High efficacy observed in the UK PPE study
The PPE to all participants of the PROUD study earlier
Posted in: 16 2014 October in AIDSMAP.
The Steering Committee * of the PROUD study on pre-exposure prophylaxis (PPE) in gay men in England today announced that participants who are currently in the postponed study group, who have not yet started PPE, will be called back to their clinics and will have the opportunity to start the EPP ahead of schedule. This is due to the efficacy observed in the study that exceeded the threshold determined for the continuation of the trial.
Although the exact efficacy observed in the study still awaiting outstanding analysis and monitoring of participants to be established, there are indications that have considerably exceeded the result that the researchers had originally anticipated.
In PROUD, 545 gay men at high risk of HIV infection were recruited from sexual health clinics 13 in London, Brighton, Manchester, Birmingham, Sheffield and York.
All participants received a kit with a common HIV test and sexually transmitted infections (STI), condoms, safer sex support, behavioral research and monitoring, and were randomized into two groups. One group received tenofovir + emtricitabine (Truvada) Immediately (the 'instant' group) while the other group so far received Truvada one year after the start of the study.
The purpose of this design is to check whether participants who know they are taking PPE will change their HIV risk behaviors (such as using condoms less or not using them at all) and, if so, whether this would reduce or beneficial effects of PrEP.
This study was done because some PEP critics predicted that PPE would have a negative overall effect: in August, Michael Weinstein Executive Director of the AIDS Healthcare Foundation, a foundation that fights AIDS, said: "We want the public to know that the increase "It is very important to know whether people like Weinstein are right or wrong and whether PPE will have a negative effect if people know they are taking the medication.
The PROUD pilot was not designed to determine the effectiveness of PPE itself. When it was designed it was believed that it would be necessary to do a large study with 5000 participants to reach the number of HIV infections required to determine a clear measure for the effectiveness of PPE in reducing (or not) virus infections in participants .
However, in April 2014, it became clear that the PPE offer attracted a subset of gay men characterized by a higher rate of risk of HIV infection than it had been originally taken into account when the size of the study group was calculated. This meant that the pilot study would be potentially able to produce a clear answer on the effectiveness, despite its smaller size. So organized a Data Monitoring Independent Committee (IDMC).
IDMCs have a privileged position in randomized study groups: They are the only people with access to unmasked data before the end of the study, and their role is to monitor the data for signs that the study should be discontinued. Criteria for disruption include: When it is clear that the intervention tested can cause harm, that the study will never arrive at a clear result (known as 'futility') or because the intervention is so beneficial that it would be unethical to deny it to others in the study.
The IDMC PROUD met three times and the third time, on 6 October, decided that the intervention was clearly beneficial; they concluded that the effectiveness of immediate PPE exceeded the threshold which was previously stipulated.
This threshold is not really effective; is less likely to be effective to allow the likely outcomes or, in technical terms, the lower limit of 95% confidence interval. In terms of the number of infections encountered, the observed efficacy is likely to be higher. The final difference is not clear until clinics have called the most participants as possible since there is no doubt there will be some early cases of HIV infection not detected in both groups. There are currently 130 people in the group who will still get delayed PEP.
Full results are expected in early next year.
The PROUD study was not stopped: He will continue because it is still important to find the long-term trends: Did the participants' adherence to PEP, which has been high, may fall over time? Do the levels of risk behaviors will continue without changes? Does drug resistance will exist to a significant extent? These are important questions to be answered and it is very likely that the British Health System (NHS) to want answered before making a decision regarding the administration of
This event provides opportunities for the study of other drugs or regimens as well, but above all, opens the opportunity to make a big impact on the HIV epidemic among gay men in the UK and elsewhere.
Dr Adrian Palfreeman, Vice President of the British HIV Association (BHIVA), said: "We were delighted with the news that we have made significant progress in efforts to prevent HIV in men who have sex with men, when the current transmission in the UK remains unacceptably high, and we look forward to seeing the results when they become available. The BHIVA, along with other stakeholders, are working with the British NHS to set a policy that considers future availability of pre-exposure prophylaxis, as well as existing to prevent infection within the NHS in future measurements.
* Gus Cairns is vice president of the PROUD study committee director.
Translation: Lilian Lamb
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