It's one of the trials whose results are the most anticipated; however they do not come up to the desired expectations. iPrEx is the first trial of the treatment of AIDS prevention in men and transgenders (male to female) who have sex with other men.
A 44% DROP IN THE RISK OF INFECTION
The 2499 participants (in six different countries) included in iPrEx have received every day during the time of the trial either a placebo or Truvada, an antiretroviral drug, already on the market. During the time of the trial, 36 patients in the Truvada group have become seropositive as opposed to 64 in the placebo group. This suggests a 44% drop in the occurrence of HIV due to the use of the drug, a product of the Gilead laboratory. The authors, who publish the first results of the trial in the November 23 issue of the New England Journal of Medicine, stressed that this drop is very significant but not as high as what was expected during the preparation of the trial. Our sources tell us that the investigators counted on the drop being nearer 55 to 60%.
BAD ADHERENCE TO TREATMENT
A remarkable fact is that even if the patients said that they were using Truvada every day, the exposure to the drug was lower as far as the biological measures were concerned. It's in part this bad adherence to the treatment that might explain such a low result of protection compared to the expectations. The treatment has been more often rediscovered in the seronegative patients than in the seropositive in the Truvada group. There is, therefore, the authors of the article of NEJM tell us, a very strong correlation between the detectability of the drug and the prophylactic effect. In its press release, made public this Tuesday morning, the National Agency of Research on AIDS (NARA) explains: «When the drug is detectable in the blood, risk reduction is at 92%, suggesting the fundamental role of adherence to the treatment.» However, they don't know yet why the participants weren't taking their medication.
AIDES IS PLEASED BUT IS CAREFUL AT THE SAME TIME
If the AIDES Association has quickly reacted by congratulating itself on these results, it is very careful, saying: «Although this result is a hopeful sign of good news, we are far from getting rid of Prep in real life.» Furthermore, this strategy, although interesting, has some drawbacks: «the constraint of a continuing treatment for people who are seronegative poses some problems of acceptance, tolerance in the long run, and cost.» And for them to add this warning: «In the meantime, AIDES appeals to the greatest caution concerning the wild use of ARV [antiretroviral, ndlr] by people who are seronegative in an effort to protect themselves against HIV.»
A FRENCH TRIAL IN PREPARATION
These results are going to be analyzed with a magnifying glass by the French teams who are working on a trial of AIDS prophylaxis through the use of antiretrovirals, a trial that we have already mentioned on Yagg in a chat with Hugues Fischer of Act Up–Paris and Francois Berdougo of the TRT-5. The pilot study, an effort of Pr Jean-Michel Molina and paid for by the National Agency of Research on AIDS (NARA), proposes a different plan from that of iPrEx: instead of taking a dose of the drug continuously, the participants in the Franco-Quebecois trial would take it two hours at the latest before the sexual exposure at risk and would take another dose 24 hours after the first dose. If the exposure is prolonged, the participant would continue to take the dose every twenty-four hours. This trial is very expensive, costing several million euros. NARA is now reflecting on a better plan to launch an experimental phase of its own trial: «which will come out no doubt in the course of the first semester of 2011», according to Jean-Francois Delfraissy, its director.
[Update, 14h10] The inter-associative group TRT-5 is participating in the detailed and elaborate work of the study in the planning stage and explains that in view of the results of the iPrEx trial, «TRT-5 will continue its work […] so as particularly to watch over the interests and rights of future participants.»
[Update, 16h58] Act Up-Paris has reacted in turn to the publication of the results of this trial,saying: «It's a very encouraging result for the researchers. It simply shows the significance of this technique of biomedical prevention.» The association, however, reminds everyone that «the use of condoms, simple, less expensive, and available, remains the only sure way to protect against HIV.»
Translated by Guy Estinvil:
Guy Estinvil was born on the beautiful island of Haiti. He is the author of In love with a Straight Man: A Collection of Gay Short Stories.
Mr. Estinvil attended college in the United States and has three Masters of Arts degrees—one in Philosophy, another one in Education, and a third in French Literature. He also held a Bachelor of Arts degree in French Literature.
Mr. Estinvil came to the United States at a very early age and has resided here ever since. He has worked with the Chicago Board of Education as a teacher and is currently on sabbatical leave while honing his writing skills and working diligently on his novels.
The original article in French, on Yagg: VIH: Résultats mitigés pour le premier essai de traitement pré-exposition chez les gays
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