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Author Topic: Prep in europe Truvada version vs US approved Truvada version. Are they same?  (Read 2591 times)

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Offline Needforaction34

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I was prescribed truvada for prep.  However as I checked that truvada version approved by cdc is different then europe

CDC approved version is

200 mg emtricitabine / 300 mg tenofovir disoproxil fumarate


Europe is

200 mg emtricitabine / 245 mg tenofovir disoproxil fumarate

Has anybody know any information about it if please? I am worried to start using it just to see this difference

If they work same do you have any reserach about it?

Thanks you so much for your help

Offline Jim Allen

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I suspect you are comparing summaries or patient information between the US & EU and hence the confusion.

USA - FDA - Truvada:
TRUVADA is available as tablets. Each tablet contains 200 mg of emtricitabine and
300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil).

Page 22: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf

EU:
Truvada contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
https://www.medicines.org.uk/emc/product/3890/smpc

Ireland:
The active substances are emtricitabine and tenofovir disoproxil. Each Truvada film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).

https://www.medicines.ie/medicines/truvada-film-coated-tablets-34068/patient-info see: Truvada IE & XI pill PDF.

It is exactly the same, just written differently.

Quote
If they work same do you have any reserach about it?

Years and years worth. Truvada has been tested and studied for safety and effectiveness in the EU for many years. It's highly effective in preventing HIV. 

Your doctor, the EU and the drug companies are not short-changing you or giving you an inferior product. Drug approval within the EU is rigorous and not only at an EU level, as each nation-state regulatory body, must also review and approve it before usage.

I am not a librarian, but here are some PrEP studies conducted in the EU as a reference. There are plenty more to be found online.

https://ecom.ngo/wp-content/uploads/2018/01/clarity_on_PrEP_SLIDES-2.pdf
“On Demand” oral PrEP with TDF/FTC was very effective with a 86% (95% CI: 40-99) reduction in HIV-incidence

Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. New England Journal of Medicine. 2010;363(27):2587-99.

McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53-60.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00056-2/fulltext "Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. "

Molina J-M, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. On-Demand Pre-exposure Prophylaxis in Men at High Risk for HIV-1 Infection. New England Journal of Medicine. 2015;373(23):2237-46

« Last Edit: December 01, 2023, 06:45:44 am by Jim Allen »
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Offline Jim Allen

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I hope this has helped but if you are still concerned then I recommend you go back to your doctor or to a qualified pharmacist and discuss your concerns with them.

« Last Edit: December 01, 2023, 06:37:42 am by Jim Allen »
HIV 101 - Everything you need to know
HIV 101
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

My Instagram
Threads

 


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