Ggd Amsterdam Gets Permission To Start A Prep Test Project

[NLbear]

Amsterdam newspaper "Het Parool" announces today that the Amsterdam health care services GGD is finally allowed to start a PrEP investigating project. 370 Gay men and transgenders will be selected to participate in a test project over the next 3 years.
 
It will be the first time that PrEP will be tested in the Netherlands and the first time worldwide that participants will be given a choice between taking daily medication OR using PrEP before or after having condomless sex.
 
The number of new HIV infections in the Netherlands has been stable for some years at around 1100 per year, of which about 370 in Amsterdam. 71% of those are gay men.
 
 
The investigative project will focus on:
- Interest to start using PrEP (how many and why)
- True to therapy (i.e. use the medication as prescribed)
- What it is like to use PrEP
- Will the cost of this project weigh up against the cost of people getting infected with HIV and cost of  medication after that as a result.
 
Project runs from June 1025 until december 2018.
 
http://www.ggd.amsterdam.nl/nieuwsoverzicht/proef-prep-strijd/

 
--------------------------
 
1) I am glad that FINALLY PrEP is being tested in NL
2) I am disappointed it is a project that runs until 2018 before they publish the results. While results are available from countries where PrEP is already available.
3) I am disappointed that it is only the city of Amsterdam running this project and not other Dutch GGD organizations as well.
 
Still, better than nothing I guess.

[bearbandit]

Better than nothing, true, but the Netherlands isn't so large that people from outside couldn't travel to Amsterdam for the trial.

But on a more global note, are we really so different in each differing country that we need to repeat the same piece of research over and over again?

 

How many people are interested is, I suppose, something that could vary from nation to nation. Adherence figures won't differ much between countries: the older guys amongst us lived through the eighties and nineties and saw for ourselves what HIV can do, while the younger guys learn from us older guys what it was like. (And let's not forget that people are still dying of HIV disease, either!) What is it like to use PrEP: there are thousands of Americans who can answer that question, And a number of guys from the UK and other countries running similar trials, repeating the same work. As for price, I've just been reading the British HIV Association's draft guidelines for 2015 and they put the cost of PrEP at present (ie while both components of truvada are under patent) at £8000 per year as opposed to a lifetime care cost of someone with HIV disease as between £250,000 and £350,000.

If this is the only way that PrEP is going to be available in the Netherlands, then I'm pleased for the Dutch that at least something is happening, but when it's been in use for several years in the USA with excellent results and the British trial was essentially ended early because the initial results were so good, it's such a waste of money to tread the same old ground again!

[NLbear]

I fully agree with you Bearbandit. Don't know why Amsterdam wants to reinvent the wheel when so many tests are already available. Must be Dutch health authorities (who are destroying the Dutch health system as we speak in general).

 

As for getting access to the Amsterdam GGD program, you cannot access the program If you do not live in Amsterdam or neighboring villages or towns that fall under this GGD organization. So people living in other parts of the country are not allowed to participate.

 

I am just sad that apparently nothing is going to happen until the project is finished in 3 years, and then another few years for evaluating, discussing it for another few years and getting on the market by, what? 2020?. We are way behind the USA.

 

Dutch politics and health care services makes me so incredibley mad....

[Guest ff-whole]

bloody Dutch nitty gritty rules... they are obsessed with rules.

Very sad... I hope to be in Europe in about 1 or two years and hope there is a way to get Prep.

[wood]

Better than nothing, true, but the Netherlands isn't so large that people from outside couldn't travel to Amsterdam for the trial.

But on a more global note, are we really so different in each differing country that we need to repeat the same piece of research over and over again?

 

How many people are interested is, I suppose, something that could vary from nation to nation. Adherence figures won't differ much between countries: the older guys amongst us lived through the eighties and nineties and saw for ourselves what HIV can do, while the younger guys learn from us older guys what it was like. (And let's not forget that people are still dying of HIV disease, either!) What is it like to use PrEP: there are thousands of Americans who can answer that question, And a number of guys from the UK and other countries running similar trials, repeating the same work. As for price, I've just been reading the British HIV Association's draft guidelines for 2015 and they put the cost of PrEP at present (ie while both components of truvada are under patent) at £8000 per year as opposed to a lifetime care cost of someone with HIV disease as between £250,000 and £350,000.

If this is the only way that PrEP is going to be available in the Netherlands, then I'm pleased for the Dutch that at least something is happening, but when it's been in use for several years in the USA with excellent results and the British trial was essentially ended early because the initial results were so good, it's such a waste of money to tread the same old ground again!

 

I am fairly certain that the lack of action on the part of other countries is strictly because of cost.  In many cases outside of the way certain drugs are handled or prescribed, the majority of the world follows the FDA fairly close, and in a reasonable timeframe.  The FDA isnt perfect, but our drug testing and approval standards are very rigorous.  

 

IMO what some other countries are afraid of, especially those with large public heath systems is that they are going to be stuck with a large increase in cost vs using existing prevention methods, IE condoms and education.  The simple fact is truvada is still very expensive.  Especially when you take into account, its simply for prevention.  If you look at the cost of other preventative drugs, like statins for cholesterol, they are much cheaper.

 

It is a waste to continue doing studies but the cost is still going to be  factor regardless, and I would love to see some real reduction in cost from Gilead, not just savings cards.      

[rawfuckr]

I am fairly certain that the lack of action on the part of other countries is strictly because of cost.  In many cases outside of the way certain drugs are handled or prescribed, the majority of the world follows the FDA fairly close, and in a reasonable timeframe.  The FDA isnt perfect, but our drug testing and approval standards are very rigorous.  

 

IMO what some other countries are afraid of, especially those with large public heath systems is that they are going to be stuck with a large increase in cost vs using existing prevention methods, IE condoms and education.  The simple fact is truvada is still very expensive.  Especially when you take into account, its simply for prevention.  If you look at the cost of other preventative drugs, like statins for cholesterol, they are much cheaper.

 

It is a waste to continue doing studies but the cost is still going to be  factor regardless, and I would love to see some real reduction in cost from Gilead, not just savings cards.      

 

Cost seems to be the problem in Europe. I would like to see exactly when we could get generic Truvada in Europe. I've heard some people say 2016? USA seems 2017 is the year, but first generic versions may not be much cheaper than the brand name. Fascinating read about generic Truvada availability in the USA can be found here: http://www.ethantheblog.info/?p=50  

[NLbear]

The GGD estimates that the costs of PrEP will be €10,000 per person per year.

Not even sure if health insurance in NL will cover it when it becomes an approved medication. Not sure if it will in the "basic Insurance package" which everyone in NL is obliged to buy.

[LocalGuyTopNL]

I subscribed for this trial but am still waiting for a responce. There is a limited amount of participants so I have to wait and see if I can join in.

They want to try 2 different methods of taking the meds:

1) Take one pill every day

2) Take one pill the day before you have bareback sex and continue with one pill a day till two days after

Participants can choose their own method.

It's the first time I heard of option 2 so if I'm selected I tend to go for option 1. Does anybody have experience with option 2?

[NLbear]

I hope you get in. I can't as I am not local.

 

Curious to know too if anyone has experience with option #2. But then again, option #2 only seems to be for planned bb sex. What happens when you're horny and have sex the same day/evening? In that case #1 sounds like the better protection.

[LocalGuyTopNL]

dagelijks PrEP (u neemt elke dag, met voedsel, 1 tablet Truvada) en intermittent PrEP (U neemt Truvada met voedsel in volgens een speciaal schema: 2 pillen tussen de 24 en 2 uur voordat u verwacht risico te lopen op hiv, daarna 1 tablet elke 24 uur tot 48 uur na het laatste risico

This is from the information leaflet: either 1 pill every day, or two pills 24 up 2 hours before possible exposure and then 1 tablet every 24 hrs till 48 hrs after the risk. I'm not sure if they mean 3 after possible exposure (one straight after the risk, one after 24 hrs and one after 48 hrs) or just one after 24 and one after 48hrs..

Am really curious about experience with this 2nd option.. Maybe I should start a new topic about it..

[bearbandit]

The way I read the original (and it seems to concur with the IPERGAY study is 2 pills in the 24 hours prior to taking a risk and then two pills, 24 hours apart after the risk. So, two pill up to 24 hours before the risk event, one immediately afterwards and then one pill 24 hours later. With my over-cautious mind, I feel ambivalent about PrEP on demand and feel that the dosing is insufficient... better to my mind to go with the first option and then you're ready to go without any planning

[fskn]

In a nutshell, the Dutch are asking questions that others have already answered, and are doing it to delay.

I was at an HIV prevention research conference a few weeks ago. The ethicist who opened the conference explained that governments sometimes avoid research that would identify populations whose existence is denied (e.g., gay people in most African countries) or whose behavior is illegal (e.g., gay men in Muslim countries, drug users in China). Governments also avoid research that would identify groups of people who need treatments not locally available or not funded (e.g., HIV-positive people in developing nations).

In Europe, you have the opposite of the last case, in my opinion. Given evidence that daily Truvada prevents HIV in another developed, western country, European governments are launching their own studies so that they can delay approving and paying for preventive use of Truvada. Either someone in Strasbourg or Geneva has pencilled out the numbers and determined that it's cheaper to fund treatment than to prevent new infections, at Europe's low HIV infection rates, or the Conservative Party in each country has decided that the people being infected today are not worth saving. (One would have expected this in the US, where most new HIV infections occur among people of color.)

The Dutch open-label study is absurd, coming hot on the heels of IPERGAY. We already know from two US studies, iPrEx (double-blind) and iPrEx-OLE (open-label), that daily Truvada works for PrEP. In the meantime, IPERGAY has already established, with a rigorous, double-blind design, that the same episodic dosing schedule that the Dutch want to explore on a less rigorous, open-label basis, lowers risk by 86%!

(A double-blind study has two randomly-drawn groups, one that receives real medicine and one that receives a fake, or placebo. Neither participants nor doctors know who is in which group. The participants in an open-label trial choose to receive real medicine, and the doctors know, too. Double-blind is more rigorous; the results carry much more statistical weight.)

It is certainly valuable to continue comparing daily and episodic Truvada dosing. It is not ethical to use that as an excuse to withhold daily Truvada for PrEP. Similarly, in the US, where daily Truvada for PrEP is already approved, available, and covered by most insurers, the IPERGAY study design would be unethical but the Dutch one would be ethical. If we ran IPERGAY in the US, participants in the placebo arm would get substandard care (no PrEP), without knowing. If we ran the Dutch study in the US, participants receiving substandard care (less-than-daily PrEP) would know. Basically, an ethical study might secretly enhance, but will never secretly reduce, standard care.

I should add that local, population-based studies can be valuable. Truvada is an effective preventive for American gay men, at a community-wide level, but it was ineffective in an early study of African straight women, for whom social and cultural constraints deterred adherence. Separate PrEP studies for white and Black gay men in the US would probably show different community-level effects -- in one country!

But Western Europe and the US are similar enough that general PrEP research results will hold in both places. Much HIV testing and treatment work has already crossed the pond in one direction or the other.

Edited July 20, 2015 by fskn