PrEP should be routinely offered now as part of sexual health services, says editorial
The results of the HIV pre-exposure prophylaxis (PrEP) study using the tenofovir daily dose plus emtricitabine (Truvada) from the PROUD study have now been published in the scientific journal The Lancet. PROUD, along with another randomized European PrEP study, Ipergay, demonstrated considerably higher levels of PrEP efficacy in preventing HIV infections than any previous study. The results of both studies were presented in February this year at the conference on retroviruses and opportunistic infections (CROI 2015).
There is little difference between the results in The Lancet and which would be presented at CROI but newspaper publishing is important to provide PrEP in Europe as both European agencies of medicines, the European Agency drug (EMA), which regulate the licensing drugs, and the European Centre for Disease Prevention and Control (ECDC), which issues public health recommendations, both require the publication of studies of newspaper to be included in their evidence.
There were subtle differences. A statistically significant change in behavior in PrEP men has been detected by researchers (an increase in the proportion of men who had high numbers of partners without a condom as the receptive partner) but on the other hand, is more clear than before no change the incidence of sexually transmitted infections (STIs), when men began to PrEP.
The efficacy of PrEP in PROUD remains at 86% (meaning, that is, PrEP prevented about 17 infections in each niche from 20 likely HIV infections that would otherwise have occurred), and the number of men needed to be treated with PrEP to prevent an HIV infection remains in 13. However, the lower limit of the confidence interval of 90% for the effectiveness of PrEP has moved up from 58 to 65: what this means is that there is a less of a possibility of contagion in a table of twenty contagion possibilities whenever the study was repeated, PrEP would become more than 65% effective.
Demography remains almost the same as those reported in April 2014 when recruitment was complete: 544 men were enrolled in clinical 13 sexual health in England: 275 were randomly assigned to take daily Truvada as PrEP immediately and 269 to wait a year before starting it.
Three HIV infections were observed in allocated men to start preparing immediately, but of these almost certainly contracted HIV before it started PrEP (he was tested HIV-positive in his second visit a month after the beginning), while others two had stopped taking PrEP months before contracting the AIDS virus.
There were also three men (not six as stated in the February aidsmap.com piece) who tested HIV-positive at their first clinical visit on the day they were receiving PrEP for the first time and should have contracted this at most 2-3 weeks before.
Two of the men who started PrEP while they already had HIV, including diagnosed on his second visit, had developed resistance to emtricitabine: no one developed resistance to tenofovir.
In contrast 20 (not as originally thought 19) men in the deferred arm contracted HIV during the year they were waiting for the onset of PrEP and this means that the annual HIV incidence observed slightly changed to 9% in the deferred arm and 1.2% in the immediate arm. The incidence of 9% seen in the deferred arm is very high; more or less seven times greater than 1,34% seen in homosexual men attending English sexual health clinics in 2012.
This underlines that the men who came forward or were referred to the PROUD were a highly selected group of gay men at higher risk.
Another fact supporting this is that 64 of the study participants had an STI diagnosed in the year before joining the study - an aggregate figure that has not been reported in BHIVA Spring 2014 conference when judgment based Demographics were presented (only the numbers individual been reported STD).
This means that there clearly was no increase in STIs in participants taking PrEP: 57 immediately and 50 arm in the deferred arm were, respectively, an STD diagnosed during the study, but because men in the immediate arm had more tests, after adjustment this is just a difference in 7pessoas, which is not statistically significant. In particular, after adjustment there was no difference at all in the third of the men who took a rectal bacterial STDs, the most sensitive indicator of being the receptive partner bareback anal sex, which is 17 times riskier than being the active partner when it treat HIV infection.
There was a statistically significant difference in behavior. During the study, a greater proportion of participants in the immediate arm PrEP reported receptive anal sex without a condom with ten or more partners in the three months preceding that participants in the deferred arm (21 against 12, 0,03 probability). However when this was an increase over the baseline did not translate into more STDs and the number of partners with whom participants had anal sex did not change.
The researchers conclude: "Our results strongly support the addition of preparation for the standard of prevention for men who have sex with men at risk of HIV infection." M an accompanying editorial, PrEP researcher Ken Fenway Health Mayer in Boston, USA and Chris Beyrer, president of the International AIDS Society, commented: "The results of PROUD suggest that the pragmatic implementation of preparation should be part of any relevant primary strategy HIV prevention ... PrEP should be part of the range of services offered by any clinical program relates to sexual health. Just the time for preventive speculation: HIV prevention services should be expanded around the world, providing PrEP routinely for those who could benefit. "
Published: 14 September 2015
Translated and revised from the original in PROUD PrEP study results published by Claudio Souza on the 17 night of September of 2015
McCormack S et al. Pre-exposure prophylaxis to Prevent the acquisition of HIV-infection 1 (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomized trial. The Lancet, early online publication. DOI: http://dx.doi.org/10.1016/S0140-6736(15)00056-2. 2015.
Mayer KH and Beyrer C. Antiretroviral chemoprophylaxis: PROUD and pragmatism. The Lancet, early online publication. DOI: http://dx.doi.org/10.1016/S0140-6736(15)00153-1. 2015.