All participants in the study who received placebo PROUD have received PrEP drugs before the end of the study
The Steering Committee of the study Proud trial of pre-exposure prophylaxis (PrEP) in homosexual men in England today announced that participants currently in the study of the control arm, which have not yet started PrEP will be called back to their clinics and will have the opportunity receiving the PrEP drug early. This is because the effectiveness seen in the study exceeded the limit set for the continuation of the trial.
Although the exact efficacy seen in the trial is yet to be established pending analysis and monitoring of participants, the indications are that the results are considerably higher than what was originally provided by the researchers.
In PROUD, 545 gay men at high risk of HIV infection were recruited through clinical 13 sexual health in London, Brighton, Manchester, Birmingham, Sheffield and York.
Participants all offered me a regular test suite for HIV and sexually transmitted infections (STIs), condoms, support for safer sex, behavioral research and monitoring randomized into two groups.
One group also received tenofovir and emtricitabine (Truvada) immediately (the 'instant arm'), while the other, until now, has offered one-year study (the 'deferred arm').
The object of this project is to establish whether participants who know they are taking PrEP will change their HIV risk behavior (eg using condoms less or to not use them at all) and, if so, whether it could reduce or even cancel the beneficial effect of PrEP
This design is being used by some critics, providing that the PrEP will have an overall negative effect: in August, the chief executive of the AIDS Healthcare Foundation, Michael Weinstein said: "We want the public to know that widespread scale government-sanctioned above seems to be a public health disaster." So it's very important to know if people like Weinstein are right or wrong, and if PrEP will have a negative effect if people know they are taking Truvada.
Translator's note, though I may seem like a Cassandra of Revelation the fact is that, for example, in Brazil, there is a large refractory attitude to condom use and left me doubtful whether such a scheme will not fall in Oba, Oba, released general!
The pilot Proud is not designed to establish the efficacy of the preparation as such. At the time it was designed, it was thought that a large trial with 5000 participants would be required in order to generate the number of HIV infections required to establish a clear measure of the effectiveness of the introduction of Truvada reduction (or otherwise) of HIV infections in subjects.
However, in April 2014, it became clear that the preparation of offer had called for a subset of gay menCharacterized by a higher HIV infection rate than were originally taken into account when calculating the size of the study. This implied that the pilot study would be potentially able to produce a clear answer on the effectiveness, despite its small size. Independent data and safety monitoring committee (IDMC), so we were created.
IDMCs has a privileged position in randomized trials: they are the only ones to see the data unblinded (Translator's note - In scientific studies on treatment efficiency of any kind is customary to use the term blinded - or double blind, so that only the laboratory can accurately assess the results of the research, since even the doctors know for those who are offering medication or placebo) before the end of the study, and his job is to monitor the data to see if there are signs that the study should be discontinued. Reasons to stop a study includes data such as, for example, know that the study took particular course and it became clear that the intervention being tested is bad for patients, the study will never produce a clear result (treated as futility * * ) or that the intervention is beneficial as it would be unethical to hide it from the people in the study. The study Proud IDMC met three times and at the third meeting of 6 October 2014 was decided that the intervention was clearly beneficial; They found that the effectiveness of the preparation appeared to have exceeded the threshold they were defined.
This limit will not be the real effectiveness: Is the possibility of lowest possible likely effectiveness allowed to opportunity results or, in technical terms, the lower limit of the confidence interval 95. In terms of real numbers views infections, the observed efficacy is probably higher. The final difference will not be clear until clinical have done recall the maximum possible number of participants, because there will doubtless some other HIV infections not previously found in both groups. Currently 130 people in the deferred arm are still being offered PrEP
Full results are expected early next year.
The PROUD study did not stop: it will continue because it is still important to find out the long-term trends: the adherence of the participants to PrEP, which was clearly high, will fall over time? Risk behavior levels remain unchanged? There will be significant resistance development?
These are extremely important questions to be answered and the English NHS wants all of them answered before making a decision as to whether to provide PrEP This development opens up opportunities to study other drugs or regimens too- but above all, it opens an opportunity to produce a major impact on the HIV / AIDS epidemic in gay men in the UK and elsewhere.
Dr Adrian Palfreeman, Vice-President of the British Association of HIV, said: We welcome the news that has made significant progress in efforts to prevent HIV in men who have sex with men, where the current broadcast in the United Kingdom remains inevitably high, and eager to see the results when they become available. BHIVA, along with other stakeholders, are working with the NHS in England to design a policy to consider the future availability of pre-exposure prophylaxis, along with measures to prevent infection, within the NHS in the future "
Published: October 16 2014
Gus Cairns is co-chairman of the steering committee of the study Proud.
Seropositive editor considerations Web Site. I have observed here and there, some people have abandoned the use of condoms (both HIV-positive people as sorointerrogativas) believe in panaceas that perhaps in the future, convert into real progress. But medicating a person who is not ill with a remedy about which we know little, considering that he has ten years of use would not rather an extra feature to fill the coffers of the laboratory that developed Truvada, money "easy"?
I think so.
For if we have, in a scenario such as Brazil, 600.000 people infected and half of them engage in divergent serum relationships that lead to 300.000 monthly boxes of this product to be sold (the Brazilian Government paid, and paid in dollar, by these remedies) monthly .
And research on vaccines? A long time I hear them and not speak when I hear, are always bad news, such as "more a hope that goes away ...).
Is it ethically acceptable medicating people who are not sick, with very strong medicines with side effects of all kinds instead of investing massively in serious campaigns AIDS prevention in the Brazilian media.
Note that the TV stations in Brazil operate in the concession mode and the government can if you want, just cut the grant and, failing that, so radical, it would be abuse of power (...) take broadcasters and make inserts a minute every programming 15 with videos prepared by people who know the problem in the skin and blood, rather than brown (azular) Truvada pills?
There is also the risk of poor compliance. In this way, we could be creating a tough supervirus to Truvada and as a natural consequence of things, a new humanitarian crisis, like the one we had in the years 80?
Someone set me something intelligence as to learn from experience.
One of two things: Either there was not enough experience or is missing use or possession of intelligence
Another Note: Anyone who has access to my publications, always with the aim of trying to reduce the typing and grammar mistakes (I'm dyslexic) read this text and enthusiastically called me "pessimistic". I could say that, in general, the pessimist is always a much better person briefed ...
But is not the point. I'm in a process of "cleaning in my blog, eliminating pages that no longer make sense being here. They still exist, only that will not be visible to site users.
And reread many of them and, in doing so, I remembered how much hope I felt every new publication of this ilk to, weeks, sometimes days later, see all end in glitter, glitter and disillusionment.
The fact is that these experiences over 15 years (or nearly so) to work on this site, I learned to expect, but with relative anxiety and yet not let fireworks every new news. Today I watch the news with the look of the skeptic who has a question that remains:
How will the research in relation to vaccines? Both preventive as curative?
I know she has sent, but when the field is vaccination, long time is consumed until it reaches a large-scale study with non-positive people for HIV, with the addendum that you can not, just because applied a dose x the experimental vaccine, advise the research subject it to come out there and behave as "super man" or "Wonder Woman".
And after all, as is applied in terms of time, brains and MONEY for these studies?
This, to me, is the question that begs.
Lately it's all very cute and undetectable state stood at a level where the subject with an undetectable viral load would offer zero risk of contagion to / a parciero / a
My relationship with my wife, also HIV positive is kept in "Old Fashioned Way." With condoms.
And if I were a person who could not keep me faithful to domestic thalamus, for sure I would use the condom and think of tremendous irresponsibility going to the pulpit, to say "no activist" and shoot, the armored platform to square helpless a nonsense of these.
Advances are yea, and in effect.
But in terms of AIDS, which is a matter of life and death, the safer the better. Click here and read a very interesting article on AIDS prevention