High efficacy observed in the UK study on PEP
Should be offered toPPEall study participants PROUD earlierGus Cairns Posted in: 16 October 2014 in AIDSMAP.
* The Steering Committee of the PROUD study of pre-exposure prophylaxis (PPE) in gay men in England today announced that participants who are currently in the delayed group study, which has not started PPE, will be called back to their clinics and have the opportunity to initiate PEP 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 pending awaiting analysis and monitoring of participants to be established, there are indications that the results have considerably exceeded what 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 common test for HIV and sexually transmitted infections (STIs), condoms, support for safer sex, behavioral research and monitoring, and were separated into two groups randomly. 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 goal of this design is to verify that the participants who know they are taking the PPE will change their risk behaviors for HIV (using condoms less or no use at all) and, if so, whether this would reduce or nullify the beneficial effects of Prep.
This study was done because some critics predicted that the PPE PPE will 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 widespread of PPE government-sanctioned appears to be a real disaster. "It is very important to know if people like Weinstein are right or wrong, and if PPE will have a negative effect if people know they are taking the medication.
The pilot PROUD was not designed to determine the effectiveness of the PPE itself. When it was designed, it was believed that it would be necessary to do a large study with 5000 participants to arrive at the number of HIV infections required to determine a clear measure of the effectiveness of PPEna reduction (or not) of HIV infections in participants .
However, in April 2014, it became clear that the supply of PPE attracted a subset characterized by a higher rate of risk of HIV infection in gay men than they had originally been taken into consideration when the size of the study group was calculated. This meant that the pilot study would be potentially able to produce a clear answer about the effectiveness, although its size is smaller. So we organized an Independent Data Monitoring Committee (IDMC).
The IDMC have a privileged position in groups of randomized trials: They are the only people with access to information not masked before the end of the study, and their role is to monitor the data to see if there are signs that the study should be stopped. The criteria for discontinuation include: when it becomes clear that the tested intervention may cause harm, the study never reach a clear result (known as 'futility') or because the intervention is beneficial as it would be unethical to deny it to others in the study.
The IDMC PROUD met three times and the third time, on October 6 decided that intervention was clearly beneficial; they concluded that the effectiveness of PPE immediately surpassed the threshold that had been 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 has not been discontinued: It will continue because it is still important to find the long-term trends: Does the adherence of participants to PPE, which has been high, may fall over time? Will the levels of risk behavior continue unchanged? Will drug resistance exist to a significant extent? These are important questions to be answered and it is very likely that the British Health System (NHS) will respond to them before making the decision on the administration of this event opens opportunities for the study of other drugs or regimens as well, but most of all : opens up the opportunity to have a major 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.
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