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Author Topic: FDA Approves Generic Truvada  (Read 2526 times)

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Offline POZ Editors

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FDA Approves Generic Truvada
« on: June 09, 2017, 02:57:32 pm »
In a move that has taken HIV advocates by considerable surprise, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster antiretroviral (ARV) Truvada (tenofovir disoproxil fumarate/emtricitabine). This decision could have major implications for the future cost of Truvada, to insurers and consumers alike.

The approval, which grants Teva Pharmaceuticals the right to produce generic Truvada, is for the combination tablet’s use as a component of an HIV treatment regimen and as pre-exposure prophylaxis (PrEP). Generic Truvada will come in the same form as the brand-name version: as a fixed-dose combination tablet, although the famous powder-blue color may change.

Read more...
https://www.poz.com/article/fda-approves-generic-truvada

Offline leatherman

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Re: FDA Approves Generic Truvada
« Reply #1 on: June 09, 2017, 07:07:10 pm »
what a great win for HIV prevention and treatment!
leatherman (aka mIkIE)

There's no rain, there's no storm, though the blue sky makes you wonder
Don't you fear what will come will come
And right now we're in the sun
Sure enough, seasons change
But don't let today get lost 'cause today the sun's on us
Today the sun's on us
- Sophie Ellis-Bextor

chart from 1992-2017
Isentress/Prezcobix

Offline JimDublin

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Re: FDA Approves Generic Truvada
« Reply #2 on: June 10, 2017, 05:14:35 pm »
Yeah, this is a bit of good news indeed.
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Offline terrymoore

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Re: FDA Approves Generic Truvada
« Reply #3 on: June 11, 2017, 10:53:31 pm »
is this really NEWS? I have been using generic Truvada (Ricovir-EM) for almost 2 years.

Offline mecch

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Re: FDA Approves Generic Truvada
« Reply #4 on: June 12, 2017, 02:24:35 am »
And what country is that terrymoore?

Far as I know, this is the first time a developed country will approve a generic form of Truvada. 

There is no generic truvada in Switzerland thats for sure.

Generic Truvada has existed for years but it only legally sold in pharmacies in some countries.  Many countries had to respect the patent to the bitter expensive end.
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline leatherman

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Re: FDA Approves Generic Truvada
« Reply #5 on: June 12, 2017, 06:28:31 am »
is this really NEWS?
considering the full patent doesn't end until 2021, this is huge news for most of the world, especially America

It looks like some agencies in the UK that have patients who have been using a generic Truvada for PReP produced outside the patent (mainly  manufactured in India) have been doing therapeutic drug monitoring to ensure that the generic version their patients have been taken has actually been up to standards.
https://daviebuyersclub.wordpress.com/home/frequently-asked-questions/
« Last Edit: June 12, 2017, 06:33:20 am by leatherman »
leatherman (aka mIkIE)

There's no rain, there's no storm, though the blue sky makes you wonder
Don't you fear what will come will come
And right now we're in the sun
Sure enough, seasons change
But don't let today get lost 'cause today the sun's on us
Today the sun's on us
- Sophie Ellis-Bextor

chart from 1992-2017
Isentress/Prezcobix

Offline terrymoore

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Re: FDA Approves Generic Truvada
« Reply #6 on: June 12, 2017, 12:11:04 pm »
Quote
And what country is that terrymoore?

Far as I know, this is the first time a developed country will approve a generic form of Truvada. 

There is no generic truvada in Switzerland thats for sure.

Generic Truvada has existed for years but it only legally sold in pharmacies in some countries.  Many countries had to respect the patent to the bitter expensive end.


Quote
considering the full patent doesn't end until 2021, this is huge news for most of the world, especially America

It looks like some agencies in the UK that have patients who have been using a generic Truvada for PReP produced outside the patent (mainly  manufactured in India) have been doing therapeutic drug monitoring to ensure that the generic version their patients have been taken has actually been up to standards.
https://daviebuyersclub.wordpress.com/home/frequently-asked-questions/




Ohhh sorry guys - i had no idea. I must have sounded a bit arrogant - sorry. Just me being misinformed

Offline JimDublin

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Re: FDA Approves Generic Truvada
« Reply #7 on: June 12, 2017, 12:17:50 pm »
Understandable though lots of people and other nations taking though legal loopholes the generic version, but its huge that FDA has approved this.

Like UK as mentioned the generic drug is purchased in a legal loophole for own use as "PreP" and as pointed out in this thread GP and Clinics supporting it monitor for side effects/tolerance etc. https://www.iwantprepnow.co.uk/
HIV 101 - Everything you need to know
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HIV Transmission and Risks
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Offline terrymoore

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Re: FDA Approves Generic Truvada
« Reply #8 on: June 14, 2017, 02:16:07 pm »
So here in Thailand they openly sell the generic (my doc even recommends i buy it!) at the Red Cross Anonymous Clinic and i think also at public hospitals. Maybe it is worth it for you guys to come for a shopping trip (and also a short vacation!)?

Offline JimDublin

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Re: FDA Approves Generic Truvada
« Reply #9 on: June 15, 2017, 08:49:20 pm »
Well I get my meds for free so i'm okay, but Thailand is on the list of places to visit before i kick the bucket.  :)

Jim

HIV 101 - Everything you need to know
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Transmission and Risks:
HIV Transmission and Risks
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HIV Testing
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HIV TasP
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PEP and PrEP

Offline Giancarlo

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Re: FDA Approves Generic Truvada
« Reply #10 on: June 30, 2017, 10:13:05 am »
This is indeed good news for the US!
Regarding the European Union, the European Medicines Agency recommended last May the granting of a marketing authorisation for a generic version of Atripla: link.

I think this still has to go through a decision of the European Commission (and intense lobbying against it by Gilead?), but it looks promising...
Nov 2011: HIV-
Jul 2012: HIV+
Aug 2012: VL 8,900 / CD4 822 (28%)
Oct 2012: VL 13,500 / CD4 887 (30%)
Jul 2013: VL 9,000 / CD4 ?
Sep 2013: VL 24,000 / CD4 625 (34%)
Oct 11th 2013: Start Atripla
Nov 7th 2013: VL 84 / CD4 665 (37%)
Dec 11th 2013: VL UD (<40) / CD4 960 (35%)

Offline harleymc

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Re: FDA Approves Generic Truvada
« Reply #11 on: July 05, 2017, 05:22:10 am »
I wonder why the POZ Editors thought that his is research news?

Offline CaveyUK

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Re: FDA Approves Generic Truvada
« Reply #12 on: July 05, 2017, 03:33:03 pm »
I thought the patent on Truvada ran out this year. Is it running to a different timescale in the US?

Edit: Ok, found it......It's not Truvada, but the Tenofovir component that comes off patent this year. I guess when this happens, there is a chance to prescribe generic Tenofovir along with generic 3TC (as opposed to FTC which is in Truvada)
« Last Edit: July 05, 2017, 03:57:06 pm by CaveyUK »
HIV - Basics
HIV 101
You can read more about Transmission and Risks here:
HIV Transmission and Risks
You can read more about Testing here:
HIV Testing
You can read more about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read more about HIV prevention here:
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You can read more about PEP and PrEP here:
PEP and PrEP

Offline JimDublin

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Re: FDA Approves Generic Truvada
« Reply #13 on: July 05, 2017, 03:48:42 pm »
Only part of the patent expired in 2016/2017 if i understand it correctly, and other parts of the patent expires much later like 2020 - 2021. So the approval by the FDA of the generic is interesting. (However I admit to have no real knowledge at all of how it works)

https://www.drugs.com/availability/generic-truvada.html
« Last Edit: July 05, 2017, 03:51:05 pm by JimDublin »
HIV 101 - Everything you need to know
HIV 101
Transmission and Risks:
HIV Transmission and Risks
Read more about Testing here:
HIV Testing
Read about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read about HIV prevention here:
HIV prevention
Read about PEP and PrEP here
PEP and PrEP

Offline CaveyUK

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Re: FDA Approves Generic Truvada
« Reply #14 on: July 05, 2017, 03:57:33 pm »
thanks Jim. I just edited my original post while you were posting...
HIV - Basics
HIV 101
You can read more about Transmission and Risks here:
HIV Transmission and Risks
You can read more about Testing here:
HIV Testing
You can read more about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read more about HIV prevention here:
HIV prevention
You can read more about PEP and PrEP here:
PEP and PrEP

Offline Giancarlo

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Re: FDA Approves Generic Truvada
« Reply #15 on: June 27, 2018, 11:18:03 am »
Regarding the European Union, the European Medicines Agency recommended last May the granting of a marketing authorisation for a generic version of Atripla: link.

A short update of the situation in France: the generic version of Atripla has been available since last March, for a monthly cost of 270€ (instead of 609€ for the "original").
Nov 2011: HIV-
Jul 2012: HIV+
Aug 2012: VL 8,900 / CD4 822 (28%)
Oct 2012: VL 13,500 / CD4 887 (30%)
Jul 2013: VL 9,000 / CD4 ?
Sep 2013: VL 24,000 / CD4 625 (34%)
Oct 11th 2013: Start Atripla
Nov 7th 2013: VL 84 / CD4 665 (37%)
Dec 11th 2013: VL UD (<40) / CD4 960 (35%)

Offline mecch

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Re: FDA Approves Generic Truvada
« Reply #16 on: July 11, 2018, 10:29:20 am »
That's some bullshit pricing for the "generic", IMO.  Crissakes.
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline LeftyBowler300

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Re: FDA Approves Generic Truvada
« Reply #17 on: July 12, 2018, 05:21:33 pm »
I think they have enough weight behind the reduced side effects by the TAF component in Descovy to not have to worry about the reduced cost of Truvada in developed countries.
I know I'm not switching from TAF to TDF.
Generic Descovy would have been nice, but of course they gotta make their billions off of it before that happens.
Apr 1, 2017 DX - CD4 8 , VL 820,000
OI's: Disseminated Histoplasmosis, Thrush, PCP
Apr 17, 2017 started Genvoya, Bactrim, Sporanox, Azitrhomycin
Jun 9, 2017 - CD4 42 (3%) , VL 100
Jul 17, 2017 - CD4 57 (4%) , VL 53
Sep 16, 2017 - CD4 57 (4%) , VL 130 - Ugh... wtf
Oct 20, 2017 - CD4 63 (5%) , VL 100
Dec 1, 2017 - CD4 56 (3%) , VL <20
Mar 15, 2018 - CD4 73 (5%) , VL <20
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