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Author Topic: Drugs available in Europe?  (Read 3190 times)

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Offline Magnus

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  • Posts: 63
Drugs available in Europe?
« on: March 08, 2008, 08:50:06 AM »
Hello, going to start treatment soon and just wondering if the new drugs like Atripla and Intelence are available in Europe yet?

Do drugs have to be approved by the EU or is it by individual country?

Thanks fellow europeans.

Online Miss Philicia

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Re: Drugs available in Europe?
« Reply #1 on: March 08, 2008, 02:32:21 PM »
I'm quite sure Atripla is EU approved now.  Intelence was just approved in the US in January, so it may not have happened yet for you folks over there.
"Iíve slept with enough men to know that Iím not gay"

Offline frenchpat

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Re: Drugs available in Europe?
« Reply #2 on: March 08, 2008, 04:14:59 PM »
Magnus,

as far as I know the approval for the sale of drugs is a country's right in Europe and not a decision taken at the European level. As far as France is concerned there is what is called AMM (Autorisation de Mise sur le Marchť) without which a drug cannot be sold. The most recent drugs to have received said AMM are:

Atripla (13 december 2007)

Isentress (Raltegravir) (20 december 2007)

Celsentri (maraviroc) (24 september 2007)

Because of the contamination that occured at a manufacturing plant, Viracept had had its AMM taken away but was reinstated in the first days of 2008.

I have not found any info regarding Intelence.

Hope this helps,


Pat
People have the power - Patti Smith

Offline Magnus

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  • Posts: 63
Re: Drugs available in Europe?
« Reply #3 on: March 08, 2008, 06:15:19 PM »
Thanks for that Philly +  pat.

Hm that looks promising that those new ones are available in France Pat.  I'm finding it hard to find a set of published guidelines for my own country regarding approved drugs and i don't even know if we have set guidelines for "preferred" firstline treatment.

I guess ill have to consult with my docs.

Thanks again.......

Online Miss Philicia

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Re: Drugs available in Europe?
« Reply #4 on: March 08, 2008, 06:31:19 PM »
Magnus, I assume you're treatment naive.  You should be aware that most of the newly approved HIV drugs are for treatment resistant patients and will not be offered to you as an option for first line treatment.  At some point in the future, once more studies are done, I would assume that will change.

Of course, Atripla is the exception because it's just a new combination pill of 3 pre-existing medications, but the other ones are for treatment resistant patients.
"Iíve slept with enough men to know that Iím not gay"

Offline Magnus

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Re: Drugs available in Europe?
« Reply #5 on: March 08, 2008, 06:48:29 PM »
I am treatment naive Philly, but i don't know if the strain of HIV i have is resistant yet- I contracted it in Thailand where there was a lot of mono and dual therapy going on up until recently, leading to a lot of potential NRTI & NNRTI resistance.

I sincerely hope i haven't picked up a resistant strain- i would love to be able to start on Atripla or Viramune & Truvada and then have a greater range of options for the future......

Online Miss Philicia

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Re: Drugs available in Europe?
« Reply #6 on: March 08, 2008, 06:55:58 PM »
Even if you show some mutations in your lab results once you have a geno/phenotype, my assumption is that they will still start you with the older meds.  You're still treatment naive, and that's more what matters.

I'm reading you old posts right now, and I don't see where you've stated when you tested positive or what you current cd4 and VL numbers are.  Oh, I see now that you said those haven't been taken, but then you say your doctor is recommending meds already.  Uh, that makes no sense.  No doctor should recommend going on meds before having these lab numbers.

When is your doctor planning on testing you, and further more why is he waiting?
"Iíve slept with enough men to know that Iím not gay"

Offline Magnus

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  • Posts: 63
Re: Drugs available in Europe?
« Reply #7 on: March 08, 2008, 07:12:59 PM »
Thanks for that- I'm hopeful i wont be resistant.

I haven't stated anything about testing positive- its still fairly traumatic and id prefer not to talk about it. I'm keeping myself sane by focusing on treatment.

Going to a different consultant Monday to see about CD4, Viral Load and resistance . The doc who tested me said i would prob be starting meds soon due to the way i was feeling and a few minor OI's.

Online Miss Philicia

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Re: Drugs available in Europe?
« Reply #8 on: March 08, 2008, 07:21:59 PM »
Good luck.  Don't over worry yourself.  Treatment for HIV is world's better now.
"Iíve slept with enough men to know that Iím not gay"

Offline Ann

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  • It just is, OK?
    • Num is sum qui mentiar tibi?
Re: Drugs available in Europe?
« Reply #9 on: March 09, 2008, 05:19:29 AM »
Hi Magnus, welcome to the forums.

If you're in the UK, don't expect to start treatment unless you really need it. Also, while Atripla may have been approved, it's more in theory than reality. Atripla is very expensive in comparison to it's component parts (Truvada + Sustiva) and you would most likely be given the two separately. It's no big deal really, it means taking two pills once a day as opposed to one pill once a day.

Take it easy - the rollercoaster you find yourself on will slow down in time.

Ann
 
Condoms are a girl's best friend

Condom and Lube Info  



"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Offline Magnus

  • Member
  • Posts: 63
Re: Drugs available in Europe?
« Reply #10 on: March 09, 2008, 10:02:18 AM »
Hi Ann-

Thanks for the kind words. Yes a neverending terrifying roller coaster is a good way to describe it.

However the excellent, factual, no-nonsence Lessons  on this site, as well as all the  knowledgeable people in the forums have really helped me out. Knowledge is power this site helped me take control of my fear and start working towards getting this illness under control. It helped me realise my life has changed forever but its not over!

No I'm not in UK, I'm in Ireland and its so hard to get info here.  Actually I hope its different to England where everyone is started on meds after they hit 200 CD4! That is a terrible system!

Offline Ann

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  • It just is, OK?
    • Num is sum qui mentiar tibi?
Re: Drugs available in Europe?
« Reply #11 on: March 10, 2008, 11:43:59 AM »
Hi Magnus,

I'm in the Isle of Man, but I get my hiv care in Liverpool. They don't wait until you're UNDER 200, but approaching 200 or if you are symptomatic.

My doc and I have discussed me going on meds when my numbers were very good but I was having gastro and joint problems (they're still good, but starting to go south. No meds yet....) but I declined. I felt like "better the devil you know".

I plan on going on the meds when my numbers are consistently under 300 and I know I will have no objections from my doc. I've been positive nearly eleven years now and I'm made up that I've gotten this far without the meds. They're nothing to be taken lightly or rushed into, but when the time comes, I have no problem with taking them. I'm grateful we have them!

Ann
Condoms are a girl's best friend

Condom and Lube Info  



"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Online Miss Philicia

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  • Posts: 24,211
  • celebrity poster, faker & poser
Re: Drugs available in Europe?
« Reply #12 on: March 10, 2008, 12:01:48 PM »
Just curious because of frenchpat's post, but how are drugs approved in Europe?  I always read "the EU approved" in the treatment news section of AIDSmeds.com so I just assumed that there was a EU process, and that it was not done on a country by country basis.
"Iíve slept with enough men to know that Iím not gay"

Offline RobT

  • Member
  • Posts: 319
Re: Drugs available in Europe?
« Reply #13 on: March 25, 2008, 08:52:48 PM »
All-
I am planning y slow and ongoing process of immigrating over to London to b w/ my partner. He currently lives over there and has no intention of living in the US- he is a dual citizen. I just want to kow if my drug (s) that I have taken for the longest time will b available under the NHS. Perhaps some British citizens cud offer advice, hmmmmmm?

RobT


Current meds: Atripla
VL: undetectable
CD4: 630

Offline alberche

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  • Posts: 212
  • a distancia del mundo incierto, saludo mi suerte
Re: Drugs available in Europe?
« Reply #14 on: April 15, 2008, 08:14:55 PM »
Hiya all,

Drugs in Europe should go first under the approval of EMEA, European Agency for Evaluating Meds, based on London, UK.

Once EMEA says OK to a drug, then this is each country that has a particular procedure to approvals that consists, basically, in negotiating drug prices with labs. (Drugs are free of cost for people through public health care systems).

These negotiations usually last from 6 to 12 months after EMEA approval. Each country can also made some changes or have specific regulations to have ways to a faster and urgent approval procedures, such as this happens in France. And also some countries may apply with some variations the medical or clinical recommendations for use.

But, generally speaking, drugs in Europe are available one year later than in the U.S. ... and may last even a bit more to get to every single hospital.

And, sometimes, when it is cheaper for healthcare systems to provide separate drugs instead of combined form (see Atripla, Trizivir, etc...), they tend to keep providing first the separate formulations...

So, drugs are for free in most of EU countries, but, in contrast, you will have much less possibilities to choose, this is mainly your doctor and hospital that rule the options for you.

If you are lucky and go to a good hospital, you will get the best treatments, otherwise, you will be treated but will not be receiving new or better drugs untill these drugs become really a standard.

hugs!! ;-)
love is blindness...  a wonderful song!

Offline newt

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  • Posts: 3,885
  • the one and original newt
Re: Drugs available in Europe?
« Reply #15 on: April 15, 2008, 08:31:01 PM »
In England, marketing approval is a matter for the EMEA (European regulators) but (1) purchasing arrangements are made by local consortiums and (2) consortiums can purchase unapproved (by the EU) drugs if they like (3) plus individual clinics can make there own arrangements (4) individual doctors -- technically -- can prescribe what they like.

Scotland, Wales and NI being different countries -- different rules apply.

For Europe, Atripla is approved for people with an "undetectable" viral load for 3 months+. Raltegravir is approved for people with PI resistance. Celsentri is approved for treatment-experienced people with CCR5-tropic only. But they's not always used that way.

Clear as mud -- yes it is...

- matt
"The object is to be a well patient, not a good patient"

 


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