that when I took Olysio back in January-April, my bilirubin went up to almost 6!  It went down somewhat, but only normalized when I completed therapy.  Lucky I guess.  This has become a known RARE problem in certain patients (me included) with this drug.
Mark

[FRED220]

Same meds. I am currebtly on S & O  and I was told that Olysio would increase my bilirubin so I insisted on having labs every two weeks.

[hrsepwrguy]

How much proof do you folks need, they are NOT the same, do some more research and prove me wrong

Have a great day

[hrsepwrguy]

http://www.medhelp.org/user_photos/list/1747881?personal_page_id=2257209

[can-do-man]

" they are NOT the same, do some more research and prove me wrong"

You are correct they are not the same. As for certain people doing or understanding any research. Good luck there.

[NYCMark]

From drug description:
OLYSIO (simeprevir) for oral administration is available as 150 mg strength hard gelatin capsules. Each capsule contains 154.4 mg of simeprevir sodium salt, which is equivalent to 150 mg of simeprevir. OLYSIO (simeprevir) capsules contain the following inactive ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate and sodium lauryl sulphate. The white capsule contains gelatin and titanium dioxide (E171) and is printed with ink containing iron oxide black (E172) and shellac (E904).

The patients' deaths may be completely unrelated to simeprevir/simeprevir sodium, and merely coincident with this drug administration.

We'll have to agree to disagree on whether Olysio = Sovriad.  Sovriad was not approved as a brand name in this country because it could be confused with similar-sounding drugs

Mark

[nan535]

I'm not going to comment on whether they are the same or different. What I will say is every patient is different with different degrees of liver disease. These new meds are powerful and if the patient is seriously ill may prove very difficult to handle.  My husband was not on Olysio but had a really hard time on his Sovaldi + Ribavirin treatment (continual episodes of serious HE / was hospitalized 5 times / fell 5 times).  In contrast, since stopping treatment, he has not been in the hospital in 4 months and has not had an HE episode in two months.
My point is the meds may not be causing the deaths but the patient's medical condition may make it very difficult for the patient to withstand it. The bottom line is patients need very close monitoring while on any of these meds, especially those with advanced cirrhosis.

Nan