High efficacy observed in the British PrEP study

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LGBT Awareness Day gives LGBT November 2014 PREP Gender Sexuality Healthy Living
no aids conceptGus Cairns Publicado em: 16 de outubro 2014 O Comitê Diretor* do estudo PROUD sobre a profilaxia pré-exposição (PrEP) em homens gays na Inglaterra anunciou hoje que os participantes que estão atualmente no grupo adiado do estudo, que ainda não começaram a PrEP, serão chamados de volta às suas clínicas e terão a oportunidade de iniciarem a PrEP antes do previsto. Isto se dá pela eficácia observada no estudo que ultrapassou o limiar determinado para a continuação do ensaio. Apesar da exata eficácia observada no estudo ainda estar aguardando análises pendentes e o acompanhamento dos participantes para ser estabelecida, há indicações de que tenha ultrapassado consideravelmente o resultado que os pesquisadores haviam antecipado originalmente. No PROUD, 545 homens gays com alto risco de infecção de HIV foram recrutados por 13 clínicas de saúde sexual em Londres, Brighton, Manchester, Birmingham, Sheffield e York. Todos os participantes receberam um kit com teste comum de HIV e infecções sexualmente transmissíveis (IST), Condoms, support for safer sex, behavioral research and monitoring, and were randomly separated into two groups. One group received tenofovir + emtricitabine (Truvada) immediately (the 'immediate group') while the other group has so far received Truvada one year after the study began. The purpose of this design is to see if participants who know they are taking PrEP will change their HIV risk behaviors (such as using condoms less or not at all) and, if so, whether it would reduce or nullify beneficial effects of PrEP. This study was done because some critics of PrEP predicted that PrEP will have a negative global effect: in August, Michael Weinstein Executive Director of AIDS Healthcare Foundation, the AIDS Foundation, said: “We want the public to know that the widespread increase in government-sanctioned PrEP seems to be a real disaster.” 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 the medication. The PROUD pilot was not designed to determine the effectiveness of PrEP itself. When it was designed, it was believed that it would be necessary to conduct a large study with 5000 participants to arrive at the number of HIV infections required to determine a clear measure for the effectiveness of PrEP in reducing (or not) virus infections in participants. However, in April 2014, it became clear that the PrEP offering attracted a subset of gay men characterized by a higher rate of risk of HIV infection than what had been taken into account originally when the size of the study group was calculated. This meant that a pilot study would potentially be able to produce a clear answer about effectiveness, despite its smaller size. For this reason, an Independent Data Monitoring Committee (IDMC) was organized. 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 stopped. Criteria for interruption include: when it is clear that the tested intervention is likely to cause harm, that the study will never reach a clear outcome (known as 'futility') or because the intervention is so beneficial that it would be unethical to deny it to others in the study. PROUD IDMC met three times and the third time on October 6 decided that the intervention was clearly beneficial; they concluded that the efficacy of immediate PrEP exceeded the threshold that had previously been stipulated. This threshold will not be actual effectiveness; it is the least possible probability of effectiveness that allows the likely results or, in technical terms, the lower limit of 95% confidence interval. In terms of the number of infections found, the observed effectiveness is likely to be greater. The final difference will not be clear until clinics have called in as many participants as possible as there is no doubt that there will be some previous cases of HIV infection undetected in both groups. There are currently 130 people in the deferred group who are yet to receive PrEP. Full results are expected in early next year. The PROUD study was not interrupted: It will continue because it is still important to find long-term trends: Will the participants' adherence to PrEP, which has been high, fall over time? Will levels of risky behavior continue to change? 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 want them answered before making a decision on the administration of PrEP. 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. O Dr Adrian Palfreeman, Vice Presidente da Associação Britânica para o HIV (BHIVA), disse: “Ficamos felizes com a notícia de que fizemos um progresso significante nos esforços de prevenir o HIV em homens que têm relações sexuais com outros homens, quando a atual transmissão no Reino Unido permanece inaceitavelmente alta, e ansiamos para ver os resultados quando estes estiverem disponíveis. BHIVA, together with other stakeholders, are working with the British NHS to define a policy that considers future availability of pre-exposure prophylaxis, as well as existing measures to prevent infection, under the NHS in the future. * Gus Cairns is vice president of the PROUD study committee director. Translation: Lilian Lamb http://www.linkedin.com/in/liliancordeirotradutora Published in 14 / 10 / 2014 no Aidsmap

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